GWS, Anthrax and Vaccine A

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troutster
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GWS, Anthrax and Vaccine A

Post by troutster » Wed Nov 17, 2004 10:51 am

I just noticed an interesting reaad over at Slate:

http://slate.com/id/2109808/
RainbowRising

Gulf War Illness and Other Links / Anthrax Vaccine Issues

Post by RainbowRising » Wed Jan 12, 2005 9:10 pm

Rainbow Rising


January 12, 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/

Political Satire http://www.slick.com/


American Gulf War Veterans Association http://www.gulfwarvets.com/
National Gulf War Resource Center: http://www.ngwrc.org/
Desert Storm.Com: http://www.desert-storm.com/
New Hampshire Gulf War Syndrome Association: http://www.nhgws.org/index.htm
Lots of documents http://Odssa-l@odssa.com/
The Reigle Report: What veterans have been exposed to and a look at the U.S. government’s involvement: http://www.gulfwarvets.com/arison/banking.htm
Department of Veterans Administration : https://iris.va.gov/phonenbrs.asp
Angel Flight For Veterans Who Need Specialized Care : http://www.angelflightveterans.org/
Compensation & Pension Info Link : http://www.vba.va.gov/bln/21/Benefits/exams/index.htm
http://www.hadit.com/
Suggestions to help your immune system : http://www.milvacs.org/Sick/Suggestions.cfm
________________________________________________________________________________________________________________________________________________


Advocacy Groups :
PUBLIC CITIZEN : http://www.citizen.org/ or email at hrg1@citizen.org
THEIR LITIGATION GROUP : weblitigationmail@citizen.org
TEXAS OFFICE : jcarraway@citizen.org
CONGRESS WATCH : congress@citizen.org
CITIZENS FOR HEALTH : info@citizens.org
CITIZENS ADVOCACY GROUP ( CHICAGO ) : cac@citizenadvocacycenter.org
Citizen Advocacy in Cherwell & West Oxfordshire : info@CITAD33a.freeserve.co.uk
Vermont Public Interest Research Group (VPIRG : info@VPIRG.org
Sjudd@vpirg.org ben@vpirg.org paul@vpirg.org
Patty Gates/ New Priorities Foundation : Patty@NewPriorities.org
FEDERATION OF AMERICAN SCIENTISTS : sgleason@fas.org
Project SHAD : http://www.projectshad.org/
Adopt a Platoon : http://adoptaplatoon.org/new/
Adopt a Soldier : http://www.brandonblog.com/Adopt-A-Soldier.html
Soldiers Angels : http://www.soldiersangels.org/heroes/ad ... oldier.php






Man Claims Anthrax Vaccine Almost Killed Him : THE STORY OF BRAD PRIESTER http://www.firstcoastnews.com/news/loca ... ryid=27100
Man Claims Anthrax Vaccine Almost Killed Him
By Tiani Jones
First Coast News
HOW THE ANTHRAX VACCINE AFFECTED Sr. Airman Thomas J. Colosimo
http://members.tripod.com/tomcolosimo/id27.htm


VA COVERED HOSPITAL CARE IN NON-VA FACILITIES

Authorized Contract Hospital Care and Medical Services in Non-VA Health Care Facilities Am I eligible?
Eligibility criteria
In order to qualify for this benefit program, you must have been in military service and must not have been dishonorably discharged.
Description
VA may authorize a non-VA health care facility to provide necessary medical care services when such services are not routinely available at a VA health care facility, or VA determines that such services can be obtained outside the VA more economically or more appropriately due to geographic inaccessibility. Non-VA care must be authorized by VA in advance.
Managing organization
Veterans Health Administration (VHA) http://www.va.gov/
Program contact information & web resources
To inquire about authorized hospital care and medical services in non-VA health care facilities, call your nearest VA health care facility. Contact information for VA health care facilities in your state can be obtained through the VA Facilities Directory:
http://www.va.gov/sta/guide/division.asp?divisionId=1

You may also contact the Health Benefits Service Center at the following toll-free telephone number:
877-222-8387



******************************************************************************************************************************
VIDEO STORY LINKS

CBS NEWS LINKS PAGE :
http://search.atomz.com/search/?sp-q=an ... s=doc_date

ALSO CLICK ON THE VIDEO TRAILER BEYOND TREASON @
http://www.gulfwarvets.com

DU TRAINING VIDEO

http://www.amc.army.mil/amc/sf/DU_Q4.html

A-10 VIDEO LINK ( NOTE HOW PLANE FLYS THROUGH CANNON SMOKE AND GUNSMOKE PASSING THROUGH GE TF-34 ENGINES )
http://www.dm.af.mil/demoteam/images/AVI/straff.avi

TEST VIDEO OF CANNON AT GROUND LEVEL
http://www.dm.af.mil/demoteam/2002pages/A-10gau-8.avi



Behind the Scenes Look at SSI Disability Thinking

http://frwebgate.access.gpo.gov/cgi-bin ... s/data/gao

http://www.gulfwarvets.com/ubb/Forum4/HTML/000025.html
I would also submit that the makers of Lariam be investigated.
(Nineteen pages of known and unknown side effects of anti-malarial drug. ) http://www.vethealth.cio.med.va.gov/Pubs/102004007.pdf

Necessary Vaccine or Betrayal : Article From Winds of http://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 Steven 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 Wright 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 Gary 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? Steven 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 Wright'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 Carter (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

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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 Powell, 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 Cooperative 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. Powell 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 Reed 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 Reed 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, Maryland; 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 William 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
Rodriguez. 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. Powell, Chapter 7, "A compendium of Vaccine Adjuvants
and Excipients," Vaccine Design: The Subunit and Adjuvant
Approach, M. F. Powell 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) http://www.milvacs.org/News/NewsArchives.cfm



"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"



http://www.milvacs.org/News/NewsArchives.cfm



THERE MAY BE SOME DUPLICATIONS FROM OTHER POSTINGS.

ANTHRAX VACCINE PROBLEMS / RESEARCH / ARTICLES /

http://www.immed.org/

HOUSE REPORT 105-388, 1997 VA,DOD CONTINUE TO RESIST STRONG EVIDENCE LINKING TOXIC CAUSES TO CHRONIC HEALTH EFFECTS

http://www.gulfweb.org/bigdoc/hsr105-388.cfm

BIOETHICS HISTORY & LINKS TO VACCINE LAWSUITS UNDERWAY

http://www.sskrplaw.com/bioethics/chronology.html

VACCINE LITIGATION

http://www.sskrplaw.com/vaccine/index.html

More DRUG-SAFETY QUESTIONS INCREASE DOUBTS ABOUT FDA 12/20/04
http://story.news.yahoo.com/news?tmpl=s ... tsaboutfda

FDA MISHANDLES CHIRON FLU VACCINE PROBLEMS ( Rep. Henry Waxman D-Calif. )

http://www.cidrap.umn.edu/cidrap/conten ... 04fda.html

WARNING TO FLU VACCINE MAKER RELEASED/ REPORTS OF “NOT SAFE’/”ADULTERATED PRODUCT”

http://www.usatoday.com/news/health/200 ... htm?csp=34

VETERANS FREE LEGAL ADVICE SITE ( FAQ’s )/ INCLUDES FORM FINDER TOOL

http://www.advicetool.com/faq/17.html

PEOPLES LAW LINK - VETERANS COMPENSATION

http://www.peoples-law.com/income/gov-b ... sation.htm

DISABLED WOMEN VETERANS

http://www.militarywoman.org/disabled.htm

DRUG TO COMBAT HEPATITIS C

http://www.davny.org/mar01news-pg4.htm#hepc

LUNG CANCER LINKED TO GULF OIL FIRES

http://www.msnbc.msn.com/id/6737722/








BONE MARROW CELLS USED IN RESEARCH TO HELP SEVERE LIVER DAMAGE

http://www.newscientist.com/article.ns?id=dn6804


MVAC-PAC Calls Latest Push to Force Anthrax Vaccine Irresponsible Abuse of Power by the DOD  12/20/04

Is FDA on automatic pilot?  12/20/04

FDA'S sad slide: warnings went unheeded 







Chiron Gets Subpoena From US Congressional Committee

http://money.iwon.com/jsp/nw/nwdt_rt.js ... oney/cm/nw








Captain Joyce Riley : GULF WAR SYNDROME

http://www.all-natural.com/riley.html






HISTORY OF SECRET EXPIREMENTS IN THE US

http://www.global-conspiracies.com/history.htm

EMERGING INFECTIOUS DISEASES WITH BREAKDOWN BY JOB/RACE/SEX RISKS & GOOD GRAPHS BY THE NAVY HEALTH RESEARCH CENTER< SAN DIEGO CA. APRIL-JUNE 1998
( 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, Stewart G, Thompson 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 SETT
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