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black8



Joined: 28 Jan 2005
Posts: 2

PostPosted: Sat Jan 29, 2005 5:52 am    Post subject: DSMS Reply with quote

Task Force 1/32 Armor, 1st Cavalry Division
Oct 1990-April 1991

"SECRET" Anthrax Vaccine
WHO record noted;
"20 Jan. 1991 VACC-A"
no lot number

May 1991-Flu-like symptoms, angiolipoma, headaches, dizziness, anxiety, depression, dermatitis, back problems,fatigue, some memory loss.

1992-numbness and tingling arms bilateral and legs intermittently,localized scleroderma legs bilateral, more fatigue, more of everything except the flu-like symptoms subsided. first VA visit in August.

1993-1994 Persian Gulf Registry Program, did not warrant further evaluation by Physicians Assistant conducting examination. I strongly requested advanced testing, PA terminated exam session. Filed first claim for undiagnosed illness. WBC high

1995-1997 DXed by VA with "dystemic disorder with anxiety" and "mild carpel tunnel syndrome that would not explain the veterans complaints of unknown etiology" VA Neurologist noted in 1997 report "it seems the veteran is describing Lhermitte's Phenomenon, however, he can continue working" no further testing was ordered. WBC high

1998- Lower back went out, apparent "acute lumbar strain"

1999-2001- VA Mycoplasma study, I started requesting MRI,SPECT, PET, etc.
2000- VA Urgent Care, chest pains, normal EKG, VA suspected rib fracture? x-ray negative for rib fracture, no DX.
Repeat EMG, no further testing."mild carpel tunnel"

2000- First prime care appt. refused carpel tunnel surgery, requested MRI, no records available, will review next visit.
Next visit, refused carpel tunnel surgery, requested MRI, records not available, will review next visit, went to the clerk to reschedule, there lay my records..

May 2004- requested MRI, MRS, etc. at VA C&P exam, Physician noted MRI request and "I do not feel these tests are medically appropriate"
Repeat EMG, EKG, no further testing. "mild carpel tunnel"

18 Nov. 2004- VA Urgent Care- stroke like symptoms- could not write, walk, or speak normally, right side affected. VA first suspected stroke, EKG normal, CBC normal. WBC high. VA DXed Psychological problems associated with anxiety disorder. prescribed sleeping pills and MHC followup in 10 days.

23 Nov. 2004-Went to private Hospital ER with same symptoms as 18 Nov. 2004. DX-Acute MS Attack- Tumefactive form of Multiple Sclerosis--DXed by Neurologists outside the VA, report stating "I have no doubt this is the basis for his complaints since 1991" based on multiple lesions and review of medical records from 1991 to present.

Can one fully recover from an acute ms attack?

WR declined to see me, big surprise there.

Requesting ASA, will go anywhere, anytime.


Victory or Death,

Black8
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Dr. Asa
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PostPosted: Sun Jan 30, 2005 5:28 am    Post subject: MS and squalene Reply with quote

The ASA would allow you to know if you were exposed to squalene. Squalene is known to cause EAE, which is the animal model of MS. Others have developed MS after exposure to squalene.
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Gary M - Author
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PostPosted: Sun Jan 30, 2005 5:59 am    Post subject: Reply to "black8"; RE: DSMS Reply with quote

Dear "black8": Given Dr. Asa's surname, I think the abbreviation "ASA" is a little confusing. ASA stands for anti-squalene antibodies. "EAE" stands for Experimental Allergic Encephalomyelitis, which is the animal version of MS.

"Exposure" to squalene means "injection" with squalene. At this writing, there is no experimental or clinical data suggesting that animals or humans can develop anti-squalene antibodies by topical application to the skin, or by ingestion.

Sincerely,
Gary Matsumoto
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Gale
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PostPosted: Mon Jan 31, 2005 3:51 am    Post subject: Blood tests Reply with quote

Hi. It's me, Gale, again. I don't know if this will recognize me as "Gale" or "guest", so I'll just identify myself to begin with.

Gary said, "The answer is they could not be that selective (the U.S. Defense Intelligence Agency pointed this out as early as 1993); nor is there forensic evidence that these theoretically engineered or mutated mycoplasma, or the CIA's alleged nerve agent plume, even existed."

There have been many changes in the CIA's reporting since 1993. The 1995 Shays Congressional Hearings used the CIA's reports as entertainment, calling them, 'the most unintelligent intelligence report Congressman Shays had ever seen.'

The latest RAC report (Nov, 2004) states:


http://www1.va.gov/rac-gwvi/docs/ReportandRecommendations_2004.pdf

(pages 56 - 58 )

After reviewing a large body of evidence concerning
exposure to these types of compounds in theater, their potential effects
alone and in combination, and their associations with illness in studies of
Gulf War veterans and other populations, the Committee concludes that
evidence supports a probable link between exposure to neurotoxins during
the Gulf War, most prominently acetylcholinesterase inhibitors, and the
development of Gulf War veterans’ illnesses.
Neurotoxic exposures during the Gulf War. The question of
whether Gulf War veterans were exposed to chemical weapons has long
been debated. Prior to the war, military officials were greatly concerned
that the Iraqi regime would use chemical agents offensively during the war,
as they had in their recent war with Iran.114 Thousands of chemical alarms
were reported to have sounded during the war, and when veterans began to
report unexplained symptoms after they returned home many believed that
these conditions were the result of chemical exposures. Early government
reports maintained, however, that there had been no confirmed offensive
use of chemical weapons during the war, requiring a consideration of other
explanations. Anecdotal reports from veterans indicated that some had
become ill when they took NAPP pills, the nerve agent prophylaxis pill
with the active ingredient pyridostigmine bromide (PB), taken as a
protective measure in the event of chemical attack. Others voiced concerns
about the heavy use of multiple types of insect repellants and pesticides
during deployment, due to the profusion of insects and the risk of infectious
diseases in the desert environment. Excess pesticide exposure has been
associated with chronic neurological symptoms in humans, and animal
research has indicated that some combinations of pesticides, or pesticides
in combination with PB and/or nerve agents, can produce greater damage
Finding 4
Research Advisory Committee on Gulf War Veterans’ Illnesses
2004 Report and Recommendations • 48
than exposure to any of these compounds alone. Therefore a number of
neurotoxins encountered during the Gulf War must be considered for their
possible contribution to the chronic illnesses and unexplained symptoms
affecting veterans. For each category of exposure, it is important to
evaluate evidence relating both to the extent of exposure and the potential
for such exposures to cause chronic illnesses similar to those experienced
by veterans.
Exposure to chemical weapons during the Gulf War.
19 Jan 91. Seabees of Naval Mobile Construction Battalion
24, stationed near the port of Al Jubayl, report a bright flash in
the night sky followed by a detonation-concussion. Chemical
alarms sound, and troops don MOPP gear. After the all clear,
troops unmask and experience an acrid smell, choking,
profuse nasal secretions, facial numbness, a burning
sensation on exposed skin and a metallic taste in the mouth.
Two M256 detection kits are positive for chemical blister
agent. During the weeks following the incident, many of the
exposed troops develop skin rashes and chronic ailments.
- Evidence Iraq Used Chemical Weapons
During the 1991 Persian Gulf War300
In the early years following the Gulf War, government reports indicated
that it was unlikely that exposure to chemical agents during the war could
have contributed to veterans’ unexplained health problems, since there had
been no documented use of chemical weapons in theater. Conclusions
regarding chemical weapons exposures were called into question when, in
1996, reports emerged verifying that chemical agents had been present in
theater and that U.S. military personnel had been in the area of a large
weapons storage depot containing nerve agents near Khamisyah, Iraq,
when it was destroyed after the ceasefire. Verification of this incident
brought about a dramatic change in thinking about chemical weapons
exposures during the war. The Department of Defense reported that the
weapons depot had contained the nerve agents sarin and cyclosarin, and
sponsored multiple efforts to estimate how many and which veterans may
have been exposed and at what levels. Investigators concluded, after
several intensive modeling efforts, that approximately 100,000 U.S. troops
may have been exposed to low levels of nerve agents as a result of the
Khamisiyah demolitions.320
While the estimate of 100,000 troops is disturbing, it is still unclear
whether or not it represents a good approximation of the total number of
personnel who may have been exposed to nerve agents during the Gulf
War. Contrary to regulations, military logs detailing nuclear, biological,
and chemical weapons incidents during Desert Shield and Desert Storm
were destroyed after the war.306 Reports from government and nongovernment
sources have described multiple incidents involving evidence
of possible chemical weapons exposures in addition to the Khamisiyah
incident.79,300,307-310,312-319,337,347 Military reports indicate that 75 percent of
Finding 4
Research Advisory Committee on Gulf War Veterans’ Illnesses
2004 Report and Recommendations • 49
chemical targets, including weapons manufacturing and storage sites, were
destroyed during the war.66 A recent report from the U.S. General
Accounting Office (GAO, renamed the Government Accountability Office
in July, 2004) found that DOD’s Khamisiyah modeling efforts were
seriously flawed and that available evidence indicates there were likely to
have been multiple additional incidents during the war that potentially
exposed Coalition troops to chemical weapons.343 As a result, GAO
investigators concluded that the total number of Gulf War veterans who
may have encountered low-level exposures to nerve agents in theater may
exceed that currently identified in association with DOD’s Khamisiyah
plume models.345 The GAO report also concluded that results of
epidemiologic studies that have relied on DOD’s plume models to evaluate
health effects related to the Khamisiyah exposures are likely to be
unreliable.

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

For me (and many other GW Veterans who deployed to the AOR, like myself), I simply want to be tested for the possible presence of squalene or mycoplasma f.i., to "rule out" anthrax vaccine injury. There are so many other factors for causes of our illnesses, I don't believe anyone will ever be able to prove there is "just one" cause. Personally, I arrived in the theatre of operations and was transported straight to the field hospital for three days, after experiencing bad side-effects from the anti-malarial tablets. After that, I spent several months of working in a cesspool of toxins, especially during the Kuwaiti oil well fires.

Bioport is certainly culpable in dispersing outdated, uninspected, and possibly contaminated lots of the anthrax vaccine to U.S. soldiers-- even ten years after the Gulf War. For those who did not deploy, this may be the only possible cause of their illnesses:

http://www.gulfwarvets.com/ubb/Forum4/HTML/000013.html

http://www.gulfwarvets.com/ubb/Forum4/HTML/000098.html

http://www.gulfwarvets.com/ubb/Forum4/HTML/000025.html

We have an entire forum on vaccines at:

http://www.gulfwarvets.com/cgi-bin/forumdisplay.cgi?action=topics&number=4&forum=Anthrax+Vaccine,+Lariam,+and+other+vaccines&DaysPrune=1000&startpoint=0

There's even a thread about someone's book on "Vaccine-A"
Very Happy here:
http://www.gulfwarvets.com/ubb/Forum4/HTML/000096.html
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RainbowTom
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PostPosted: Mon Jan 31, 2005 12:28 pm    Post subject: The Mullberry Bush Reply with quote

You tell 'em Gale!

But seriously folks. I think you are missing the point.

We have many people who need testing. It is on a need to know basis. Our various courses of treatment and quality of care and thus quality of life hinge on knowing right away whether or not we were victims of tainted anthrax vaccine shots or not. I myself may have symptoms of both vaccine and solvent injuries combined in some way since I was a jet engine mechanic and exposed to trichlorethline, JP-8 jet fuel and other residues from cleaning and sandblasting planes & equipment that came back from the Gulf.

In my case and probably others such as my good friend Gale, we may have had more than our fair share of exposures!

Even though I did not deploy to Saudi Arabia as scheduled due to the quick end of the war, I certainly had my overseas shots at Lackland AFB in June 1989 and I have concerns about my brother and sister airmen that were in my flight and for all soldiers.

Please explain the delay in opening up the assay to the public. The way things stand now, it looks like you are holding out for a fat DOD contract.

We respect and applaud your efforts Dr. ASA, Dr. Garry, etc. but there has to come a time to consider the health and welfare of persons who need to rule this in or out of their medical profile. With great power come great responsibility and you will lose your moral high ground here in very short order without at least an adequate explaination. We are perfectly aware of your patents and of Autoimmune Inc.

In my case, don't be surprised if you get contacted by the Cleveland Clinic in a couple of days in order to formally request testing. I have not been able to work for over a year and we are in danger of losing our house!

If I have squalene antibodies I need to know for my claim and course of treatment!

I was hospitalized for bronchitis right out of basic training in July! of 1989. I also had incredible back pain during sit-ups and the obstacle course. In England I suffered many upper respiratory infections, fatigue, anal bleeding, hypertension, maddening groin itch, and depression.

I even had to treat a female airmen at Chanute AFB for first aid that went into convulsions so bad that she ended up banging her head on the concrete in the middle of a road! The Air Force claimed she was an epleptic and discharged her.

When I got out in 1991 I had trouble standing as a cook for long periods of time and lost a job at FORD within 30 days due to carpal tunnel symptoms like Black 8. I also sprained the other wrist and shoulder.

I was out of work for over 3 months in therapy.

By the mid-1990,s I was working in factory jobs and self medicating because of the back pain and went on PROZAC for a number of years for depression and was seen by a chiropractor who never thought to give me X-rays or MRI'.

Back pain, headaches, muscle aches, joint stiffness, all became gradually worse. Rashes develpoed on the tops of my feet.

In 2002 I was in a whiplash accident and things got worse. After finally getting X-rays and MRI's it was shown that I had 6 herniated discs, joint facet disease, arthrytis of the spine, spinal scoliosis, 3 other bulging discs along with diagnosis of fibromyalgia, chronic pain syndrome, eye twitching, memory loss, irritability, anxiety, more depression and a host of other symptoms.

I am now being evaluated by the Cleveland Clinic in both Neurology and Infectious Disease departments. I tested positive for a thing called Babinski's reflex and have been told that it can indicate many things including MS.

Please consider allowing testing for myself, other vets at www.gulfwarvets.com and the veteran community at large
that have a dire need to know which way their course of treatment is heading. If not for me and my grouchy way of writing this to you, please do it for my family.

Sincerely,

Thomas W. Trefts aka RAINBOWRISING
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Gale
Guest





PostPosted: Mon Jan 31, 2005 2:24 pm    Post subject: Blood tests Reply with quote

Hi. Gale here (again).

You'll have to pardon RainbowTom... Someone let him out the box I had him in!

I'd like to suggest a way in which veterans can be tested for the presence of squalene and testing of mycoplasma f.i. The VA does use the presence of mycoplasma (although it is uncertain which strain of mycoplasma was tested for) in awarding favorable ratings for chronic fatigue:

http://www.gulfwarvets.com/ubb/Forum2/HTML/000240.html


Dr Nicolson at least provided instructions on having individuals' blood drawn and sent to his lab (when it was open). At first, veterans had to pay for the testing out of their own pockets (approximately $300), but then, Dr Nicolson was able to do it through private insurance (if a veteran had it).

I did have my blood drawn in a private, local lab, and sent it on dry ice to his lab for testing. The only thing was the lab forgot to send in the prescription with my blood and by the time everybody discovered why the test hadn't been performed (because there was no prescription included), the blood was too old.

So, if you know of a way veterans can obtain testing for the presence of squalene (and/or mycoplasma), I'm sure there are those who are willing to go through the procedures and personal expense of having it done-- if for no other reason than "just knowing".
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PostPosted: Mon Jan 31, 2005 2:40 pm    Post subject: ASA testing Reply with quote

Dear Gary & Pam,

First, thank you so much for your efforts to assist veterans. I for one appreciate real people doing real research and having the strength and courage to face those who work hard to dismiss the truth as "conspiracy theories".
Since 1992, I have been seen by neurologists at the VA who by my own accounts have dismissed all of my symptoms, failed to recognize any illness other than skin problems.

I was given a "SECRET" anthrax vaccine on 20 Jan 1991.
I was recently diagnosed with MS, tumefactive form. 'no doubt from 1991'

I apologize for the confusion. I am requesting the blood test Antibodies to Squalene. Walter Reed turned my request down stating only Tulane could perform the testing.

I have filed claims since 1993, been denied the entire time because the VA refused to perform advanced testing on me ie MRI.

My claim is sitting in Wash D.C. on remand at the Appeals Management Center. I am requesting this Antibodies to squalene test for several reasons.
1.) I would like to know if I was an experimenal guinea pig.
2.) I require proof that I developed MS most likely from this experimental one shot "secret vaccine" or other pre-deployment vaccines I received.
3.) I am attempting to gather all evidence possible to present to my congressman, other officials, media, etc. with solid evidence.
4.) I want this information so I may cram it down the throats of incompetent VA Physicians who have dismissed my problems as psychiatric "depression".
5.) I served over 8 years active duty, I took an oath, I fulfilled my oath. Doctors also took an oath...Most I have encountered at the VA have shown arrogance, apathy, and dismissed me right off ie "his motivations seem questionable" by suggesting I became sick from Desert Storm.
6.) I have a family I want to be taken care of, yes, I am seeking compensation for me and "my family" from being misdiagnosed and untreated for MS for 13 years. I see Negligence, Malpractice, Misdiagnosis.
I cannot provide for my family an longer, therefore, I am seeking to hold those accountable. I honestly do not know how long I have left, therefore, I am attempting to expedite these matters so my family will be taken care of. I had an Acute MS attack, and from what I have read, some may never recover, reality is, next attack may target vital functions, and I would be done. I am not seeking sympathy, I am facing reality, I cannot wait for politics.
7.) When my family is provided for, my focus will be on these matters to assist others. I have already started, I contacted my congressman as I mentioned, but not for my claim, I requested my congressman to look at my case as a model for the problems many others are facing, perhaps in the thousands. I will keep pounding my congressman on this front as long as it takes.
8.) I have all the medical records showing malpratice, negligence, and arrogance, as well as the psychological damage from being misdiagnosed, given psych. drugs, 8 letters to the DVA requesting an MRI.
The VA documenting "Lherrmittes phenomenon", a sign of MS, and failing to perform testing to rule out MS=MALPRACTICE
I could file a torte claim for malpractice for these damages, If the VA treats me fairly this time, I will not file a torte. I am in this for my family, if it weren't for them, and the fact that I am not the only guinea pig out there.
As you said Gary, "2 + 2 = 5", this is the VA mentality I have encountered at every turn within the VA medical system.

I have not read your book Gary, I order it and should receive it 2-4 days. So I may not be up to speed on all of this. However, from my humble point of view, having lived this nightmare, There is most likely an epidemic of MS vets that have been misdiagnosed simply for lack of am MRI. My VAfacility does not have an MRI machine, HOW MANY OTHERS?

Pam, I have contacted you already and you kindly responded last week and I am very greatful for your response. Thank you for all you have done for us. You, Gary, and others are far too few of the kind of people we need!

Thanks,

Black8
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arizroughrider
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PostPosted: Mon Jan 31, 2005 3:41 pm    Post subject: Dr. Nicolson's reply on Mycoplasma Reply with quote

Yes, there are different theories for GWI, and not every patient has
the same
medical problem. We have always tried to be very flexible in
describing our
own research as not the sole cause of GWI, and in fact, our findings on
the
presence of mycoplasmal infections in approx. 40% of GWI cases has been
confirmed in at least 3 other labs. Just becuase the Armed Forces
Institute of
Pathology can't confirm it, of at least won't admit to it, doesn't mean
much
because they patented the bug, and no one would expect them to
acknowledge
that the Army knew about this problem. But, in fact, they did
immediately after
the Gulf War. Some of our patients from the 3 AD were tested by Dr. Lo
and
found to be positive, but the samples were later destroyed and the
results
subsequently denied.

That infections such as Mycoplasma fermentans can resolve on their own
is just
fantastic, but not true, irrespective of what was placed in the Merk.
In Dr. Lo's
own publications from the AFIP using military personnel these
infections can
progress to a lethal disease. The Uniform Services University medical
school
at Bethesda Naval Medical Center trains medical students who will all
practice
in the military. They teach the following (from their Pathology Block
training
manual):

Mycoplasma fermentans

"The most serious presentation of M. fermentans infection is that of a
fulminating
systemic disease that begins as a flu-like illness. Patients rapidly
deteriorate
developing severe complications, including adult respiratory distress
syndrome,
disseminated intravascular coagulation, and/or multiple organ failure."

"The organs of patients with fulminant M. fermentans infections exhibit
extensive
necrosis. Necrosis is most pronounced in lung, liver, spleen, lymph
nodes,
adrenal glands, heart and brain. M. fermentans is identified in areas
of
necrosis, particularly in the advancing margin of necrosis, by the
immunohisto-
chemistry using specific anti-M. fermentans and M. fermentans
incognitus
antibiody and/or by in situ hybridization assays using cloned
incognitus strain
DNA. Mycoplasma-like particles are found intracellularly and
extracellularly by
electron microscopy."

These are quotes right out of the pathology manual from CMDR A. Marty
of the
AFIP, an instructor at the USUHS medical school.

I don't doubt that squalene was used in some experimental military
vaccines,
but it didn't cause the M. fermentans and other infections. It may
cause
autoimmune signs and symptoms, but GWI is much more than that (please
see
our publications were we characterized the signs and symptoms in over
700
veterans) Why would GWI patients like you respond to antibiotics like
doxycycline, azithromycin or ciprofloxacin if they just had an
autoimmune
disease caused by sqaulene? Why would immune enhancement help
patients,
when it should do just the opposite if they only had an autoimmune
disorder?

The most reasonable explanation is that experimental vaccines were used
and
some contained squalene, but some were also contaminated with
microorganisms (this has been found by a VA scientist working in San
Diego).
Moreover, there are other explanations for the presence of infections
like M.
fermentans because it is an airborne infection. This is why some
family
members of myco-positive GWI patients came down with similar illnesses
and
later tested positive for the same infection (see our publication in
Journal of
Chronic Fatigue Syndrome 2003 posted on our website, www.immed.org).

I'm not going to respond to the finding of part of the HIV env gene in
some of the
veterans blood samples along with M. fermentans. The only other times
we
ever saw this were in prison guard samples from specific prison units
in TX
where experimental vaccine testing was taking place for the Army and in
some
USMC survivors of medical experiments at Balboa Naval Hospital in San
Diego
before the Gulf War. Also, this finding does not affect in any way the
involvement of microorganisms like Mycoplasmas in similar illnesses,
such as
Chronic Fatigue Syndrome and Fibromyalgia Syndrome. (These infections
are
also found in MS and ALS patients). Some mycoplasmal infections are
neurotrophic and invade the Central Nervous System as Dr. Lo of the
AFIP
originally documented with M. fermentans. We believe that they can set
up an
autoimmune illness against the cells and tissues invaded by the
microorganism.
This may explain why a majority of Rheumatoid Arthritis patients also
have
these infections.

We could not continue the research on the HIV inserts because of lack
of funds,
but some day some one will continue this and I am sure confirm the
findings.
They are very difficult experiments to perform since it is extrememly
difficult to
grow out M. fermentans from clinical samples, and this was well known
before
the Gulf War. From the perspective of diagnosing a fatiguing illness
and treating
it successfully, whether a piece of the env gene is present or not is
not
important, and that is why we did not focus on or continue our work on
this
interesting finding. It was just not important enough to continue.
Instead, we
concentrated on developing new treatment regimens for fatiguing
illnesses.

We have hellped thousands of Armed Forces personnel recover from life
threatening illnesses from the Gulf War, and this is why my wife and I
were
made Honorary Colonels of the Army Special Forces and Honorary US Navy
SEALs (We are the only honorary SEALs in the history of the Navy for
our efforts
in helping the SEALs recover from illnesses after the Gulf War).

We have our own book in production, named after the Army code name for
the
mycoplasma project. It should be out in about June. It will explain
how we
found M. fermentans and what was done to us to prevent this information
from
ever becoming public. It is not a nice story. I certainly don't blame
this particular
author for pumping up his own book by dismissing other's research, but
the
bottom line is whether this has helped anyone recover from their
illness or
saved any lives in the process, or simply sold more books. We will
continue to
assist patients who are sick with unusual illnesses, and this seems to
have
taken up essentially all of our time at the moment.

Prof. Garth Nicolson
The Institute for Molecular Medicine
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Gary M - Author
Guest





PostPosted: Mon Jan 31, 2005 4:47 pm    Post subject: Reply to Gale: RE: Sarin, et al. Reply with quote

Dear Gale: Based on your postings I suspect you haven't read VACCINE A.

In the book, I discuss the problems with the nerve agent hypothesis at length. The information in the Defense Intelligence Agency report is just one of many documents that I cite, which casts doubt on the nerve agent theory. But irrespective of whether one is citing DIA reports on the etiology of GWS written in 1993, or a government advisory committee report on the etiology of GWS written in 2004, several things remain unchanged.

First, Gulf War Syndrome is still undefined, which makes any discussion about causation moot. This is not just elementary pathology; it is also elementary logic. You cannot identify the cause of an illness before you identify the illness.

There's an example of what I'm talking about at the beginning of the book. VACCINE A opens in Sverdlovsk, during the anthrax outbreak in 1979 that occurred when a plume of weaponized anthrax accidentally escaped from a soviet military facility. At first, Soviet physicians in the city thought their patients' lung congestion, headaches and high fevers were due to meningitis or a new type of hemorrhagic influenza. The doctors treated the symptoms (e.g. patients with high fevers got the Russian version of Tylenol). But having failed to diagnose the illness at the beginning of the outbreak, these symptom-driven responses were ineffective. Many patients died.

STILL A MYSTERY?
Finally admitting after more than a decade that many of Gulf War veterans have neurological injuries still does not define the nature of those injuries. Neurological injury can result from a physical blow, from atherosclerotic disease or from autoimmunity, to name just a few things. Injecting squalene has been proven to cause neurological damage in animals by many laboratories around the world. If the neurological injuries in troops resulted from nerve agent poisoning there would be a very specific type of damage that could be observed at the molecular level. That type of damage has not been observed.

THE PATHOLOGY—TWO PLUS TWO EQUALS FIVE?
Which brings me to another problem that remains unchanged since 1993, or since 1943 for that matter. Gulf War Syndrome does not match well known, well documented nerve agent toxicology. The Nazis started experimenting with nerve agents in the 1930s. Iraq used them against the Kurds and the Iranians in the 1980s. In the 1990s, the Japanese cult, Aum Shin Rikyo, used them against Japanese civilians in two terror attacks carried out in the cities of Matsumoto (1994) and Tokyo (1995). The survivors of these attacks do not suffer from chronic illnesses. They do not have any lingering sequelae resembling Gulf War Syndrome.

During the first Gulf War, there wasn't a single verified case of nerve agent poisoning. No soldier, sailor, airman or marine manifested one of the most distinctive hallmarks of nerve agent intoxication, miosis. Miosis is the constriction of the pupils to near pinpoints. No doctor or nurse ever reported seeing this symptom in any service member during or after the war. No one service member ever self-administered the nerve agent antidote, atropine.

Nerve agents don't cause rashes. They don't cause tinnitus (incessant ringing in the ears). They don't cause uncontrollable muscle fasciculation. They don't cause granulomatous lesions. They don't cause chronic fatigue or muscle and joint pain. They don't cause autoantibodies. They don't cause multiple sclerosis or rheumatoid arthritis or systemic lupus erythematosus. Nerve agents don't cause any of these problems in animals or humans. Yet these are the problems most commonly reported by sick veterans. Thus, nerve agents cannot account for many of the symptoms that are cited in the 1998 Air Force case definition of Gulf War illness.

Quote:
These are the initial signs of nerve agent exposure:

1. miosis (eye pupil constriction, resulting in dimmed vision)
2. frontal headache, eye pain
3. runny nose
4. anorexia (loss of appetite)
5. nausea
6. excessive sweating
7. tightness in the chest, heartburn

These are the effects of more severe nerve agent poisoning:

1. abdominal cramps
2. vomiting
3. profuse sweating
4. dyspnea (shortness of breath)
5. diarrhea
6. tenesmus (painful, ineffective straining to urinate or defecate)
7. drooling and tearing
8. urinary frequency
9. involuntary urination or defecation
10. excessive bronchial secretion

If exposed to a lethal amount of nerve agent, these are the effects:

1. ataxia (lack of muscle control)
2. slurred speech
3. coma
4. areflexia (loss of reflexes)
5. Cheyne-Stokes respiration (alternating periods of rapid breathing and not breathing)
6. generalized convulsions
7. finally, cessation of breathing and death


The above effects occur immediately after exposure to nerve agents. They do not have a delayed onset. They do not persist years after exposure.

Here's what the Persian Gulf War Illnesses Task Force had to say on all this in a CIA report published in April 2002 titled "Chemical Warfare Agent Issues During the Persian Gulf War." Below is a quote from that report, and its accompanying footnote. It's taken from the section called "Iraqi Chemical Agents and Their Effects":

Quote:
"Low-level exposure to Iraq’s deployed chemical agents is not usually associated with the most common long-term symptoms associated with Gulf war illnesses (GWI).16

16.The most common long-term symptoms reported by veterans are fatigue, rashes, headaches, muscle aches, joint pain, abdominal pain, diarrhea, hair loss, memory loss, difficulty sleeping, depression, and concentration problems."


Here's the link for this report:
http://www.cia.gov/cia/publications/gulfwar/cwagents/cwpaper1.htm#appendixa1


EPIDEMIOLOGY—THE IMPORTANCE OF WHO'S GOT GWS AND WHO DOESN'T
All this brings me to a final point about the case against nerve agents, or the nerve agent/pyridostigmine bromide/pesticide cocktail theory. These theories are undermined by certain stark epidemiological facts.

Go back and look at the CIA computer model of the Khamisiyah plume. It shows where this hypothetical plume allegedly drifted over a period of four days (March 10-13, 1991). Many service members who developed a chronic illness during or shortly after the war were no where near the areas in this CIA computer model.

They were deployed all over the Saudi peninsula. They were in Bahrain, and at sea. Some were in Turkey. Some never left the United States. Most of these people could not have been exposed to nerve agents in either large or low doses. What these people have in common are immunizations.

Most coalition troops never developed Gulf War Syndrome; only 4 out of the 30+ countries in the coalition report having cases of it. Journalists covering the war don't have GWS either. There were thousands of journalists in the region at the time; none of them have this mysterious illness. More significant than the absence of GWS in the journalist cohort, perhaps, is its absence among the people who live in the region year round. They don't have GWS. The Saudis don't have it. Neither do the Iraqis or the Kuwaitis, or the Kurds and the Bedouin tribe's people for that matter. Many of these folk were down range of the hypothetical Khamisiyah plume, and, like the rest of us, they would have been exposed to a variety of mycoplasma as well as the theoretical plume of cyclosarin from Khamisiyah.

So why don't these people have GWS? Because they didn't wear flea collars? I was in Saudi Arabia and Iraq for four months and did not see a single service member wearing a flea collar. I didn't see any Saudis, Kuwaitis or Iraqis wearing flea collars. Many journalists wore the pesticide impregnated BDUs, but they don't have GWS either. I heard all those chemical alarms going off; I was in full MOPP 4 gear many, many times. I took the PB pills. I, like every other journalist I know, do not have GWS.

VACCINE A IS NOT REALLY ABOUT GWS
The book is about clinical experiments on troops with experimental vaccines and the evidence that a series of trials to develop a second generation anthrax vaccine resulted in a public health debacle. Veterans of the first Gulf War developed autoimmune diseases, post-immunization, as did troops immunized during the AVIP program that ran from 1998-2000. Now troops immunized for the second Gulf War are developing anti-squalene antibodies and independently verified allergic and autoimmune diseases. And we know they weren't exposed to nerve agents. We couldn't find any.

Hundreds of sick military personnel have now tested positive for antibodies to squalene. Squalene, and other oil-based vaccine adjuvants, is known for its ability to induce allergic and autoimmune diseases in animals. Since 1987, the military has been adding squalene to prototypes of its second generation anthrax vaccine.

I can't say much for those veterans who have no diagnosis or have diseases other than those that are allergic or autoimmune.

What is Gulf War Syndrome? VACCINE A does not really define it. However, the book shows that in some cases, what had been labeled a mysterious syndrome was, in fact, a fully diagnosable autoimmune disease. So for those service members suffering from MS, lupus or rheumatoid arthritis, or other allergic and autoimmune diseases, anti-squalene antibodies have thus far proven to be a "marker" for injection with a substance known to cause these diseases in animals, and a substance that the Army has been adding since the late 1980s to its experimental vaccines for anthrax, malaria, HIV and influenza. Upon consultation with their physicians, service members with chronic but as yet undiagnosed maladies may want clinical testing for autoimmune disease.

INTERESTING TIMING
When the Office of the Special Assistant for Gulf War Illnesses (OSAGWI) began declassifying documents from the first Gulf War on WMD defense, the CIA and the Army released its Khamisiyah story.

It looked like a mea culpa.

The press and Congress cycled through this story, and, after a period of many years, various government investigators concluded the CIA's computer modeling of the plume was so flawed it warranted formal censure by the Senate. The press, suffering from Gulf War Syndrome story fatigue, just stopped covering it.

In 2004, knowing that a book about military experimentation on troops with unlicensed vaccines was about to come out, we have a new mea culpa.

We were right about nerve agents, after all, says this report. And you know how we dismissed Gulf War Syndrome as a phantom illness that was probably psychosomatic? Well, we were wrong about that too. Many sick veterans, in fact, have a neurological injury.

At least one member of the committee that wrote this report knew that VACCINE A was about to come out. How do I know that? Because I know one of the committee's principle advisors, a British scientist named Dr. Jack Melling. I interviewed him many times over the past four years. I am a great admirer of Dr. Melling. I think he is an exceptional scientist and an honorable man.

It is also worth noting, I think, that Dr. Melling helped manufacture the biological warfare vaccines used by Britain during the first Gulf War. After the war, Dr. Melling ran the Salk Institute in Swiftwater, PA, which oversaw the scale-up production of the second generation anthrax vaccine for Dr. Arthur Friedlander of USAMRIID. This Salk Institute, per USAMRIID's instructions, incorporated novel adjuvants into the recombinant anthrax vaccine. At the time, USAMRIID was already using the squalene-based adjuvant, MF59.

INCONSISTENT RESPONSES

So let's see. DOD and the CIA had no data on the volume or density of the alleged Khamisiyah plume. It had no data on the entirely theoretical dosages of cyclosarin received by an unknown number of troops. And sick veterans have presented symptoms that are inconsistent with the known sequelae of nerve agent poisoning.

But DOD and the CIA, the two main propagators of the nerve agent theory, have acknowledged that the effects of low doses of nerve agent needed to be investigated further.

Here's what DOD put in a press release dated July 24, 1997:

Quote:
"TROOPS NOT EXPOSED TO DANGEROUS LEVELS OF CHEMICAL AGENT

Defense Department and CIA officials reported today the results of a year long effort to learn the extent to which U.S. troops may have been exposed to harmful agents when Iraqi chemical weapons were destroyed at Khamisiyah on March 10, 1991. Their analysis confirmed that no U.S. units were close enough to the demolitions to experience any noticeable health effects at the time of the event.

Based on new data, computer models and interviews with troops involved in the demolitions, officials now believe 98,910 service members were in an area generally south of Khamisiyah and were possibly exposed to a very low level of nerve agent vaporized during the weapons destruction. Little is known about delayed effects from a brief, low-level exposure to nerve agents such as might have occurred in this case, however, current medical evidence indicates that long term health problems are unlikely. The Presidential Advisory Committee on Gulf War Veterans' Illnesses, in its Dec. 31, 1996 Final Report, wrote, "Current scientific evidence suggests that subclinical exposure to OP (organophosphate) CW (chemical warfare) nerve agents does not result in long-term neurophysiological and neuropsychological health effects." There is, however, limited medical information on the impact of such low level, short duration exposures. Therefore, the Departments of Defense and Veterans' Affairs recognized the need for further research in this area."


Here's the link:
http://members.aol.com/vetcenter1/dod724.htm

On the other hand, there is incontrovertible proof that troops have been exposed to squalene. The concentrations detected by the FDA and SRI in anthrax vaccine administered to troops during the AVIP program provide molecularly precise dosages. The sequelae in service members injected with squalene-tainted anthrax vaccine lots—allergic and autoimmune diseases—are entirely consistent with the observed effects of squalene injection in animals. These sequelae, the allergic and autoimmune diseases, also match what has been diagnosed in some Gulf War veterans.

At issue now are the "low doses" of squalene, which the Army and the FDA argue are harmless. The Army and FDA do not provide any data to support this conclusion. No studies have been performed in animals to determine the effects of low doses of injected squalene. In VACCINE A, I report the de facto evidence that such a study was, in fact, conducted on troops with disastrous effect.

Despite the slimmest of circumstantial evidence that low dose nerve agent exposures took place during the Gulf War, DOD and the VA "recognized the need for further research in this area," and funded it.

There a considerable body to support the need for further research into the alleged vaccine experiments on troops, and the injuries allegedly resulting from those experiments:

Quote:
(1) Forensic scientific evidence—(gas chromatographic/mass spectrometry evidence of squalene in 6 lots of anthrax vaccine);

(2) Clinical evidence—(anti-squalene antibodies and autoimmune diagnoses in troops);

(3) Documentation of military experimentation with squalene in anthrax vaccine—(USAMRIID's published data) and;

(4) Related documents showing the military's propensity to experiment on troops, and its long history of doing so—(declassified documents, in fact, show the Army's plans to run vaccine experiments on troops during the first Gulf War, and the regulations and directives written since then to justify this activity).


With all the evidence now available for squalene-induced autoimmunity in lab animals, and in U.S. and British military personnel; and with zero published data on the immunological effects of low doses of squalene injected into animals, DOD has concluded that—inconsistent with its assertion that "further research" on the effects of low dose exposures to nerve agents is necessary because of a paucity of available data—no research on low dose exposures to squalene is necessary, despite a similar paucity of data.

It was, in part, because of such inconsistencies that I felt it necessary to write this book.

Sincerely,
Gary Matsumoto
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RainbowTom
Guest





PostPosted: Tue Feb 01, 2005 12:01 am    Post subject: HOW CAN WE GET TESTING? Reply with quote

It's a cruel joke to be told that there is only one place to get tested for a potentially deadly disease....

Only to be told that the testing is not being performed at this time.

I love what you're doing and the insight and the brilliance and I even applaud the creation of AUTOIMMUNE INC. and like I've said before, from a laymans point of view, I'm fascinated by how this all happened. It should really be a movie or something.

Can you please indulge my curiosity about the delay in the release of testing to the public?

One reason to test me is that I have not seen Lackland AFB as a source of any of the tainted lots. If you got a positive reading out of me, then that would mean an even broader based problem , correct? I remember in retrospect that a lot of airmen in my barracks were unusually hyper and the female airmen seemed sick a lot.

There are several military/DoD areas for Gulf War Illness Studies and Tests. I just thought it highly peculiar that Lackland AFB where we all have to process into BASIC TRAINING happens to be one also. Maybe they are just too lazy to be very good at covering their tracks.

AutoImmune LLC will make more money in the long run by releasing the assay at least by some special screening for autoimmune symptoms in patients first. Why not go public?

It sounds like the immune system modulator drugs are going to be very promising.

Having another sad day in hell,

Thomas W. Trefts
cato6169@sbcglobal.net
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Gale
Guest





PostPosted: Tue Feb 01, 2005 4:57 am    Post subject: Blood tests Reply with quote

Hi. This is Gale again.

Dear Gary,

I have not read your book, however, in responding to your posts, I have found that some of material you've used in arriving at your theory in your posts here is outdated or no longer officially recognized by DoD or the VA. For instance, the terms in identifying illnesses due to exposures in the Gulf War have changed. I was one of the first to receive a favorable rating for "Gulf War Illness". Now, as most of us know, that term is no longer used. "Gulf War Syndrome" is no longer used by the DoD or the VA, either. The only way in which "syndrome" has been used in identifying Gulf War Illnesses is when it is used to identify "undiagnosed conditions" like "chronic fatigue syndrome" or "irritable bowel syndrome", or "fibromyalgia syndrome". You can check the VA's own healthcare protocol manual here:

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1002

The conditions that are now recognized as related to exposures in the Gulf War are identified and diagnosed by the Environmental Agents Service of the VA:

http://www1.va.gov/environagents/

It is wrong to try to assign one syndrome (Gulf War Syndrome) to so many troops who were exposed to so many different kinds of environmental exposures. Not everyone was exposed to the same toxins, and not everyone has the same kinds of reactions to those exposures. That is why there is an office in place now to treat each kind of illness seperately (Environmental Agents Service).

I can only say, "Thank God" that the gov't has changed its perspective as to the causes of our illnesses. No longer are they attributing everything to PTSD.

I will have to come back to this at a later time. I am tired now and I can only spend limited time in the exchange of information with you. I will try to respond as I have the strength and stamina.

Gale



The following is extracted from the VA -10 Policy Manual:

1-1

CHAPTER 1. PERSIAN GULF REGISTRY (PGR) PROGRAM

1.01 PURPOSE

a. This chapter provides procedures to establish a Persian Gulf Registry (PGR) Program at all Department of

Veterans Affairs (VA) health care facilities for concerned participants of "Operation Desert Shield /Storm."

1.02 BACKGROUND

a. According to the Department of Defense (DOD) approximately 690,000 American servicemen and women

were involved in the Persian Gulf War. There may be a substantial number of troops actually exposed to unignited

petroleum and/or smoke from the sabotage of Kuwaiti oil wells by retreating Iraqi forces as well as other industrial

and environmental hazards.

b. Establishment of a PGR will assist VA in initiating a program to identify possible diseases which may result

from service of United States (U.S.) military personnel in certain areas of Southwest Asia (see par. 2.02). These

diseases may be endemic to the area or due to hazardous exposures, including heavy metals. Furthermore, air

pollutants, i.e., carbon monoxide sulfur oxides, hydrocarbons, particulate matter, and nitrogen oxides, singly or in

combination, can cause chronic as well as acute health problems.

(1) These health problems may include:

(a) Chronic bronchitis,

(b) Chronic obstructive pulmonary disease,

(c) Pulmonary emphysema,

(d) Bronchial asthmas, and

(e) Lung cancer.

NOTE: U.S. veterans who served in the Persian Gulf theatre of war are henceforth in M-10. Part III, referred to

as Persian Gulf veterans.

(2) Persian Gulf veterans have reported a wide variety of symptoms and exposures as a consequence of

Persian Gulf service. These include, but are not limited to exposure to:

(a) Oil, smoke and other petrochemical agents;

(b) Leishmaniasis (Sand flies);

(c) Pyridostigmine bromide, malaria prophylaxis and other prophylactic drug treatments;

(d) Depleted Uranium (DU);

(e) Inoculations (Anthrax, botulism, etc.);

(f) Pesticides;

(g) Diesel and jet fuels and other petrochemicals and solvents;

(h) Chemical Agent Resistant Compound (CARC) paint;

(I) Chemical and/or biological warfare agents; and

M-10, Part III August 8, 1995

Chapter 1

1-2

(j) Contaminated food and water obtained in the Persian Gulf.

(3) The following symptoms have been reported by a number of Persian Gulf veterans:

(a) Gastrointestinal problems;

(b) Flu-like conditions;

(c) Skin rashes;

(d) Sinus congestion, post nasal drip;

(e) Joint pains and/or muscle soreness;

(f) Hair loss;

(g) Headaches;

(h) Memory loss;

(i) Chronic fatigue;

(j) Thickened saliva;

(k) Loose teeth, sore and/or bleeding gums;

(l) Dizziness, vertigo;

(m) Sleep disturbance; and

(n) Other symptoms and/or exposures.

(4) During the examination process, these exposures and health conditions will be identified and documented

in the Consolidated Health Record (CHR) and VA Form 10-9009A (July 1995), Persian Gulf Registry Code Sheet.

c. The creation of a registry containing medical and other data on exposed veterans will signal VA’s

commitment to address questions concerning possible future effects of air pollutant exposure, other environmental

agents, and serve as the basis for future medical surveillance. NOTE: VA is in the process of requesting

support for future computerization of this registry.

1.03 AUTHORITY AND HEALTH CARE SERVICES PROVIDED

Title 38, United States Code (U.S.C.) Chapter 17, Section 1710, provides for health care only, and a

determination that the veteran is eligible for such care does not constitute a basis for service-connection or in any

way affect determinations regarding service-connection.

a. Health care services will be provided to veterans who while serving on active duty in the Southwest Asia

theater of operations during the Persian Gulf War may have been or were exposed to a toxic substance or

environmental hazard. Verification of service in the Persian Gulf during the Persian Gulf era (August 2, 1990 - no

ending data established by law) will be required. Inasmuch as VA presumes that a veteran was exposed to a toxic

substance or environmental hazard during any service in the Persian Gulf, a verified claim of such in-country

service constitutes the required contention of exposure and establishes eligibility for medical care within these

provisions.
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RainbowTom
Guest





PostPosted: Tue Feb 01, 2005 11:35 pm    Post subject: Here's some other interesting media links on this topic Reply with quote

This document is mostly anthrax related and has some interesting video links to CBS news and delawareonline

There is other stuff about ( DU ) that I don't have the time or energy to edit.

Rainbow Rising


February 1, 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.yahoo.com/search?p=Dr.+Pamela+Asa&btn=Search&ei=UTF-8&fr=sbc-web&b=21

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, Robert Garry. ) Tulane University
SQUALENE ANTIBODY TESTING FOR GULF WAR ILLNESS http://www.autoimmune.com/

WALTER REED SQUALENE STUDY : http://deploymentlink.osd.mil/deploymed/projects/DoD100.shtml

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-l@odssa.com/
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
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


SPECIAL VA RELATED LINKS
________________________________________________________________________

VA's -10 healthcare protocol policy manual for Gulf War Veterans. http://www1.va.gov/vhapublications/publications.cfm?Pub=4
There are about five chapters to this if you go to the VA publications site to look it up.
Phase I PGR http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1004
Phase II PGR http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1005
Then, the ajudication laws can be found here:

Title 38 Index
Parts 0-17 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid=5601440f9a028e2b353f1be27d4535d2&c=ecfr&tpl=/ecfrbrowse/Title38/38cfrv1_02.tpl
Part 18
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid=e7f228f056f66128a3cf40196efa0323&c=ecfr&tpl=/ecfrbrowse/Title38/38cfrv2_02.tpl
Title 38
Part 3 – Adjudication
Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=0a5cc4e74c654c10874b651cc99ff1b4;rgn=div5;view=text;node=38%3A1.0.1.1.4;idno=38;cc=ecfr

Title 38
Pensions, Bonuses & Veterans’ Relief
(also § 3.317 Compensation for certain disabilities due to undiagnosed illnesses found here)
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?type=simple;c=ecfr;cc=ecfr;sid=89bb312d6d613680e34d4df4625d7f3b;region=DIV1;q1=gulf%20war;rgn=div8;view=text;idno=38;node=38%3A1.0.1.1

Title 38
§ 4.16 Total disability ratings for compensation based on unemployability of the individual. PART 4—SCHEDULE FOR RATING DISABILITIES
Subpart A—General Policy in Rating
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1b7e1c80768900fe79b3126a180a3da6&rgn=div8&view=text&node=38:1.0.1.1.5.1.98.11&idno=38

The main difference in PGRCs and the WRIISCs is that the post deployment research that was performed for Gulf War Veterans in the PGRCs will now include all eras of veterans (including wars before and after the Gulf War). At one time, each VA was mandated to have a Persian Gulf Coordinator. Now, the title has changed to "Environmental Health Coordinator", who will be in charge of the evaluations for environmental, toxic exposures for all eras of veterans. The site the VA WRIISC uses and referrs to now is at: http://www1.va.gov/environagents/
My other contact in the DC VA states that the Gulf War Manual is being revised that will include the replacement
of the Gulf War Referral Centers with reference to a Handbook on the War Related Illness and Injury Study Centers that expands services to combat veterans with unexplained, disabling illnesses.
Also, a separate Handbook for the WRIISC has been revised but waiting for
related directives on determining combat eligibility to be issued before it
can be published. Until related directives have been issued and certain
legislation passed, the GW and WRIISC Handbooks are in a waiting pattern.
The revised Gulf War Handbook will be accessible at:
www.va.gov/gulfwar/
The Gulf War registry will continue and include the veterans from Operation Iraqi Freedom. Verification of service in the Persian Gulf during the Gulf War era (August 2, 1990 - no ending date established by law) and Operation Iraqi Freedom (starting March 3, 2003- ) will be required.
**************************************************************************
WEB SITES OF THE OFFICE OF PUBLIC HEALTH AND ENVIRONMENTAL HAZARDS
The Office of Public Health and Environmental Hazards is part of the headquarters of the Department of Veterans Affairs (VA). The focus of the office is to improve the health of veterans through professionally developed policies for the VA medical system relating to surveillance, prevention and treatment, energetic outreach, and special attention to the unique healthcare needs of special populations, including women veterans, veterans with hepatitis C or HIV/AIDS, and veterans exposed to environmental hazards, as well as to other emerging health issues..
www.va.gov/environagents/ -- This site directs readers to VA Web sites on the Gulf War, Agent Orange, and Ionizing Radiation programs, material for Afghanistan veterans, and information about the VA War-Related Illnesses and Injury Study Centers (WRIISCs), previously known as the Centers for the Study of War-Related Illnesses.
www.va.gov/gulfwar/ -- This site deals with the health problems and concerns of Gulf War veterans and their families. It includes the VA Gulf War Veterans Information helpline number 1-800-PGW-VETS, lists VA Gulf War-related articles, reviews and publications, including a Gulf War Research Report to Veterans, a Questions-and-Answers brochure, journal article summaries, VA’s Gulf War manual, a Gulf War fact sheet, also the Gulf War Risk Factor Report Reprints. There are links to the Gulf War Review newsletters, demonstration projects, an online independent study course for health professionals, and other information and material.
www.va.gov/agentorange/ -- This site provides readers with information about herbicides used in Vietnam. It starts with an Agent Orange overview, an Agent Orange General Information brochure, and a fact sheet on veterans benefits for those exposed to Agent Orange. There are links to the Agent Orange Review newsletters, Agent Orange Brief fact sheet series, news releases, VA disability compensation (including information about online filing), an online independent study course for health professionals, and more.
www.va.gov/oph/cold/ -- Health care professionals may wish to complete this self-study independent study guide on the effects of cold injury.
www.va.gov/irad/ -- The site includes the VA Ionizing Radiation handbook and a radiation fact sheet.
www.va.gov/shad/ -- This site provides information about Project 112 (including Project SHAD). Project SHAD (Shipboard Hazard and Defense was a series of tests conducted by the Department of Defense (DoD) during the 1960s to determine the effectiveness of shipboard detection of chemical and biological warfare agents, the protective measures against these agents, and the potential risk to U.S. forces posed by the agents. Project 112 involved similar tests conducted on land. The site includes information letters, a Questions-and-Answers document, several DoD fact sheets, plus information about filing a claim, including doing so online.
www.publichealth.va.gov/ -- The Public Health Strategic Health Care Group includes the Center for HIV Research Resources, Center for Quality Management in Public Health, Hepatitis C Resource Centers, HIV/Hepatitis C Program Office, and the HIV Hepatitis C Prevention, HIV/Hepatitis C Training/Education and Smoke Free programs. This site includes VA directives and information letters, AIDS information, , smoking and tobacco use cessation program information, conferences/continuing education information, and much more.
www.va.gov/hepatitisc -- The Web site of the VA’s National Hepatitis C Program provides comprehensive information for both patients and health professionals on this common viral infection of the liver.
www.publichealth.va.gov/SARS -- SARS (severe acute respiratory syndrome) is a serious illness characterized by fever and other flu-like symptoms that progresses rapidly to pneumonia and other problems. VA is greatly concerned about reports of the spread of SARS, from Asia to other parts of the world. The VA SARS Web site is designed to help VA staff and patients, and others concerned with veterans’ health, to be better informed about the disease.
www.va.gov/emshg/ -- The Emergency Management Strategic Healthcare Group site provides information about its organization, missions, accomplishments, and current activities relating to disaster response and recovery operations. It includes a EMSHG directory, newsletter, annual report, and more.
For additional information, contact the Office of Public Health and Environmental Hazards, Department of Veterans Affairs, 810 Vermont Avenue, N.W., Washington, DC 20420, at 202-273-8575. The fax numbers are 202-273-9080, 9079, or 9078.


________________________________________________________________________________________________________________________________________________
CARBON TETRICLORIDE

HR 4179 : VETERANS CARBONTETRICLORIDE BENEFITS ACT amendment to 38 CFR to make Carbon Tetrachloride exposure a presumptive service connection for specific conditions....

Bill wording includes listing of presumptive diseases

1. Depleted vision.. floater cataracts
2.Hearing impairments ... high pitch ringing .. sensitive to loud noise ...etc
3.Memory loss
4.Growths
5.swelling of hands and feet
6.aching bones and joints not associated with arthritis
7.Loss of hair
8. deterioration of nervous system
9. pulmonary edema
10.hemorragic congestion

Bill W
VETS VA CORNER

http://home.comcast.net/~deggans2/vacorner.html

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/adopt_a_soldier.php






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 Jones
First Coast News
HOW THE ANTHRAX VACCINE AFFECTED Sr. Airman Thomas J. Colosimo
http://members.tripod.com/tomcolosimo/id27.htm




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

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

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/useftp.cgi?IPaddress=162.140.64.88&filename=he97002.txt&directory=/diskb/wais/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 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; (Cool
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 Squ
Back to top
RainbowTom
Guest





PostPosted: Tue Feb 01, 2005 11:35 pm    Post subject: Here's some other interesting media links on this topic Reply with quote

This document is mostly anthrax related and has some interesting video links to CBS news and delawareonline

There is other stuff about ( DU ) that I don't have the time or energy to edit.

Rainbow Rising


February 1, 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.yahoo.com/search?p=Dr.+Pamela+Asa&btn=Search&ei=UTF-8&fr=sbc-web&b=21

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, Robert Garry. ) Tulane University
SQUALENE ANTIBODY TESTING FOR GULF WAR ILLNESS http://www.autoimmune.com/

WALTER REED SQUALENE STUDY : http://deploymentlink.osd.mil/deploymed/projects/DoD100.shtml

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-l@odssa.com/
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
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


SPECIAL VA RELATED LINKS
________________________________________________________________________

VA's -10 healthcare protocol policy manual for Gulf War Veterans. http://www1.va.gov/vhapublications/publications.cfm?Pub=4
There are about five chapters to this if you go to the VA publications site to look it up.
Phase I PGR http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1004
Phase II PGR http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1005
Then, the ajudication laws can be found here:

Title 38 Index
Parts 0-17 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid=5601440f9a028e2b353f1be27d4535d2&c=ecfr&tpl=/ecfrbrowse/Title38/38cfrv1_02.tpl
Part 18
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid=e7f228f056f66128a3cf40196efa0323&c=ecfr&tpl=/ecfrbrowse/Title38/38cfrv2_02.tpl
Title 38
Part 3 – Adjudication
Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=0a5cc4e74c654c10874b651cc99ff1b4;rgn=div5;view=text;node=38%3A1.0.1.1.4;idno=38;cc=ecfr

Title 38
Pensions, Bonuses & Veterans’ Relief
(also § 3.317 Compensation for certain disabilities due to undiagnosed illnesses found here)
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?type=simple;c=ecfr;cc=ecfr;sid=89bb312d6d613680e34d4df4625d7f3b;region=DIV1;q1=gulf%20war;rgn=div8;view=text;idno=38;node=38%3A1.0.1.1

Title 38
§ 4.16 Total disability ratings for compensation based on unemployability of the individual. PART 4—SCHEDULE FOR RATING DISABILITIES
Subpart A—General Policy in Rating
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1b7e1c80768900fe79b3126a180a3da6&rgn=div8&view=text&node=38:1.0.1.1.5.1.98.11&idno=38

The main difference in PGRCs and the WRIISCs is that the post deployment research that was performed for Gulf War Veterans in the PGRCs will now include all eras of veterans (including wars before and after the Gulf War). At one time, each VA was mandated to have a Persian Gulf Coordinator. Now, the title has changed to "Environmental Health Coordinator", who will be in charge of the evaluations for environmental, toxic exposures for all eras of veterans. The site the VA WRIISC uses and referrs to now is at: http://www1.va.gov/environagents/
My other contact in the DC VA states that the Gulf War Manual is being revised that will include the replacement
of the Gulf War Referral Centers with reference to a Handbook on the War Related Illness and Injury Study Centers that expands services to combat veterans with unexplained, disabling illnesses.
Also, a separate Handbook for the WRIISC has been revised but waiting for
related directives on determining combat eligibility to be issued before it
can be published. Until related directives have been issued and certain
legislation passed, the GW and WRIISC Handbooks are in a waiting pattern.
The revised Gulf War Handbook will be accessible at:
www.va.gov/gulfwar/
The Gulf War registry will continue and include the veterans from Operation Iraqi Freedom. Verification of service in the Persian Gulf during the Gulf War era (August 2, 1990 - no ending date established by law) and Operation Iraqi Freedom (starting March 3, 2003- ) will be required.
**************************************************************************
WEB SITES OF THE OFFICE OF PUBLIC HEALTH AND ENVIRONMENTAL HAZARDS
The Office of Public Health and Environmental Hazards is part of the headquarters of the Department of Veterans Affairs (VA). The focus of the office is to improve the health of veterans through professionally developed policies for the VA medical system relating to surveillance, prevention and treatment, energetic outreach, and special attention to the unique healthcare needs of special populations, including women veterans, veterans with hepatitis C or HIV/AIDS, and veterans exposed to environmental hazards, as well as to other emerging health issues..
www.va.gov/environagents/ -- This site directs readers to VA Web sites on the Gulf War, Agent Orange, and Ionizing Radiation programs, material for Afghanistan veterans, and information about the VA War-Related Illnesses and Injury Study Centers (WRIISCs), previously known as the Centers for the Study of War-Related Illnesses.
www.va.gov/gulfwar/ -- This site deals with the health problems and concerns of Gulf War veterans and their families. It includes the VA Gulf War Veterans Information helpline number 1-800-PGW-VETS, lists VA Gulf War-related articles, reviews and publications, including a Gulf War Research Report to Veterans, a Questions-and-Answers brochure, journal article summaries, VA’s Gulf War manual, a Gulf War fact sheet, also the Gulf War Risk Factor Report Reprints. There are links to the Gulf War Review newsletters, demonstration projects, an online independent study course for health professionals, and other information and material.
www.va.gov/agentorange/ -- This site provides readers with information about herbicides used in Vietnam. It starts with an Agent Orange overview, an Agent Orange General Information brochure, and a fact sheet on veterans benefits for those exposed to Agent Orange. There are links to the Agent Orange Review newsletters, Agent Orange Brief fact sheet series, news releases, VA disability compensation (including information about online filing), an online independent study course for health professionals, and more.
www.va.gov/oph/cold/ -- Health care professionals may wish to complete this self-study independent study guide on the effects of cold injury.
www.va.gov/irad/ -- The site includes the VA Ionizing Radiation handbook and a radiation fact sheet.
www.va.gov/shad/ -- This site provides information about Project 112 (including Project SHAD). Project SHAD (Shipboard Hazard and Defense was a series of tests conducted by the Department of Defense (DoD) during the 1960s to determine the effectiveness of shipboard detection of chemical and biological warfare agents, the protective measures against these agents, and the potential risk to U.S. forces posed by the agents. Project 112 involved similar tests conducted on land. The site includes information letters, a Questions-and-Answers document, several DoD fact sheets, plus information about filing a claim, including doing so online.
www.publichealth.va.gov/ -- The Public Health Strategic Health Care Group includes the Center for HIV Research Resources, Center for Quality Management in Public Health, Hepatitis C Resource Centers, HIV/Hepatitis C Program Office, and the HIV Hepatitis C Prevention, HIV/Hepatitis C Training/Education and Smoke Free programs. This site includes VA directives and information letters, AIDS information, , smoking and tobacco use cessation program information, conferences/continuing education information, and much more.
www.va.gov/hepatitisc -- The Web site of the VA’s National Hepatitis C Program provides comprehensive information for both patients and health professionals on this common viral infection of the liver.
www.publichealth.va.gov/SARS -- SARS (severe acute respiratory syndrome) is a serious illness characterized by fever and other flu-like symptoms that progresses rapidly to pneumonia and other problems. VA is greatly concerned about reports of the spread of SARS, from Asia to other parts of the world. The VA SARS Web site is designed to help VA staff and patients, and others concerned with veterans’ health, to be better informed about the disease.
www.va.gov/emshg/ -- The Emergency Management Strategic Healthcare Group site provides information about its organization, missions, accomplishments, and current activities relating to disaster response and recovery operations. It includes a EMSHG directory, newsletter, annual report, and more.
For additional information, contact the Office of Public Health and Environmental Hazards, Department of Veterans Affairs, 810 Vermont Avenue, N.W., Washington, DC 20420, at 202-273-8575. The fax numbers are 202-273-9080, 9079, or 9078.


________________________________________________________________________________________________________________________________________________
CARBON TETRICLORIDE

HR 4179 : VETERANS CARBONTETRICLORIDE BENEFITS ACT amendment to 38 CFR to make Carbon Tetrachloride exposure a presumptive service connection for specific conditions....

Bill wording includes listing of presumptive diseases

1. Depleted vision.. floater cataracts
2.Hearing impairments ... high pitch ringing .. sensitive to loud noise ...etc
3.Memory loss
4.Growths
5.swelling of hands and feet
6.aching bones and joints not associated with arthritis
7.Loss of hair
8. deterioration of nervous system
9. pulmonary edema
10.hemorragic congestion

Bill W
VETS VA CORNER

http://home.comcast.net/~deggans2/vacorner.html

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/adopt_a_soldier.php






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 Jones
First Coast News
HOW THE ANTHRAX VACCINE AFFECTED Sr. Airman Thomas J. Colosimo
http://members.tripod.com/tomcolosimo/id27.htm




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

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

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/useftp.cgi?IPaddress=162.140.64.88&filename=he97002.txt&directory=/diskb/wais/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 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; (Cool
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 Squ
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PostPosted: Tue Feb 01, 2005 11:39 pm    Post subject: NO VETERAN LEFT BEHIND Reply with quote

NO VETERAN LEFT BEHIND

Issue: Feres Doctrine

Dear Friends and Fellow Veterans,

We encourage you to take a few minutes to read about and sign a petition to repeal the current law that allows our military to be used in experimental studies That’s because the military is under no obligation to inform our American soldiers whether they are taking part in an experimental vaccination program or not. They are technically covered from this by a little known document called the Feres Doctrine.

I am asking for your help in repealing that law. If you go to the following link, you can find out more about this topic and have an opportunity to add your name to mine and many others who oppose this ruling because it allows for experimental vaccines to be used on our troops without their consent, knowledge, or reporting information about what to do if they have adverse reactions to these injections. As a layman, I have concerns based on reports of the health hazards that accompany any large grouping of vaccinations at the same time and reports of autoimmune reactions based on this practice alone ; regardless of what was in the shots.

Here is the link. PETITION TO STOP HUMAN TESTING ON SOLDIERS http://www.petitiononline.com/fd1950/
Serious health effects have been directly linked to poor standards and negligence by DoD, and the company, Bioport, who was providing outdated and uninspected vaccines. To find out more about the serious health consequences linked to the tainted anthrax vaccines made by Bioport, Inc. for the DOD please visit :

1: http://www.gulfwarvets.com/cgi-bin/forumdisplay.cgi?action=topics&forum=Anthrax+Vaccine,+Lariam,+and+other+vaccines&number=4&DaysPrune=1000&LastLogin=

2: http://www.gulfwarvets.com/ubb/Forum4/HTML/000013.html

3: http://www.gulfwarvets.com/ubb/Forum4/HTML/000069.html

All veterans, their spouses, health professionals, and concerned citizens are welcome to join with us to encourage the raising of awareness of veterans health and safety concerns in the news media.
For a partial list of email links please go to :

http://www.gulfwarvets.com/cgi-bin/forumdisplay.cgi?action=displayprivate&number=33&topic=000010


To be evaluated for symptoms and conditions recognized in the Gulf War Illnesses, the VA's healthcare protocol can be found in the VA's M-10 Manual, under Environmental Agents Service: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1002

At present, there is no provision in the M-10 for treatment or benefits for those who did not deploy, but who may have fallen ill to the tainted vaccines. Any kind of treatment and benefits require that the veteran had to be deployed to the Area of Responsibility (AOR). There needs to be an effort to test for mycoplasma and squalene for all veterans who may have received bad inoculations, and a remedy to award benefits to those who are sick, but did not deploy.

I would like to advise anyone who may have been in any branch of the military from any time from the mid-1980’s onward who has even a few of these sometimes subtle and slow developing symptoms to go immediately to your local VA and sign up for your VA medical card and consider registering yourself in the Gulf War Registry. If you had an adverse reaction to any of your immunizations you are entitled to go online or by mail to fill out an adverse reactions form which may help your case and provide the powers that be with critical feedback from these earlier programs in which the maker of the anthrax vaccine was cited repeatedly for a variety of violations.

To Enter Data Online : go to https://secure.vaers.org/VaersDataEntryintro.htm

To Enter Data Offline :
You may obtain more information about the VAERS Program and download printable copies of the VAERS form from the following Internet Sites:
The VAERS Web site at http://www.vaers.org. Download a copy of the VAERS form (PDF 23K).
The Food and Drug Administration's Web site at http://www.fda.gov/cber/vaers/vaers.htm.
The Centers for Disease Control and Prevention Web site at http://www.cdc.gov/nip.

Submissions by mail may be sent to:
Vaccine Adverse Event Reporting System
P.O. Box 1100
Rockville, MD 20849-1100
A copy of the VAERS reporting form and instructions for how to submit it can be obtained by calling toll-free 1-800-822-7967 or by toll-free fax at 1-877-721-0366.
We are interested in any positive input from other veterans, concerned citizens and health and clergy professionals. Visit our Bulletin Board at: http://www.gulfwarvets.com/cgi-bin/Ultimate.cgi?action=intro&BypassCookie=true

Remember that by helping us raise awareness in this area we can help our deployed troops learn to avoid environmental hazards as well as urging our fellow veterans to get full health screenings that can help them to get the benefits they and their families deserve for putting their bodies on the line in the service of our country.

Stop by on the internet and become a registered member of our bulletin board at http://www.gulfwarvets.com/cgi-bin/Ultimate.cgi?action=agree and see what you can do to help raise awareness in the area of veterans rights. Help us to ensure that NO VETERAN IS LEFT BEHIND.




Sincerely,


Concerned members of the AGWVA bulletin board @ www.gulfwarvets.com
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RAINBOWTOM
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PostPosted: Tue Feb 01, 2005 11:41 pm    Post subject: WHATEVER GETS YOU THRU THE NIGHT Reply with quote

GALE AND I WROTE THE ABOVE LETTER

GOD BLESS OUR VETERANS !!!
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