Interesting Links on Anthrax Vaccine Health Concerns

[Guest guest]

Rainbow Rising

February 16, 2005

Dear Friends and Fellow Veterans,

THIS DOCUMENT IS A NEW ACCUMULATION OF WEB LINKS ABOUT ANTHRAX

VACCINE AND ENVIRONMENTAL HAZARDS OF THE FIRST GULF WAR.

PETITION TO STOP HUMAN TESTING ON SOLDIERS

http://www.petitiononline.com/fd1950/

Dr. Pamela Asa's Response To Critics

http://www.avip2001.net/OfficialDocuments_files/DrAsa.htm

Homeland Security Policy Group

http://search./search?p=Dr.+Pamela+Asa & btn=Search & ei=UTF-

8 & fr=sbc-web & b=21

VACCINE A HOMEPAGE - A BOOK BY CNN SPECIAL REPORTER GARY MATSUMOTO

http://www.vaccine-a.com/

Testimony by Ross Perot on Govt. Reform

http://www.hspig.org/ipw-web/bulletin/bb/viewtopic.php?

t=2102 & highlight=ross+perot

Autoimmune Technologies ( Dr. Pamela Asa, Garry. ) Tulane

University

SQUALENE ANTIBODY TESTING FOR GULF WAR ILLNESS

http://www.autoimmune.com/

Female Sgt. Dead From Anthrax Vaccine

http://www.gulfwarvets.com/dead3.htm

COLO. WOMAN WAGING WAR ON ANTHRAX VACCINE

http://www.denverpost.com/Stories/0,1413,36~53~2535720,00.html

Expert : Anthrax Vaccines Not Proven

http://www.gulfwarvets.com/anthrax11.htm

Medical examiner links death to anthrax vaccine BioPort

officials shocked by word

Of employees autopsy :

http://www.gulfwarvets.com/anthrax11.htm

ARE VACCINES CAUSING MORE ILLNESS THAN THEY ARE CURING?

http://www.gulfwarvets.com/vexing.htm

ADDITIVE FOUND IN ANTHRAX VACCINES

http://www.gulfwarvets.com/additive.htm

SHAY'S REPORT FROM 2000

http://www.gulfwarvets.com/shays.htm

WALTER REED SQUALENE STUDY :

http://deploymentlink.osd.mil/deploymed/projects/DoD100.shtml

SQUALENE CAN PRODUCE ARTHRITIS IN RATS

http://www.nccn.net/~wwithin/squalene.pdf

Lot Numbers and Locations Where Squalene Laced Anthrax Vaccine Was

Given ( From Matsumoto's book site )

http://forums.perseusbooksgroup.com/phpBB2/viewtopic.php?

t=59 & start=90 & sid=7ea694230306feeb96914c695ffbe753

Health Impact Study of Gulf War Illness

http://www.cdc.gov/nceh/publications/gulfwar/report.pdf

MOD website referring to Gulf War Illnesses:

http://www.mod.uk/issues/gulfwar/index.html

Statement by the Ministry of Defence:

http://www.mod.uk/issues/gulfwar/info/medical/bwa.htm

King's Centre for Military Health Research:

http://www.kcl.ac.uk/kcmhr

Problems With Vaccines In General

http://www.anthraxvaccine.org/vaccinearticles.htm

Induction and Detection of Antibodies to Squalene

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?

cmd=Retrieve & db=PubMed & list_uids=11042279 & dopt=Abstract

Statement of Congressman Jack Metcalf ( 2000 )

http://www.autoimmune.com/SqualeneInVaccine.html

American Gulf War Veterans Association www.gulfwarvets.com/

National Gulf War Resource Center: www.ngwrc.org/

Desert Storm.Com: http://www.desert-storm.com/

New Hampshire Gulf War Syndrome Association: www.nhgws.org/index.htm

Lots of documents http://Odssa-lodssa/

The Reigle Report: What veterans have been exposed to and a look at

the U.S. government's involvement:

www.gulfwarvets.com/arison/banking.htm

MILVACS: http://www.milvacs.org/Sick/Suggestions.cfm

You may view the archives of at:

http://onelist.com/archive/ Below is a 'must read' very

informative and professional

http://mars.healthnet.org/MGS/V5N2Anthrax.html

Man Claims Anthrax Vaccine Almost Killed Him : THE STORY OF BRAD

PRIESTER http://www.firstcoastnews.com/news/local/news-article.aspx?

storyid=27100

Man Claims Anthrax Vaccine Almost Killed Him

By Tiani

First Coast News

HOW THE ANTHRAX VACCINE AFFECTED Sr. Airman J. Colosimo

http://members.tripod.com/tomcolosimo/id27.htm

*********************************************************************

*********************************************************

VIDEO STORY LINKS

Air Force Sgt. Claims Anthrax Vaccine Nearly Killed Him ( video

link )

http://ww2.abc11tv.com/global/video/popup/pop_index.asp?

LaunchPageAdTag=News & ClipID1=351994 & h1=VIDEO%3A%20Eyewitness%20News%

20Investigates%3A%20Air%20Force%20Sergeant%20Says%20Anthrax%20Shot%

20Nearly%20Killed%20Him & vt1=v & at1=News%20-%20Special%

20Coverage & d1=298933 & activePane=playlist & playerVersion=9 & rnd=8705526

CBS NEWS LINKS PAGE :

http://search.atomz.com/search/?sp-q=anthrax+vaccine+video & sp-k= & sp-

a=sp1001c63c & sp-p=all & sp-f=ISO-8859-1 & sp-s=doc_date

ALSO CLICK ON THE VIDEO TRAILER BEYOND TREASON @

www.gulfwarvets.com

Necessary Vaccine or Betrayal : Article From Winds of

www.windsofchange.net/archives/006063.php

December 23, 2004

Necessary Anthrax Vaccinations, or Betrayal?

by Joe Katzman at December 23, 2004 08:06 AM

Yesterday's story about Den Beste's degenerative disease, and

the methods he used to keep blogging, was unutterably sad (great

comment, T.J. Madison). It's past time I addressed another story - a

chilling story - about degenerative disease. Kudos to Ron of

HSPIG for bringing it to my attention.

What if " Gulf War Syndrome " is real (contrary view here), and it and

other degenerative diseases showing up in U.S. veterans were the

result of a " second generation " U.S. government vaccine against

anthrax administered to troops without informed consent in 1991?

The U.S. military is about to restart that vaccine program (see also

this oficial .MIL site), despite that experience and despite a long

history of medical understanding that a key vaccine component called

squalene was a dangerous catalyst for degenerative auto-immune

diseases.

This is a story you need to read.

Award-winning journalist Matsumoto has done a lot of research

on this topic, and written a book whose conclusions are summarized

here. Some excerpts follow.

From the book site:

" For the past 17 years, the Army has been working on a new anthrax

vaccine that contains no anthrax, and is made with an ingredient

that it does not want to name. That ingredient is called squalene.

Squalene is an oil. Without it, the new vaccine will not work any

better than the old one. In fact, for all intents and purposes,

without squalene the new vaccine is the old one. What makes squalene

so important is its proven ability to stimulate a strong response

from the immune system. That is something the main ingredient of the

new vaccine, the now ultra-purified protein secreted by the anthrax

microbe—recombinant protective antigen—cannot do by itself. It is

too weak.

Immunologists have a special name for substances used to boost

feeble vaccines. They are called adjuvants. Adjuvants are arguably

the most extensively researched pharmaceutical product in the last

quarter century that you never heard of. I have used the word

adjuvant three times in this paragraph so far and that is probably

three times more than you have ever seen it in print before. This is

partly because the most effective adjuvants, those formulated with

oils, are too dangerous for human use. That is squalene's other

proven ability, causing incurable disease.... As early as the 1930s,

these oil additives were notorious for inducing illness. By the

1950s, scientists knew these illnesses were specifically autoimmune.

Today that is their chief use in research—inducing disease instead

of preventing it. Scientists studying autoimmune disease cannot wait

around for its spontaneous appearance in a lab animal; they inject

it with Freund's Complete Adjuvant to reproduce autoimmunity on

demand. "

Auto-immunity? Den Beste could give the full explanation, but

here's a short one:

" Autoimmune diseases are chronic and progressively debilitating

ailments; some, like multiple sclerosis and lupus, can be fatal.

They occur when the immune system loses its ability to distinguish

what is " self " from what is foreign. Under normal circumstances,

your immune system ignores the constituents of your own body;

immunologists call this " tolerance. " But if tolerance is broken, the

immune system turns relentlessly self-destructive, attacking the

body it is supposed to defend. "

A vaccine using such substances? " How the hell could this happen, "

you may ask. A combination of reasons, it seems - some of which are

legitimate and potentially defensible decisions, some that are less

so, and some that don't strike me as defensible in any context.

Let's start with the attractive abilities of adjuvants:

" Despite their dangers, oil adjuvants have come to exert an

irresistible, almost magical allure on researchers. If they could

truly stimulate the immune system safely, oil additives could help

defend mankind from diseases like malaria and HIV. For germs such as

these, no one dared make a classic vaccine - the kind made from the

germ itself - for fear of accidentally infecting someone with an

incurable, if not fatal infection. By splicing off just little bit

of such a germ - not enough to make anyone sick - and combining that

shard with an adjuvant, scientists hoped to protect people from

lethal microbes. If they could do it for HIV, they reasoned, they

could do it for any germ in creation. This siren song was so

powerful that it did more than induce researchers to indulge in

cynical risk/benefit calculations; in some cases, it made them

forget the risks altogether. "

Over to 1991 on the eve of Gulf War 1, as the Pentagon weighed the

relative risks:

" At the start of Gulf War One, our military leaders believed anthrax

attacks against the troops on the ground were a real and potentially

devastating possibility. When they looked in their pantry of

vaccines, they found only a few doses of an anthrax vaccine that

takes six shots over a long period to instill immunity to attack.

Further, the pantry had no battlefield detection devices to even

know if soldiers had been exposed. Casualties could be very high,

the deaths would be ghastly, and press cameras were always at the

ready. The military leadership ordered subordinates to find a

solution.

Coincidentally, some military and civilian researchers had been

working on a new, second generation vaccine for anthrax. One or two

shots would do it. Immunity developed quickly and strongly. Soldiers

would live to fight another day. It was safer to manufacture since

whole anthrax particles were not used, only bits and pieces.... "

It's not such an obvious decision when looked at in that light, but

some aspects including the lack of informed consent are absolutely

inexcusable. There was also old research not recalled from a similar

situation:

" By all accounts, the great Spanish Flu pandemic of 1918 wasn't

really Spanish at all. It was American. In fact, it was an Army flu.

The first victim, the " index patient, " was an Army private named

Albert Gitchell who worked as a cook at the Army's Camp Funston on

the vast Fort Riley military reservation in Kansas. It is believed

that U.S. troops heading to Europe brought this flu with them.

Before it was over, more than 20 MILLION people had died of

influenza around the world—the deadliest natural disaster in world

history. Army scientists wanted to prevent another global killer

from emerging from an Army post where new recruits might become an

unintended hatchery for some vicious new flu strain that once again

could wipe out millions of people. Trying out a new oil additive on

troops seemed like a relatively modest risk in comparison to the

benefits of a better flu vaccine.

.....The Armed Forces Epidemiological Board (AFEB), which would be

sponsor a large number of the experiments conducted on military

personnel, would later recommend the injecting an experimental flu

vaccine containing oil into every man and woman in the U.S. military

without their informed consent. The risk of an outbreak of killer

flu seemed too great to do otherwise. To run this experiment, the

Army would contract none other than Jonas Salk..... "

Nor was this the only instance.

" Long before the last study was completed, AFEB proposed the

adoption of an experimental flu vaccine with oil for everyone in the

military. In 1963 and 1964, AFEB recommended injecting every man and

woman in the armed forces with the new vaccine. The board also

recommended that Department of Defense also commence studies with

oil added to tetanus and diphtheria toxoids, and polio vaccines....

Here is what they were not telling anybody. By 1964, the year when

everyone in the military was supposed to get immunized with an oil-

boosted influenza vaccine, the Army already knew the risks this

vaccine presented for a very specific type of illness.....

autoimmune diseases.

The final study on the Fort Dix [JK: 1951] troopers had data that

none of the previous ones had: autopsy results..... a " significant

excess of deaths " in soldiers given the oil-boosted vaccine, which

the investigators related to " ill-defined vascular lesions of the

central nervous system. " They attributed this fact to the greater

number of autopsies available for the soldiers given the oil-boosted

vaccine. But there were hints of a problem with autoimmunity. Ten

percent of the soldiers studied, who were injected with the oil-

boosted vaccine, developed a " collagen disease, " which is a term

doctors used to use interchangeably with autoimmune disease. Still,

the number of patients in this study was too low to extrapolate any

reliable conclusions from the data. That did not prevent government

and military doctors from doing just that. They concluded that the

oily flu vaccine was safe. Nevertheless, what the government then

did not do was telling. The FDA never licensed the vaccine, or the

oil adjuvant, for human use. "

Fast forward to 1991. Over to Marilyn 's summary:

" Someone had forgotten or ignored solid research showing squalene

was very bad news for the lab animals injected with it. And now the

same symptoms were showing up in veterans. And only veterans who got

the shot got sick, whether or not they were exposed to ground

conditions in Iraq. Some sick vets had never even left the U.S. It

was the vaccine that was the common denominator.

In the meantime, the government and the manufacturer of squalene

were moving forward with plans to develop other vaccines using the

new wonder ingredient... "

One of the first strong indicators that something was amiss was data

published in the February 2000 and August 2002 issues of

Experimental and Molecular Pathology, which strongly suggested that

Gulf War Syndrome is caused by a vaccine contaminated with squalene.

Matsumoto has picked up the ball, and brought together information

from many sources to move this story forward.

This is a story of corners cut and forced decisions amidst the

pressures of war, of crippling side effects for some U.S. troops,

and of recent moves to restart this vaccination program that are

hard to see as anything but recklessness bordering on betrayal if

Matsumoto's charges hold up.

Note my use of the word " if " . There may well have been exaggerated

stories in the past along similar lines, most notably in relation to

Agent Orange. The reality of Gulf War Syndrome itself is open to

debate among reasonable people. Nevertheless, there's a lot of

research here whose conclusions seem to fit, and Matsumoto has said

that he welcomes close scrutiny.

I say, bring it on. I don't have the necessary level of medical

expertise to full evaluate this story... but I'd like to hear from

people who do.

Our troops deserve the truth here - and the unalterable right of

informed consent. They are free citizens serving by choice, not

guinea pigs. If Matsumoto is right, that's exactly how they're being

treated. And that would be truly inexcusable.

UPDATE: Phil (author of Intel Dump) emails me to note that

Jon Cohen penned a very critical review of Mastumoto's book in Slate

last month. It's an excellent summation of the other side of the

argument.

GOVERNMENT TRANSCRIPTS ADMITTING USE OF SQUALENE BEFORE & AFTER 1ST

GULF WAR

_____________________________________________________________________

_________________________________________________

Gulf War Illnesses: Questions About the Presence of Squalene

Antibodies

in Veterans Can Be Resolved (Letter Report, 03/29/99, GAO/NSIAD-99-

5).

Pursuant to a congressional request, GAO investigated the reports

that

the blood samples of some ill Gulf War-era veterans contained

antibodies

for squalene, a component of adjuvant formulations used in some

experimental vaccines but not in any licensed vaccines, focusing on

whether: (1) the Department of Defense (DOD) or the National

Institutes

of Health (NIH) performed or sponsored research using squalene; (2)

DOD

considered using adjuvant formulations in vaccines administered to

Gulf

War-era veterans; and (3) any research has detected the presence of

squalene in ill Gulf War-era veterans.

GAO noted that: (1) prior to and following the Gulf War, DOD and NIH

used adjuvant formulations of squalene to perform research on the

development of more effective vaccines; (2) DOD officials stated they

considered, but decided against, using vaccines with experimental

adjuvant formulations during the Gulf War; (3) according to

independent

researchers, as part of their treatment of sick Gulf War-era

veterans,

they developed and administered a test, referred to as an assay, that

detected antibodies to squalene in the blood of sick Gulf War-era

veterans; (4) the researchers stated this assay is similar to a

standard

assay used in other types of research; (5) as of March 1999, the

research has been subjected to peer review, but had not been

published;

(6) this process is often lengthy, sometimes taking a year or more;

(7)

according to DOD officials, DOD could develop such an assay

inexpensively and test it on a sample of sick Gulf War-era veterans;

(8)

however, DOD plans to wait until the research is published before

deciding whether to conduct testing; and (9) given the researchers'

assessment, DOD's comments about the feasibility of developing an

assay

and that veterans have been waiting for the past 7 years for answers

on

the nature and origin of their illnesses, DOD has the opportunity to

expand on the research already performed.

--------------------------- Indexing Terms --------------------------

---

REPORTNUM: NSIAD-99-5

TITLE: Gulf War Illnesses: Questions About the Presence of

Squalene Antibodies in Veterans Can Be Resolved

DATE: 03/29/99

SUBJECT: Veterans

Research reports

Medical research

Disease detection or diagnosis

Testing

IDENTIFIER: Persian Gulf War

NS99005.book GAO United States General Accounting Office

Report to the Honorable Jack Metcalf House of Representatives

March 1999 GULF WAR ILLNESSES

Questions About the Presence of Squalene Antibodies in Veterans

Can Be Resolved

GAO/NSIAD-99-5

GAO/NSIAD-99-5

United States General Accounting Office Washington, D. C. 20548

Lett er

Page 1 GAO/NSIAD-99-5 Gulf War Illnesses

GAO

National Security and International Affairs Division Lett er

B-278779 March 29, 1999 The Honorable Jack Metcalf House of

Representatives

Dear Mr. Metcalf: You expressed concern about reports that the

blood samples of some ill Gulf War- era veterans contained

antibodies for squalene 1 a component of adjuvant formulations

used in some experimental vaccines but not in any licensed

vaccines. 2 As requested, we identified whether (1) the Department

of Defense (DOD) or the National Institutes of Health (NIH)

performed or sponsored research using squalene, (2) DOD considered

using adjuvant formulations in vaccines administered to Gulf War-

era veterans, and (3) any research has detected the presence of

squalene in ill Gulf War- era veterans.

Results in Brief Prior to and following the Gulf War, DOD and NIH

used adjuvant formulations of squalene to perform research on the

development of more effective vaccines. DOD officials stated they

considered, but decided against, using vaccines with experimental

adjuvant formulations during the Gulf War. According to

independent researchers, as part of their treatment of sick Gulf

War- era veterans, they developed and administered a test,

referred to as an assay, that detected antibodies to squalene in

the blood of sick Gulf War- era veterans. The researchers stated

this assay is similar to a standard assay used in other types of

research. As of March 1999, the research had been subjected to

peer review, but had not been published. This process is often

lengthy, sometimes taking a year or more. According to DOD

officials, DOD could develop such an assay inexpensively and test

it on a sample of sick Gulf War- era veterans. However, DOD plans

to wait until the research is published before deciding whether to

conduct testing. Given the researchers' assessment, DOD's comments

about the feasibility

of developing an assay and that veterans have been waiting for the

past 1 Squalene is found in shark liver oil, some vegetable oils,

and the human liver and can also be manufactured through chemical

engineering. Squalane is the hydrogenated form of squalene. When

we use the term squalene by itself, it refers to both squalane and

squalene. 2 An adjuvant is a substance incorporated in a vaccine

to accelerate, enhance, or prolong a specific immune response. An

antigen is a substance that stimulates production of an antibody.

Neither squalane or squalene is a complete adjuvant by itself.

Both serve as vehicles in which adjuvant formulations and vaccine

antigens can be mixed and delivered.

B-278779 Page 2 GAO/NSIAD-99-5 Gulf War Illnesses

7 years for answers on the nature and origin of their illnesses,

DOD has the opportunity now to expand on the research already

performed.

Background Many of the approximately 700,000 veterans of the Gulf

War have reported health problems. Some fear that their illnesses

might be due to exposure to chemicals, pesticides, and other

agents used during the war, including

vaccines administered to protect them against biological warfare

agents. Questions about vaccine adjuvant formulations were raised

to DOD in June 1994. At that time, an immunologist from the

private sector notified the

Defense Science Board that some symptoms being reported by Gulf

War- era veterans were very similar to those of her patients with

autoimmune diseases. These patients had a range of symptoms

affecting more than one of the body systems and the immunologist

believed they were associated with exposure to vaccine adjuvant

formulations. In October 1995, DOD, before a meeting of the

Presidential Advisory Commission on Gulf War illnesses, dismissed

this hypothesis on the grounds that it had administered only

vaccines with aluminum salts as adjuvants. In November 1996 and

again in 1997, the immunologist notified DOD, based on independent

research, that she had found antibodies to squalene in the blood

of a few sick veterans who had served in the military during the

Gulf War. However, DOD has not responded to these findings.

According to the researcher, she continues to be willing to

discuss the

research with DOD. To date, aluminum hydroxide is the only

adjuvant used in vaccines licensed by the Food and Drug

Administration (FDA) in the United States. While widely considered

to be safe, this adjuvant provides only a limited boost in the

immune response, and researchers have long emphasized the critical

need for new, more effective adjuvant formulations. According to

the National Institute of Allergy and Infectious Diseases (NIAID),

the branch of NIH that sponsors most of its vaccine- related

research, a new generation of novel adjuvant formulations are

being developed. These formulations are

intended to enhance and optimize immune responses to vaccines;

enable easier delivery of antigens, and reduce the amount of

antigen and the number of immunizations required for protective

immunization. Squalene is a common component of these new

formulations. As with all drugs and biological products, the

absolute safety of adjuvant formulations can never

B-278779 Page 3 GAO/NSIAD-99-5 Gulf War Illnesses

be guaranteed. 3 Safety concerns have been cited 4 regarding the

use of novel adjuvant formulations in vaccines, including

squalene, and the associated adverse reactions. 5 It has also been

suggested that the safety of vaccines containing these

formulations must be evaluated in conservative ways. 6

DOD and NIH Performed and Sponsored Research With Squalene

DOD and NIAID officials reported that, to help develop more

effective vaccines, they conducted research using adjuvant

formulations with squalene. In all, they performed or sponsored 28

clinical trials on vaccines using adjuvant formulations with

squalene, and 1,749 human subjects participated in these trials.

Prior to the Gulf War, both organizations were devising ways to

induce a rapid response to several vaccines using adjuvant

formulations with squalene. DOD officials stated that they

considered, but

decided against using vaccines with adjuvant formulations

including those with squalene to protect Gulf War troops.

DOD Research Between 1988 and 1998, DOD sponsored 101 clinical

trials on vaccines as part of a process required by FDA for

licensing investigational new drugs (IND). At least 21 of these

trials involved vaccines with adjuvant formulations, and 5 of

these 21 involved adjuvant formulations containing

squalene. These formulations were available from U. S. firms. 7

(See app. I for specific information on these firms and the

development of adjuvant formulations with squalene.) In the five

trials involving squalene, 572 human subjects volunteered and

participated. Of the five trials, two began

before the Gulf War. DOD officials could not confirm whether any

of the 3 J. L. Bussiere et al., " Preclinical Safety Assessment

Considerations in Vaccine Development " In , M. F. and

Newman, M. J. (Eds.) (1995). Vaccine Design: The Subunit and

Adjuvant Approach (New York: Plenum Press), pp. 61- 75. 4

Goldenthal, K. L. et al., " Safety Evaluation of Vaccine Adjuvants:

National ative Vaccine Development Meeting Working Group, "

AIDS Research and Human Retroviruses, vol. 9 (1993), pp. S47- S51.

Lorentzen, J. C. Identification of Arthritogenic Adjuvants of Self

and Foreign Origin. Scandinavian Journal of Immunology, vol. 49

(1999), pp. 45- 50. 5 Adverse reactions are local or systemic.

Local reactions include pain and swelling at the injection site.

Systemic reactions include fevers and toxicity of organs and

systems. 6 M. F. and M. J. Newman, Vaccine Design: The

Subunit and Adjuvant Approach (New York: Plenum Press, 1995) 7

This information was derived from DOD data submitted to FDA and

may not include cooperative research efforts with others.

B-278779 Page 4 GAO/NSIAD-99-5 Gulf War Illnesses

volunteers in studies that DOD sponsored had deployed to the Gulf

War. The five trials are described as follows: In April 1988,

DOD's first clinical trial of an experimental malaria vaccine with

an adjuvant containing squalene was approved, 8 but according to

DOD, doses were actually administered from June 1989 to January

1990. Five volunteers were given the vaccine. In August 1990,

another trial of the malaria vaccine was approved, using

the same adjuvant with squalene on 12 volunteers. 9 In 1994, DOD

began another study on a malaria vaccine containing an adjuvant

with squalene. 10 Both 110 experimental subjects and 11 control

subjects were given the adjuvant. An additional arm of the study,

using human subjects from Gambia, was withdrawn before any

vaccines were given because of concerns about the stability of the

product. In 1995, through a cooperative research and development

agreement, the Chiron Biocine Company and the Walter Army

Institute of Research began a clinical trial of a vaccine for

Human Immunodeficiency Virus (HIV) that contained an adjuvant with

squalene. 11 The vaccine containing squalene was given to 41

healthy volunteers in Thailand, and the adjuvant with squalene

without the rest of the vaccine was given as a placebo to 13

people in a control group.

In 1997, the Walter Army Institute of Research began to

cosponsor another study in Thailand on an HIV vaccine with an

adjuvant formulation containing squalene, which is ongoing. 12

This study will give both the experimental and control subjects

the adjuvant formulation with squalene. Three hundred and eighty

subjects have been recruited for this study; 3 are Americans and

the remaining are Thai citizens.

8 IND 2699. " Safety and Immunogenicity of a Plasmodium falciparum

Malaria Sporozoite Vaccine, R32NS1 81 With DETOX TM As An

Adjuvant. " 9 IND 3714. " The Protective Efficacy of a Plasmodium

falciparum Vaccine, R32NS1 81 and MPL/ CSW as an Adjuvant. " 10 IND

6043. " Plasmodium falciparum Circumsporozite Antigen Vaccine

(Recombinant, Yeast) with Alum, QS21, MPL and SB62 Adjuvant

Combinations. " 11 IND 4096. " A Phase I Trial of Biocine HIV SF2 gp

120/ MF59 Vaccine in Seronegative Thai Volunteers. "

12 IND 7172. " A Phase I/ II Double- blind, Placebo- controlled

study of the Chiron HIV Thai E gp 120/ MF59 Vaccine Administered

alone or Combined with the Chiron HIV SF2 gp120 Antigen in Healthy

HIV- Seronegative Thai Adults. "

B-278779 Page 5 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix II provides further details on these studies, and

appendix III provides a list of DOD research publications on those

trials involving human subjects.

In addition, DOD has conducted several experiments on animals,

using vaccines with adjuvant formulations containing squalene, for

a wide range of diseases, including anthrax, toxic shock, and

malaria. The anthrax vaccine experiments with adjuvant

formulations containing squalene began in 1987, and some of the

results have been presented at conferences and published in

several medical journals. (See app. IV for a list of some of DOD's

animal research on adjuvant formulations with squalene). DOD's

animal studies are of interest for two reasons. First, because

tests on

animals are generally performed before human trials, they

represent the first step of vaccine research and provide a more

complete picture about the state of research on adjuvant

formulations with squalene before the

Gulf War. Second, since vaccines against biological warfare cannot

be tested for efficacy in humans, animal research is considered

essential by researchers.

NIH's Research on Vaccines With Adjuvant Formulations Containing

Squalene

NIAID officials stated they have sponsored vaccine trials on

various adjuvant formulations, including several with squalene.

NIAID's research on vaccines and adjuvant formulations has

increased substantially over the last 10 years. The total number

of active vaccine projects more than doubled, from 212 in 1987 to

539 in 1997. Research involving adjuvant formulations expanded at

an even faster pace, from 13 studies in 1987 to

59 active projects in 1997. NIAID's clinical research on novel

adjuvant formulations involving human subjects began in 1988.

NIAID- sponsored basic/ preclinical studies on adjuvant

formulations with squalene began in 1987, and clinical trials

began at the same time as Operation Desert Storm, in January 1991.

Since then, NIAID has sponsored at least 23 trials of vaccines

involving adjuvant formulations with squalene, with 1,177 human

volunteers. 13 Nineteen of the 23 trials involved an HIV vaccine

tested on a total of 935 volunteers; the 4 remaining trials

involved a vaccine for herpes with 242 subjects. (See app. V for a

list of the 23 studies.

13 Establishing the exact number of studies is difficult because

NIAID's databases often do not specify the adjuvants used in both

preclinical and clinical studies. Also, 2 years after the studies

are completed, the records are routinely destroyed and only an

index is maintained.

B-278779 Page 6 GAO/NSIAD-99-5 Gulf War Illnesses

DOD Officials Report They Considered, but Decided Against, Using

Vaccines With Novel Adjuvent Formulations, Including

Squalene In August 1990, DOD established various committees to

address its concerns about the threat of Iraqi biological warfare

agents and the

insufficient supply of vaccines to immunize all troops against

these agents. These committees identified several problems. They

determined that DOD had neither a sufficient quantity of vaccine

nor the manufacturing capacity to protect the force. It also did

not have sufficient time to administer the

required six anthrax shots over 18 months and faced formidable

logistical problems in giving multiple shots to troops in various

locations in the Persian Gulf region. According to DOD officials,

the use of novel adjuvant formulations for the anthrax vaccine was

rejected because any alteration in the licensed vaccine would

require relicensure, and DOD would not receive FDA approval in

time. Other alternatives were pursued. DOD requested help from

commercial U. S. and foreign vaccine manufacturers; NIH, through

its

National Cancer Institute facility at Fort Detrick, land; and

additional military production facilities at Fort Detrick and

Porton Down, United Kingdom. According to the commercial

manufacturers, they turned DOD down because developing a safe and

effective vaccine takes sustained investment and planning and DOD

had not previously been willing to invest the money and time. DOD

began immunizing troops in Janaury 1991. However, it should be

noted that even if the manufacturing capacity had

been increased, DOD never had the 18- month time span needed to

fully immunize the troops in the Gulf War because of the war's

short duration.

Although DOD awarded contracts to the National Cancer Institute to

produce additional anthrax vaccine and began planning production

of additional botulinum toxoid vaccine at the U. S. Army Medical

Research Institute of Infectious Diseases, also located at Fort

Detrick, the two institutes were unable to begin production before

the war. DOD officials said that botulinum toxoid vaccine was

acquired from Porton Down, United Kingdom, but was not used.

Consequently, according to DOD, the only vaccines against

biological warfare agents anthrax and botulinum toxoid given

during the Gulf War were produced by the Michigan Department of

Public Health. It subsequently became an independent

agency, the Michigan Biologic Products Institute, and was recently

privatized as BioPort. Officials at BioPort said that they have

never used adjuvant formulations containing squalene.

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

B-278779 Page 7 GAO/NSIAD-99-5 Gulf War Illnesses

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.

Independent Researchers State They Have Detected

Squalene Antibodies in Gulf War- Era Veterans

In examining the pathology of illnesses afflicting Gulf War- era

veterans, independent researchers examined whether antibodies to

squalene were present in patients who had and had not been

deployed to the Gulf War. Using an assay that they developed the

researchers stated that they

detected squalene antibodies in the blood of sick Gulf War- era

veterans. The immunologist who headed this study and laboratory

researchers at a major university medical center that were

involved in the study shared their methodology and findings with

us. The results of the research have been submitted to a medical

journal to be peer reviewed and published. As

of February 1999, there was no set date for publication. According

to the researchers, the antisqualene antibody assay that they

developed in their study is a variant of the common Western Blot

assay 14 and is similar in format to a test cited in a published

report on silicone antibodies. 15 Using the antisqualene antibody

assay, the independent researchers stated they found most veterans

with Gulf War illnesses in their research had the antibodies to

squalene, regardless of whether they were deployed or not.

Non veterans in the research that were known to have received

adjuvant formulations with squalene as volunteers in clinical

trials of experimental vaccines also had the antibodies to

squalene and had an array of symptoms similar to symptoms of the

Gulf War patients. On the other hand, those participants (in the

control groups) that were healthy with no autoimmune symptoms,

those non- Gulf War veterans with autoimmune diseases of

unknown origin, and those who had received other adjuvant

formulations were found not to have antibodies to squalene. The

independent researchers concluded that, while the reason for the

presence of the

14 The Western Blot assay applies a protein or polymer such as

squalene to test strips, which are then incubated with patient

serum. If the antibody of interest is present, test strips turn

bluish black. A darker color indicates a higher concentration of

antibodies.

15 S. A. Tenenbaum et al., " Use of anti- polymer antibody assay in

recipients of silicone breast implants, " The Lancet, vol. 349

(1997), pp. 449- 454. For correspondence concerning this study see

" Antipolymer antibodies, silicone breast implants, and

fibromyalgia, " The Lancet, vol. 349 (1997), pp. 1170-- 1173.

B-278779 Page 8 GAO/NSIAD-99-5 Gulf War Illnesses

squalene antibodies remains unclear, the presence of these

antibodies could potentially be a contributing factor to Gulf War

illnesses. DOD officials stated they could develop an assay, or

test, for detecting antibodies to squalene. According to these

officials, it would not be expensive to develop the assay and test

it on a sample of Gulf War- era veterans that are sick. However,

they believed that since DOD did not use adjuvants with squalene,

DOD does not need to develop such an assay or to screen the

veterans for the antibodies. Second, squalene is a substance that

occurs naturally in the human body, and they doubted that an assay

could be developed to differentiate antibodies to natural and

manufactured squalene. Third, they noted that squalene is also

found in numerous topical creams that some soldiers could have

used. Finally, DOD officials do not believe that funding squalene

antibodies in veterans would prove that the

antibodies caused Gulf War illnesses. Consequently, DOD intends to

wait until the independent researchers publish their research in a

peer- reviewed journal before deciding whether to conduct testing.

Conclusions and Recommendation

Time is critical for many Gulf War- era veterans who continue to

suffer from illnesses and have been waiting for the past 7 years

for an explanation about the nature of their illnesses. It is

therefore important that DOD takes advantage of any opportunity to

obtain and evaluate additional information on the veterans'

symptoms and potential contributing factors. Independent

researchers, using an assay that they state is similar to standard

research assays, have concluded that squalene antibodies are

present in sick Gulf War- era veterans that participated in their

research and are a potential contributing factor to these

veterans' illnesses. DOD officials stated that it is feasible to

develop and apply an assay to test for squalene antibodies. Yet

for various reasons, including its assertion that it did not use

adjuvant formulations with squalene, DOD plans to wait until the

researchers' research is published before considering whether to

conduct its own

testing. However, publication is usually a lengthy process and may

take more than a year. Given that Gulf War- era veterans have

already waited a significant amount of time for information on

their illnesses, we believe that DOD should act now to expand on

the research already conducted.

Although the origin of the antibodies may be important to assess,

the first step is to determine the extent to which they are

present in a larger group of sick Gulf War- era veterans. We

therefore recommend that the Secretary of Defense review the

independent research that researchers report has revealed the

presence of squalene antibodies in the blood of ill Gulf War- era

B-278779 Page 9 GAO/NSIAD-99-5 Gulf War Illnesses

veterans and conduct its own research designed to replicate or

dispute these results. Agency Comments In written comments on a

draft of our report, DOD disagreed with our recommendation to test

for antibodies for squalene in the blood of ill Gulf War- era

veterans. DOD stated there is no basis for believing veterans were

exposed to vaccines containing squalene. DOD further believes that

the proposed testing for the presence of squalene antibodies will

not appropriately address or assist in resolving the issue of

whether such antibodies may be a contributing cause to the

illnesses of Gulf War- era veterans. Specifically, DOD stated no

experimental vaccines with squalene had been used in U. S. troops

during the Gulf War and that the manufacturer of vaccines verified

it had never used adjuvant formulations containing

squalene. DOD noted that we concluded there was no evidence that

Gulf War- era veterans were given adjuvant formulations containing

squalene, and it therefore believes our proposal to test veterans

seems scientifically and fiscally irresponsible. DOD suggested

that our report be titled Gulf War Illnesses: Gulf War Veterans

Did Not Receive Vaccine Adjuvant

Formulations Containing Squalene. DOD further stated the assay

developed by independent researchers has not been validated

through peer review or publication in scientific literature and

that it is correctly adhering to widely accepted standards by

awaiting such validation before considering the use of the assay

in Gulf War illness studies. It also believed our recommendation

to test for squalene antibodies showed a lack of understanding of

scientific methods. In particular, DOD stated the presence of

antibodies would not establish an

association with adverse health outcomes and establishing an

association would require a statistically meaningful study of

randomly selected Gulf War veterans and non deployed veterans. DOD

noted that any

experimental design to test for this association must be evaluated

for scientific merit through independent peer review.

DOD misstated our finding on whether Gulf War- era veterans may

have received vaccine adjuvant formulations containing squalene.

We did not conclude that Gulf War era veterans were not given

adjuvant formulations containing squalene. Rather, we cannot say

definitively whether or not Gulf War- era veterans were given

these formulations. We have modified the report text to make this

point clear. Furthermore, it was not our

B-278779 Page 10 GAO/NSIAD-99-5 Gulf War Illnesses

intention to focus on how squalene antibodies may have been

introduced into the blood of the veterans. Rather, the focus

should be on the opportunity to resolve whether such antibodies

are present in the blood of ill Gulf War- era veterans, and if so,

whether or not they play a role in their illnesses. In this

respect, the results of the independent research suggesting that

antibodies to squalene are present in ill Gulf War- era veterans

participating in their research cannot be ignored.

We continue to believe that DOD should take this opportunity to

begin addressing and potentially resolving the question of whether

or not squalene antibodies may be contributing to the illnesses of

Gulf War- era

veterans. Specifically, DOD should conduct research designed to

replicate or dispute the independent research results that

revealed the presence of squalene antibodies in the blood of ill

Gulf War- era veterans. We modified our recommendation to clarify

this position. If DOD's research affirms the

presence of these antibodies, additional research should be

conducted that is designed to assess the significance of that

finding. This would simply be a first step in the research process

and would not finally resolve the issue of whether or not squalene

antibodies are a marker for, contribute to, or cause the

illnesses. Follow- on research would be required to address those

issues.

DOD also provided technical comments, which we incorporated as

appropriate. DOD's comments are printed in their entirety in

appendix VI. Scope and Methodology

To develop the information in this report, we conducted multiple

literature searches of public and agency databases and reviewed

both published and unpublished literature on the use of adjuvant

formulations in vaccine, including DOD research protocols and

agency documentation. In addition, we interviewed officials at

DOD, NIH, FDA, and the Veterans Administration. We interviewed

vaccine experts in academia,

pharmaceutical firms, and the American Medical Association and

confirmed the validity of using assays as a means of determining

the presence of antibodies. We also interviewed the immunologist

who headed the independent research and laboratory researchers

from Tulane University in New Orleans who developed the anti-

squalene assay, and they shared their methodology and findings

with us. Finally, we interviewed responsible officials at BioPort.

Our work was completed between August 1997 and August 1998 in

accordance with generally accepted government auditing standards.

B-278779 Page 11 GAO/NSIAD-99-5 Gulf War Illnesses

We are sending copies of this report to other interested

congressional committees. We are also sending copies to the

Honorable Cohen, Secretary of Defense; the Honorable Togo

D. West, Jr., Secretary of Veterans Affairs; and the Honorable

Donna E. Shalala, Secretary of Health and Human Services. Copies

will also be made available to others upon

request. If you have any questions or would like additional

information, please contact me at (202) 512- 3092. Major

contributors to this report were Sushil K. Sharma and Dan

. Sincerely yours,

Kwai- Cheung Chan Director, Special Studies

and Evaluations

Page 12 GAO/NSIAD-99-5 Gulf War Illnesses

Contents Letter 1 Appendix I Development of Adjuvant Formulations

With Squalene

15 Appendix II DOD's Clinical Trials on Novel Vaccines With

Adjuvant Formulations Containing Squalene

17 Appendix III DOD's Published Research on Vaccines With Adjuvant

Formulations Containing Squalene That Involved Human Subject

Volunteers

18 Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene

19

Page 13 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix V National Institute of Health Studies Using Adjuvants

With Squalene

21 Appendix VI Comments From the Department of Defense

22 Tables Table I. 1: Pharmaceutical Firms' Adjuvant Formulations

That May

Contain Squalene or Squalane 16

Abbreviations

DOD Department of Defense FDA Food and Drug Administration HIV

Human Immunodeficiency Virus IND Investigational new drgus NIAID

National Institute of Allergy and Infectious Diseases NIH National

Institutes of Health

Page 14 GAO/NSIAD-99-5 Gulf War Illnesses

Page 15 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix I Development of Adjuvant Formulations With Squalene

Appendi x I

Biotechnology research and development of adjuvant formulations

with squalene began in the 1970s and the first clinical study

began in 1984. At the time of the Gulf War, at least three firms

Ribi ImmunoChem Research Inc. of Hamilton, Montana; Chiron of

Alameda, California; and Syntex of Palo Alto, California had

developed adjuvant formulations with squalene

and were distributing them for vaccine research and development.

Research on adjuvant formulations with squalene has continued. At

least seven biotechnology and pharmaceutical firms have developed

nine different adjuvant formulations that may contain squalene. In

five of the adjuvant formulations, squalene or squalane is always

a component, and in the other four, it is used optionally (see

table I. 1). According to Chiron, its adjuvant formulation with

squalene has been tested on over 9,000 human subjects. Ribi

ImmunoChem reports that its adjuvant formulations with squalene

have been tested on over 1,000 human subjects.

Appendix I Development of Adjuvant Formulations With Squalene

Page 16 GAO/NSIAD-99-5 Gulf War Illnesses

Table I. 1: Pharmaceutical Firms' Adjuvant Formulations That May

Contain Squalene or Squalane

Note: Much of this information in this table is from F. R. Vogel

and M. V. , Chapter 7, " A compendium of Vaccine Adjuvants

and Excipients, " Vaccine Design: The Subunit and Adjuvant

Approach, M. F. and M. J. Newman, (New York: Plenum Press,

1995). Additional and updated information was gathered from F. R.

Vogel and other sources.

Name of adjuvant formulation

Name of pharmaceutical firm Compound used

Always contains squalane or squalene

Squalene or squalane is used optionally

Antigen Formulation IDEC

Pharmaceuticals Corporation

Squalane Yes No CRL 1005 (Block Copolymer P1205)

Vaxcel Corporation Squalene No Yes Detox RibiImmunoChem Research,

Inc. Squalane Yes No Gerbu Adjuvant CC Biotech

Corporation Squalane No Yes GMDP Peptech, Ltd., UK Squalane No Yes

MF59 Chiron Squalene Yes No MPL RibiImmunoChem Research, Inc.

Squalene No Yes

Ribi adjuvant system RibiImmunoChem Research, Inc. Squalene Yes No

Syntex adjuvant formulation (SAF)

Syntex Research Squalane Yes No

Page 17 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix II DOD's Clinical Trials on Novel Vaccines With Adjuvant

Formulations Containing Squalene Appendi x I I

The following table identifies vaccine trials with adjuvant

formulations that contained squalene and squalane conducted by DOD

under the Food and Drug Administration's (FDA) process for

approving investigational new drugs (IND). New drugs and vaccines

under development generally have to be tested in humans for safety

and efficacy before they are approved for general human use.

Therefore, FDA grants IND waivers allowing human subject

experiments after reviewing information on the product, its

manufacture and testing, and the proposed clinical study.

a Date IND approved by FDA's Human Subject Research Review Board.

b As of December, 1997. c The control group received a placebo

consisting of the adjuvant MF59 alone without the rest of the

vaccine.

Date IND approved for human subject research a IND

number Number of human subjects Country of

subjects Vaccine Adjuvant

containing squalene or squalane

4/ 27/ 88 2699 5 United States Malaria Detox 8/ 8/ 90 3714 12

United States Malaria Detox 12/ 7/ 94 6043 121 b United States

Malaria MPL 2/ 8/ 95 4096 41 vaccine,

13 placebo c Thailand HIV MF59 9/ 18/ 97 7172 300 vaccine,

80 placebo c 377- Thailand 3- United States HIV MF59

Total 5 572 Malaria HIV Detox

MPL MF59

INDs using U. S. citizens 3 138 Malaria HIV Detox

MPL MF59

INDs using foreign citizens 2 434 HIV MF59

Page 18 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix III DOD's Published Research on Vaccines With Adjuvant

Formulations Containing Squalene That Involved Human Subject

Volunteers Appendi x I I I

Rickman, L. et al. " Use of adjuvant containing mycobacterial cell-

wall skeleton monophosphoryl lipid A, and squalane in malaria

circumsporozite protein vaccine. " Lancet. Vol. 337, 1991, pp. 998-

1001. Hoffman, S. L. et al. " Safety, immunogenicity, and efficacy

of a malaria sporozite vaccine administered with monophosphoryl

lipid A, cell- wall skeleton of mycobacteria, and squalene as

adjuvant. " American Journal of Tropical Medical Hygiene. Vol. 51/

5, 1994, pp. 603- 612.

Stoute, J. A. et al. " A preliminary evaluation of recombinant

circumsporozoite protein vaccine against plasmodium falciparum

malaria. " New England Journal of Medicine. Vol. 336, 1997, pp. 86-

91.

Page 19 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene Appendi x I V

Anthrax Iacono- Connors, L. et al. " Protection against Anthrax

with Recombinant Virus- Expressed Protective Antigen in

Experimental Animals, " Infection

and Immunity. Vol. 59, 1991, pp. 1961- 1965. Ivins, B. et al.

" Experimental anthrax vaccines: efficacy of adjuvants combined

with protective antigen against an aerosol Bacillus anthraces

spore challenge in guinea pigs. " Vaccine, Vol. 13, 1995, pp. 1779-

1784.

Ivins, B. et al. " Experimental Anthrax Vaccines: Efficacy Studies

in Guinea Pigs. " Abstracts of the 93rd General Meeting of the

American Society for Microbiology. 1993, p. 160.

Ivins, B. et al. " Comparative efficacy of experimental anthrax

vaccine candidates against inhalation anthrax in rhesus macaques. "

Vaccine. Vol. 16, 1998, pp. 1141- 1148.

Ivins, B. et al. " Cloned Protective Activity and Progress in

Development of Improved Anthrax Vaccines. " Salisbury Medical

Bulletin Special Supplement. 1990, pp. 86- 88. Ivins, B. et. al.

" Immunization against Anthrax with Bacillus anthraces Protective

Antigen Combined with Adjuvants. " Infection and Immunity. Vol. 60,

1992, pp. 662- 668.

Ivins, B. et. al. " Adjuvant Efficacy in Experimental Anthrax

Vaccines: Protection Studies in Guinea Pigs. " Abstracts of the

91st General Meeting of the American Society for Microbiology.

1991, p. 121.

Ivins, B. et. al. " Vaccine Efficacy of Bacillus Anthraxis

Protective Antigen Produced in Prokayotic and Iukaryotic Cells. "

Abstracts of the 94th General Meeting of the American Society of

Microbiology, 1994, p. 150.

Little S. F. et. al. " Protection against experimental anthrax

infection using fragments of Protective antigen. " Proceedings of

the International Workshop on Anthrax. Vol. 87, 1996, p. 129.

Little S. F. et al. " Passive Protection by Polyclonal Antibodies

against Bacillus anthraces Infection in Guinea Pigs. " Infection

and Immunity. Vol. 65, 1997, pp. 5171- 5175.

Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene

Page 20 GAO/NSIAD-99-5 Gulf War Illnesses

Malaria Malik A. et al. " Induction of cytotoxic T lymphocytes

against the Plasmodium falciparum circumsporozoite protein by

immunization with soluble recombinant protein without adjuvant, "

Infection and Immunity.

Vol. 61, 1993, pp. 5062- 5066. Toxic Shock Syndrome Stiles, B. et

al. " Biological Activity of Toxic Shock Syndrome Toxin 1 and a

Site- Directed Mutant, H135A, in a lipopolysaccharide- Potentiated

Mouse Lethality Model. " Infection and Immunity. Vol. 63,1995, pp.

1229- 1234.

Page 21 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix V National Institute of Health Studies Using Adjuvants

With Squalene Appendi x V

a NIAID is the National Institute of Allergy and Infectious

Diseases, AVEG is the AIDS Vaccine Evaluation Group, and DIR is

the Division of Intramural Research.

Date Investigational New Drug (IND) study began Vaccine Institute

IND number Adjuvant with squalene No. of subjects

1/ 28/ 91 HIV NIAID/ AVEG a 005A MF 59 16 3/ 22/ 91 HIV NIAID/

AVEG 005B MF 59 46 10/ 1/ 91 Herpes NIAID/ DIR a 92- I- 0267 MF 59

40 10/ 29/ 91 HIV NIAID/ AVEG 005C MF 59 14 12/ 19/ 91 HIV NIAID/

AVEG 007A MF 59 32 2/ 04/ 92 HIV NIAID/ AVEG 007B MF 59 17 11/ 16/

92 HIV NIAID/ AVEG 007C MF 59 10 07/ 28/ 92 HIV NIAID/ AVEG 008 MF

59 14 10/ 1/ 92 Herpes NIAID/ DIR 93- I- 0141 MF 59 174 12/ 09/ 92

HIV NIAID/ AVEG 201 MF 59 149 5/ 19/ 93 HIV NIAID/ AVEG 012A MF 59

15 6/ 03/ 93 HIV NIAID/ AVEG 015 MF 59 30 6/ 03/ 93 HIV NIAID/

AVEG 015 MPL 30 6/ 03/ 93 HIV NIAID/ AVEG 015 SAF/ 2 30 10/ 1/ 93

Herpes NIAID/ DIR 94- I- 0086 MF 59 18 10/ 12/ 93 HIV NIAID/ AVEG

012B MF 59 59 5/ 11/ 95 HIV NIAID/ AVEG 022 MF 59 59 9/ 14/ 95 HIV

NIAID/ AVEG 024 MF 59 30 10/ 1/ 95 Herpes NIAID/ DIR 96- I- 0024

MF 59 10 7/ 10/ 96 HIV NIAID/ AVEG 022A MF 59 129 2/ 06/ 96 HIV

NIAID/ AVEG 026 MF 59 85 7/ 31/ 96 HIV NIAID/ AVEG 029 MF 59 28 5/

22/ 97 HIV NIAID/ AVEG 202 MF 59 142

Total INDs and subjects 23 1177

Page 22 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix VI Comments From the Department of Defense Appendi x VI

Appendix VI Comments From the Department of Defense

Page 23 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix VI Comments From the Department of Defense

Page 24 GAO/NSIAD-99-5 Gulf War Illnesses (713014) Let t er

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MILITARY VACCINE EDUCATION CENTER // SERIES OF INTERESTING ARTICLES

INCLUDING A COMPLIMENTARY REVIEW ON GARY MATSUMOTO'S BOOK : VACCINE A

….including this excerpt….PAGE 69 (pdf page 78 of 152)

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" A number of potential problems with the anthrax vaccine have been

suggested, including problems with quality control during the

manufacturing process,335,339 changes in the manufacturing process

that may have resulted in increased levels of active antigen,341 and

the use of unapproved adjuvants to bolster the immunological

reactivity of the vaccines.23,340 Reports have indicated that the

anthrax vaccine administered during the Gulf War, commonly referred

to as AVA (anthrax vaccine adsorbed) is associated with a relatively

high rate of acute adverse reactions,342 and have pointed out that

there is insufficient evidence to determine whether the AVA vaccine

formulation may be associated with long-term health

sequelae.134,339 "

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THERE MAY BE SOME DUPLICATIONS FROM OTHER POSTINGS.

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( HOSPITALIZATIONS FOR UNEXPLAINED ILLNESSES AMONG US VETERANS OF

THE PERSIAN GULF WAR )

http://www.cdc.gov/ncidod/EID/vol4no2/knoke.htm

SECRET GOVT. DATABASE OF ADVERSE REACTIONS TO VARIOUS VACCINES ( $

25.00 )

http://thinktwice.com/secret.htm

AIR FORCE STUDY BY PUBLIC MED.COM ON AIR FORCE VETERANS

Chronic multisymptom illness affecting Air Force veterans of the

Gulf War.

Fukuda K, Nisenbaum R, G, WW, Robin L, Washko RM,

Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC.

Division of Viral and Rickettsial Diseases, National Center for

Infectious Diseases, Centers for Disease Control and Prevention,

Atlanta, GA 30333, USA.

CONTEXT: Gulf War (GW) veterans report nonspecific symptoms

significantly more often than their nondeployed peers. However, no

specific disorder has been identified, and the etiologic basis and

clinical significance of their symptoms remain unclear. OBJECTIVES:

To organize symptoms reported by US Air Force GW veterans into a

case definition, to characterize clinical features, and to evaluate

risk factors. DESIGN: Cross-sectional population survey of

individual characteristics and symptoms and clinical evaluation

(including a structured interview, the Medical Outcomes Study Short

Form 36, psychiatric screening, physical examination, clinical

laboratory tests, and serologic assays for antibodies against

viruses, rickettsia, parasites, and bacteria) conducted in 1995.

PARTICIPANTS AND SETTING: The cross-sectional questionnaire survey

included 3723 currently active volunteers, irrespective of health

status or GW participation, from 4 air force populations.The cross-

sectional clinical evaluation included 158 GW veterans from one

unit, irrespective of health status. MAIN OUTCOME MEASURES: Symptom-

based case definition; case prevalence rate for GW veterans and

nondeployed personnel; clinical and laboratory findings among

veterans who met the case definition. RESULTS: We defined a case as

having 1 or more chronic symptoms from at least 2 of 3 categories

(fatigue, mood-cognition, and musculoskeletal). The prevalence of

mild-to-moderate and severe cases was 39% and 6%, respectively,

among 1155 GW veterans compared with 14% and 0.7% among 2520

nondeployed personnel. Illness was not associated with time or place

of deployment or with duties during the war. Fifty-nine clinically

evaluated GW veterans (37%) were noncases, 86 (54%) mild-to-moderate

cases, and 13 (8%) severe cases. Although no physical examination,

laboratory, or serologic findings identified cases, veterans who met

the case definition had significantly diminished functioning and

well-being. CONCLUSIONS: Among currently active members of 4 Air

Force populations, a chronic multisymptom condition was

significantly associated with deployment to the GW. The condition

was not associated with specific GW exposures and also affected

nondeployed personnel.

PMID: 9749480 [PubMed - indexed for MEDLINE

GULF WAR SYNDROME HEARINGS IN UNITED KINGDOM PARLIAMENT

http://traprockpeace.org/RokkeParliament.html

AUSTALIAN STUDY OF FEMALE GULF WAR VETS

http://www.dva.gov.au/media/publicat/2003/gulfwarhs/html/ch15.htm

AVAIATION/ VIRTUAL FLIGHT SURGEON PAGE/ LOOK UNDER CONCERNS ABOUT

THE VACCINE -- it will give interesting info on squalene detection.

http://www.aviationmedicine.com/beta/anthrax_facts.htm

VETERANS BOARD OF APPEALS SEARCH FOUND TWO CASES WITH MICOPLASM

FINDINGS

http://www.index.va.gov/search/va/va_search.jsp

AMERICAS CHANGING POSITION ON GULF WAR ILLNESS ( GOOD OVERVIEW )

http://www.mercola.com/2004/nov/17/gulf_war_syndrome.htm

GULF WAR 2 ARTICLE / HEALTH RISKS

http://www.gulfwarvets.com/news13.htm

CONTAMINATION OF PERSIAN GULF WAR VETS BY DU

http://www.antenna.nl/wise/uranium/dgvd.html

REGISTRY OF SPOUSES AND CHILDREN OF GULF WAR VETERANS

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1007

NEW CASE

http://www.cbsnews.com/stories/2004/03/01/eveningnews/main603284.shtm

l?CMP=ILC-SearchStories

ANTHRAX VACCINE OFFICIAL DOCUMENTS ( PDF Format )

http://www.avip2001.net/OfficialDocuments.htm

TREATMENT FOR GULF WAR ILLNESS

http://my.webmd.com/content/article/62/71644?

src=Inktomi & condition=Mental%20Health

ASSISTANT SECRETARY FOR LEGISLATION GOVT. REPORT CIRCA 2000

http://www.hhs.gov/asl/testify/t001005a.html

INSTITUTE OF MOLECULAR MEDICINE ARTICLE SHOWING 40% OF SICK VETS

HAVE TRANSMITTABLE INFECTIONS ( INCLUDING MYCOPLASMAS )

http://www.immed.org/illness/gulfwar_illness_research.html

Excerpt from the above article as follows :

Gulf War Syndrome or Gulf War Illness has been used to describe a

collection of chronic signs and symptoms reported by U.S., British,

Canadian, Czech, Danish, Saudi, Egyptian, Australian and other

Coalition Armed Forces that were deployed to Operation Desert Storm

in 1991. Over 100,000 American veterans of Desert Storm /Desert

Shield (approximately 15% of deployed U. S. Armed Forces) returned

from the Persian Gulf and slowly (6-24 months or more) and presented

with a variety of complex signs and symptoms characterized by

disabling fatigue, intermittent fevers, night sweats, arthralgia,

myalgia, impairments in short-term memory, headaches, skin rashes,

intermittent diarrhea, abdominal bloating, chronic bronchitis,

photophobia, confusion, transient visual scotomata, irritability and

depression and other signs and symptoms that until recently have

defied appropriate diagnoses (see publications). These symptoms are

not localized to any one organ, and the signs and symptoms and

routine laboratory test results are not consistent with a single,

specific disease.

Although there is not yet a case definition for Gulf War Illness,

the chronic signs and symptoms loosely fit the clinical criteria for

Chronic Fatigue Syndrome and/or Fibromyalgia Syndrome. Some patients

have additionally what appears to be neurotoxicity and brainstem

dysfunction that can result in autonomic, cranial and peripheral

nerve demyelination, possibly due to complex chemical exposures.

Often these patients have been diagnosed with Multiple Chemical

Sensitivity Syndrome (MCS) or Organophosphate-Induced Delayed

Neurotoxicity (OPIDN). Chemically exposed patients can be treated by

removal of offending chemicals from the patient's environment,

depletion of chemicals from the patient's system and treatment of

the neurotoxic signs and symptoms caused by chemical exposure(s). A

rather large subset (~40%) of GWI patients have transmittible

infections, including mycoplasmal and possibly other chronic

bacterial infections, that have resulted in the appearance of GWI in

immediate family members and civilians in the Gulf region. It is

likely that veterans of the Gulf War who are ill with GWI owe their

illnesses to a variety of exposures: (a) chemical mixtures,

primarily organophosphates, antinerve agents and possibly nerve

agents, ( radiological sources, primarily depleted uranium and

possibly fallout from destroyed nuclear reactors, and © biological

sources, primarily bacteria, viruses and toxins, before, during and

after the conflict. Such exposures can result in poorly defined

chronic illnesses, but these illnesses can be treated if appropriate

diagnoses are forthcoming.

ANTHRAX VACCINE TESTIMONY ( INCLUDES TESTIMONY FROM AUTHOR TOM

HEEMSTRA )

http://www.avip2001.net/CongressionalTestimony.htm

BOOK REVIEW OF VACCINE A by GARY MATSUMOTO

http://www.militaryink.com/books/2004/october/046504400X.htm

http://www.vaccinationnews.com/Scandals/feb_8_02/AnthrVaxRisks.htm

BIOPORT CORPORATE SITE

http://www.bioport.com/

PROBLEMS AT DOVER AFB. LETTER FROM MAJOR SONNIE G. BAITS

http://www.dallasnw.quik.com/cyberella/Anthrax/Starbuck2.html

ANTHRAX VACCINE LINKS

http://www.dallasnw.quik.com/cyberella/

ANTHRAX VACCINE NEWS ARTICLES

http://www.avip2001.net/NewsArticles.htm

10/14/2004 ( NEW ) FOUR INQUIRIES INTO ANTHRAX ALLEGATIONS DEMANDED.

DELAWARE CONGRESSIONAL DELEGATION GIVES RUMSFELD A MONTH TO REPORT

ON SQUALINE USE

http://www.delawareonline.com/newsjournal/local/2004/10/15fourinquiri

esin.html

MUSLIM CEO's OF U.S. FIRMS FIGHT TERRORISM " STOP EVIL "

http://www.usatoday.com/money/2004-05-18-muslim-ceos_x.htm

FDA INSPECTION OF BIOPORT BEGINS

http://www.lsj.com/news/bioport/011213_bioport_1b.html

GREED & GUINEA PIGS :RISKING THE EHALTH OF THE U.S. MILITARY

http://www.militarycorruption.com/greed.htm

US Govt. PATENT ON MICROPLASMA

http://www.gulfwarvets.com/micopat.htm

Mycoplasma Research : MYCOPLASMA FERMENTANS ( incognitos strain )

By Dr's Garth and Nicolson

http://www.gulfwarvets.com/nicolson.htm

BIOLOGICAL WAREFARE AND VACCINES

http://www.mercola.com/article/anthrax/anthrax_warfare.htm

OFFICIAL ARMY DISPENSATION OF VACCINE FOLKLORE & URBAN LEGEND

http://www.anthrax.osd.mil/resource/qna/qaAll.asp?cID=100

UNIVERSITY OF ALABAMA ANTHRAX VACCINE RESEARCH STUDY

OR HOW TO KILL 300 STUDENTS WITHOUT REALLY TRYING

http://main.uab.edu/show.asp?durki=61718

SQUALINE ANTIBODY STUDY

http://www.autoimmune.com/NewsRel15July02.html

http://www.anthraxvaccine.org/

NEW VACCINE PROBLEMS

http://www.anthraxvaccine.org/problems.html

THE ANTHRAX VACCINE NETWORK

http://www.anthraxvaccine.net/

BIOPORT FDA INSPECTION REPORTS AND DOCUMENTATION

http://www.anthraxvaccine.net/FDA.htm

MORE BIOPORT VACCINE PROBLEMS

http://www.gulflink.org/Vaers/inspection.htm

MANDITORY PARTICIPATION IN MILITARY ANTHRAX VACCINE STUDY

http://www.phoenixnewtimes.com/issues/2000-01-27/feature.html

ANTHRAX VACCINATION PROGRAM EXPOSED

http://www.avip2001.net/

ANTHRAX VACCINES : MAJOR FACTOR IN GULF WAR ILLNESS

http://www.rense.com/general56/gulf.htm

ANTHRAX VACCINE SAFETY & EFFIACY ( Worse than MD 20/20 on a roller

coaster ride. )

http://www.dallasnw.quik.com/cyberella/Anthrax/safety4.html

CHRONIC FATIGUE RELATED STUDIES

http://www.immed.org/illness/fatigue_illness_research.html

AUTOIMMUNE ILLNESS AND DEGENERATIVE DISEASE

http://www.immed.org/illness/autoimmune_illness_research.html

CHRONIC FATIGUE SYMPTOMS

http://www.immed.org/signsympt.htm

LETTERS TO THE INSTITUTE FOR MOLECULAR MEDICINE

http://www.immed.org/letters.htm

CLINICAL TESTING PROCEDURES FOR AUTOIMMUNE DISORDERS ( INTERESTING )

http://www.immed.org/illness/clinical_testing.html

SIGNS AND SYMPTOMS OF THE ABOVE

http://www.immed.org/signsympt.htm

TREATMENT CONSIDERATIONS FOR CHRONIC ILLNESS

http://www.immed.org/illness/treatment_considerations.html

LIST OF NEWS AND MEDIA REPORTS

http://www.immed.org/newsreports.html

WEBSITES THAT ARE USEFUL TO CHRONIC ILLNESS PATIENTS ( HUGE

RESOURCE )

http://www.immed.org/weblinks.htm

DEATH OF THE ANTHRAX VACCINE

http://www.angelfire.com/nm/redcollarcrime/anthrax14.htm

ANTHRAX VACCINE CAUSES GULF WAR ILLNESS

http://www.anthraxvaccine.org/AnthraxGWS.htm

COMMITTEE ON GOVERNMENT REFORM

http://reforhm.house.gov/

CHRONIC ANTHRAX

http://www.centurytel.net/tjs11/bug/anth1.htm

GULF WAR ILLNESS

http://www.desert-storm.com/GWI/

BRITISH PROBLEMS WITH ANTHRAX VACCINATIONS

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?

cmd=Retrieve & db=PubMed & list_uids=12615429 & dopt=Abstract

INFO ON HISTORY OF ANTHRAX VACCINE

http://www.pathlights.com/onlinebooks/chapter4.htm

Pdf File - 24 + anthrax shots in military career

http://www.avip2001.net/OfficialDocuments_files/FlyerR.pdf

MEDICAL INFORMATION NETWORK - PAGES OF INTEREST

http://www2.rpa.net/~lrandall/

*********************************************************************

*********************************************************************

*********************************************************************

*********

SUMMARY OF ANTHRAX VACCINE ISSUES

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 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 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 (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@...

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, Matsumoto, The Pentagon's Toxic Secret, May

1999, p. 82

10. Washington Post Sunday Magazine, Arthur , " 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, 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, Broad and Judith , " 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, Broad and Judith , " Germ Defense

Plan in Peril as Its Flaws are Revealed 8-7-98.

25. New York Times, Broad and Judith , " The Threat of

Germ Weapons is Rising. Fear, Too, " 12/27/98.

26. Washington Post, Brown, " The $115 Million Question, "

11/23/98, p. 15.

27. Army Times, 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,

, 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, 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, , " 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, B. Ottaway, " U. S. Gave Iraq Bacteria,

Sen. McCain Charges, " 1/26/89, p. A16. & #65532;

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GULF WAR VETS SITE ARTICLE ON ANTHRAX VACCINE SAFETY ISSUES

http://www.gulfwarvets.com/anthrax5.htm

Doctors for Disaster Preparedness

STATEMENT FOR THE RECORD

Submitted by

DOCTORS FOR DISASTER PREPAREDNESS

2509 N.

Box 272

Tucson AZ 85719

(520) 325-2680

Hearings on

U.S. DEPARTMENT OF DEPARTMENT OF DEFENSE

ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)

March 24, 1999

Doctors for Disaster Preparedness is a national organization of

physicians and scientists founded in 1983. We are dedicated to

increasing public awareness of threats from both man-made and

natural disasters, and to promoting life-saving preparedness

including homeland defense.

We recognize a serious threat of biological and chemical warfare, as

well as the potential for use of other weapons of mass destruction.

The Department of Defense has responded to this threat by

implementing the Anthrax Vaccine Immunization Program (AVID) to

inoculate 2.4 million military personnel.

But the threat is not limited to military personnel engaged in

warfare. Last year, the CDC received reports of a series of

bioterrorist threats of anthrax exposure to domestic civilian

targets. These were in the form of letters purportedly contaminated

with the bacillus, or in telephone threats about contaminated

ventilation systems.

Because of the potential exposure of civilians, we are concerned

that the Anthrax Vaccine Immunization Program will be expanded to

other diseases or contaminants, and used as a model for the

mandatory vaccination of civilian children as well as adults

The Assistant Secretary for Defense for health Affairs, Dr. Sue

, states that the AVID is " not primarily a medical program. "

Yet the DOD is administering to our soldiers a medical procedure

which raises the following scientific and medical concerns:

1. VACCINE NO SUBSTITUTE FOR OTHER PROTECTIONS

Because of the wide diversity of agents that could be used, no

single vaccine or combination of vaccines and antidotes is sure to

be effective: thus, there is no substitute for shelter and adequate

protective gear. We believe that both military and civilian

populations should have access to the type of NBC shelters that are

standard in Swiss homes.

2. LACK OF CLINICAL STUDIES

While anthrax has long been recognized as a serious threat, having

been weaponized by a number of potential adversaries, currently

available anthrax vaccine falls far short of optimal. The anthrax

vaccine was licensed in 1970 on the basis of one published study,

with only five inhalation cases.

Animal studies have shown survival rates as low as 4% and as high as

100% after anthrax challenge. A 1994 Staff Report for the Committee

on Veterans Affairs is quoted as saying that ``its [the vaccine's]

safety, particularly when given to thousands of soldiers in

conjunction with other vaccines, is not well established'' (Lancet

351:657, 1998, quoting a ProMED-mail posting). The one U.S.

producer, Michigan Biologic Products Institute (now Bioport Corp.),

would have closed last year except for a last-minute plea by the

Pentagon, because of serious concerns about its manufacturing

practices.

3. MEDICAL EFFICACY IN DOUBT

Textbooks of military medicine and The Medical Letter (40:52-53,

1998) state that the anthrax vaccine is ``safe and effective.'' The

British secretary of state for defence was vaccinated on camera in

an effort to convince service personnel and the public of the

vaccine's safety. However, several epidemiologists at the University

of Bristol described the state of current thinking as one of

``clinical equipoise'' and recommended randomizing troops to receive

or not receive vaccine (Br Med J 316:1322, 1998).

Certainly, there is a need to develop a better vaccine. on's

Principles of Internal Medicine states: ``The current vaccines are

impure and chemically complex, elicit only slow-onset protective

immunity, provide incomplete protection, and cause significant

adverse reactions.''

4. VACCINE NO DEFENSE AGAINST NEW STRAINS OF ANTHRAX

The vaccine is not completely protective against all natural strains

of Bacillus anthracis. An additional threat in the context of

biological warfare is the potential use of genetically engineered

strains, against which both vaccine and antibiotics may be

ineffective (CMAJ 158:633, 1998). Russian scientists have already

produced vaccine resistant strains

5. POTENTIAL IMPACT ON IMMUNE SYSTEM & LINK TO GULF WAR SYNDROME

Anthrax vaccine has been suggested as a possible cause for the Gulf

War Syndrome. While evidence that anthrax vaccine alone can cause

such a syndrome has not been forthcoming, it is possible that the

combination of agents may have induced unexpected adverse changes in

the immune response. Additionally, pertussis vaccine may have been

administered as an adjuvant to increase the immune reactions to

other vaccines, especially anthrax (Jamal GA: " Adverse Drug

React " Toxicol Rev 17:1-17, 1998). There is a report that the anthrax-

pertussis combination induced ``severe loss of condition and

weight'' in animals (Nature 390:3, 1997).

6. POOR RECORD KEEPING & FOLLOW UP STUDIES

Fear and mistrust are fueled by poor record-keeping about chemical

exposures and vaccines in the Gulf War. There are no adequate

records of recipients of special immunizations not in general use

(anthrax and botulinum) (Wegman DH et al.: Am J Epidemiol 146:704-

711, 1997). The British defence ministry has also admitted that

``medical record-keeping in the Gulf was not satisfactory,''

according to researcher Alan Silman of the University of Manchester

(Nature 384:604, 1996). Moreover, ``the MOD [ministry of defence]

suffers from an excessive culture of secrecy'' (Nature 390:3- 4,

1997).

7. EXPANSION OF MANDATORY VACCINES TO CIVILIAN SECTOR

The questions raised about adverse reactions due to vaccine

cocktails are highly pertinent in the civilian sector, now that such

a large number of vaccines are mandated for administration to

children, with exclusion from school and even charges of child

neglect or abuse as penalties for noncompliance.

RECOMMENDATIONS & CONCLUSION

Because of the limited efficacy of the anthrax vaccine, prevention

of exposure with shelters and protective gear remains indispensable.

In addition to improved vaccines with limited toxicity, the

Department of Defense should consider more advanced and less

invasive tools, such as decontamination agents.

For example, a material developed by D. Craig of Novavax,

Inc, which may be able to rapidly destroy a wide variety of

dangerous bacteria and viruses, including anthrax spores. The

material, called BCTP, is made from water, soybean oil, Triton X 100

detergent, and the solvent tri-n-butyl phosphate. Laboratory mice

and rats thrive when fed the material. Rapid inactivation of anthrax

bacteria and spores combined with low toxicity could make BCTP a

promising candidate as a broad-spectrum post exposure

decontamination agent.

In summary, better passive protection measures and expanded research

into vaccines are urgently needed. At present, mandatory vaccination

of all troops with the available anthrax vaccine has raised a number

of well-founded concerns that should be addressed openly. Our

organization is available for any questions or concerns of this

committee.

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ARMY VACCINES & GULF WAR SYNDROME

The Vaccines Anthrax vaccine

[Jan 2003] GULF WAR ILLNESS SHOCKER

159,238 US Gulf War I Casualties

Gulf War Vaccines

[Media UK, May 2003--Osteoporosis] Soldier hails Gulf case win

[Media UK, April 2003] GULF WAR JABS 'LIES' BY HOON

[Nov 2002] NEW BOOK- About the Gulf War and the Problems

Testimony of B. Urnovitz, Ph.D. (1/24/02)

Testimony of B. Urnovitz, Ph.D. (2/2/00)

TESTIMONY OF DR. HOWARD B. URNOVITZ August 3, 1999 COMMITTEE ON

GOVERNMENT REFORM AND OVERSIGHT

Dr Urnovitz interview Dec 1999 CFS Radio

A Lecture By Captain Joyce Riley in Houston, Texas on January 15,

1996

The Gulf Bio War: How a New AIDS-like Plague Threatens Our Armed

Forces by Alan R. Cantwell, Jr., M.D.

[Media July 2001] Illegal vaccine link to Gulf war syndrome

" Similarly, U.S. legislators learned in 1999 the little reported

fact that Gulf War troops, as many as 200,000, were unwittingly used

in AIDS vaccine experiments wherein portions of the AIDS virus, HIV,

were recombined with a pathogenic mycoplasma, isolated, tested, and

then patented by Dr. Shyh-Ching Lo of the Armed Forces Institute of

Pathology for the American Registry of Pathology in Washington, D.C.

The patent is reprinted and discussed in this authors book, Healing

Codes for the Biological Apocalypse (Tetrahedron Publishing Group,

1999). " --Dr Horowitz

Possible Link Between the Administration of Multiple Thimerosal

Containing Vaccines, Stress Induced Increases in Blood-Brain Barrier

Permeability and Gulf War Syndrome

http://www.altcorp.com/gulfwar.htm

Interview with Dr Nicolson

Role of bioengineering in CFS, GWS & AIDS--Dr Mazlen

Vaccine cocktail and stress `doomed Gulf War heroes (May

2000)

Statement on anthrax vaccine safety

STATEMENT OF SONNIE G. BATES, MAJOR, USAF (Anthrax vaccine--Burton

hearings)

Statement by Major L. Rempfer

Media 8/99: Secret vaccine sparks new fear for Gulf vets

Anthrax Vaccine Links and Information

http://www.dallasnw.quik.com/cyberella/index.htm

VACCINES & AIDS: Interview of Dr Eva Snead by Lee on September

19th 1992.

Anthrax vaccine, possible dangers

http://www.nccn.net/~wwithin/anthrax4.htm#TOP

Experimental vaccine and Gulf War syndrome http://www.new-

atlantean.com/global/ith_gulf.html

http://www.new-atlantean.com/global/secret.html

Objection to Gulf War vaccine was overridden

http://www.ohio.com/bj/news/ohio/docs/029677.htm

Anthrax vaccine: Cure or Conspiracy?

http://www.gulfwarvets.com/vaccine.htm

Vaccine guinea pigs http://www.gulfwarvets.com/winds.htm

http://home.sprynet.com/sprynet/Gyrene/gulfwar.htm

Gulf War Syndrome Pg.6

http://pathfinder.com/Life/essay/gulfwar/gulf06.html

GWS Link To Innoculations found

http://www.sonic.net/daltons/melissa/gws5.html

Health threat from bioweapons http://physlab.web2010.com/bio/bw.htm

Germ Warfare against America

http://physlab.web2010.com/bio/mcv.htm#Top

Gulf War Forced Inoculations http://www.all-natural.com/gwi-1.html

Null http://www.garynull.com/documents/GulfWarLegacy2.htm

Bosnia:

Army misled troops

http://www.cleveland.com/news/pdnews/frontpage/oabosnia.htm

Experimental vaccine

http://home.sprynet.com/sprynet/Gyrene/bosnia.htm

Department of Defense, Navy, and national immunization policies and

practice. http://www-nehc.med.navy.mil/prevmed/immun/imunmain.htm

GULF WAR SYNDROME http://www.new-atlantean.com/global/ith_gulf.html

http://www.immed.org/

http://members.aol.com/rgm1/private/nicolson.htm http://www.all-

natural.com/gwi-1.html http://www.trufax.org/menu/gulf.html

http://www.techmgmt.com/restore/gulfwarp.htm

http://www.insigniausa.com/gulflink.htm

http://www.dtic.mil/gulflink/

Mission Impossible http://www.dorway.com/possible.html

Is Desert Storm Syndrome NutraSweet Disease?

http://www.dorway.com/betty/deserts.txt

[Vaccines]

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Administrator & #65532;posted November 20, 2003 21:54 & #65532; & #65532; & #65532;

http://courant.ctnow.com/projects/anthrax/

Story Archive: 1994-2000

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Pilot Who Refused Shots May Face Court-Martial

The Air Force decided Thursday to go forward with the controversial

court-martial of one of the highest-ranking officers to refuse to be

inoculated with the anthrax vaccine.

Lawmaker: Testimony On Vaccine May Have Prompted Retaliation

A U.S. congressman, the chairman of a committee investigating the

health effects of the military's anthrax vaccine, is seriously

concerned over the Air Force's push Friday to court-martial one of

the committee's key witnesses, a spokeswoman said Saturday.

Major May Face Court-Martial

A flurry of communications among a powerful congressman, the

Pentagon and a U.S. Air Force major finally led Friday to a decision

by the Air Force to proceed toward court-martialing the major for

refusing to take the anthrax vaccine.

Was Toxic Plutonium Dust On Gulf War Battlefield?

A Persian Gulf War veterans' advocacy group says the Pentagon

probably used plutonium in ammunition and tank coatings that during

wartime explosions emitted toxic smoke and dust, sickening many of

those exposed.

Marine Who Lost Vaccine Fight Is AWOL

A U.S. Marine Corps private who two weeks ago lost his legal

challenge to the military's mandatory anthrax vaccination program is

missing from duty.

Failed Inspection Slows Military's Anthrax Vaccine Program

Critics of the military's anthrax vaccination program are saying the

failure of the manufacturer's new plant to pass a federal inspection

is yet another reason the program should be halted.

Mandatory Anthrax Vaccine On Trial

A U.S. Marine headed Thursday into U.S. District Court in

Pittsburgh, reportedly the first to legally challenge the Pentagon's

mandatory anthrax vaccination program.

Anthrax Study Request Refused

Federal health authorities are refusing a request by four

congressmen, including Connecticut Republican Shays,

that they further study the anthrax vaccine as an experimental drug.

State's Air Guard Off Schedule for Anthrax Shots

The Connecticut Air National Guard has insisted for months that it

is 90 percent in compliance with deadlines for anthrax vaccinations.

But figures supplied to Congress recently show the local guard unit

was close to 90 percent out of compliance for one shot of the series

alone.

Military Anthrax Shots A Prickly Subject

Lawmakers heard vastly different takes Wednesday on the effect a

mandatory anthrax vaccination program is having on the ranks in the

nation's National Guard and reservists.

Anthrax Shots Put On Hold At Base

Hurricane Floyd was a hazard to thousands on the East Coast, but it

was a relief for many of the 600 members of the Air National Guard

in Newburgh, N.Y., who were scheduled to take anthrax shots.

Program Lags in Battle Against Anthrax

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.

Anthrax Vaccine Deal Criticized

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 is drawing

fire from military watchdogs, soldiers and members of Congress.

Defense Secretary Called Lax In Vaccine Case

Six congressmen, including Connecticut's U.S. Rep.

Shays, say a congressional inquiry shows that Secretary of Defense

S. Cohen failed to carry out plans to ensure the safety of

the anthrax vaccinations for all 2.4 million U.S. troops.

Service Members Tell Panel Of Anthrax-Shot Complications

Jon Richter's health troubles started shortly after he took his

second shot of the military's mandatory anthrax vaccine Feb. 19. A

transport jet pilot in the reserves at Delaware's Dover Air Force

Base, Richter dutifully took part in the program, despite rumors of

nasty side effects and concerns about the vaccine.

Anthrax Vaccine's Safety Questioned

Newly obtained U.S. Army and other military documents raise

questions about the anthrax vaccine's safety and effectiveness in

light of the positive way the U.S. Department of Defense has been

advertising the vaccine.

Pentagon Official Tells Congress Anthrax Vaccine Is Safe

A top Pentagon official told Congress Wednesday that the

controversial anthrax vaccine is safe, despite an Army memorandum

that voices concerns about possible adverse health effects on

American troops now required to receive it.

Military Knew Of Vaccine's Hazards

The secretary of the U.S. Army conceded in a September 1998 memo

that the anthrax vaccine eventually to be administered to 2.4

million service people could cause adverse reactions and might not

even protect some against anthrax attacks.

Anthrax Shots Are Resumed After Hiatus

A commander at Dover Air Force Base in Delaware became the highest-

ranking member of the military to defy the Defense Department when

he suspended most anthrax vaccinations at his base last week. But

Col. Felix M. Grieder's stand was short-lived.

Doctors Politicians Boost Opposition To Pentagon's Vaccine Policy

More than a year into its mandatory anthrax vaccination program, the

U.S. military finds itself facing challenges from the medical

community, some members of Congress and a growing number of its

servicemen and women.

Anthrax Vaccine Debate Moves To Congress

The Department of Defense is in the midst of an effort to immunize

all 2.4 million active duty personnel against deadly anthrax spores,

potentially spread by enemy troops or terrorists. The estimated cost

of the inoculations -- the first attempt to protect the entire

military against a germ warfare agent -- is $130 million.

Pilots Quit Guard Unit In Anthrax Argument

Eight veteran combat pilots from the Connecticut Air National Guard -

- almost a quarter of the 103rd Fighter Wing -- are resigning to

protest a requirement that they be inoculated with a controversial

anthrax vaccine.

Military Anthrax Shot Challenged

A dispute has arisen over recent use of the anthrax vaccine to

protect U.S. troops from biological warfare during the military

deployment in the Persian Gulf area.

Defense Documents Support Claims Of Gulf War Veterans

U.S. Department of Defense documents contradict the Pentagon's

assertions that Persian Gulf War soldiers were not exposed to Iraqi

chemical or biological weapons.

Experimental Drugs Cited In Gulf War Illnesses

Experimental drugs and vaccines used to protect U.S. soldiers in the

Persian Gulf War may have caused the mysterious illnesses plaguing

some of them since. Many soldiers received anthrax shots to protect

them from biological warfare, and anti-nerve-agent pills, called

pyridostigmine, to shield them from nerve gas.

Gulf War Veteran Seeks Army Recognition Of Syndrome

Gulf war veteran M. Guerrette is tired, demoralized - and

waging the fight of his life. Like thousands of other gulf war

veterans, the 33-year-old Willimantic native thinks he got sick in

the war against Iraq. He's not sure exactly how.

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Administrator & #65532;posted November 20, 2003 21:56 & #65532; & #65532; & #65532;

http://courant.ctnow.com/projects/anthrax/

Anthrax Vaccine:

Care Or Curse?

The Vaccine:

A treatment designed to protect against anthrax, a livestock disease

that is almost 100 percent fatal to humans.

Why Use It?

The Pentagon says vaccination of military personnel is necessary to

guard against one of the world's top biological warfare threats.

Anthrax is considered the easiest germ weapon to make and use. It

can be produced in a dry form that can be ground into tiny particles

and stored. When inhaled, the particles can cause severe pneumonia

and death within a week.

Why Resist It?

Critics question the safety and effectiveness of the vaccine, saying

a link may exist between diseases developed by Persian Gulf War

veterans and anti-anthrax shots administered to 150,000 U.S. troops

who served in the 1991 conflict. Their worries were reinforced when

Food and Drug Administration inspectors said testing and record-

keeping at the Michigan plant that produces the vaccine did not meet

federal standards.

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Administrator & #65532;posted November 20, 2003 21:58 & #65532; & #65532; & #65532;

http://www.ctnow.com/news/specials/hc-anthrax-detrick.storygallery?

coll=hc%252

SPECIALS

Anthrax Attacks

Dozens of scientists are under scrutiny because they had access to

the strain of anthrax used inlast fall's anthrax attacks and the

knowledge to use it as a weapon. But so far, Dr. J. Hatfill

is the only one who has been publicly served with a search warrant.

October 9, 2002

An Anthrax Widow May Sue U.S. - Hartford Courant

Ineligible for financial aid to victims of Sept. 11 and angry over

signs that an Army lab may have unwittingly provided the anthrax

that killed her husband last fall, the widow of a Florida tabloid

editor is exploring a lawsuit against the federal government.

September 7, 2002

Anthrax Killer Outlasting Hunters - Hartford Courant

Five months after the deadly anthrax letters were mailed last fall,

FBI investigators finally got around to subpoenaing laboratories

that worked with the Ames strain used in the attacks.

September 4, 2002

Hatfill Fired From Job - Hartford Courant

The former army scientist at the center of the FBI's anthrax

investigation was fired Tuesday from a government-funded teaching

job at Louisiana State University.

August 14, 2002

New Anthrax Clue, Same Hatfill Focus - Hartford Courant

On the heels of the first big break in the anthrax investigation in

months -- the discovery of a New Jersey mailbox where the anthrax-

laced letters may have been mailed -- federal agents Tuesday

blanketed the area flashing a picture of the man they have refused

to call a suspect.

August 12, 2002

Hatfill Speaks Out - Hartford Courant

The man at the center of the FBI probe of last fall's anthrax

attacks launched a public campaign this weekend proclaiming his

innocence and trying to quell what he described as a humiliating

``feeding frenzy'' for information about his personal life.

August 2, 2002

Scientist Again Under Scrutiny - Hartford Courant

FBI anthrax investigators are turning up the heat on former Army

bioterrorism scientist Hatfill, searching his land

apartment for a third time Thursday and questioning students who

attended an African medical school with Hatfill 20 years ago.

June 28, 2002

Hatfill Teaching Bioterrorism Course - Hartford Courant

J. Hatfill, the microbiologist at the center of the FBI's

anthrax investigation, has been working as part of an $11.5 million

government-funded program to train police and firefighters in the

event of a bioterrorism attack.

June 13, 2002

Anthrax Theory Emerges - Hartford Courant

The FBI is investigating whether the anthrax spores used in last

fall's attacks could have been grown secretly inside an Army lab and

then taken elsewhere to be weaponized, according to three sources

familiar with the ongoing probe.

February 1, 2002

Most Samples Tracked: Anthrax Still Missing - Hartford Courant

The Army has been unable to locate an anthrax specimen that

disappeared from its biowarfare research institute 10 years ago,

although it now can account for most of 26 other lab samples that

went missing, an Army spokesman said Thursday.

January 20, 2002

Anthrax Missing from Army Lab - Hartford Courant

Lab specimens of anthrax spores, Ebola virus and other pathogens

disappeared from the Army's biological warfare research facility in

the early 1990s, during a turbulent period of labor complaints and

recriminations among rival scientists there, documents from an

internal Army inquiry show.

December 20, 2001

Anthrax Easy to Get Out of Lab - Hartford Courant

Pink-slipped in 1997 after 11 years working with the world's

deadliest toxins at the Army biodefense lab in Fort Detrick, Md.,

Crosland reluctantly packed a box of personal items into his

red Mustang and drove home.

December 19, 2001

Turmoil in a Perilous Place - Hartford Courant

Days before the anthrax attacks became known, Dr. Ayaad Assaad sat

terrified in a vault-like room at an FBI field office in Washington,

D.C. The walls were gray and windowless. The door was locked. It was

Oct. 3.

December 6, 2001

Anthrax Investigation Tracks Vaccinations - Hartford Courant

The FBI has asked laboratories around the country for records of

workers vaccinated against anthrax, as investigators pursue a

growing suspicion that whoever mailed the anthrax-laden letters in

New Jersey must have taken extraordinary steps to avoid dying in the

process.

What You Need To Know About Anthrax - Hartford Courant

View our information on Anthrax.

October 24, 2001

Anthrax: Questions, Answers - Hartford Courant

Q. How are people infected?

October 23, 2001

What You Need to Know About Anthrax - Newsday

Here is a collection of stories, photos, graphics and links to

health websites with answers about anthrax and its treatment.

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Administrator & #65532;posted December 05, 2003 23:22 & #65532; & #65532; & #65532;

http://www.ngwrc.org/anthrax/default.asp

Welcome to the Anthrax Vaccine Network

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ANTHRAX VACCINE GOVT. INFORMATION

http://www.avip2001.net/GovernmentInformation.htm

ANTHRAX SHOTS DRIVE AIR FORCE VETERAN FROM THE SERVICE

http://www.avip2001.net/OfficialDocuments_files/MA.htm

LETTERS OF OPINION/ATTEMPTS TO INFORM GOVT. OFFICIALS

http://www.avip2001.net/Opinion.htm

MORE ANTHRAX VACCINE SITES

http://www.avip2001.net/InformativeWWWSites.htm

BOOK REVIEW ON " VACCINE A " - By GARY MATSUMOTO/CNN Special Reporter

http://www.vaccine-a.com/

BOOK REVIEW ON " ANTHRAX - A DEADLY SHOT IN THE DARK " by TOM

HEEMSTRA

Web Won't Let Government Hide

Given the government keeps tabs on the world using armies of agents,

algorithms and wiretaps, how can a citizen compete? Try a browser.

Governments at every level these days are providing less information

about their inner workings, sometimes using fear of terrorism as an

excuse. But it's precisely times like these that mandate citizens'

rights to check the efficiency of their government and hold those

who fail accountable, open government advocates say. The government

itself won't make it easy, so an increasing number of websites and

data crunchers are stepping in to provide information about the

inner workings of government. For starters, there's Google's little-

known government specific search engine. One can even find homeland

security alerts about truck bombs (PDF) and the intelligence needs

of the FBI. Another trove of information is Washington

University's National Security Archive, which contains thousands of

documents acquired through patient Freedom of Information Act

requests. And there's CoolGov, a blog devoted to ferreting out

quirky tidbits such as videos of airline crashes. Those interested

in the nitty-gritty of how and why the government hides information

can subscribe to Aftergood's Secrecy News listserv, which is

part of his work as the director of Federation of American

Scientists' Project on Government Secrecy. Aftergood, who publishes

a couple times a week, has built up an archive of previously

unpublished reports created for Congress and information about the

CIA's ongoing opposition to the publication of its budget. Chris

Hoofnagle, a lawyer for the Electronic Privacy Information Center

(which is known for its prowess with Freedom of Information Act

requests), calls Aftergood's work a must-read for anyone interested

in a " nuanced interpretation of government information policy. "

Aftergood uses FOIA requests only sparingly though, calling them

cumbersome, relying instead on contacts and tips. " Information has

gravitational properties, " Aftergood said. " Over time, more and more

information flows to me. " When asked what motivates him, Aftergood

gives both a principled and pragmatic answer. " Openness is essential

to self-government, " Aftergood said. " If we mean to be our own

rulers, then we need access to information. What keeps me going,

though, is that, fortunately, a lot of this work is fun -- it is fun

to collect information and to share it with like-minded others and

to discover that small groups of interested citizens can be more

effective and agile than large government bureaucracies. " Aftergood

is not the only one-man information bank on the internet. Russ Kick

keeps information alive at The Memory Hole, where he archives

documents pulled from government websites. He is famous for

successfully using FOIA to obtain and publish photos of American

soldiers' coffins being unloaded at the Dover Air Force Base. " We

aren't experts, so if we can find it -- these folks are much smarter

than we give them credit for, they are almost certain to already

have it, " Young said. " They use the internet avidly and have a lot

more time to do this than I do. If I can find it and not let it be

known, it creates a greater hazard. " EPIC's Hoofnagle sees these

efforts as part of an " overall system that has a skeptical worldview

of government action. " " Our FOIA work has proven it pays to be

skeptical, " Hoofnagle said. " EPIC is perhaps best known for our FOIA

requests into the Carnivore system, which the FBI described as a

precise and surgical computer forensic tool that turned out to be

more like a vacuum cleaner. " Unless one can put their hands on the

actual agency documents, the public has to rely upon representations

that may be jaundiced.

posted December 19, 2004 11:41

You can be tested for ASA (Anti-Squalene Antibodies), however I

don't know if the VA will test for this. I would call the

VA/Environmental Agents Service near you and ask if they can test

you for it.

http://www.milvacs.org/Sick/Mycoplasm.cfm

Squalene, an orgamic polymer which occurs naturally in the human

body, is, in remanufactured form, an adjuvant, or vaccine " booster, "

used in several experimental vaccines. The purpose of such an

adjuvant is to boost the immune system's reaction to the vaccine. It

is illegal for use on human beings in the United States and Great

Britain. There is evidence that when injected, squalene is

responsible for arthritic conditions and pain. Squalene appears to

be highly reactive when injected, although not as reactive when

ingested orally.

Although the Dept. of Defense denied the presence of Squalene in the

anthrax vaccine for many years, the FDA tested several lots for the

presence of the adjuvant, and found it - in varying levels. Those

lots are (ppb=parts per billion):

AVA 020 - 11 ppb squalene

AVA 030 - 10 ppb squalene

AVA 038 - 27 ppb squalene

AVA 043 - 40 ppb squalene

AVA 047 - 83 ppb squalene

Squalene has also been found in the vaccine administered in Great

Britain, although the Ministry also denied its presence. See MOD

(Ministry of Defense - UK - ANTHRAX VACCINE CONTAINS SQUALENE)

Recent research by Pamela B. Asa, B. , and F.

Garry links the anthrax vaccine to Gulf War Syndrome through the

presence of squalene antibodies, as noted in the introduction to

their report:

" Date: 2002-07-15 Received August 15, 2001, and in revised form

October 26, 2001 "

" We previously reported that antibodies to squalene, an experimental

vaccine adjuvant, are present in persons with symptoms consistent

with Gulf War Syndrome (GWS) (P. B. Asa et al., Exp. Mol. Pathol 68,

196-197, 2000). The United States Department of Defense initiated

the Anthrax Vaccine Immunization Program (AVIP)

in 1997 to immunize 2.4 million military personnel. Because adverse

reactions in vaccinated personnel were similar to symptoms of GWS,

we tested AVIP participants for anti-squalene antibodies (ASA). In a

pilot study, 6 of 6 vaccine recipients with GWS-like symptoms were

positive for ASA. In a larger blinded study, only 32% (8/25) of AVIP

personnel compared to 15.7% (3/19) of controls were positive (P

0.05). Further analysis revealed that ASA were associated with

specific lots of vaccine. The incidence of ASA in personnel in the

blinded study receiving these lots was 47% (8/17) compared to an

incidence of 0% (0/8; P 0.025) of the AVIP participants receiving

other lots of vaccine. Analysis of additional personnel revealed

that in all but one case (19/20; 95%), ASA were restricted to

personnel immunized with lots of vaccine known to contain squalene.

Except for one symptomatic individual, positive clinical findings in

17 ASA-negative personnel were restricted to 4 individuals receiving

vaccine from lots containing squalene. ASA were not present prior to

vaccination in pre-immunization sera available from 4 AVIP

personnel. Three of these individuals became ASA positive after

vaccination. These results suggest that the production of ASA in GWS

patients is linked to the presence of squalene in certain lots of

anthrax vaccine. 2002 Elsevier Science (USA) "

*********************************************************************

*****************************************************************

THE FOLLOWING ARTICLE COME FROM A HOMELAND SECURITY FORUM

Posted: Mon Dec 27, 2004 12:46 pm Post subject: VACCINES -Clinton

Orders Human Experiments December 27, 2004

VACCINES - Clinton Orders Human Experiments

By W. Maier

A day after Republican Rep. Shays of Connecticut ended

congressional hearings on the controversial decision mandating the

inoculation of 2.4 million U.S. troops against anthrax, President

Clinton quietly signed an executive order, or EO, that denies

soldiers the right to refuse experimental vaccines.

EO13139, titled " Improving Health Protection of Military Personnel

Participating in Particular Military Operations, " caught Congress

off guard as it directed the Pentagon to disregard the authority of

the Food and Drug Administration, or FDA. The order authorized use

of experimental vaccines - those not approved by the FDA and

therefore illegal - to be administered to members of the armed

forces without informed consent.

Some congressmen saw this as an attack by the president on the House

Government Reform subcommittee on National Security, Veterans

Affairs and International Relations, where testimony indicated the

Pentagon had violated the FDA's procedures on how to administer the

anthrax vaccine. Those hearings - as well as others held by the full

House Committee on Government Reform - had put the FDA on the spot

for letting the Pentagon disregard sensible FDA regulations. The

Pentagon wanted to administer the shots now and, as a result, long-

range studies were not conducted and an inadequate reporting system

was set up to hide the large number of adverse effects, critics

charged.

As a result of the unprecedented implementation of the vaccination

program, more than 1,000 troops are awaiting trial on a felony

charge of refusing to obey, hundreds more have left the armed forces

and dozens have been prosecuted.

The FDA's failure to take a stand against the Pentagon has prompted

a group of concerned congressmen, led by Republican Rep. Walter

Jr. of North Carolina, formally to complain to the

agency. " The FDA didn't do its job, " says , a member of the

House Armed Services Committee. " Our men and women are too valuable

and they're not going to be guinea pigs. "

, who has asked the Pentagon's inspector general to launch a

probe into the growing anthrax controversy, warns that Clinton's

executive order " might encourage more men and women to get out of

the military. I think Clinton did it to give cover to what the DOD

[or Department of Defense] is doing. " And with the FDA having rolled

over, says, he is even more determined to learn why the White

House and the Pentagon doubled the contract of Michigan-based

BioPort Corp., which manufactures the vaccine, from $25.7 million to

$49.8 million and at the same time reduced the volume to be

delivered by 2.3 million shots (see " Why BioPort Got a Shot in the

Arm, " Sept. 20).

The Pentagon has claimed the inoculation protects against all

anthrax strains, and BioPort made the same claim to Insight -

despite the fact that an experiment at the Fort Detrick chemical and

biological warfare center in land using guinea pigs showed nine

of the 27 anthrax strains tested killed 50 percent of the vaccinated

subjects.

…for more on this article and other posts go to

www.hspig.org/ipw-web/bulletin/bb/viewtopic.php?t=1930

SITES ABOUT SOLDIERS USED IN GOVT> TEST PROGRAMS

http://projects.sipri.se/cbw/research/ssf-cwc-fs-eif.html

http://www.wsws.org/articles/2004/dec2004/port-d11.shtml

http://www.ceip.org/files/publications/Harigelreport.asp?p

http://www.rand.org/publications/MR/MR1018.5/MR1018.5.pdf/MR1018.5.ch

1.pdf

http://www.nnn.se/vietnam/health.pdf

http://www.bordeninstitute.army.mil/cwbw/Ch8.pdf

http://www.fpif.org/briefs/vol1/chem_body.html

http://www.asanltr.com/newsletter/02-1/articles/021d.htm

http://www.leaonline.com/doi/abs/10.1207/S15327876MP1402_5;jsessionid

=jaIPVNgaD7h-?cookieSet=1

http://www.iupac.org/publications/pac/1995/pdf/6705x0841.pdf

http://www.iupac.org/publications/pac/1995/pdf/6705x0841.pdf

http://www.nap.edu/books/030904832X/html/131.html

http://www.nap.edu/books/030904832X/html/21.html

http://ccrweb.ccr.uct.ac.za/archive/two/10_3/biological.html

http://www.loc.gov/rr/scitech/tracer-bullets/chemicalbiotb.html

http://www.nbc-med.org/SiteContent/HomePage/WhatsNew/MedAspects/Ch-

3electrv699.pdf

http://www.csis.org/burke/hd/reports/Buffy012902.pdf

http://www.wws.princeton.edu/cgi-

bin/byteserv.prl/~ota/disk1/1993/9346/934604.PDF

http://www.bordeninstitute.army.mil/cwbw/Ch12.pdf

http://www.opcw.org/docs/csp9/c9dec03.pdf

http://www.wws.princeton.edu/cgi-

bin/byteserv.prl/~ota/disk1/1993/9346/934604.PDF

http://www.opcw.org/docs/csp9/c9dec03.pdf

http://www.cepis.ops-

oms.org/tutorial1/fulltex/armas/bioweapons/bioweapons.pdf

The above web sites are mostly from US Government sponsored research

or from internationally known organizations and their research is

accepted world wide.

Marilyn s article on Anthrax Vaccines

http://www.hspig.org/ipw-web/bulletin/bb/viewtopic.php?t=1864

_____________________________________________________________________

_____________________________________________________________________

______

List of U.S. Veteran Web Sites

http://members.aol.com/veterans/warlib6.htm

http://www.vetfriends.com/organizations/index.cfm

List of Veterans Service Organizations

http://www.vasthcs.med.va.gov/vso.htm

List of U.S. Radio and Television Stations

http://www.journalismnet.com/radio/us.htm

List of U.S. Colleges

http://www.cs.queensu.ca/FAQs/email/country/United-States-of-America-

C.html

List of U.S. Newspapers

http://www.usnpl.com/

List of Congressional Members

http://www.webslingerz.com/jhoffman/congress-email.html

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Breakthrough on Gulf War Illness By M.

After a year of stonewalling by the DOD, a new study at the

prestigious Tulane University Medical School confirms that victims

of a mysterious sickness may have been poisoned.

It started with a telephone call nearly two years ago, a call with a

question not yet fully answered: How did antibodies to a chemical

compound called squalene get into the bloodstreams of sick soldiers

who served overseas during the Persian Gulf War, and even of some

whose service during that era never took them outside of the United

States?

.. . . . The sick soldiers had one thing in common -- they all had

received a full complement of military immunizations. And with that

in mind, laboratories contacted by Insight began searching for

allied clues related to the so-called Gulf War Syndrome.

.. . . . Now, after nearly 18 months of intensive study, checking and

rechecking related data, the prestigious Tulane University Medical

Center School of Medicine's department of microbiology and

immunology, in New Orleans, has confirmed test results first

reported by this magazine a year ago.

.. . . . According to Tulane, antibodies to squalene indeed do appear

in the bloodstreams of the sick veterans -- in fact, the sicker the

veteran, the higher the level of such antibodies.

.. . . . Tulane's final laboratory results are highly significant.

Although squalene is a naturally occurring substance in the human

body, associated with cholesterol, the presence of the antibodies

strongly suggests that an outside antigen -- or medical cause -- is

involved here. When Insight first reported the presence of the

squalene antibodies, the Defense Department resisted the findings,

suggesting that some human condition gone awry might explain them.

Certainly that speculation no longer will do.

.. . . . " Yes, it's pretty significant, " says B. ,

president of Autoimmune Technologies, LLC, a medical marketing and

research firm in New Orleans hired by Tulane to publicize and market

its groundbreaking research into squalene antibodies. " We're not

saying we know how [the antibodies] got there [in the sick

soldiers], but we are saying we have proof positive of an objective

marker that they do exist. "

.. . . . Garry, the widely respected lead scientist at

Tulane's department of microbiology and immunology, whose peer-

reviewed medical experiments led to the assay that confirms the

presence of squalene antibodies, modestly describes his findings to

Insight as important. " We can say for certain now that these

antibodies do exist in sick soldiers we've tested, " Garry says.

.. . . . " How this plays into the illnesses of these patients will

require more work, but certainly this is an important marker to

begin conducting research, " he adds. " We're not saying we know how

or what caused the antibodies to appear, but we now can confirm they

do exist and that further testing certainly is in order to find out

why, because it would be extremely remote that such antibodies would

appear as a result of natural causes. "

.. . . . Put another way, according to , himself a Ph.D. in

cellular microbiology, it is unlikely these antibodies to squalene

resulted from a naturally occurring cellular dysfunction in the

human body. " The objective marker Tulane has discovered suggests

other causes, " says. " It suggests they were induced from an

outside source. "

.. . . . And so the mystery deepens. From the beginning of Insight's

investigation, the DOD has mustered statements from Secretary of

Defense Cohen down to the various surgeons general of the

armed forces and the Veterans Administration and Walter Army

Medical Center denying any knowledge, let alone responsibility, for

this presence of squalene antibodies. One reason for the nervousness

at the Pentagon, as congressional investigators and top military

brass privately have told this magazine, is that any linkage between

the DOD and the discovery of the antibodies could suggest that some

experimental vaccine was given to soldiers just before the war began

in 1991.

.. . . . Although the DOD vehemently denied it ever had used anything

other than alum-based immunizations on American troops, Insight

learned 18 months ago that in fact DOD medical experts had been

working secretly for several years developing an alternative and

more powerful substance to help make certain immunizing drugs work

more effectively and faster. Such compounds are called adjuvants.

Because these compounds can so powerfully affect the body, alum is

the only U.S.-approved adjuvant for humans.

.. . . . However, in the experimental fields of medicine, cutting-

edge biochemical therapies are worked on every day, including

alternative adjuvants to alum. Their use on humans is strictly

controlled and only permitted with government approval in advanced

scientific research. Squalene is one such experimental adjuvant. A

powerful immune stimulant, it has been tested at Walter and the

National Institutes of Health for treatment of herpes, malaria and

AIDS.

.. . . . Indeed, Walter not only is the only known U.S.

government manufacturer of squalene, but it has been using squalene

in secret anti-HIV tests in Thailand for a number of years. Yet when

Insight first began probing squalene antibodies as a possible cause

for some of the gulf-war sicknesses, the DOD and Walter denied

ever using squalene. They denied even knowing that such an adjuvant

existed or that it was one of a series of high-tech

experimental " medicines " undergoing tests by the military. Only

after this magazine reported the preliminary test results on the

sick vets -- without identifying the role of Tulane's medical

laboratory -- did the DOD finally acknowledge its experiments with

squalene. But for two years DOD officials steadfastly have denied

that they ever administered any secret vaccines to gulf-war soldiers

or that they administered anything not approved by the Food and Drug

Administration, or FDA.

.. . . . Despite repeated requests from this magazine and from

interested lawmakers, DOD officials also have refused on the record

so much as to investigate whether squalene antibodies have in fact

been found in the sick soldiers. The response has been: We never

used it, it's only a theory -- and therefore we don't need to pursue

it. Moreover, DOD officials have waged a major behind-the-scenes

campaign for the better part of a year to try to discredit Insight's

initial reports about these matters. " They came in and briefed us

and told us your story was full of shit, " said a senior aide on the

House Veterans' Affairs Committee. Rep. Shays, a Connecticut

Republican who chairs the Government Reform and Oversight

subcommittee on Human Resources, says that when he tried to look

into the issue he was assured there was nothing to it.

.. . . . Shays and members of the Veterans' Affairs and Armed

Services committees who had promised to pursue the mystery of the

squalene antibodies all ran into the DOD's disinformation campaign.

Also, the initial test results Insight reported were just that.

Without a peer-reviewed paper in a scientific journal to confirm

details or the name of the laboratory conducting the research, the

DOD flacks managed to stonewall and cast doubt on the story.

.. . . . Another and equally important reason the issue was dropped,

according to congressional and DOD officials, was a campaign

directed at a Tennessee immunologist named Pamela Asa. She was the

first to advance the theory that one of the causes of so many

unexplained illnesses in gulf-war vets might be an autoimmune

dysfunction caused by immunizations. Because she is not a nationally

renowned scientist like Garry, it was suggested that she could not

be taken seriously by DOD and her theory was bunk. Behind the

scenes, DOD secretly commissioned a " study " three years ago that,

according to a high-level DOD medical scientist, was designed to

bury the Asa theory when she became " a pain in our butt, calling

around and causing trouble. " That " study " lay dormant until Insight

broke the initial squalene story. DOD officials then trotted it out

as " proof " that not only was her theory wacky but there was no

medical basis for claims that an " unknown adjuvant " might be one of

the causes of so much sickness.

.. . . . Contrary to the odd picture painted by the DOD, however, the

Pentagon never did an exhaustive study on whether an experimental

squalene adjuvant was used on soldiers, let alone the theory of

adjuvants' disease. What DOD commissioned was a study concerning the

plausibility of the theory that adjuvants could have had any role in

making so many soldiers sick. Since the study's authors were told

that only alum was used, the research paper concluded that Asa's

theory was not plausible.

.. . . . The DOD even put out press releases and Internet messages

arguing that because it never used squalene in any immunizations

during the Persian Gulf War, the Insight story must have been based

on bogus test procedures that simply picked up molecular traces of

the naturally occurring squalene.

.. . . . Meanwhile, in the intervening year, Tulane's Garry and his

team quietly continued to perfect their testing protocol and

systematically eliminated possibilities put forth by DOD. Scientific

literature reviewed shows that squalene could not be absorbed orally

or topically. And Tulane determined that production of antibodies to

a naturally occurring substance in the human body would be remote,

if not virtually impossible.

.. . . . " I think you would discover that life exists on Mars before

you could believe these [antibodies] were naturally occurring, " says

Garry. " My God, the human body is a very tough customer from a

cellular biological perspective. Even people who were exposed to

radiation from World War II did not show basic changes in their

molecular biology. "

.. . . . Rep. Jack Metcalf, a Washington Republican, dissatisfied

with the shaky DOD responses, called on the General Accounting

Office for an investigation. The yearlong GAO probe, though still

confidential, has not found evidence that the DOD used squalene in

immunizations given to gulf-war troops. But its investigators are

troubled by the confusing and incomplete facts offered by DOD

concerning the now-undeniable presence of squalene antibodies. In

the as-yet-unpublished report, the GAO has recommended that Congress

conduct hearings.

.. . . . " The responses and documents obtained by GAO closely tracked

what you at Insight got, " says one of more than two dozen sources

familiar with both the GAO probe and the medical tests conducted by

Tulane's medical department. " First the DOD said they didn't have

[squalene]; then they said they did but never used it; then they

said they used it but only after the war; then they admitted they

had manufactured it prior to the war but claimed they never used it;

then it was confirmed that it has been used overseas in trials for a

number of years; then, well, you get the picture, " says one of these

Insight sources.

.. . . . Tulane's confirmation contains immense implications,

according to several DOD, congressional and government

scientists. " What this tells us is that something containing

squalene was exposed to these patients, " says Asa, who long has

suspected that with good intentions but disastrous results the

military administered an unknown experimental vaccine just prior to

the Persian Gulf War.

.. . . . No evidence yet has surfaced to confirm this scenario, say

those who have investigated the mystery of the squalene antibodies.

And a highly sensitive DOD often makes this point in response to

media inquiries. However, based partly on the medical tests and

partly on DOD's contradictory responses concerning squalene's uses

in experimental sciences, a number of medical, military, laboratory

and veterans groups now are skeptical -- and nervous -- about the

possibility that something that went awry is being hidden.

.. . . . Veterans' fears are not being assuaged by DOD's refusal to

release records involving its experiments with squalene -- nor is

there comfort in its refusal to release details of what its various

vaccines during the gulf war contained. The FDA, reportedly at the

request of DOD, has declined to provide any information whatsoever

related to those vaccines -- even to the GAO.

.. . . . " They have created an air of mystery by their actions that

has certainly raised suspicions, " a government official says. " Even

if they are innocent, they have acted so guilty as to raise

questions. It would be such a simple thing to just go and test for

these antibodies. " Indeed, to Garry, Asa and hundreds of gulf-war

vets who have volunteered for strict double- and triple-blind tests

for squalene antibodies as administered by Tulane's Medical School,

these actions by the military are deeply troubling. " I don't

understand their position, " confesses Garry, who often has worked

with DOD and other government agencies. " They could have taken our

testing protocol and quickly determined if there was any validity to

the allegation. "

.. . . . Many of the DOD officials interviewed by Insight, as well as

those interviewed by the GAO, have gone to extraordinary lengths to

distance the Pentagon from the issue of the squalene antibodies. One

reason advanced by many of the veterans and their families may have

to do with the way several hundred of the sick soldiers were treated

immediately after the gulf war and ever since. Scores of them were

placed in Walter 's special HIV ward and isolated even from

their doctors by personnel brought in from special DOD units to

conduct medical evaluations based on AIDS-related symptoms. Many of

these patients not only never learned what the specialist teams

discovered, or for that matter what they failed to find, but they

were required to submit to further semiannual HIV-examination

testing procedures for many years without explanation.

.. . . . Metcalf says the reasons behind any stonewalling are not

nearly so important as getting help to thousands of sick gulf-war

soldiers. " I have been deeply concerned about this issue since it

was first brought to my attention by veterans suffering from gulf-

war illnesses, " he says in a statement prepared for Insight. " They

had read the news reports about blood samples of some Gulf War-era

veterans containing antibodies to squalene. They want to know the

truth about why they are sick. "

.. . . . Metcalf continues, " I believe that any legitimate research

that could provide clues as to the nature and treatment of their

illnesses must be pursued vigorously. I asked the GAO to look into

the issue ... and to determine if there was any possibility that

veterans had received squalene and to determine if the reported

research was valid. "

.. . . . The magnitude of the problem is considerable. " With over

100,000 of our veterans suffering, the DOD history of foot-dragging

and obfuscation on this issue is inexcusable, " Metcalf says. " The

GAO study tells us that we can spend just a few thousand dollars and

possibly unravel the mystery of gulf-war illnesses. We have a moral

obligation to stand with the honorable men and women who sacrificed

for this nation in their search for effective treatment ... and I

demand DOD act on the GAO recommendations. " Calls to DOD for

official comment were not returned.

.. . . .

Anatomy of a Discovery: Leading University Confirms Suspicions

.. . . . It was nearly seven years ago. By a quirk of fate, a

shipping label accidentally was left on a batch of test tubes

containing blood specimens taken from sick vets. The squalene

mystery began to unfold.

.. . . . At the time, U.S. soldiers returning home were complaining

about strange illnesses. Defense Department and Veterans

Administration officials said there were no medical reasons for

their sickness. No chemical or biological weapons had been used in

theater, nor were there nuclear-related reasons. But more and more

veterans, initially those who served overseas and then those who

never left the United States, complained of autoimmune ailments that

had no known cause. And more and more the soldiers were told their

illnesses were psychological or possibly related to a combination of

desert heat and allergy to insecticides -- and not to worry. What

was occurring behind the scenes, however, told another story,

according to a two-year investigation by Insight into the discovery

of antibodies to squalene in the blood of the sick.

.. . . . As it worked feverishly in public to deny any link between

the odd illnesses and symptoms reported by a growing number of

soldiers who served during the gulf war, medical personnel inside

the military and the VA were working quietly to determine whether

something indeed was causing gulf-era soldiers to fall ill and, in a

growing number of cases, to die for unexplained reasons.

.. . . . While the Pentagon denied that a secret arsenal had been

unleashed by Iraq on U.S. forces in theater, Walter Army

Medical Center was working on a variety of theories involving

possible biological or chemical weaponry.

.. . . . In one of many experiments -- conducted without the

knowledge of soldiers, family and (in many cases) even the patient's

doctors -- teams of medical specialists secretly obtained blood

samples of sick veterans. In one case, blood collected from sick

gulf-war soldiers was shipped to s Hopkins University in

Baltimore, where specialists in environmental sciences were asked to

determine if anything unusual could be detected in the samples. At

the request of a doctor at Walter who worked in the HIV

experimental-sciences section, s Hopkins was asked to conduct

unusual but very specific tests for an autoimmune disease --

notwithstanding that the DOD had denied it was searching for such a

cause.

.. . . . Enter Tulane University Medical School and Dr. Garry.

Unable to conduct the specialized tests requested, s Hopkins

made arrangements with Garry, a noted retrovirologist, to test for

HIAP (Human Intracisternal A-type Retroviral Particle), a medical

marker associated with autoimmune diseases believed to be linked

with HIV, the AIDS precursor. To conduct such tests, Tulane was sent

blood samples drawn from sick vets. Garry initially believed these

came from s Hopkins. It was not for several years, when checking

a saved shipping label to answer a reporter's questions, that Garry

and Tulane realized the blood samples had come via Hopkins from the

Walter physician who worked on HIV.

.. . . . Garry examined the blood and reported negative findings to

s Hopkins -- which, in turn, so informed Walter . When he

had finished his research for s Hopkins in the early 1990s,

Garry called to determine what to do with the blood samples still on

hand. He was told to do whatever he cared to: Since the tests were

negative, s Hopkins said that neither it nor its client needed

them returned.

.. . . . Unknown to s Hopkins, as well as Walter , Garry's

laboratory froze the samples and locked them away until 1997, when

Pamela Asa began looking for clues about the possible causes of Gulf

War Syndrome. She had theorized that an unrevealed vaccine or

vaccine component such as an adjuvant might be contributing to the

illnesses reported by sick soldiers.

.. . . . Over many months of testing, Asa zeroed in on squalene as an

experimental adjuvant that the military might have used to protect

soldiers from biological- or chemical-warfare agents. Knowing of

Garry's work in the polymer sciences, she contacted the Tulane

expert and they began a loose collaboration, sharing information and

conducting tests on patients to search for clues.

.. . . . When Insight began investigating Asa's theory of possible

squalene-related causes, Garry had just begun working on a protocol

test based on blood he obtained from sick soldiers. Remembering he

had received similar samples a few years earlier via s Hopkins,

he also started testing the older samples. It was then that the

antibodies to squalene began to be detected -- Asa's theory was

beginning to show promise.

.. . . . Tracking doctors involved in experimental medicine at Walter

, Insight came across the name of the military doctor mentioned

by chance to Garry, who remembered the same doctor had shipped the

s Hopkins blood samples to him. When the original shipping

labels and medical-test orders were reviewed -- like the blood

samples, the meticulous Garry had saved the shipping labels and

instructions -- Garry's memory was confirmed: It was the same

doctor, a medical specialist at Walter 's advanced-sciences

section, who had been working for years on experimental AIDS

vaccines in Thailand using squalene as a possible adjuvant. Further

checks of confidential military records also confirmed that Walter

was the only known manufacturer of this experimental substance

on record.

.. . . . Working with his forgotten but now invaluable consignment of

early vet blood samples supplied by s Hopkins via Walter ,

Garry and his team at Tulane went forward with their protocol to

search for squalene. After months of testing using both natural and

synthetic forms of the adjuvant, the protocol confirmed the presence

of squalene antibodies in the blood of only the sick soldiers --

both those who served overseas and also sick veterans who served

during the era but never got to the Middle East. The only link was

that all got their full complement of immunizations.

.. . . . Along the road to discovery, however, there were some bumps.

At one point the Garry tests did not detect naturally produced

squalene, only the synthetic form. This seemed odd and was pounced

upon by DOD officials when Insight reported the initial test

results. Over time, however, Garry realized that, unless it is very

fresh, naturally occurring squalene will begin to break down at a

molecular level. With fresh supplies of naturally occurring squalene

on hand, the tests still came back positive, just as they had (and

should have) with the synthetic squalene samples.

.. . . . Garry began to refine his protocol and continued testing

until both he and Tulane, along with Asa and her laboratories, were

confident of the testing procedures and results. Because of the

importance of the study, Tulane and Garry agreed to file a patent

jointly with Asa and to submit their findings separately to peer-

reviewed medical/science journals.

.. . . . Once all these elements were put together, Insight was

released from its pledge of confidentiality. In the next few days,

supported by the General Accounting Office's separate investigation

and the soon-to-be published results of the laboratory findings

reported here, Washington Republican Rep. Jack Metcalf will be

asking for full-blown hearings by the House Veterans' Affairs and

Armed Services committees.

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ROBERT F. GARRY ( TULANE UNIVERSITY ) ON THE RECORD

STATEMENT FOR HEARING RECORD

The House Subcommittee on National Security, Veterans Affairs,

and International Relations

January 24, 2002

Submitted by:

F. Garry, Ph.D., Professor

Department of Microbiology and Immunology

Tulane Medical School, Room 568 JBJ

1430 Tulane Avenue

New Orleans, Louisiana 70112

SUMMARY

This Statement concerns our research with anti-squalene antibodies,

including the discovery of these antibodies in the blood of patients

with Gulf War illness. Our published data and additional data which

has been accepted for publication strongly suggests that Gulf War

illness is closely associated with an abnormal immune response to

squalene indicated by the presence of these antibodies.

Our research also links specific lots of anthrax vaccine known to

contain squalene to the production of anti-squalene antibodies. In

addition, our research demonstrates that the blood test for

detecting these antibodies, the anti-squalene antibody assay, may be

an excellent tool to aid in the diagnosis of Gulf War illness.

U.S. Army researchers have verified our discovery of the antibodies

and, in May of this year, submitted a patent application covering

their anti-squalene antibody work. Our patent, U.S. Patent No.

6,214,566, " Method for Detecting Anti-Squalene Antibodies, " which we

believe covers the same technology, had already issued in April of

this year. The Army researchers have made a disingenuous attempt to

discredit our work, and they have not yet published any studies

designed to confirm our discovery of a link between the antibodies

and Gulf War illness, though they state that such studies may be

feasible.

We believe that such confirmatory studies and additional studies

should be undertaken without delay. We also believe that the anti-

squalene antibody assay should immediately be made available under

government sponsorship to all physicians interested in using it to

investigate the condition of their Gulf War illness patients.

DATA AND OBSERVATIONS

Research data which we published in February 2000 strongly suggests

that anti-squalene antibodies are closely associated with Gulf War

illness. Specifically, we found in our study participants that 95%

of the Gulf War veterans with Gulf War illness and 100% of the non-

deployed veterans with Gulf War illness were positive for the

presence of anti-squalene antibodies, while 0% of the healthy

deployed veterans were positive. Additional research data which has

now been accepted for publication shows, in a limited number of

samples tested, that an increased prevalence of anti-squalene

antibodies in Anthrax Vaccine Immunization Program (AVIP) personnel

correlated with administration of lots of anthrax vaccine

subsequently shown by the FDA to contain trace amounts of squalene.

Our results strongly suggest that the production of anti-squalene

antibodies is linked to symptoms of Gulf War illness and to the

presence of squalene found in certain lots of anthrax vaccine.

Though the source of the squalene in the vaccine lots has not, to my

knowledge, been identified, squalene is used as an adjuvant in

animal vaccines. The use of squalene as an adjuvant in human

vaccines has not been approved, and human exposure to squalene in

vaccines has been shown by others to cause immunological symptoms

similar to those found in Gulf War illness patients.

Gulf War illness is present both in Gulf War veterans who were

deployed to the Persian Gulf War theater of operations and in

personnel who were not deployed, including personnel who never left

the United States. The absence of an association between the

presence of Gulf War illness and deployment indicates that the

causative agent or factor is not associated with the Persian Gulf.

Consistent with this observation are the results of a recent

epidemiological study finding that vaccinations that were given to

both deployed and non-deployed personnel are associated with ill

health.

U.S. Army researchers have confirmed our discovery that anti-

squalene antibodies do exist and can reliably be detected, and the

Army researchers published this work in November 2000. Army

representatives filed a U.S. patent application covering anti-

squalene antibody technology on May 18, 2001, and we believe that

the technology for which the patent was filed is the same technology

that was described in the November 2000 article.

A U.S. patent covering our anti-squalene antibody technology issued

as of April 10, 2001. The patent is assigned to Tulane University

and is licensed to a New Orleans biomedical company. We believe that

the claims awarded in the Tulane patent cover the work that was

published by the Army researchers. On May 23, 2001, Tulane's

licensee wrote a letter to the Department of Defense offering to

sublicense this patented technology to the Army so that the Army

researchers could perform a study designed to confirm whether the

antibodies are linked to Gulf War illness. An Army representative

declined this offer on June 6, 2001.

The journal that published the November 2000 article by the Army

researchers received the submitted article on April 18, 2000. The

material submitted to the journal on that date demonstrated that the

Army researchers had confirmed our discovery of anti-squalene

antibodies. In June 2000, one of these same researchers, an Army

colonel, published a letter to the editor of the journal which had

published our original article in February 2000. In the June 2000

letter, the colonel stated that our published results constituted

a " new, unproven assay that claims to detect a novel antibody. " The

colonel made this statement despite the fact that he had already

confirmed our discovery and had already submitted his findings for

publication. Further, when the colonel's article appeared in

November 2000, it cited his own letter of June 2000 to call our

original findings into question. The colonel's letter expressing an

opinion which he himself had already proven to be baseless was thus

used twice in efforts to discredit our work.

The last paragraph of the November 2000 article published by the

Army researchers reads as follows:

" With the development of the ELISA using PVDF membranes, as

described in this paper, it may now be possible to undertake studies

with serum from sick and healthy individuals to determine whether

naturally-occurring antibodies to SQE [squalene] exist, and whether

the appearance or amounts of such antibodies have any relationship

to normal physiologic functions or whether they are associated with

any illness. "

With the serum samples available to the Army researchers, such

studies would in our opinion be very straightforward and would take

a short amount of time to complete. The Army has had its own version

of the necessary test available for more than two years but has

published no such studies.

Based on the Army's actions with respect to our work, we suspect

that the Army has in fact conducted these studies and elected not to

publish them. Our published research makes a compelling case that,

first, anti-squalene antibodies exist, and second, that there is a

link between the antibodies and Gulf War illness. Before the

publication date of our research, some of our research data was

discussed in a GAO report to the Honorable Jack Metcalf entitled

Gulf War Illnesses: Questions about the Presence of Anti-Squalene

Antibodies Can Be Resolved (GAO/NSIAD-99-5, March 1999). The GAO

report specifically recommended that the DoD conduct its own

research designed to replicate or dispute our results. The colonel's

research group subsequently published a confirmatory study that

looked only at our first finding and ignored the second. A

confirmatory study of our second finding would be very easy for the

Army to do in a short time, and we find it difficult to believe that

the colonel's group has not already done such a study, since any

good and inquisitive scientist with ready access to test samples

would want to do it. Instead of following the GAO's recommendation,

however, the colonel chose to publicly ignore our second finding and

to make misleading public statements that denigrated our work.

Later, when the Army and the colonel were offered the opportunity to

license our technology and finish the confirmatory work, they

declined the offer.

The presence of anti-squalene antibodies in ill people and the

absence of the antibodies in healthy people is the first hard

laboratory evidence that Gulf War illness is what some might refer

to as a " real disease. " It is also the first evidence that an

abnormal immunological response is under way in Gulf War illness

patients. The anti-squalene antibody assay thus represents the first

laboratory test for Gulf War illness. As such we believe that it has

great clinical value as a diagnostic aid, and it suggests that

therapies designed to modulate the immune response to antigens

should be investigated in patients with Gulf War illness.

Recent unpublished observations from the Veterans Administration

indicate that there is a significant increase in the prevalence of

the neuro-degenerative disease amyotrophic lateral sclerosis (ALS)

in Gulf War veterans. The data that we published in February 2000

shows that some of the patients who were ill with Gulf War illness

and who tested positive on the anti-squalene antibody assay

exhibited neurological symptoms. These results suggest that a

possible relationship between anti-squalene antibodies and ALS in

Gulf War veterans may exist and should be investigated.

Further research with the anti-squalene antibody assay continues on

a limited scale using private funds, but the test is not currently

available to individual physicians for investigation into the

conditions of their patients. More than two years have now elapsed

since DoD researchers have had access to a version of this test.

While the DoD has proceeded with an attempt to win its own patent on

the test, in our opinion it has done nothing with the test to help

any Gulf War illness patient. It is therefore our very strong

recommendation that an agency of the U.S. government immediately

commission a large study of anti-squalene antibodies and Gulf War

era veterans and other personnel, including appropriate ALS

patients. Such an investigation should be conducted in the context

of, or coordinated with, a population-based study of Gulf War era

veterans similar to the ongoing and successful Ranch Hand study of

Agent Orange. It is our further very strong recommendation that an

agency of the U.S. government immediately begin to provide the anti-

squalene antibody assay to all physicians treating patients with

Gulf War illness.

REFERENCE INFORMATION

(1) Our initial study concerning anti-squalene antibodies was

published in the February 2000 issue of Experimental and Molecular

Pathology. The results of this study strongly suggest two things:

(1) that humans can indeed raise serum antibodies against squalene,

and (2) that, in the people studied, the presence of the antibodies

correlated very closely with the presence of the symptoms of Gulf

War illness both in personnel who had been deployed to the Persian

Gulf theater and in personnel who had not been deployed there. A

copy of this article, entitled " Antibodies to Squalene in Gulf War

Syndrome, " is attached hereto ( " the Asa/Garry article " ).

(2) The anthrax bacillus is incapable of producing squalene, and

squalene is not present as a constituent of the growth medium used

to produce the organism for the anthrax vaccine. Squalene is widely

used as a vaccine adjuvant in animals, but it is clearly harmful to

many humans when used in that manner and is not approved for use in

human vaccines.

(3) A letter to the editor published in the June 2000 issue of

Experimental and Molecular Pathology addresses the work presented in

the Asa/Garry article. The letter attempts to find fault with our

testing technique, calling our test a " ... new, unproven assay that

claims to detect a novel antibody .... " The letter further states

the following:

" The conclusions of Asa and colleagues, purporting to correlate anti-

squalene [sic] with Gulf War illnesses, in our opinion, rely on

circular logic. Positive results with an assay not previously

validated cannot be used as scientific proof that antibodies to the

antigen exist in samples of unknowns. It is premature to proceed

directly to testing serum samples from healthy people and sick

people before conducting the fundamental validation steps. "

This letter was written by Col. Carl Alving of the Walter Army

Institute of Research and Grabenstein of the U.S. Army Medical

Command. A copy of this letter ( " the Alving/Grabenstein letter " ),

together with our published response and an editorial note, is

attached hereto.

(4) In the November 2000 issue of the Journal of Immunological

Methods, four researchers from the Walter Army Institute of

Research, including Col. Alving, published an article confirming

that anti-squalene antibodies do exist and can reliably be detected.

The study described in this article reproduces and expands upon our

work and validates our anti-squalene antibody assay. A copy of this

article, entitled " Induction and Detection of Antibodies to

Squalene, " is attached hereto ( " the Alving article " ).

(5) A notation by the Journal of Immunological Methods which appears

under the title line at the top of the Alving article states that

the manuscript for the article was received by the journal from Col.

Alving and his colleagues on 18 April 2000. The Alving/Grabenstein

letter was published six weeks later, in June 2000. This means that

when Col. Alving and his colleague Grabenstein were publicly

characterizing our test as a " ... new, unproven assay that claims to

detect a novel antibody ..., " Col. Alving and his other colleagues

had already written the Alving article confirming that the new

antibodies did in fact exist.

(6) The note from the journal's editors which accompanies the

Alving/Grabenstein letter points out that this letter

" ... relates to methodology. Drs. Alving and Grabenstein offer no

data against the conclusions of Asa et al. "

Since the Alving article confirms that the novel antibody was indeed

discovered by our detection method, the Alving/Grabenstein letter is

therefore rendered entirely meaningless by the Alving article.

Despite this, the Alving article includes the following paragraph:

" What, if any are the potential consequences of induction of

antibodies to SQE [squalene]? A recent publication claims to have

detected antibodies to SQE in sick but not in healthy individuals

(Asa et al., 2000) [the Asa/Garry article]. However, we believe that

such a conclusion may be premature, based on a technical critique of

the reported Western blot-type assay that was used (Alving and

Grabenstein, 2000) [the Alving/Grabenstein letter]. "

The Alving article thus cites the Alving/Grabenstein letter, which

the Alving article itself refutes, to call into question our second

discovery, that the anti-squalene antibodies we discovered are found

in sick but not healthy individuals.

(7) After the Asa/Garry article was published, we learned that in

June 1999, investigators at the U.S. Food and Drug Administration

(FDA) had assayed the Department of Defense's anthrax vaccine for

the presence of squalene. Using a sensitive gas-liquid

chromatography procedure, the FDA had identified squalene in certain

lot numbers (FAV 020, 030, 038, 043 and 047) of the vaccine.

Although the amounts of squalene found in these lots of the vaccine

by the FDA were small (parts per billion), in principle even these

small amounts may have been sufficient to induce in some vaccine

recipients the immune response that is now being manifested by the

presence of anti-squalene antibodies. The published work of other

researchers has strongly linked exposure to the anthrax vaccine and

other vaccines to the development of Gulf War illnesses. Moreover,

many pathological effects of exposure to squalene-containing vaccine

adjuvants are well known to rheumatologists, and a number of these

pathologies bear striking similarity to the signs and symptoms

displayed by some ill Gulf War era veterans.

(8) On April 10, 2001, U.S. Patent No. 6,214,566, " Method for

Detecting Anti-Squalene Antibodies, " was awarded and assigned to

Tulane University. A copy of this patent is attached. Tulane has

licensed the anti-squalene antibody technology to Autoimmune

Technologies, LLC of New Orleans. On May 23, 2001, the LLC Manager

of that firm wrote a letter to The Secretary of Defense with a copy

to Col. Alving offering to sublicense the patented technology to

Department of Defense researchers. On June 6, 2001, an intellectual

property counsel of the Army wrote back to decline the offer. Copies

of both the May 23rd and the June 6th letters are attached.

(9) On October 22, 2001, in accordance with 37 CFR 404.6, the

Department of the Army filed a notice of the " Availability for Non-

Exclusive, Exclusive, or Partially Exclusive Licensing of U.S.

Patent Application No. 09/859,389 entitled 'Detection of Antibodies

to Squalene in Serum' filed May 18, 2001. " On November 8, 2001, the

LLC Manager of Autoimmune Technologies spoke on the telephone with

the patent attorney and the licensing officer at Fort Detrick who

were administering this license. Neither the attorney nor the

licensing officer was aware of the existence of U.S. Patent No.

6,214,566, and neither person knew whether U.S. Patent Application

No. 09/859,389 was based upon the work done by Col. Alving and his

colleagues. The LLC Manager pointed out to both of them that, in our

opinion, the work done and published by Col. Alving's group is

covered by the claims awarded in U.S. Patent No. 6,214,566. The LLC

Manager also asked for further information about the technology

which the Army was proposing to license. As of December 18, 2001,

the LLC Manager had not received this additional information, and he

wrote a letter on that date to both the attorney and the licensing

officer. A copy of that letter is attached.

# # #

Return to Witness Testimony List | Return to VetCenter's Main Lobby

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ANTI-SQUALENE ANTIBODIES

LINK GULF WAR SYNDROME TO ANTHRAX VACCINE

Data published in the February 2000 and August 2002 issues of

Experimental and Molecular Pathology strongly suggests that Gulf War

Syndrome is caused by a vaccine contaminated with squalene.

The August 2002 article is entitled " Antibodies to Squalene in

Recipients of Anthrax Vaccine " (Exp. Mol. Pathol. 73,19-27 (2002)).

Gulf War Syndrome, or GWS, is the term which has been applied to the

multi-symptom rheumatic disorder experienced by many veterans of the

1990-1991 Persian Gulf war. A similar disorder appeared in 1990-1991-

era personnel who were never deployed to the Persian Gulf theater of

operations and also in other military personnel, including

participants in the Anthrax Vaccine Immunization Program, or AVIP,

which was inaugurated in 1997. No data has ever suggested that the

disorder experienced by the deployed 1990-1991 soldiers is different

from the disorder experienced by the other groups of patients, but

the other cases have not been considered to be cases of GWS.

Squalene was found by the U.S. Food and Drug Administration in five

lots of the AVIP anthrax vaccine. The discovery of serum anti-

squalene antibodies and the development of a test to detect these

antibodies has made it possible to see that links appear to exist

between the contaminated AVIP vaccine lots, the illness experienced

by post-1997 vaccine recipients, the illness experienced by non-

deployed 1990-1991-era patients, and the illness in deployed 1990-

1991-era patients that has been referred to as GWS.

The data establishing these links is presented in the peer-reviewed

February 2000 and August 2002 articles. The published findings (1)

strongly suggest that the GWS-like illness being reported by all of

the various patient groups is the same illness, (2) strongly suggest

that the contaminated vaccine caused the illness in the AVIP group,

and (3) further suggest that squalene contamination of one or more

1990-1991-era vaccines accounts for the GWS cases from that era.

Before the anti-squalene antibody test was developed, there was no

specific laboratory test for GWS. Both articles suggest that the

antibodies can serve as an excellent laboratory marker to help

identify patients with GWS. Using the antibodies as a laboratory

marker for GWS could be very useful in helping physicians diagnose

the disorder and in differentiating it from other rheumatic

illnesses.

Anti-squalene antibodies might also provide a key to more

effectively treating GWS patients. The presence of the antibodies in

GWS patients indicates that the immune system is involved in the

development of GWS. Effective drugs which modulate the human immune

system are already in wide use, but they have not been previously

considered to be appropriate for GWS patients. The published data

now suggests that the use of immune modulators in GWS patients

should be studied.

A detailed discussion of the data in the February 2000 and August

2002 articles can be found in the Autoimmune Technologies news

release dated July 15, 2002.

Further information about the discovery of squalene in the AVIP

vaccine lots can be found in the statement made by former U.S.

Congressman Jack Metcalf on September 27, 2000 to the House

Subcommittee on National Security, Veterans Affairs, and

International Relations.

In March 1999, the United States General Accounting Office (the GAO)

encouraged the Department of Defense to investigate the discovery of

anti-squalene antibodies. In GAO/NSIAD-99-5, " Gulf War Illnesses -

Questions About the Presence of Squalene Antibodies in Veterans Can

Be Resolved, " the GAO urged the DoD to conduct its own research into

anti-squalene antibodies with two objectives in mind: (1) to confirm

the existence of the newly-discovered antibodies, and (2) to acquire

patient data, explore the apparent link between the antibodies and

the illness in GWS patients, and attempt to confirm or disprove the

existence of such a link. Click on GAO/NSIAD-99-5 for a PDF version

of this report. See Notes on PDF Files if you would like help with

the PDF format.

To satisfy the first GAO objective, the Army researchers confirmed

that anti-squalene antibodies do indeed exist and can reliably be

detected. They published their findings in an article

entitled " Induction and Detection of Antibodies to Squalene, " which

appeared in the November 2000 issue of the Journal of Immunological

Methods (J Immunol Methods 2000 Nov 1;245(1-2):1-14). The Army

researchers conducted their testing by applying squalene to the

wells of ELISA plates. Dr. F. Garry, the Tulane Medical

School professor who discovered anti-squalene antibodies and

developed the test for detecting them, and his colleagues conducted

their testing for the February 2000 and August 2002 articles by

applying squalene to nitrocellulose strips in a Western-blot-type

assay. There is no material difference between the two test methods,

and both are covered by the patent which subsequently issued to

Tulane.

Although the Army researchers confirmed the validity of the test and

thus added support to the February 2000 patient data, their November

2000 article included no patient data of its own and as a result did

not specifically address the GAO's second objective. The Army

researchers also failed to embrace the peer-reviewed February 2000

data itself, as is discussed in the statement submitted by Dr. Garry

to the House Subcommittee on National Security, Veterans Affairs and

International Relations for the record of its hearing into Gulf War

illnesses on January 24, 2002. Dr. Garry's statement can be seen on

the Subcommittee's Web site at

http://www.house.gov/reform/ns/statements_witness/garry_jan_24.htm

and on the Autoimmune Technologies Web site at Garry 24 Jan 2002

House Subcommittee Statement.

Tulane has licensed the anti-squalene antibody technology to

Autoimmune Technologies. U.S. Patent No. 6,214,566 covering the anti-

squalene antibody test, which the Company calls the Anti-Squalene

Antibody Assay or ASA Assay, was awarded to Tulane in April 2001.

Because this patent covers the method which was used by the Army

researchers to verify the existence of the antibodies, Autoimmune

Technologies has offered the ASA Assay technology to the Department

of Defense for use in conducting a large confirmatory study of the

patient data in the February 2000 and August 2002 articles. The

Company has urged the DoD to sponsor such a study.

For information about the patented Anti-Squalene Antibody Assay, go

to the Gulf War Syndrome Laboratory Test Page.

This material is not intended to take the place of a physician's

advice.

See the Autoimmune Technologies GWS News Release dated July 15, 2002

See the Autoimmune Technologies GWS News Release dated January 31,

2000

Go to the Autoimmune Technologies Home Page

LABORATORY TEST FOR GULF WAR SYNDROME

The Patented Anti-Squalene Antibody Assay, or ASA Assay

The patented Anti-Squalene Antibody Assay, or ASA Assay, is a test

that detects antibodies to squalene in human blood. Peer-reviewed

research data that was obtained by using this test has linked

squalene-contaminated lots of the vaccine used in the DoD's post-

1997 Anthrax Vaccine Immunization Program (AVIP) to the development

of anti-squalene antibodies. These antibodies were previously linked

to the multi-symptom rheumatic illness known as Gulf War Syndrome.

For more information about this data and its implications, see the

Gulf War Syndrome Research Page.

U.S. Army researchers duplicated this test, and in November 2000 the

Army researchers published their research confirming the discovery

of anti-squalene antibodies. A patent on the ASA Assay was awarded

in April 2001, and Autoimmune Technologies holds the rights to that

patent. The patent covers various methods for detecting anti-

squalene antibodies, including the testing method that was used by

the Army researchers. To enable the DoD to sponsor a large

confirmatory study of the link between squalene contamination in

vaccines and GWS, Autoimmune has offered the patented ASA Assay

technology to the Department of Defense and has strongly urged the

DoD to sponsor such a study.

In addition to helping identify patients with GWS, the discovery of

anti-squalene antibodies might also provide a key to more

effectively treating GWS patients. The presence of the antibodies in

GWS patients indicates that the immune system is involved in the

development of GWS. Effective drugs which modulate the human immune

system are already in wide use, but they have not been previously

considered to be appropriate for GWS patients. The published data

now suggests that the use of immune modulators in GWS patients

should be studied.

Autoimmune Technologies is not currently offering the ASA Assay for

investigation into individual GWS cases, but when the benefits of

the test become clear to all of the groups involved in assessing

GWS, Autoimmune will immediately make the ASA Assay available to

interested physicians for investigational use.

GWS patients or physicians who would like to receive notification

when the Assay does become available for investigational use may

send their name, mailing address, and their physician's name if they

are a patient, to GWS@... via e-mail or to the postal

address given in the How to Contact Us page. IMPORTANT NOTE

CONCERNING E-MAIL: Because of the recent proliferation of " spam "

messages, the GWS@... mailbox is now being filtered by

subject line. Please begin the subject line of your e-mail message

with the word Test in order to pass through the filter.

For more information, go to the Gulf War Syndrome Research Page

Go to the Autoimmune Technologies Home Page

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Letter From Sen. ph R. Biden, Sen. R. Carper and Rep.

N. Castle to Sec. Rummsfeld

http://www.delawareonline.com/newsjournal/local/2004/10/15squalene_le

tter.html

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Letter from 2002 Petitioning against Anthrax Vaccine

From: JH88008@...

Sent: Wednesday, January 02, 2002 10:09 PM

fdadockets@...

Subject: Copy of petition

FDA

cc Congressman Rick Boucher

From C. Hammell, President

International Advocates for Health Freedom

POB 625 Floyd VA 24091

FDA:

In light of the points below, I agree with the Anthrax Vaccine

Network http://www.anthraxvaccine.net/ and totally oppose the

Anthrax vaccine. I would like the FDA to ban this dangerous vaccine

and revoke Bioport's license to manufacture it. It is clearly a very

dangerous drug. You cannot legally justify approving this drug for

use by the public, and it is wrong that members of the military are

forced to take it.

I would like to know how you intend to handle this matter, and am

forwarding this to Congressman Rick Boucher, my congressman, as well

as to my email distribution list. I am also posting this letter to

you on my website in the Anti Vaccination section.

I regard you to be terrorists. Many other armed Americans also

regard you to be terrorists. In light of the points below, how can

we possibly come to any other conclusion? If you dispute this

information, and feel that it is incorrect in any particular, I

would like to know your specific views on this issue. Any lack of

response on your part will be construed by me to be tacit agreement

on your part that you are indeed terrorists, and that you are on a

genocidal mission to kill as many Americans as you possibly can via

this improperly tested, clearly dangerous vaccine.

1. The vaccine's manufacturer, Bioport of Lansing,

Michigan, has never passed an FDA inspection. Numerous problems

include lack of sterility, contamination problems, quality control

problems, lack of consistency in manufacturing, falsification of the

expiration dates on some lots of the vaccine (labels were switched),

and the presence of squalene, an adjuvant which is illegal in the

United

States.

2. Adverse reactions to this vaccine range from

40% in men to 70% in women, according to an Army study. Yet when the

program began the FDA-approved product label admitted to only a 0.2%

adverse reaction rate; now it says 5-35%. Adverse reactions range

from severe bone and joint pain, to loss of vision, severe skin

problems, blackouts and loss of consciousness (crashing from a

standing position leads to other injuries, of course), grand mal

seizures, internal organ problems, ALS, multiple sclerosis -- and

death. If this was a civilian vaccine, it would long ago have been

taken off the market.

3. The current vaccine, licensed in 1970, failed

to meet federal requirements to prove efficacy in humans prior to

licensure; the required trials to prove safety were conducted, but

were of limited scientific validity. The only trial of an anthrax

vaccine in humans, in the late 1950's, was for a different vaccine

and showed efficacy only for cutaneous, or skin contact. The Dept.

of Defense wanted a vaccine against aerosolized anthrax - that which

would be " weaponized " - and for mass inoculation, and in 1996

submitted to the FDA an Investigational New Drug (IND) application

requesting permission to use it for this purpose. By law (10 USC

1107), an IND requires informed consent, or a Presidential waiver of

that consent, neither of which currently exist. Absent either, a

military order to take the vaccine is illegal. Yet, if troops refuse

the vaccine, they are most often fined, court-martialed, jailed, and

separated from the service under less than honorable conditions.

4. The General Accounting Office last year

(October, 2000) came out with a report that in the the Air National

Guard and Air Force Reserve units that were required to be

vaccinated, 25% of its pilots resign rather than take it.

5. Even if this vaccine were not so dangerous, it

may be of limited value in the short-term. The FDA-approved protocol

for taking it calls for three shots each spaced 2 weeks apart; then

three more shots at 6, 12, and 18 months, then annual boosters for

life.

(This is a copy of a petition that I am passing on in support of.)

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Chronic multisymptom illness affecting Air Force veterans of the

Gulf War.

Fukuda K, Nisenbaum R, G, WW, Robin L, Washko RM,

Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC.

Division of Viral and Rickettsial Diseases, National Center for

Infectious Diseases, Centers for Disease Control and Prevention,

Atlanta, GA 30333, USA.

CONTEXT: Gulf War (GW) veterans report nonspecific symptoms

significantly more often than their nondeployed peers. However, no

specific disorder has been identified, and the etiologic basis and

clinical significance of their symptoms remain unclear. OBJECTIVES:

To organize symptoms reported by US Air Force GW veterans into a

case definition, to characterize clinical features, and to evaluate

risk factors. DESIGN: Cross-sectional population survey of

individual characteristics and symptoms and clinical evaluation

(including a structured interview, the Medical Outcomes Study Short

Form 36, psychiatric screening, physical examination, clinical

laboratory tests, and serologic assays for antibodies against

viruses, rickettsia, parasites, and bacteria) conducted in 1995.

PARTICIPANTS AND SETTING: The cross-sectional questionnaire survey

included 3723 currently active volunteers, irrespective of health

status or GW participation, from 4 air force populations.The cross-

sectional clinical evaluation included 158 GW veterans from one

unit, irrespective of health status. MAIN OUTCOME MEASURES: Symptom-

based case definition; case prevalence rate for GW veterans and

nondeployed personnel; clinical and laboratory findings among

veterans who met the case definition. RESULTS: We defined a case as

having 1 or more chronic symptoms from at least 2 of 3 categories

(fatigue, mood-cognition, and musculoskeletal). The prevalence of

mild-to-moderate and severe cases was 39% and 6%, respectively,

among 1155 GW veterans compared with 14% and 0.7% among 2520

nondeployed personnel. Illness was not associated with time or place

of deployment or with duties during the war. Fifty-nine clinically

evaluated GW veterans (37%) were noncases, 86 (54%) mild-to-moderate

cases, and 13 (8%) severe cases. Although no physical examination,

laboratory, or serologic findings identified cases, veterans who met

the case definition had significantly diminished functioning and

well-being. CONCLUSIONS: Among currently active members of 4 Air

Force populations, a chronic multisymptom condition was

significantly associated with deployment to the GW. The condition

was not associated with specific GW exposures and also affected

nondeployed personnel.

PMID: 9749480 [PubMed - indexed for MEDLINE]

*********************************************************************

*********************************************************************

****************************

Prevalence and patterns of Gulf War illness in Kansas veterans:

association of symptoms with characteristics of person, place, and

time of military service.

Steele L.

Kansas Commission on Veterans Affairs, Topeka 66603, USA.

kspgwvets@...

Gulf War veterans have reported health problems that they attribute

to their military service, but little is understood about the nature

or extent of these conditions. To determine whether Kansas Gulf War

veterans are affected by excess health problems, a population-based

survey of 1,548 veterans who served in the Persian Gulf War (PGW)

and 482 veterans who served elsewhere (non-PGW) was conducted in

1998. Gulf War illness, defined as having chronic symptoms in three

of six domains, occurred in 34% of PGW veterans, 12% of non-PGW

veterans who reported receiving vaccines during the war, and 4% of

non-PGW veterans who did not receive vaccines. The prevalence of

Gulf War illness was lowest among PGW veterans who served on board

ship (21%) and highest among those who were in Iraq and/or Kuwait

(42%). Among PGW veterans who served away from battlefield areas,

Gulf War illness was least prevalent among those who departed the

region prior to the war (9%) and most prevalent among those who

departed in June or July of 1991 (41%). Observed patterns suggest

that excess morbidity among Gulf War veterans is associated with

characteristics of their wartime service, and that vaccines used

during the war may be a contributing factor.

PMID: 11092441 [PubMed - indexed for MEDLINE]

*********************************************************************

**************¡ö Before sending this sample, call the DU program

office at 1-800-815-7533 so that we can anticipate delivery. A copy

of this checklist, and a completed copy of VA Form 10-9009D, must be

faxed to 410-605-7943.

Notification of the results can be expected in approximately 45

days.

VA Form 10-9009E REPRODUCE LOCALLY Page 2

July 1998

*****************************************

*********************************************************************

*************************************************************

Gulf War Illnesses: Questions About the Presence of Squalene

Antibodies

in Veterans Can Be Resolved (Letter Report, 03/29/99, GAO/NSIAD-99-

5).

Pursuant to a congressional request, GAO investigated the reports

that

the blood samples of some ill Gulf War-era veterans contained

antibodies

for squalene, a component of adjuvant formulations used in some

experimental vaccines but not in any licensed vaccines, focusing on

whether: (1) the Department of Defense (DOD) or the National

Institutes

of Health (NIH) performed or sponsored research using squalene; (2)

DOD

considered using adjuvant formulations in vaccines administered to

Gulf

War-era veterans; and (3) any research has detected the presence of

squalene in ill Gulf War-era veterans.

GAO noted that: (1) prior to and following the Gulf War, DOD and NIH

used adjuvant formulations of squalene to perform research on the

development of more effective vaccines; (2) DOD officials stated they

considered, but decided against, using vaccines with experimental

adjuvant formulations during the Gulf War; (3) according to

independent

researchers, as part of their treatment of sick Gulf War-era

veterans,

they developed and administered a test, referred to as an assay, that

detected antibodies to squalene in the blood of sick Gulf War-era

veterans; (4) the researchers stated this assay is similar to a

standard

assay used in other types of research; (5) as of March 1999, the

research has been subjected to peer review, but had not been

published;

(6) this process is often lengthy, sometimes taking a year or more;

(7)

according to DOD officials, DOD could develop such an assay

inexpensively and test it on a sample of sick Gulf War-era veterans;

(8)

however, DOD plans to wait until the research is published before

deciding whether to conduct testing; and (9) given the researchers'

assessment, DOD's comments about the feasibility of developing an

assay

and that veterans have been waiting for the past 7 years for answers

on

the nature and origin of their illnesses, DOD has the opportunity to

expand on the research already performed.

--------------------------- Indexing Terms --------------------------

---

REPORTNUM: NSIAD-99-5

TITLE: Gulf War Illnesses: Questions About the Presence of

Squalene Antibodies in Veterans Can Be Resolved

DATE: 03/29/99

SUBJECT: Veterans

Research reports

Medical research

Disease detection or diagnosis

Testing

IDENTIFIER: Persian Gulf War

** **

** with the message 'info' in the body. **

******************************************************************

NS99005.book GAO United States General Accounting Office

Report to the Honorable Jack Metcalf House of Representatives

March 1999 GULF WAR ILLNESSES

Questions About the Presence of Squalene Antibodies in Veterans

Can Be Resolved

GAO/NSIAD-99-5

GAO/NSIAD-99-5

United States General Accounting Office Washington, D. C. 20548

Lett er

Page 1 GAO/NSIAD-99-5 Gulf War Illnesses

GAO

National Security and International Affairs Division Lett er

B-278779 March 29, 1999 The Honorable Jack Metcalf House of

Representatives

Dear Mr. Metcalf: You expressed concern about reports that the

blood samples of some ill Gulf War- era veterans contained

antibodies for squalene 1 a component of adjuvant formulations

used in some experimental vaccines but not in any licensed

vaccines. 2 As requested, we identified whether (1) the Department

of Defense (DOD) or the National Institutes of Health (NIH)

performed or sponsored research using squalene, (2) DOD considered

using adjuvant formulations in vaccines administered to Gulf War-

era veterans, and (3) any research has detected the presence of

squalene in ill Gulf War- era veterans.

Results in Brief Prior to and following the Gulf War, DOD and NIH

used adjuvant formulations of squalene to perform research on the

development of more effective vaccines. DOD officials stated they

considered, but decided against, using vaccines with experimental

adjuvant formulations during the Gulf War. According to

independent researchers, as part of their treatment of sick Gulf

War- era veterans, they developed and administered a test,

referred to as an assay, that detected antibodies to squalene in

the blood of sick Gulf War- era veterans. The researchers stated

this assay is similar to a standard assay used in other types of

research. As of March 1999, the research had been subjected to

peer review, but had not been published. This process is often

lengthy, sometimes taking a year or more. According to DOD

officials, DOD could develop such an assay inexpensively and test

it on a sample of sick Gulf War- era veterans. However, DOD plans

to wait until the research is published before deciding whether to

conduct testing. Given the researchers' assessment, DOD's comments

about the feasibility

of developing an assay and that veterans have been waiting for the

past 1 Squalene is found in shark liver oil, some vegetable oils,

and the human liver and can also be manufactured through chemical

engineering. Squalane is the hydrogenated form of squalene. When

we use the term squalene by itself, it refers to both squalane and

squalene. 2 An adjuvant is a substance incorporated in a vaccine

to accelerate, enhance, or prolong a specific immune response. An

antigen is a substance that stimulates production of an antibody.

Neither squalane or squalene is a complete adjuvant by itself.

Both serve as vehicles in which adjuvant formulations and vaccine

antigens can be mixed and delivered.

B-278779 Page 2 GAO/NSIAD-99-5 Gulf War Illnesses

7 years for answers on the nature and origin of their illnesses,

DOD has the opportunity now to expand on the research already

performed.

Background Many of the approximately 700,000 veterans of the Gulf

War have reported health problems. Some fear that their illnesses

might be due to exposure to chemicals, pesticides, and other

agents used during the war, including

vaccines administered to protect them against biological warfare

agents. Questions about vaccine adjuvant formulations were raised

to DOD in June 1994. At that time, an immunologist from the

private sector notified the

Defense Science Board that some symptoms being reported by Gulf

War- era veterans were very similar to those of her patients with

autoimmune diseases. These patients had a range of symptoms

affecting more than one of the body systems and the immunologist

believed they were associated with exposure to vaccine adjuvant

formulations. In October 1995, DOD, before a meeting of the

Presidential Advisory Commission on Gulf War illnesses, dismissed

this hypothesis on the grounds that it had administered only

vaccines with aluminum salts as adjuvants. In November 1996 and

again in 1997, the immunologist notified DOD, based on independent

research, that she had found antibodies to squalene in the blood

of a few sick veterans who had served in the military during the

Gulf War. However, DOD has not responded to these findings.

According to the researcher, she continues to be willing to

discuss the

research with DOD. To date, aluminum hydroxide is the only

adjuvant used in vaccines licensed by the Food and Drug

Administration (FDA) in the United States. While widely considered

to be safe, this adjuvant provides only a limited boost in the

immune response, and researchers have long emphasized the critical

need for new, more effective adjuvant formulations. According to

the National Institute of Allergy and Infectious Diseases (NIAID),

the branch of NIH that sponsors most of its vaccine- related

research, a new generation of novel adjuvant formulations are

being developed. These formulations are

intended to enhance and optimize immune responses to vaccines;

enable easier delivery of antigens, and reduce the amount of

antigen and the number of immunizations required for protective

immunization. Squalene is a common component of these new

formulations. As with all drugs and biological products, the

absolute safety of adjuvant formulations can never

B-278779 Page 3 GAO/NSIAD-99-5 Gulf War Illnesses

be guaranteed. 3 Safety concerns have been cited 4 regarding the

use of novel adjuvant formulations in vaccines, including

squalene, and the associated adverse reactions. 5 It has also been

suggested that the safety of vaccines containing these

formulations must be evaluated in conservative ways. 6

DOD and NIH Performed and Sponsored Research With Squalene

DOD and NIAID officials reported that, to help develop more

effective vaccines, they conducted research using adjuvant

formulations with squalene. In all, they performed or sponsored 28

clinical trials on vaccines using adjuvant formulations with

squalene, and 1,749 human subjects participated in these trials.

Prior to the Gulf War, both organizations were devising ways to

induce a rapid response to several vaccines using adjuvant

formulations with squalene. DOD officials stated that they

considered, but

decided against using vaccines with adjuvant formulations

including those with squalene to protect Gulf War troops.

DOD Research Between 1988 and 1998, DOD sponsored 101 clinical

trials on vaccines as part of a process required by FDA for

licensing investigational new drugs (IND). At least 21 of these

trials involved vaccines with adjuvant formulations, and 5 of

these 21 involved adjuvant formulations containing

squalene. These formulations were available from U. S. firms. 7

(See app. I for specific information on these firms and the

development of adjuvant formulations with squalene.) In the five

trials involving squalene, 572 human subjects volunteered and

participated. Of the five trials, two began

before the Gulf War. DOD officials could not confirm whether any

of the 3 J. L. Bussiere et al., " Preclinical Safety Assessment

Considerations in Vaccine Development " In , M. F. and

Newman, M. J. (Eds.) (1995). Vaccine Design: The Subunit and

Adjuvant Approach (New York: Plenum Press), pp. 61- 75. 4

Goldenthal, K. L. et al., " Safety Evaluation of Vaccine Adjuvants:

National ative Vaccine Development Meeting Working Group, "

AIDS Research and Human Retroviruses, vol. 9 (1993), pp. S47- S51.

Lorentzen, J. C. Identification of Arthritogenic Adjuvants of Self

and Foreign Origin. Scandinavian Journal of Immunology, vol. 49

(1999), pp. 45- 50. 5 Adverse reactions are local or systemic.

Local reactions include pain and swelling at the injection site.

Systemic reactions include fevers and toxicity of organs and

systems. 6 M. F. and M. J. Newman, Vaccine Design: The

Subunit and Adjuvant Approach (New York: Plenum Press, 1995) 7

This information was derived from DOD data submitted to FDA and

may not include cooperative research efforts with others.

B-278779 Page 4 GAO/NSIAD-99-5 Gulf War Illnesses

volunteers in studies that DOD sponsored had deployed to the Gulf

War. The five trials are described as follows: In April 1988,

DOD's first clinical trial of an experimental malaria vaccine with

an adjuvant containing squalene was approved, 8 but according to

DOD, doses were actually administered from June 1989 to January

1990. Five volunteers were given the vaccine. In August 1990,

another trial of the malaria vaccine was approved, using

the same adjuvant with squalene on 12 volunteers. 9 In 1994, DOD

began another study on a malaria vaccine containing an adjuvant

with squalene. 10 Both 110 experimental subjects and 11 control

subjects were given the adjuvant. An additional arm of the study,

using human subjects from Gambia, was withdrawn before any

vaccines were given because of concerns about the stability of the

product. In 1995, through a cooperative research and development

agreement, the Chiron Biocine Company and the Walter Army

Institute of Research began a clinical trial of a vaccine for

Human Immunodeficiency Virus (HIV) that contained an adjuvant with

squalene. 11 The vaccine containing squalene was given to 41

healthy volunteers in Thailand, and the adjuvant with squalene

without the rest of the vaccine was given as a placebo to 13

people in a control group.

In 1997, the Walter Army Institute of Research began to

cosponsor another study in Thailand on an HIV vaccine with an

adjuvant formulation containing squalene, which is ongoing. 12

This study will give both the experimental and control subjects

the adjuvant formulation with squalene. Three hundred and eighty

subjects have been recruited for this study; 3 are Americans and

the remaining are Thai citizens.

8 IND 2699. " Safety and Immunogenicity of a Plasmodium falciparum

Malaria Sporozoite Vaccine, R32NS1 81 With DETOX TM As An

Adjuvant. " 9 IND 3714. " The Protective Efficacy of a Plasmodium

falciparum Vaccine, R32NS1 81 and MPL/ CSW as an Adjuvant. " 10 IND

6043. " Plasmodium falciparum Circumsporozite Antigen Vaccine

(Recombinant, Yeast) with Alum, QS21, MPL and SB62 Adjuvant

Combinations. " 11 IND 4096. " A Phase I Trial of Biocine HIV SF2 gp

120/ MF59 Vaccine in Seronegative Thai Volunteers. "

12 IND 7172. " A Phase I/ II Double- blind, Placebo- controlled

study of the Chiron HIV Thai E gp 120/ MF59 Vaccine Administered

alone or Combined with the Chiron HIV SF2 gp120 Antigen in Healthy

HIV- Seronegative Thai Adults. "

B-278779 Page 5 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix II provides further details on these studies, and

appendix III provides a list of DOD research publications on those

trials involving human subjects.

In addition, DOD has conducted several experiments on animals,

using vaccines with adjuvant formulations containing squalene, for

a wide range of diseases, including anthrax, toxic shock, and

malaria. The anthrax vaccine experiments with adjuvant

formulations containing squalene began in 1987, and some of the

results have been presented at conferences and published in

several medical journals. (See app. IV for a list of some of DOD's

animal research on adjuvant formulations with squalene). DOD's

animal studies are of interest for two reasons. First, because

tests on

animals are generally performed before human trials, they

represent the first step of vaccine research and provide a more

complete picture about the state of research on adjuvant

formulations with squalene before the

Gulf War. Second, since vaccines against biological warfare cannot

be tested for efficacy in humans, animal research is considered

essential by researchers.

NIH's Research on Vaccines With Adjuvant Formulations Containing

Squalene

NIAID officials stated they have sponsored vaccine trials on

various adjuvant formulations, including several with squalene.

NIAID's research on vaccines and adjuvant formulations has

increased substantially over the last 10 years. The total number

of active vaccine projects more than doubled, from 212 in 1987 to

539 in 1997. Research involving adjuvant formulations expanded at

an even faster pace, from 13 studies in 1987 to

59 active projects in 1997. NIAID's clinical research on novel

adjuvant formulations involving human subjects began in 1988.

NIAID- sponsored basic/ preclinical studies on adjuvant

formulations with squalene began in 1987, and clinical trials

began at the same time as Operation Desert Storm, in January 1991.

Since then, NIAID has sponsored at least 23 trials of vaccines

involving adjuvant formulations with squalene, with 1,177 human

volunteers. 13 Nineteen of the 23 trials involved an HIV vaccine

tested on a total of 935 volunteers; the 4 remaining trials

involved a vaccine for herpes with 242 subjects. (See app. V for a

list of the 23 studies.

13 Establishing the exact number of studies is difficult because

NIAID's databases often do not specify the adjuvants used in both

preclinical and clinical studies. Also, 2 years after the studies

are completed, the records are routinely destroyed and only an

index is maintained.

B-278779 Page 6 GAO/NSIAD-99-5 Gulf War Illnesses

DOD Officials Report They Considered, but Decided Against, Using

Vaccines With Novel Adjuvent Formulations, Including

Squalene In August 1990, DOD established various committees to

address its concerns about the threat of Iraqi biological warfare

agents and the

insufficient supply of vaccines to immunize all troops against

these agents. These committees identified several problems. They

determined that DOD had neither a sufficient quantity of vaccine

nor the manufacturing capacity to protect the force. It also did

not have sufficient time to administer the

required six anthrax shots over 18 months and faced formidable

logistical problems in giving multiple shots to troops in various

locations in the Persian Gulf region. According to DOD officials,

the use of novel adjuvant formulations for the anthrax vaccine was

rejected because any alteration in the licensed vaccine would

require relicensure, and DOD would not receive FDA approval in

time. Other alternatives were pursued. DOD requested help from

commercial U. S. and foreign vaccine manufacturers; NIH, through

its

National Cancer Institute facility at Fort Detrick, land; and

additional military production facilities at Fort Detrick and

Porton Down, United Kingdom. According to the commercial

manufacturers, they turned DOD down because developing a safe and

effective vaccine takes sustained investment and planning and DOD

had not previously been willing to invest the money and time. DOD

began immunizing troops in Janaury 1991. However, it should be

noted that even if the manufacturing capacity had

been increased, DOD never had the 18- month time span needed to

fully immunize the troops in the Gulf War because of the war's

short duration.

Although DOD awarded contracts to the National Cancer Institute to

produce additional anthrax vaccine and began planning production

of additional botulinum toxoid vaccine at the U. S. Army Medical

Research Institute of Infectious Diseases, also located at Fort

Detrick, the two institutes were unable to begin production before

the war. DOD officials said that botulinum toxoid vaccine was

acquired from Porton Down, United Kingdom, but was not used.

Consequently, according to DOD, the only vaccines against

biological warfare agents anthrax and botulinum toxoid given

during the Gulf War were produced by the Michigan Department of

Public Health. It subsequently became an independent

agency, the Michigan Biologic Products Institute, and was recently

privatized as BioPort. Officials at BioPort said that they have

never used adjuvant formulations containing squalene.

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

B-278779 Page 7 GAO/NSIAD-99-5 Gulf War Illnesses

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.

Independent Researchers State They Have Detected

Squalene Antibodies in Gulf War- Era Veterans

In examining the pathology of illnesses afflicting Gulf War- era

veterans, independent researchers examined whether antibodies to

squalene were present in patients who had and had not been

deployed to the Gulf War. Using an assay that they developed the

researchers stated that they

detected squalene antibodies in the blood of sick Gulf War- era

veterans. The immunologist who headed this study and laboratory

researchers at a major university medical center that were

involved in the study shared their methodology and findings with

us. The results of the research have been submitted to a medical

journal to be peer reviewed and published. As

of February 1999, there was no set date for publication. According

to the researchers, the antisqualene antibody assay that they

developed in their study is a variant of the common Western Blot

assay 14 and is similar in format to a test cited in a published

report on silicone antibodies. 15 Using the antisqualene antibody

assay, the independent researchers stated they found most veterans

with Gulf War illnesses in their research had the antibodies to

squalene, regardless of whether they were deployed or not.

Non veterans in the research that were known to have received

adjuvant formulations with squalene as volunteers in clinical

trials of experimental vaccines also had the antibodies to

squalene and had an array of symptoms similar to symptoms of the

Gulf War patients. On the other hand, those participants (in the

control groups) that were healthy with no autoimmune symptoms,

those non- Gulf War veterans with autoimmune diseases of

unknown origin, and those who had received other adjuvant

formulations were found not to have antibodies to squalene. The

independent researchers concluded that, while the reason for the

presence of the

14 The Western Blot assay applies a protein or polymer such as

squalene to test strips, which are then incubated with patient

serum. If the antibody of interest is present, test strips turn

bluish black. A darker color indicates a higher concentration of

antibodies.

15 S. A. Tenenbaum et al., " Use of anti- polymer antibody assay in

recipients of silicone breast implants, " The Lancet, vol. 349

(1997), pp. 449- 454. For correspondence concerning this study see

" Antipolymer antibodies, silicone breast implants, and

fibromyalgia, " The Lancet, vol. 349 (1997), pp. 1170-- 1173.

B-278779 Page 8 GAO/NSIAD-99-5 Gulf War Illnesses

squalene antibodies remains unclear, the presence of these

antibodies could potentially be a contributing factor to Gulf War

illnesses. DOD officials stated they could develop an assay, or

test, for detecting antibodies to squalene. According to these

officials, it would not be expensive to develop the assay and test

it on a sample of Gulf War- era veterans that are sick. However,

they believed that since DOD did not use adjuvants with squalene,

DOD does not need to develop such an assay or to screen the

veterans for the antibodies. Second, squalene is a substance that

occurs naturally in the human body, and they doubted that an assay

could be developed to differentiate antibodies to natural and

manufactured squalene. Third, they noted that squalene is also

found in numerous topical creams that some soldiers could have

used. Finally, DOD officials do not believe that funding squalene

antibodies in veterans would prove that the

antibodies caused Gulf War illnesses. Consequently, DOD intends to

wait until the independent researchers publish their research in a

peer- reviewed journal before deciding whether to conduct testing.

Conclusions and Recommendation

Time is critical for many Gulf War- era veterans who continue to

suffer from illnesses and have been waiting for the past 7 years

for an explanation about the nature of their illnesses. It is

therefore important that DOD takes advantage of any opportunity to

obtain and evaluate additional information on the veterans'

symptoms and potential contributing factors. Independent

researchers, using an assay that they state is similar to standard

research assays, have concluded that squalene antibodies are

present in sick Gulf War- era veterans that participated in their

research and are a potential contributing factor to these

veterans' illnesses. DOD officials stated that it is feasible to

develop and apply an assay to test for squalene antibodies. Yet

for various reasons, including its assertion that it did not use

adjuvant formulations with squalene, DOD plans to wait until the

researchers' research is published before considering whether to

conduct its own

testing. However, publication is usually a lengthy process and may

take more than a year. Given that Gulf War- era veterans have

already waited a significant amount of time for information on

their illnesses, we believe that DOD should act now to expand on

the research already conducted.

Although the origin of the antibodies may be important to assess,

the first step is to determine the extent to which they are

present in a larger group of sick Gulf War- era veterans. We

therefore recommend that the Secretary of Defense review the

independent research that researchers report has revealed the

presence of squalene antibodies in the blood of ill Gulf War- era

B-278779 Page 9 GAO/NSIAD-99-5 Gulf War Illnesses

veterans and conduct its own research designed to replicate or

dispute these results. Agency Comments In written comments on a

draft of our report, DOD disagreed with our recommendation to test

for antibodies for squalene in the blood of ill Gulf War- era

veterans. DOD stated there is no basis for believing veterans were

exposed to vaccines containing squalene. DOD further believes that

the proposed testing for the presence of squalene antibodies will

not appropriately address or assist in resolving the issue of

whether such antibodies may be a contributing cause to the

illnesses of Gulf War- era veterans. Specifically, DOD stated no

experimental vaccines with squalene had been used in U. S. troops

during the Gulf War and that the manufacturer of vaccines verified

it had never used adjuvant formulations containing

squalene. DOD noted that we concluded there was no evidence that

Gulf War- era veterans were given adjuvant formulations containing

squalene, and it therefore believes our proposal to test veterans

seems scientifically and fiscally irresponsible. DOD suggested

that our report be titled Gulf War Illnesses: Gulf War Veterans

Did Not Receive Vaccine Adjuvant

Formulations Containing Squalene. DOD further stated the assay

developed by independent researchers has not been validated

through peer review or publication in scientific literature and

that it is correctly adhering to widely accepted standards by

awaiting such validation before considering the use of the assay

in Gulf War illness studies. It also believed our recommendation

to test for squalene antibodies showed a lack of understanding of

scientific methods. In particular, DOD stated the presence of

antibodies would not establish an

association with adverse health outcomes and establishing an

association would require a statistically meaningful study of

randomly selected Gulf War veterans and non deployed veterans. DOD

noted that any

experimental design to test for this association must be evaluated

for scientific merit through independent peer review.

DOD misstated our finding on whether Gulf War- era veterans may

have received vaccine adjuvant formulations containing squalene.

We did not conclude that Gulf War era veterans were not given

adjuvant formulations containing squalene. Rather, we cannot say

definitively whether or not Gulf War- era veterans were given

these formulations. We have modified the report text to make this

point clear. Furthermore, it was not our

B-278779 Page 10 GAO/NSIAD-99-5 Gulf War Illnesses

intention to focus on how squalene antibodies may have been

introduced into the blood of the veterans. Rather, the focus

should be on the opportunity to resolve whether such antibodies

are present in the blood of ill Gulf War- era veterans, and if so,

whether or not they play a role in their illnesses. In this

respect, the results of the independent research suggesting that

antibodies to squalene are present in ill Gulf War- era veterans

participating in their research cannot be ignored.

We continue to believe that DOD should take this opportunity to

begin addressing and potentially resolving the question of whether

or not squalene antibodies may be contributing to the illnesses of

Gulf War- era

veterans. Specifically, DOD should conduct research designed to

replicate or dispute the independent research results that

revealed the presence of squalene antibodies in the blood of ill

Gulf War- era veterans. We modified our recommendation to clarify

this position. If DOD's research affirms the

presence of these antibodies, additional research should be

conducted that is designed to assess the significance of that

finding. This would simply be a first step in the research process

and would not finally resolve the issue of whether or not squalene

antibodies are a marker for, contribute to, or cause the

illnesses. Follow- on research would be required to address those

issues.

DOD also provided technical comments, which we incorporated as

appropriate. DOD's comments are printed in their entirety in

appendix VI. Scope and Methodology

To develop the information in this report, we conducted multiple

literature searches of public and agency databases and reviewed

both published and unpublished literature on the use of adjuvant

formulations in vaccine, including DOD research protocols and

agency documentation. In addition, we interviewed officials at

DOD, NIH, FDA, and the Veterans Administration. We interviewed

vaccine experts in academia,

pharmaceutical firms, and the American Medical Association and

confirmed the validity of using assays as a means of determining

the presence of antibodies. We also interviewed the immunologist

who headed the independent research and laboratory researchers

from Tulane University in New Orleans who developed the anti-

squalene assay, and they shared their methodology and findings

with us. Finally, we interviewed responsible officials at BioPort.

Our work was completed between August 1997 and August 1998 in

accordance with generally accepted government auditing standards.

B-278779 Page 11 GAO/NSIAD-99-5 Gulf War Illnesses

We are sending copies of this report to other interested

congressional committees. We are also sending copies to the

Honorable Cohen, Secretary of Defense; the Honorable Togo

D. West, Jr., Secretary of Veterans Affairs; and the Honorable

Donna E. Shalala, Secretary of Health and Human Services. Copies

will also be made available to others upon

request. If you have any questions or would like additional

information, please contact me at (202) 512- 3092. Major

contributors to this report were Sushil K. Sharma and Dan

. Sincerely yours,

Kwai- Cheung Chan Director, Special Studies

and Evaluations

Page 12 GAO/NSIAD-99-5 Gulf War Illnesses

Contents Letter 1 Appendix I Development of Adjuvant Formulations

With Squalene

15 Appendix II DOD's Clinical Trials on Novel Vaccines With

Adjuvant Formulations Containing Squalene

17 Appendix III DOD's Published Research on Vaccines With Adjuvant

Formulations Containing Squalene That Involved Human Subject

Volunteers

18 Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene

19

Page 13 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix V National Institute of Health Studies Using Adjuvants

With Squalene

21 Appendix VI Comments From the Department of Defense

22 Tables Table I. 1: Pharmaceutical Firms' Adjuvant Formulations

That May

Contain Squalene or Squalane 16

Abbreviations

DOD Department of Defense FDA Food and Drug Administration HIV

Human Immunodeficiency Virus IND Investigational new drgus NIAID

National Institute of Allergy and Infectious Diseases NIH National

Institutes of Health

Page 14 GAO/NSIAD-99-5 Gulf War Illnesses

Page 15 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix I Development of Adjuvant Formulations With Squalene

Appendi x I

Biotechnology research and development of adjuvant formulations

with squalene began in the 1970s and the first clinical study

began in 1984. At the time of the Gulf War, at least three firms

Ribi ImmunoChem Research Inc. of Hamilton, Montana; Chiron of

Alameda, California; and Syntex of Palo Alto, California had

developed adjuvant formulations with squalene

and were distributing them for vaccine research and development.

Research on adjuvant formulations with squalene has continued. At

least seven biotechnology and pharmaceutical firms have developed

nine different adjuvant formulations that may contain squalene. In

five of the adjuvant formulations, squalene or squalane is always

a component, and in the other four, it is used optionally (see

table I. 1). According to Chiron, its adjuvant formulation with

squalene has been tested on over 9,000 human subjects. Ribi

ImmunoChem reports that its adjuvant formulations with squalene

have been tested on over 1,000 human subjects.

Appendix I Development of Adjuvant Formulations With Squalene

Page 16 GAO/NSIAD-99-5 Gulf War Illnesses

Table I. 1: Pharmaceutical Firms' Adjuvant Formulations That May

Contain Squalene or Squalane

Note: Much of this information in this table is from F. R. Vogel

and M. V. , Chapter 7, " A compendium of Vaccine Adjuvants

and Excipients, " Vaccine Design: The Subunit and Adjuvant

Approach, M. F. and M. J. Newman, (New York: Plenum Press,

1995). Additional and updated information was gathered from F. R.

Vogel and other sources.

Name of adjuvant formulation

Name of pharmaceutical firm Compound used

Always contains squalane or squalene

Squalene or squalane is used optionally

Antigen Formulation IDEC

Pharmaceuticals Corporation

Squalane Yes No CRL 1005 (Block Copolymer P1205)

Vaxcel Corporation Squalene No Yes Detox RibiImmunoChem Research,

Inc. Squalane Yes No Gerbu Adjuvant CC Biotech

Corporation Squalane No Yes GMDP Peptech, Ltd., UK Squalane No Yes

MF59 Chiron Squalene Yes No MPL RibiImmunoChem Research, Inc.

Squalene No Yes

Ribi adjuvant system RibiImmunoChem Research, Inc. Squalene Yes No

Syntex adjuvant formulation (SAF)

Syntex Research Squalane Yes No

Page 17 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix II DOD's Clinical Trials on Novel Vaccines With Adjuvant

Formulations Containing Squalene Appendi x I I

The following table identifies vaccine trials with adjuvant

formulations that contained squalene and squalane conducted by DOD

under the Food and Drug Administration's (FDA) process for

approving investigational new drugs (IND). New drugs and vaccines

under development generally have to be tested in humans for safety

and efficacy before they are approved for general human use.

Therefore, FDA grants IND waivers allowing human subject

experiments after reviewing information on the product, its

manufacture and testing, and the proposed clinical study.

a Date IND approved by FDA's Human Subject Research Review Board.

b As of December, 1997. c The control group received a placebo

consisting of the adjuvant MF59 alone without the rest of the

vaccine.

Date IND approved for human subject research a IND

number Number of human subjects Country of

subjects Vaccine Adjuvant

containing squalene or squalane

4/ 27/ 88 2699 5 United States Malaria Detox 8/ 8/ 90 3714 12

United States Malaria Detox 12/ 7/ 94 6043 121 b United States

Malaria MPL 2/ 8/ 95 4096 41 vaccine,

13 placebo c Thailand HIV MF59 9/ 18/ 97 7172 300 vaccine,

80 placebo c 377- Thailand 3- United States HIV MF59

Total 5 572 Malaria HIV Detox

MPL MF59

INDs using U. S. citizens 3 138 Malaria HIV Detox

MPL MF59

INDs using foreign citizens 2 434 HIV MF59

Page 18 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix III DOD's Published Research on Vaccines With Adjuvant

Formulations Containing Squalene That Involved Human Subject

Volunteers Appendi x I I I

Rickman, L. et al. " Use of adjuvant containing mycobacterial cell-

wall skeleton monophosphoryl lipid A, and squalane in malaria

circumsporozite protein vaccine. " Lancet. Vol. 337, 1991, pp. 998-

1001. Hoffman, S. L. et al. " Safety, immunogenicity, and efficacy

of a malaria sporozite vaccine administered with monophosphoryl

lipid A, cell- wall skeleton of mycobacteria, and squalene as

adjuvant. " American Journal of Tropical Medical Hygiene. Vol. 51/

5, 1994, pp. 603- 612.

Stoute, J. A. et al. " A preliminary evaluation of recombinant

circumsporozoite protein vaccine against plasmodium falciparum

malaria. " New England Journal of Medicine. Vol. 336, 1997, pp. 86-

91.

Page 19 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene Appendi x I V

Anthrax Iacono- Connors, L. et al. " Protection against Anthrax

with Recombinant Virus- Expressed Protective Antigen in

Experimental Animals, " Infection

and Immunity. Vol. 59, 1991, pp. 1961- 1965. Ivins, B. et al.

" Experimental anthrax vaccines: efficacy of adjuvants combined

with protective antigen against an aerosol Bacillus anthraces

spore challenge in guinea pigs. " Vaccine, Vol. 13, 1995, pp. 1779-

1784.

Ivins, B. et al. " Experimental Anthrax Vaccines: Efficacy Studies

in Guinea Pigs. " Abstracts of the 93rd General Meeting of the

American Society for Microbiology. 1993, p. 160.

Ivins, B. et al. " Comparative efficacy of experimental anthrax

vaccine candidates against inhalation anthrax in rhesus macaques. "

Vaccine. Vol. 16, 1998, pp. 1141- 1148.

Ivins, B. et al. " Cloned Protective Activity and Progress in

Development of Improved Anthrax Vaccines. " Salisbury Medical

Bulletin Special Supplement. 1990, pp. 86- 88. Ivins, B. et. al.

" Immunization against Anthrax with Bacillus anthraces Protective

Antigen Combined with Adjuvants. " Infection and Immunity. Vol. 60,

1992, pp. 662- 668.

Ivins, B. et. al. " Adjuvant Efficacy in Experimental Anthrax

Vaccines: Protection Studies in Guinea Pigs. " Abstracts of the

91st General Meeting of the American Society for Microbiology.

1991, p. 121.

Ivins, B. et. al. " Vaccine Efficacy of Bacillus Anthraxis

Protective Antigen Produced in Prokayotic and Iukaryotic Cells. "

Abstracts of the 94th General Meeting of the American Society of

Microbiology, 1994, p. 150.

Little S. F. et. al. " Protection against experimental anthrax

infection using fragments of Protective antigen. " Proceedings of

the International Workshop on Anthrax. Vol. 87, 1996, p. 129.

Little S. F. et al. " Passive Protection by Polyclonal Antibodies

against Bacillus anthraces Infection in Guinea Pigs. " Infection

and Immunity. Vol. 65, 1997, pp. 5171- 5175.

Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene

Page 20 GAO/NSIAD-99-5 Gulf War Illnesses

Malaria Malik A. et al. " Induction of cytotoxic T lymphocytes

against the Plasmodium falciparum circumsporozoite protein by

immunization with soluble recombinant protein without adjuvant, "

Infection and Immunity.

Vol. 61, 1993, pp. 5062- 5066. Toxic Shock Syndrome Stiles, B. et

al. " Biological Activity of Toxic Shock Syndrome Toxin 1 and a

Site- Directed Mutant, H135A, in a lipopolysaccharide- Potentiated

Mouse Lethality Model. " Infection and Immunity. Vol. 63,1995, pp.

1229- 1234.

Page 21 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix V National Institute of Health Studies Using Adjuvants

With Squalene Appendi x V

a NIAID is the National Institute of Allergy and Infectious

Diseases, AVEG is the AIDS Vaccine Evaluation Group, and DIR is

the Division of Intramural Research.

Date Investigational New Drug (IND) study began Vaccine Institute

IND number Adjuvant with squalene No. of subjects

1/ 28/ 91 HIV NIAID/ AVEG a 005A MF 59 16 3/ 22/ 91 HIV NIAID/

AVEG 005B MF 59 46 10/ 1/ 91 Herpes NIAID/ DIR a 92- I- 0267 MF 59

40 10/ 29/ 91 HIV NIAID/ AVEG 005C MF 59 14 12/ 19/ 91 HIV NIAID/

AVEG 007A MF 59 32 2/ 04/ 92 HIV NIAID/ AVEG 007B MF 59 17 11/ 16/

92 HIV NIAID/ AVEG 007C MF 59 10 07/ 28/ 92 HIV NIAID/ AVEG 008 MF

59 14 10/ 1/ 92 Herpes NIAID/ DIR 93- I- 0141 MF 59 174 12/ 09/ 92

HIV NIAID/ AVEG 201 MF 59 149 5/ 19/ 93 HIV NIAID/ AVEG 012A MF 59

15 6/ 03/ 93 HIV NIAID/ AVEG 015 MF 59 30 6/ 03/ 93 HIV NIAID/

AVEG 015 MPL 30 6/ 03/ 93 HIV NIAID/ AVEG 015 SAF/ 2 30 10/ 1/ 93

Herpes NIAID/ DIR 94- I- 0086 MF 59 18 10/ 12/ 93 HIV NIAID/ AVEG

012B MF 59 59 5/ 11/ 95 HIV NIAID/ AVEG 022 MF 59 59 9/ 14/ 95 HIV

NIAID/ AVEG 024 MF 59 30 10/ 1/ 95 Herpes NIAID/ DIR 96- I- 0024

MF 59 10 7/ 10/ 96 HIV NIAID/ AVEG 022A MF 59 129 2/ 06/ 96 HIV

NIAID/ AVEG 026 MF 59 85 7/ 31/ 96 HIV NIAID/ AVEG 029 MF 59 28 5/

22/ 97 HIV NIAID/ AVEG 202 MF 59 142

Total INDs and subjects 23 1177

Page 22 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix VI Comments From the Department of Defense Appendi x VI

Appendix VI Comments From the Department of Defense

Page 23 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix VI Comments From the Department of Defense

Page 24 GAO/NSIAD-99-5 Gulf War Illnesses (713014) Let t er

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**********

posted December 19, 2004 11:41

You can be tested for ASA (Anti-Squalene Antibodies), however I

don't know if the VA will test for this. I would call the

VA/Environmental Agents Service near you and ask if they can test

you for it.

http://www.milvacs.org/Sick/Mycoplasm.cfm

Squalene, an orgamic polymer which occurs naturally in the human

body, is, in remanufactured form, an adjuvant, or vaccine " booster, "

used in several experimental vaccines. The purpose of such an

adjuvant is to boost the immune system's reaction to the vaccine. It

is illegal for use on human beings in the United States and Great

Britain. There is evidence that when injected, squalene is

responsible for arthritic conditions and pain. Squalene appears to

be highly reactive when injected, although not as reactive when

ingested orally.

Although the Dept. of Defense denied the presence of Squalene in the

anthrax vaccine for many years, the FDA tested several lots for the

presence of the adjuvant, and found it - in varying levels. Those

lots are (ppb=parts per billion):

AVA 020 - 11 ppb squalene

AVA 030 - 10 ppb squalene

AVA 038 - 27 ppb squalene

AVA 043 - 40 ppb squalene

AVA 047 - 83 ppb squalene

Squalene has also been found in the vaccine administered in Great

Britain, although the Ministry also denied its presence. See MOD

(Ministry of Defense - UK - ANTHRAX VACCINE CONTAINS SQUALENE)

Recent research by Pamela B. Asa, B. , and F.

Garry links the anthrax vaccine to Gulf War Syndrome through the

presence of squalene antibodies, as noted in the introduction to

their report:

" Date: 2002-07-15 Received August 15, 2001, and in revised form

October 26, 2001 "

" We previously reported that antibodies to squalene, an experimental

vaccine adjuvant, are present in persons with symptoms consistent

with Gulf War Syndrome (GWS) (P. B. Asa et al., Exp. Mol. Pathol 68,

196-197, 2000). The United States Department of Defense initiated

the Anthrax Vaccine Immunization Program (AVIP) in 1997 to immunize

2.4 million military personnel. Because adverse reactions in

vaccinated personnel were similar to symptoms of GWS, we tested AVIP

participants for anti-squalene antibodies (ASA). In a pilot study, 6

of 6 vaccine recipients with GWS-like symptoms were positive for

ASA. In a larger blinded study, only 32% (8/25) of AVIP personnel

compared to 15.7% (3/19) of controls were positive (P 0.05). Further

analysis revealed that ASA were associated with specific lots of

vaccine. The incidence of ASA in personnel in the blinded study

receiving these lots was 47% (8/17) compared to an incidence of 0%

(0/8; P 0.025) of the AVIP participants receiving other lots of

vaccine. Analysis of additional personnel revealed that in all but

one case (19/20; 95%), ASA were restricted to personnel immunized

with lots of vaccine known to contain squalene. Except for one

symptomatic individual, positive clinical findings in 17 ASA-

negative personnel were restricted to 4 individuals receiving

vaccine from lots containing squalene. ASA were not present prior to

vaccination in pre-immunization sera available from 4 AVIP

personnel. Three of these individuals became ASA positive after

vaccination. These results suggest that the production of ASA in GWS

patients is linked to the presence of squalene in certain lots of

anthrax vaccine. 2002 Elsevier Science (USA) "

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*****

THE FOLLOWING COMES FROM THE VA SITE @ http://www.va.gov/ms/

Question :

I served from 1987-2001 and I have MS. What benefits if any am I

eligible for with the VA?

& #65532;Answer :

If you were honorably discharged from a branch of service, then you

may be eligible for medical care, including medications and

equipment, from the VA. The majority of veterans who apply for

services are eligible.

To determine your eligibility, go to the Enrollment Clinic at a VA

and complete an Application for Health Benefits (e.g. Form 10-10EZ

or Means Test). This form requires financial information. Previously

the VA did not consider income in determining eligibility but this

has changed in recent years due to the increasing number of veterans

seeking services. Veterans whose income exceeds the VA's income

guidelines (these vary by geographic area to reflect differences in

cost of living, etc.) and are not service connected, fall into

priority group 8. Delivery of services is not mandatory for these

veterans. HOWEVER, veterans in this situation can apply for hardship

based on financial or medical circumstances. The enrollment clerk

can assist you in doing so. Veterans who are severely and

permanently disabled may meet the criteria for Catastrophic

Disability. This moves a veteran into a higher priority group (5)

and makes delivery of services mandatory.

If you had symptoms of MS in the military or within seven years

after honorable discharge, you may be eligible for service-connected

disability. If this is the case, complete the Veterans Application

for Compensation and/or Pension (VA form 21-526) available online

(http://www.va.gov) or at your Regional Office and return it to the

Regional Office for processing. Veterans service organizations, such

as the Paralyzed Veterans of America (http://www.pva.org/), United

Spinal Association (http://www.unitedspinal.org/), and Disabled

American Veterans (http://www.dav.org/) are good support resources.

Remember to bring your DD214 with you to expedite the enrollment

process. If you never received your DD214 or it has been lost, you

can contact the National Personnel Records Center in St. Louis, MO,

at 314-801-0880 to request a copy.

***************************************************************

Regulations on Vaccine Injury

Bringing this forward from a previous thread, as it may help those

who did not deploy to the AOR:

http://www.gulfwarvets.com/ubb/Forum1/HTML/000201.html

Department of Memorandum

Veterans Affairs

Date: May 14, 2002 VAOPGCPREC 4-2002

From: General Counsel (022)

Subj: Meaning of " Injury " for Purposes of Active Service – 38 U.S.C.

§ 101(24)

**************************

Director, Compensation and Pension Service (21)

QUESTION PRESENTED:

Whether a former member of the Army Reserve who received two anthrax

inocu-lations during inactive duty training and who alleges

suffering from chronic fa-tigue and chronic Lyme-like disease as a

result of these inoculations may be considered to have been disabled

by an injury in determining whether the mem-ber incurred disability

due to active service.

DISCUSSION:

1. The claimant had active duty service in the United States Army

from May 29, 1995, to June 18, 1999, and was then assigned to the

Army Reserve. In prepa-ration for a required two-week tour of duty

in Korea, the claimant received three anthrax inoculations, the

first two of which were received while on inactive duty training on

February 12 and March 11, 2000. The claimant received the third in-

oculation on March 25, 2000, while in civilian status. The claimant

was deployed to Korea from April 10, 2000, to April 24, 2000. The

claimant has filed a claim with the Department of Veterans Affairs

(VA) seeking service connection for chronic fatigue and chronic Lyme-

like illness claimed to have resulted from the anthrax inoculations.

2. Pursuant to 38 U.S.C. §§ 1110 and 1131, service-connected

disability com-pensation may be paid for disability resulting from

injury suffered or disease con-tracted in line of duty " in the

active military, naval, or air service. " Sec-tion 101(24) defines

the term " active military, naval, or air service " as

including " active duty, any period of active duty for training

during which the individual con-cerned was disabled or died from a

disease or injury incurred or aggravated in line of duty, and any

period of inactive duty training during which the individual

concerned was disabled or died from an injury incurred or aggravated

in line of duty. " (Emphasis added.) Thus, in the case of inactive

duty training, only if the individual suffered an " injury " during

such service can disability resulting from such service provide a

basis of eligibility for disability compensation.

3. The question of what constitutes an " injury " for purposes of

section 101(24) must be considered in light of three previous

General Counsel opinions in which we analyzed the distinction

between " injury " and " disease " under that statute. One such opinion,

VAOPGCPREC 86-90 (O.G.C. Prec. 86-90), concerned whether a heart

attack sustained following heavy exertion while on inactive duty

training was an injury within the meaning of section 101(24).

Medical evidence in that case indicated that the heart attack was

the result of coronary artery dis-ease, which existed prior to the

training period, although the event may have been precipitated by

physical exertion. On those facts, we concluded that the claimant's

heart attack was not caused by an injury, but rather was

attributable to disease.

4. In VAOPGCPREC 86-90, we examined the medical cause of the heart

attack. We noted the consensus among medical specialists that

excessive effort and strain cannot damage a normal heart and

concluded that the heart attack was the result of a disease process.

We further concluded that Congress intended to ex-

clude " nontraumatic incurrence or aggravation of a disease process,

and that manifestations of cardiovascular disease, such as heart

attacks of nontraumatic origin, fall within the excluded class of

disability, i.e., do not constitute injuries under the statute. " In

v. Brown, 5 Vet. App. 484, 487 (1993), aff'd, 26 F.3d 141

(Fed. Cir. 1994), the United States Court of Veterans Appeals con-

cluded that VAOPGCPREC 86-90 is consistent with the governing

statutes and Congress' policy reflected in those statutes. We note

that the focus of our hold-ing in VAOPGCPREC 86-90 was clearly on

the non-traumatic nature of the cause of the heart attack. We may

assume that a heart attack caused by a traumatic external event that

is independent of a disease process, e.g., an elec-tric shock, may

be considered an injury.

5. VAOPGC 6-86 (3-27-86) followed and relied upon what was formerly

Op. G.C. 1-81 (subsequently reissued and redesignated as VAOPGCPREC

86-90). Although VAOPGC 6-86 is not precedential, it illustrates how

the opinion now designated VAOPGCPREC 86-90 has been applied. In

VAOPGC 6-86, we de-termined that a claimant who received an

influenza vaccination by injection while on inactive duty training

and subsequently developed Guillain-Barre syndrome did not incur a

disability resulting from an injury for purposes of section 101(24).

Referencing what is now VAOPGCPREC 86-90, we reasoned that the

term " in-jury " denotes harm from external trauma, while the

term " disease " refers to some type of internal infection or

degenerative process. The opinion cited several sources for the

proposition that the term " trauma " commonly refers to the applica-

tion of external force or violence. We further reasoned that, under

modern medi-cal practice, the routine insertion of a hypodermic

needle into the body is not commonly considered to involve

application of external force or violence that is characteristic of

injury. However, we recognized that an injection could be con-

sidered to have caused a traumatic injury if contact with the needle

caused last-ing nerve or tissue damage.

6. Most recently, in VAOPGCPREC 8-2001, we held that an individual

who suf-fers from post-traumatic stress disorder (PTSD) as a result

of a sexual assault that occurred during inactive duty training may

be considered disabled by an " in-jury " for purposes of section 101

(2) and (24). This conclusion was based upon the analysis of the

preceding General Counsel opinions indicating that " injury " refers

to the results of an external trauma rather than a degenerative

process and the fact that, according to the Diagnostic and

Statistical Manual of Mental Disorders, Fourth Edition, of the

American Psychiatric Association, at 427 (diag-nostic criterion A),

a diagnosis of PTSD requires experiencing a traumatic event.

7. The concept exemplified by these VA General Counsel opinions is

that

" injury " refers to the results of an external trauma, rather than a

degenerative process. While, as noted in VAOPGC 6-86, " trauma "

frequently is defined with reference to external force or violence,

the term may commonly be considered to encompass injury to living

tissue caused by an extrinsic agent. Webster's Ninth New Collegiate

Dictionary 1256 (1990). In this regard, we believe that considera-

tion of the nature of vaccines is helpful in resolving the issue of

whether introduc-tion of a vaccine into the body may constitute

trauma for purposes of determining the nature of harm resulting from

the vaccine.

8. A vaccine is a suspension of attenuated or killed microorganisms

or of anti-genic proteins derived from them. Dorland's Illustrated

Medical Dictionary 1787 (28th ed. 1994). Vaccines artificially

induce the immune system to produce anti-bodies that will attack

invading organisms and prevent disease. National Institute of

Allergy and Infectious Diseases, How Vaccines Work, available at

http://www.niaid.nih.gov/daids/vaccine/how.htm. Although vaccines

and mass immunization programs have been extremely successful in

protecting the public health against dangerous diseases, " available

data indicate that some vaccines are associated with rare but

serious adverse effects. " The Anthrax Vaccine: Is It Safe? Does It

Work? at 85. An adverse event following a vaccination may be either

local or systemic. Id. at 86. The duration of these events may be

acute or chronic, and adverse health effects may range from mild to

severe. Id.

9. The foregoing discussion indicates that inoculation with a

vaccine involves the intro-duction of a foreign substance into the

body and that, while the substance is intended to and generally does

have a beneficial effect, adverse reactions, sometimes of a severe

nature, may result. Further, based on the above discussion, we

believe that the term " injury " in section 101(24) may be interpreted

to include harm not only from a violent en-counter but also from

exposure to a foreign substance, such as a vaccine. We recog-nize

that in our non-precedential opinion VAOPGC 6-86 we concluded that

harm result-ing from an influenza vaccination would not be

considered to have resulted from an in-jury. However, VAOPGC 6-86

focused on harm caused by the " routine insertion of a hypodermic

needle into the body " and on the absence of external force or

violence, rather than on the introduction of an extrinsic agent to

body tissue. We believe the common understanding of the concept

of " trauma, " which is recognized as the cause of " injury, "

encompasses a broader definition than the one applied in VAOPGC 6-86

and that such broader definition includes serious adverse effects on

body tissue or systems resulting from introduction of a foreign

substance. Thus, an adverse reaction to a vac-cination may be

considered an " injury " as that term is used in 38 U.S.C. § 101(24).

10. This conclusion is consistent with VAOPGCPREC 86-90, in which

the harm suffered (a heart attack) did not result from an external

force or substance, but rather from a pre-existing disease. This

conclusion is also consistent with VA-OPGCPREC 8-2001, in which we

recognized that a condition (in that case PTSD) that has

characteristics of a disease may be considered to be the result of

an injury, where it resulted from an external assault.

HELD:

If evidence establishes that an individual suffers from a disabling

condition as a result of administration of an anthrax vaccination

during inactive duty training, the individual may be considered

disabled by an " injury " incurred during such training as the term is

used in 38 U.S.C. § 101 (24), which defines " active military, naval,

or air service " to include any period of inactive duty training

during which the indi-vidual was disabled or died from an injury

incurred or aggravated in line of duty.

Consequently, such an individual may be found to have incurred

disability in ac-tive military, naval, or air service for purposes

of disability compensation under 38 U.S.C. § 1110 or 1131.

Tim S. McClain

*********************************************************************

*

ALSO PLEASE TEST FOR THE FOLLOWING

( This testing is if you think you have been injured by anthrax

vaccine or showing autoimmune symptoms )

There are a number of blood tests which may be of help in diagnosing

your husband's illness. If he has autoimmune disease following

squalene exposure, tests include, but are not limited to: ANA,

rheumatoid factor, ESR, CRP, CPK, thyroid profile with TSH, anti-

thyroid microsomal antibodies, antiphospholipid antibodies,

antineuronal antibodies, CBC with differential, ANCA, complement C3

and C4. The results from these tests may lead to further testing. If

there are neurologic symptoms, consulting a neurologist who deals

with autoimmune neurologic disease would be helpful. For

neuropathies, EMG/NCV may be indicated. If there is a question of

seizures, EEG's will be in order. Tests may need to be repeated over

time. I hope this will help him get the answers he needs. Best

wishes, Pam Asa, Ph.D. ( Tulane University )

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*

Here is an Index to Disability Examination Worksheets and links to

individual exams I got from another Forum.

Main page:

www.vba.va.gov/bln/21/ben.../index.htm

Index to Disability Examination Worksheets

" These 56 Disability Examination Worksheets are in use both by the

doctors of VHA (Veterans Health Administration) who do the

disability examinations and by the rating specialists, hearing

officers, and Decision Review Officers of VBA (Veterans Benefits

Administration) who do the disability evaluations. "

Acromegaly www.vba.va.gov/bln/21/ben...sexm01.htm

Aid and Attendance or Housebound Examination

www.vba.va.gov/bln/21/ben...sexm02.htm

Arrhythmias www.vba.va.gov/bln/21/ben...sexm03.htm

Arteries, Veins, and Miscellaneous

www.vba.va.gov/bln/21/ben...sexm04.htm

Audio www.vba.va.gov/bln/21/ben...sexm05.htm

Bones (Fractures and Bone Disease)

www.vba.va.gov/bln/21/ben...sexm06.htm

Brain and Spinal Cord www.vba.va.gov/bln/21/ben...sexm07.htm

Chronic Fatigue Syndrome www.vba.va.gov/bln/21/ben...sexm08.htm

Cold Injury Protocol Examination

www.vba.va.gov/bln/21/ben...sexm09.htm

Cranial Nerves www.vba.va.gov/bln/21/ben...sexm10.htm

Cushing's Syndrome www.vba.va.gov/bln/21/ben...sexm11.htm

Dental and Oral www.vba.va.gov/bln/21/ben...sexm12.htm

Diabetes Mellitus www.vba.va.gov/bln/21/ben...sexm13.htm

Digestive Conditions, Miscellaneous

www.vba.va.gov/bln/21/ben...sexm14.htm

Ear Disease www.vba.va.gov/bln/21/ben...sexm15.htm

Eating Disorders (Mental Disorders) Changed June 13, 2002

www.vba.va.gov/bln/21/ben...sexm16.htm

Endocrine Diseases, Miscellaneous

www.vba.va.gov/bln/21/ben...sexm17.htm

Epilepsy and Narcolepsy www.vba.va.gov/bln/21/ben...sexm18.htm

Esophagus and Hiatal Hernia www.vba.va.gov/bln/21/ben...sexm19.htm

Eye Examination www.vba.va.gov/bln/21/ben...sexm20.htm

Feet www.vba.va.gov/bln/21/ben...sexm21.htm

Fibromyalgia www.vba.va.gov/bln/21/ben...sexm22.htm

General Medical Examination www.vba.va.gov/bln/21/ben...sexm23.htm

Genitourinary Examination www.vba.va.gov/bln/21/ben...sexm24.htm

Guidelines for Disability Examinations in Gulf War Veterans

www.vba.va.gov/bln/21/ben...sexm25.htm

Gynecological Conditions and Disorders of the Breast

www.vba.va.gov/bln/21/ben...sexm26.htm

Hand, Thumb, and Fingers www.vba.va.gov/bln/21/ben...sexm27.htm

Heart www.vba.va.gov/bln/21/ben...sexm28.htm

Hemic Disorders www.vba.va.gov/bln/21/ben...sexm29.htm

Hiv-Related Illness www.vba.va.gov/bln/21/ben...sexm30.htm

Hypertension www.vba.va.gov/bln/21/ben...sexm31.htm

Infectious, Immune, and Nutritional Disabilities

www.vba.va.gov/bln/21/ben...sexm32.htm

Initial Evaluation for Post-Traumatic Stress Disorder (PTSD) Changed

June 13, 2002 www.vba.va.gov/bln/21/ben...sexm43.htm

Intestines (Large and Small) www.vba.va.gov/bln/21/ben...sexm33.htm

Joints (Shoulder, Elbow, Wrist, Hip, Knee, and Ankle)

www.vba.va.gov/bln/21/ben...sexm34.htm

Liver, Gall Bladder, and Pancreas

www.vba.va.gov/bln/21/ben...sexm35.htm

Lymphatic Disorders www.vba.va.gov/bln/21/ben...sexm36.htm

Mental Disorders (Except Initial PTSD and Eating Disorders) Changed

June 13, 2002 www.vba.va.gov/bln/21/ben...sexm37.htm

Mouth, Lips, and Tongue www.vba.va.gov/bln/21/ben...sexm38.htm

Muscles www.vba.va.gov/bln/21/ben...sexm39.htm

Neurological Disorders, Miscellaneous

www.vba.va.gov/bln/21/ben...sexm40.htm

Nose, Sinus, Larynx, and Pharynx

www.vba.va.gov/bln/21/ben...sexm41.htm

Peripheral Nerves www.vba.va.gov/bln/21/ben...sexm42.htm

Prisoner of War Protocol Examination

www.vba.va.gov/bln/21/ben...sexm44.htm

Pulmonary Tuberculosis and Mycobacterial Diseases

www.vba.va.gov/bln/21/ben...sexm45.htm

Rectum and Anus www.vba.va.gov/bln/21/ben...sexm46.htm

Residuals of Amputations www.vba.va.gov/bln/21/ben...sexm47.htm

Respiratory (Obstructive, Restrictive, and Interstitial)

www.vba.va.gov/bln/21/ben...sexm48.htm

Respiratory Diseases, Miscellaneous

www.vba.va.gov/bln/21/ben...sexm49.htm

Review Examination for Post-Traumatic Stress Disorder (PTSD) Changed

June 13, 2002 www.vba.va.gov/bln/21/ben...sexm56.htm

Scars www.vba.va.gov/bln/21/ben...sexm50.htm

Sense of Smell and Taste www.vba.va.gov/bln/21/ben...sexm51.htm

Skin Diseases (Other than Scars)

www.vba.va.gov/bln/21/ben...sexm52.htm

Spine (Cervical, Thoracic, and Lumbar) Changed December 11, 2002

www.vba.va.gov/bln/21/ben...sexm53.htm

Stomach, Duodenum, and Peritoneal Adhesions

www.vba.va.gov/bln/21/ben...sexm54.htm

Thyroid and Parathyroid Diseases

www.vba.va.gov/bln/21/ben...sexm55.htm

*********************************************************************

************

Smallpox easily treated and prevented with homeopathy

History of smallpox (many lies in what we are told)

http://www.nccn.net/~wwithin/smallpox.htm

http://www.zwire.com/site/news.cfm?

newsid=13900319 & BRD=1719 & PAG=461 & dept_id=

25271 & rfi=6

Experimental smallpox vaccine tested in St. Louis

DAVE WHALEY, The Telegraph 02/06/2005

ST. LOUIS -- Saint Louis University is one of four sites in the

country

participating in a clinical trial to study a " next-generation "

smallpox

vaccine.

VaxGen Inc. is developing the experimental vaccine -- for now named

LC16m8

-- in partnership with the Chemo-Sero Therapeutic Research Institute

in

Japan. The vaccine will be compared to Dryvax, the only smallpox

vaccine

currently licensed for use in the United States.

" Although smallpox was eradicated in the United States years ago, the

possibility that it may be used in a bioterrorist act has prompted

the

government to seek attenuated smallpox vaccines for the country's

national

stockpile, " said Dr. Sharon Frey, principal investigator in the

study.

Attenuated, or modified, vaccines are designed to be safer than

conventional live-virus vaccines such as Dryvax.

The clinical trial is enrolling study volunteers to evaluate the

safety of

the vaccine, as well as its ability to induce an immune response.

Although

LC16m8 has been licensed and safely used in Japan for more than

50,000

children, as well as in laboratory, medical and emergency response

personnel, getting licensed for use in the United States requires

completion of studies according to Food and Drug Administration

standards.

A total of 150 volunteers are being sought for a 52-week study, with

120

receiving LC16m8 and 30 receiving Dryvax. Study volunteers will be

screened

for risk factors. The screening process includes a medical history,

physical exam, and a panel of cardiac and lab tests.

All volunteers will continue to receive safety evaluations in the

clinic

after vaccination and will return for regular assessments. Frey

stressed

that no one will be exposed to smallpox as part of the clinical

study.

To be eligible, volunteers must be between 18 and 33 years old, in

good

health with no chronic illness, no heart disease, no immune system

problems, and no eczema or other significant skin conditions.

Volunteers

must not previously have been vaccinated against smallpox.

Those who have significant contact with children under the age of 1

or who

are pregnant or breastfeeding will be excluded.

Qualified volunteers will receive lab and cardiac tests, and the

vaccine,

at no charge.

For more information, call the Saint Louis University Center for

Vaccine

Development at (314) 977-6333.

dwhaley56@...

©The Telegraph 2005

*****

http://www.vaxgen.com/products/smallpox_LC16m8.html

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?

cmd=Retrieve & db=PubMed & list_ui

ds=2993828 & dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?

cmd=Retrieve & db=PubMed & list_ui

ds=3554809 & dopt=Abstract

http://news-service.stanford.edu/news/2005/january26/med-smallpox-

012605.html

also experimenting at Stanford in CA

http://vir.sgmjournals.org/cgi/content/abstract/68/10/2705

http://www.cojoweb.com/Biodefense4.html

" An attractive candidate is the LC16m8 strain developed by Hashizume

at the

Chiba Serum Institute in 1975 (7). A summary of its characteristics,

prepared by Hirayama (9), indicates that in controlled studies, the

strain

induces fewer local and febrile reactions than the standard Japanese

strain

(Ikeda), Lister and EM-63 (Russian strain derived from the New York

City

Board of Health strain). HI and neutralizing antibodies appear to be

equivalent. When the different strains were inoculated into the

thalamus of

monkeys, the Japanese strain proved to be the least pathogenic. Some

50,000

Japanese children have been vaccinated with this strain; no serious

adverse

reactions were detected. "

http://www.medscape.com/viewarticle/414504_2

" LC16m8, an attenuated VACV strain developed by Japan in 1975 for

primary

vaccination, was derived by passing the Lister strain 36 times

through

primary rabbit kidney cells at low temperature (30°C)[36]. The LC16m8

strain had a take rate of 95% (compared with 93.7% for Lister),

fever rate

of 7.7% (compared with 26.6% for Lister), and lower neurovirulence

in a

monkey assay. The lower fever rate and reduced neurovirulence were

considered indications that this was a safer vaccine[37]. Antibody

titers

and induration size were lower than those of the Lister strain;

however,

the effect of its decreased immunogenicity on the ability of this

vaccine

to protect against smallpox infection is unknown since the vaccine

was

never used in a smallpox-endemic region. "

--------------------------------------------------------

Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

$$ Donations to help in the work - accepted by Paypal account

vaccineinfo@... voicemail US 530-740-0561

(go to http://www.paypal.com) or by mail

Vaccines - http://www.nccn.net/~wwithin/vaccine.htm

Vaccine Dangers On-Line course -

http://www.nccn.net/~wwithin/vaccineclass.htm

Homeopathy On-Line course - http://www.nccn.net/~wwithin/homeo.htm

ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL

OR LEGAL ADVICE. THE DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

******

" Just look at us. Everything is backwards; everything is upside down.

Doctors destroy health, lawyers destroy justice, universities destroy

knowledge, governments destroy freedom, the major media destroy

information

and religions destroy spirituality " .... Ellner

Our Anthrax information web site:

http://www.dallasnw.quik.com/cyberella/

/files/VAERS.pdf

DESTROY QUARANTINED VACCINE:

http://www.PetitionOnline.com/mod_perl/signed.cgi?

robi2662 & amp;amp;amp;amp;1

PETITION TO OVERTURN/REPEAL FERES DOCTRINE

http://www.petitiononline.com/fd1950/petition.html

To visit Dr. Meryl Nass's web site, go to:

http://www.anthraxvaccine.org

Also visit: Anthrax Vaccine Benefit vs Risk: http://www.avip2001.net

AND http://www.MajorBates.com/

Anthrax Vaccine Network http://www.ngwrc.org/anthrax/default.asp

Military Vaccine Education Center link, http://www.milvacs.org

Sgt. Larson's story:

http://www.ngwrc.org/anthrax/heroes/sandralarson.htm

http://www.avip2001.net/CongressionalTestimony.htm

Tom Heemstra's new book -

http://www.anthraxadeadlyshotinthedark.com/index.html

Contact list owner: Gretchen at: anna_nim@...

To unsubscribe from this mailing list, or to make changes to your

subscription,

log on: then:

myprefs

http://www.forbes.com/investmentnewsletters/2005/02/14/cz_sg_0214soap

box_inl

..html

Jeff Bettendorf

www.teambettendorf.com

_____

From: Meryl Nass [mailto:mnass@...]

Sent: Tuesday, February 15, 2005 7:45 AM

Subject: [] Where is the money in bioterrorism?

http://www.forbes.com/personalfinance/strategies/2005/02/14/

cz_sg_0214soapbox_inl.html

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

207 288-5081 ext. 220

Our Anthrax information web site:

http://www.dallasnw.quik.com/cyberella/

/files/VAERS.pdf

DESTROY QUARANTINED VACCINE:

http://www.PetitionOnline.com/mod_perl/signed.cgi?robi2662

<http://www.PetitionOnline.com/mod_perl/signed.cgi?

robi2662 & amp;amp;amp;1>

& amp;amp;amp;amp;1

PETITION TO OVERTURN/REPEAL FERES DOCTRINE

http://www.petitiononline.com/fd1950/petition.html

To visit Dr. Meryl Nass's web site, go to:

http://www.anthraxvaccine.org

Also visit: Anthrax Vaccine Benefit vs Risk: http://www.avip2001.net

AND

http://www.MajorBates.com/

Anthrax Vaccine Network http://www.ngwrc.org/anthrax/default.asp

Military Vaccine Education Center link, http://www.milvacs.org

Sgt. Larson's story:

http://www.ngwrc.org/anthrax/heroes/sandralarson.htm

http://www.avip2001.net/CongressionalTestimony.htm

Tom Heemstra's new book -

http://www.anthraxadeadlyshotinthedark.com/index.html

Contact list owner: Gretchen at: anna_nim@...

To unsubscribe from this mailing list, or to make changes to your

subscription,

log on: then:

myprefs