GAO Calls for Squalene Tests

By Paul M. Rodriguez

Although the Defense Department denied having a role in the presence of the adjuvant squalene in the bloodstreams of gulf-war veterans, a GAO report raises questions about that.

In a surprisingly abrasive report released March 29, the General Accounting Office concluded -- and so recommended to Congress -- that the Defense Department immediately should begin studying the discovery of antibodies in the blood of sick Persian Gulf War veterans to a compound called squalene. The object of such studies would be to determine if squalene, however it got into the bloodstream, is a contributing factor in gulf-war illness.
. . . . The GAO report follows by a week a report in Insight detailing final laboratory results from a two-year study conducted by the prestigious Tulane School of Medicine in New Orleans (see "Breakthrough on Gulf War Illness," April 19). That study confirmed the presence of the squalene antibodies in sick veterans of the Persian Gulf War era -- antibodies found in the blood of those who served overseas as well as of those vets who never left U.S. soil during that conflict.
. . . . Squalene is an experimental adjuvant used to speed the immune system. It has not been approved by the Food and Drug Administration. Tulane's research was conducted by the widely respected immunologist Robert Garry, and his findings were peer-reviewed. According to Dr. Garry and to Dr. Russell B. Wilson of Autoimmune Technologies LLC, a firm hired by Tulane to market its patented protocol for the test, the presence of the squalene antibodies points to some outside source. They suggest, for example, experimental injections.
. . . . "Yes, it's pretty significant," Wilson tells Insight. "We're not saying we know how [the antibodies] got [in the sick soldiers], but we are saying we have proof positive of an objective marker that they do exist." Garry agrees, adding that it's up to the Congress and the Department of Defense, or DOD, to investigate further, because "we now can confirm [the squalene antibodies] do exist [in the blood of the sick vets] and that further testing certainly is in order to find out why, because it would be extremely remote that such antibodies would appear as a result of natural causes."
. . . . When Insight first reported the preliminary lab results showing these antibodies, the DOD dismissed the findings. Because the department never used squalene in any medication or vaccine given to gulf-war soldiers, let alone experimented with the substance, officials contended, the DOD would be foolish to conduct an independent analysis.
. . . . Now the General Accounting Office, or GAO, after its own six-month probe into Insight's reports concerning Tulane's previously secret laboratory work, sternly has criticized the DOD for obfuscating on the issue. Indeed, the GAO discovered that the DOD long has known about squalene as a possible adjuvant drug and that the military has been experimenting with squalene-based medicines for more than 10 years, even conducting trials in Thailand involving squalene as an adjuvant for an anti-AIDS drug.
. . . . "Time is critical for many gulf-war-era veterans who continue to suffer from illnesses and have been waiting for the past seven years for an explanation about the nature of their illnesses," the GAO report said. "Independent researchers [at Tulane] ... have concluded that squalene antibodies are present in sick gulf-war-era veterans who have participated in their research and are a potential contributing factor to these veterans' illnesses."
. . . . Although officials at the DOD told the GAO, according to the report, that the Defense Department could develop its own tests, it would not do so because the DOD claimed "it did not use adjuvant formulations with squalene" and wanted to wait for the research work to be published. The GAO was not impressed: "Given that gulf-war-era veterans already have 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" at Tulane.
. . . . The GAO report was stunning. It said that despite being told by the DOD that gulf-war-era troops were not vaccinated with a squalene-based drug, it could not "say definitively whether or not [veterans] were given vaccines with adjuvant formulations containing squalene for a number of reasons." Although DOD officials claimed to the GAO that they did not administer such vaccines, "they stated they did not have documentation on the process and results of decision-making related to the administration of vaccines at the time of the gulf war. Also, some officials involved in the decisions were no longer employed with DOD ... and we were either unable to locate them or they declined to be interviewed," the GAO said in its 24-page report (GAO/NSIAD-99-5).
. . . . Rep. Jack Metcalf, the Washington state Republican who requested the GAO probe, tells Insight that he has been "deeply concerned about this issue since it first was brought to my attention by veterans that are suffering from gulf-war illnesses. They had read [the Insight stories] about blood samples of some gulf-war-era veterans containing antibodies to squalene. They want to know the truth about why they are sick, and my sole motivation has been and remains still to help these men and women find the truth."
. . . . The three-term congressman, who has been a lone voice barking at the DOD on the issue, further told this magazine that "with over 100,000 of our veterans suffering, the DOD's history of foot-dragging and obfuscation on this issue is inexcusable.... We have a moral obligation to stand with the honorable men and women who sacrificed for this nation in their search for effective treatment of Persian Gulf War illnesses and demand DOD act on the GAO recommendations."
. . . . In ever-increasing numbers since 1991, American vets have been reporting unexplained illnesses, including symptoms of lupus and rare cancers, to name but a few. For years the DOD has stonewalled. Enter Tennessee immunologist Pamela Asa with her initial theory that so much illness might have resulted from a covert inoculation administered to the troops. Though the DOD attacked Asa and then denied -- as it since has to Insight and to the GAO -- that it ever used any secret vaccines involving experimental compounds, the military also initially denied it was experimenting with squalene.
. . . . And the GAO not only confirmed the extensive military testing using squalene-based adjuvants, it also revealed for the first time that DOD officials considered but allegedly then decided against using just such a vaccine -- supposedly to protect U.S. troops from potential Iraqi biological or chemical attacks. Congressional investigators tell Insight that they found these GAO conclusions profoundly shocking.
. . . . Although the GAO and the DOD have not revealed what immunizations were under consideration for use with squalene as an adjuvant, military and congressional sources say they believe these must have been antianthrax drugs. "It would be inconceivable that the Pentagon would have experimented on soldiers involving anything else," says a senior military official who has tracked Insight's reports on this issue but asks to remain anonymous. However, according to the GAO, the military claimed it never experimented with a squalene-based anthrax drug.
. . . . The GAO said that while determining what the DOD may have done to cause 100,000 cases of gulf-war illness has been difficult, the GAO did uncover squalene-linked human testing protocols going back to 1988 when 500 subjects were administered an antimalaria vaccine. In 1990, another 12 human subjects were given a similar concoction and then another 121 in 1994. Between February 1995 and September 1997, at least 341 people received experimental anti-AIDS vaccines in Thailand involving squalene as an adjuvant at the same time that 93 people were administered placebos.
. . . . But, the stonewalling continues. The DOD still claims that, despite changing story lines about its experiments with squalene-based drugs, it never used squalene on gulf-war soldiers, so there is no need to test. In fact, the DOD told the GAO that "to test veterans seems scientifically and fiscally irresponsible." The DOD even said the GAO's recommendation "to test for squalene antibodies showed a lack of understanding of scientific methods."
. . . . Adamant refusals by the DOD to test a relatively inexpensive protocol doesn't make sense to Garry and his people at Tulane or to the GAO, given the millions of dollars spent to date on far more complicated probes and medical investigations into the causes of gulf-war illnesses. But it is beginning to look like something will be done.
. . . . House Veterans' Affairs Committee Chairman Bob Stump of Arizona and House Armed Services Committee Chairman Floyd Spence of South Carolina say through aides they find the position taken by the DOD alarming. The two chairmen plan to refer the Tulane and the GAO studies to their committees for evaluation and possible hearings into the mystery of how antibodies to squalene got into all those sick soldiers. Meanwhile, GAO stands ready to dig deeper.

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