A study was conducted on 8,195 British Gulf War-era veterans. The British, serving alongside American forces, gave their servicemen untested vaccines as well.  There were two important findings from the study:

• The Gulf War cohort reported symptoms and disorders significantly more frequently than those in the Bosnia Era cohorts, which were similar . . . Gulf War veterans were more likely than the Bosnia cohort to have substantial fatigue, symptoms of post-traumatic stress, and psychological distress, and were twice as likely to reach the CDC case definition [of Gulf War Illness]. …Vaccination against biological warfare and multiple routine vaccinations were associated with all outcomes.[i]
• Service in the Gulf War was associated with various health problems over and above those associated with deployment to an unfamiliar hostile environment. Since associations of ill health with adverse events and exposures were found in all cohorts, however, they may not be unique and causally implicated in the Gulf War-related illness. A specific mechanism may link vaccination against biological warfare agents and later ill health, but the risks of illness must be considered against the protection of servicemen.[ii]

The state of Kansas Commission of Veterans Affairs funded a study of 2,030 Kansas Gulf War era veterans. Despite over $150 million spent on Gulf War Illness research, DoD has never conducted a comparable study on US service members. The Kansas study concluded:

Gulf War Illness . . . occurred in 34% of Persian Gulf War (PGW) veterans, 12% of non-PGW veterans who reported receiving vaccines during the war, and 4% of non-PGW veterans who did not receive vaccines . . . Among PGW veterans who served away from battlefield areas, Gulf War illness was least prevalent among those who departed the region prior to the war (9%) and most prevalent among those who departed in June or July of 1991 (41%). Observed patterns suggest that excess morbidity among Gulf War veterans is associated with characteristics of their wartime service, and that vaccines used during the war may be a contributing factor.[iii]

Britain and Canada also conducted studies and found a possible link to vaccines given to their veterans. One of the most interesting studies is one by France that found no Gulf War Illness at all among its veterans. In September 2000, France’s Defense Minister Alain Richard created an independent commission to look into the health of the French military servicemembers who participated in the Gulf War.[iv] Interestingly, a French medical corps spokesman, said that

“France’s belief that allied troops were victims of their own protective measures were based on a long series of meetings with U.S. medical experts . . .  ‘About 100,000 of the 600,000 Americans who served in the Gulf complain of ailments that have tentatively been lumped under the Gulf War syndrome heading. No one has yet come to definitive conclusions but we note that of 25,000 Frenchmen who served in the Gulf, only 180 have ailments whose origin could be in question. The only really major difference between the two groups is vaccinations,’ he said.” [v]

These studies received little to no attention in the U.S., and in some cases, were immediately disclaimed by the DoD. There was also a considerable amount of anecdotal evidence regarding adverse reactions to the anthrax vaccine. Perhaps the DoD was right in one respect, the advent of email allows large numbers of people to communicate around the world quickly. It is an ideal tool for servicemembers, who are deployed the world over, to communicate with friends quickly regardless of time zones or presence at the receiving end. I personally received dozens of emails from different people detailing adverse health effects from the anthrax vaccine. One email contained a list of at least a hundred names with phone numbers and/or addresses, as well as the particular adverse effect.

Finally, the most compelling study conducted on Gulf War Illness, and perhaps revealing the worst about the DoD, is a study conducted at Tulane University and the controversy it started. Originally, a 1999 Vanity Fair article stated that DoD had used an experimental anthrax vaccine on troops going to the Gulf War. This article explained that the vaccine was experimental because it contained a substance known as squalene.  Squalene is an experimental adjuvant. An adjuvant is a substance added to a vaccine in order to increase the body’s immune response to the vaccine itself. Squalene is produced naturally by the body in very minute quantities but it is not licensed by the FDA for injection into human beings. Squalene not only boosts the immune system’s response, it also decreases the time necessary for the body to develop immunity to the vaccine. The Vanity Fair article posited that there was squalene in the anthrax vaccine given to service members during the Gulf War.

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.[vi]

The Tulane scientists had developed a test, called an assay, for detecting the presence of squalene antibodies in the bloodstream. Some Gulf war veterans who were found to have squalene antibodies in their blood early on approached Congressman Jack Metcalf (R-WA). In 1997, Representative Metcalf asked the GAO to conduct an inquiry into the possibility that squalene was in vaccines given to service members. This study by the GAO took three years to complete and the timing of its release in March 1999 could not have been worse for the DoD. The report found a “pattern of deception” by the DoD with regards to the use of squalene adjuvants.[vii]

At an initial meeting with DoD officials, GAO notes show that the DoD claimed that they “had not performed or sponsored any research on synthetic or natural squalene or squalene until after the Gulf War.”[viii] The GAO investigators, however, found articles and databases that indicated there had been squalene studies before the Gulf War. The investigators confronted DoD officials with some of these public records and some of the DoD officials began to admit that they had conducted five human trials involving squalene and that a sixth was planned. Furthermore, the GAO investigators found that the DoD “had conducted numerous animal studies, particularly to develop a modern vaccine for anthrax. In fact, in most cases they only admitted to conducting research after we had discovered it in public records. On three occasions, people attending a meeting did not report their own research on squalene adjuvants.”[ix]

The GAO investigators also met with various officials, including the DoD’s Director of AIDS research during the Gulf War, members of the FDA, who all pointed to Colonel (Dr.) Carl Alving as the person who “was most interested in developing own adjuvants at WRAIR [Walter Reed Army Institute of Research].”[x] During meetings with DoD officials, Dr. Iving was never present nor mentioned, despite NIH and FDA officials calling him the top DoD researcher on vaccine issues. When finally interviewed by GAO investigators, Dr. Alving initially denied any participation in vaccine adjuvants. When pressed, he recalled that he had been called by someone at USAMRIID “who asked if he could develop a new, more potent anthrax vaccine on a crash basis to use in Operation Desert Shield. He worked on it and thought he could do it, but no one ever called him back. He wouldn’t say who called . . . or why he just didn’t return the call.”[xi]

Interviews with Dr. Anna Johnson-Winegar revealed a Tri-Service Task Force operation called Project Badger. Winegar mentioned that Dr. Alving was the DoD’s in-house adjuvant expert. She also mentioned that “[s]ome in the group were willing to jump out and use everything. (She refused to say who.)”[xii]

The GAO then interviewed General Blanck, Army Surgeon General, who disclosed that the DoD had very little botulism toxoid vaccine and so “we contracted with Porton to make them.” Porton refers to Porton Down, a British vaccine manufacturer.  According to General Blanck, “we got it, but didn’t use it.”[xiii] General Blanck also pointed the GAO investigators to a Peter Collis, who headed oversight for Project Badger and vaccine efforts. Peter Collis refused to talk to the GAO. First, he cited the classified nature of the research, which was a non-issue for the GAO. He then said he couldn’t look at some matters as a civilian without a clearance (GAO offered to get him a temporary clearance). Mr. Collis then called to say he didn’t know much, even though notes from Badger showed him at the center of all Badger discussions and running the briefings.”[xiv]

By September of 1998, the GAO investigators were discussing the Tulane study’s assay for determining the presence of squalene antibodies. DoD officials acknowledged that they could develop their own assay inexpensively and test Gulf War veterans, which would either refute or corroborate the Tulane results. They refused to do so, even after urging by the GAO. The DoD, in an effort to try to put the issue to rest, contracted to have lots of the anthrax vaccine tested by Stanford Research Institute (SRI) International. The tests did not find any squalene in the AVA. This gave the DoD what appeared to be unimpeachable proof that no squalene laced vaccine was given to Gulf War Veterans. The Tulane study was still very compelling, however, because of the extremely high percentage of Gulf War veterans with GWS who had squalene antibodies in their system, including those who didn’t deploy to the Gulf but received vaccines. These persons all suffered some form of autoimmune disorder. This is also in keeping with laboratory studies on animals given squalene formulations. These animals had an increased incidence of autoimmune disorders.

After the GAO report’s release in March 1999, the DoD began a concerted effort to discredit both the report and the Tulane research. The GAO encouraged the DoD to participate in the Tulane study by testing Gulf War veterans in its own studies using the Tulane assay or developing its own to validate the Tulane assay. The DoD’s response was that even though “they [DoD] could develop an assay . . . for detecting antibodies to squalene . . . [and] it would not be expensive to develop [and] . . . test it on a sample of Gulf War-era veterans that are sick” they refused to do so.[xv] The DoD medical people recited a litany of reasons why they would not and should not participate in such research.

They [DoD scientists] 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.[xvi]

Here is promising scientific research that shows a strong link between GWS and a potential cause, yet rather than at least encourage or aid the research, which one would think DoD would do if it were truly concerned about finding a cause and perhaps treatment for GW veterans’ illnesses, DoD responded by circling the wagons and denying that such a link could exist. And then offered that “topical creams” used by soldiers could be the source of the squalene. The DoD responded to the report by asking that it be definitively entitled “GULF WAR ILLNESSES: Gulf War Veterans Did Not Receive Vaccine Adjuvant Formulations Containing Squalene”.[xvii] Additionally, the DoD asserted that “in view of the GAO’s conclusion that Gulf War era Veterans did not receive vaccine adjuvant formulations containing squalene, the GAO proposal to test Gulf War veterans for the presence of squalene antibodies seems scientifically and fiscally irresponsible.”[xviii] The GAO responded in its report:

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.[xix]

Now the DoD was caught “misstating” the GAO’s conclusions and asking the GAO to change the title of its report on the squalene issue.

At the same time, the DoD began an attack on the Tulane research. On May 24, 1999, Dr. Carl Alving called Dr. Robert Garry, a respected scientist who was working o the Tulane study. Dr. Alving expressed a “purely scientific” interest in Dr. Garry’s research and asked for a copy of the in-progress work. Dr. Garry agreed to fax a copy, asking Dr. Alving not to circulate it as it was preliminary only. The final report differed significantly from the in-progress work. Dr. Alving not only circulated it, but subjected it to a scathing review and placed that review on the DoD’s website prior to the paper’s final publication. The review included an accusation that the Tulane researchers had an “anti-military agenda,” though there was little evidence to support this. In fact, the DoD claimed on its website that the Tulane “conclusions derived from the test have no scientific basis.”[xx] Dr. Garry later stated that this preemptive strike by the DoD might well hinder the chances for the research getting published in a peer reviewed journal. At the same time, the DoD repeatedly denounced the Tulane results by claiming that the paper had not been published in a peer-reviewed journal.

Notwithstanding these attempts to prevent the paper’s publication, the Tulane study was published in February 2000 in a peer-reviewed journal. Despite the DoD’s refusals, Congress finally required the DoD to participate in a squalene study as part of the Defense Appropriations bill for Fiscal Year 2000. The DoD claimed that “the FDA verified that none of the vaccines used during the Gulf War contained squalene as an adjuvant.” The FDA was queried by Representative Metcalf and responded in a much more qualified manner, stating that “neither the licensed vaccines known to be used in the Gulf War, nor the one investigational product known to have been used, contained squalene as an adjuvant in the formulations on file with FDA.”

On October 3, 2000, while I sat coolly with David Ponder and his wife Jenn in the Rayburn Building waiting for his chance to testify before Congress, Representative Jack Metcalf read from a report his staff had prepared, including the shocker (or perhaps not) that retesting of the lots revealed trace amounts of squalene in the AVA. The original tests had been sensitive to detecting squalene in parts per million. The supplemental testing detected squalene in parts per billion, 1000 times more sensitive. An independent vaccinologist from Baylor University, however, offered that even in those amounts the presence of the adjuvant could boost immune response.

The DoD then took a new position. At this point, the DoD claimed that “amounts were so minute as to be insignificant.” Additionally, the FDA came in to disclaim what its own scientists had found. What is interesting about the DoD position is that it still doesn’t explain the presence of squalene in the vaccine. It is one thing to point out that the body produces squalene naturally and that the amounts are small. The DoD, and the manufacturer, have still not come forward to state that squalene is naturally produced in the vaccine by either the bacillus anthracis or some other aspect of the manufacturing process. Until that explanation happened, and it didn’t, in addition to all of the other failed inspections and contaminated lots, the anthrax vaccine should have been considered adulterated, containing an experimental adjuvant. More startling is that on the same day that David Ponder testified before Congress, a press conference was held where DoD spokesman Ken Bacon answered questions about squalene in the anthrax vaccine.

QUESTION: And just to be clear, and I know that this has come up many times before over the years, but squalene also is not present in vaccines used during the Gulf War, before the Gulf War, after the Gulf War and to this day; is that correct?

BACON: I have been told – I’m not an expert on vaccines and certainly not on squalene, but I’ve been told that squalene has not been in vaccines for – or certainly in the anthrax vaccine for a considerable period of time.

According to this statement by DoD’s own spokesman, the Anthrax Vaccine did have squalene in it at some point, but not “for a considerable period of time.”

The history of this DoD research seems incredibly coincidental. Between 1988 and 1998, DOD sponsored 101 clinical trials on vaccines under IND protocols; this means test involving human subjects. None of these human studies involved an anthrax vaccine, although 5 studies involved squalene and two occurred before the Gulf War.  More questionable were 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 were presented at conferences and published in several medical journals. The GAO noted that

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.[xxi]

In light of all of this compelling research and evidence, the question becomes why? Why would the DoD not want to find out the cause of Gulf War Illness? Even if it were the anthrax vaccine, wouldn’t the health of veterans be more important than one vaccine? The answer to that question involves a mix of politics, personal agendas, and, of course, money. Unfortunately, it also reveals something about the leadership of the U.S. Armed Forces.

ENDNOTES

[i] Catherine Unwin, et.al., “Health of UK servicemen who served in Persian Gulf War”, The Lancet, 16 Jan 1999, page 169.

[ii] Unwin, page 169.

[iii] Lea Steele, “Prevalence and Patterns of Gulf War Illness in Kansas Veterans: Association of Symptoms with Characteristics of Person, Place, and Time of Military Service”, American Journal of Epidemiology, Vol. 152, No. 10 : 992-1002, page 1 of 14 (online).

See: http://aje.oupjournals.org/cgi/content/full/152/10/992

[iv] “France Investigates Gulf War Syndrome”, The Lancet, 18 Nov 2000, page 1747.

[v] “French to Check Liaison Officers for Gulf Syndrome”, Reuters, 14 Sep 2000.

[vi] GAO Report 99-5, March 1999 p. 2.

[vii] Background working documents, GAO Report 99-5, DI-23

[viii] Background working documents, GAO Report 99-5, DI-2

[ix] Background working documents, GAO Report 99-5, DI-23

[x] Background working documents, GAO Report 99-5, DI-20, F-5

[xi] Background working documents, GAO Report 99-5, DI-23

[xii] Background working documents, GAO Report 99-5, DI-9

[xiii] Background working documents, GAO Report 99-5, DI-8

[xiv] Background working documents, GAO Report 99-5, DI-23

[xv] GAO Report 99-5, p. 8.

[xvi] Id.

[xvii] 99-5, p.22.

[xviii] Id.

[xix] Id.

[xx] Letter from Rep. Jack Metcalf to Secretary of Defense William Cohen dtd February 25, 2000, quoting from the DoD’s anthrax website in February 2000.

[xxi] GAO Report, 99-5, p. 5.