Breakthrough on Gulf War IllnessBy Paul M. Rodriguez
After a year of stonewalling by the DOD, a new study at the prestigious Tulane
University Medical School confirms that victims of a mysterious sickness may have been
It started with a telephone call nearly two years ago, a call with a question not yet fully answered: How did antibodies to a chemical compound called squalene get into the bloodstreams of sick soldiers who served overseas during the Persian Gulf War, and even of some whose service during that era never took them outside of the United States?
. . . . The sick soldiers had one thing in common -- they all had received a full complement of military immunizations. And with that in mind, laboratories contacted by Insight began searching for allied clues related to the so-called Gulf War Syndrome.
. . . . Now, after nearly 18 months of intensive study, checking and rechecking related data, the prestigious Tulane University Medical Center School of Medicine's department of microbiology and immunology, in New Orleans, has confirmed test results first reported by this magazine a year ago.
. . . . According to Tulane, antibodies to squalene indeed do appear in the bloodstreams of the sick veterans -- in fact, the sicker the veteran, the higher the level of such antibodies.
. . . . Tulane's final laboratory results are highly significant. Although squalene is a naturally occurring substance in the human body, associated with cholesterol, the presence of the antibodies strongly suggests that an outside antigen -- or medical cause -- is involved here. When Insight first reported the presence of the squalene antibodies, the Defense Department resisted the findings, suggesting that some human condition gone awry might explain them. Certainly that speculation no longer will do.
. . . . "Yes, it's pretty significant," says Russell B. Wilson, president of Autoimmune Technologies, LLC, a medical marketing and research firm in New Orleans hired by Tulane to publicize and market its groundbreaking research into squalene antibodies. "We're not saying we know how [the antibodies] got there [in the sick soldiers], but we are saying we have proof positive of an objective marker that they do exist."
. . . . Robert Garry, the widely respected lead scientist at Tulane's department of microbiology and immunology, whose peer-reviewed medical experiments led to the assay that confirms the presence of squalene antibodies, modestly describes his findings to Insight as important. "We can say for certain now that these antibodies do exist in sick soldiers we've tested," Garry says.
. . . . "How this plays into the illnesses of these patients will require more work, but certainly this is an important marker to begin conducting research," he adds. "We're not saying we know how or what caused the antibodies to appear, but we now can confirm they do exist and that further testing certainly is in order to find out why, because it would be extremely remote that such antibodies would appear as a result of natural causes."
. . . . Put another way, according to Wilson, himself a Ph.D. in cellular microbiology, it is unlikely these antibodies to squalene resulted from a naturally occurring cellular dysfunction in the human body. "The objective marker Tulane has discovered suggests other causes," Wilson says. "It suggests they were induced from an outside source."
. . . . And so the mystery deepens. From the beginning of Insight's investigation, the DOD has mustered statements from Secretary of Defense William Cohen down to the various surgeons general of the armed forces and the Veterans Administration and Walter Reed Army Medical Center denying any knowledge, let alone responsibility, for this presence of squalene antibodies. One reason for the nervousness at the Pentagon, as congressional investigators and top military brass privately have told this magazine, is that any linkage between the DOD and the discovery of the antibodies could suggest that some experimental vaccine was given to soldiers just before the war began in 1991.
. . . . Although the DOD vehemently denied it ever had used anything other than alum-based immunizations on American troops, Insight learned 18 months ago that in fact DOD medical experts had been working secretly for several years developing an alternative and more powerful substance to help make certain immunizing drugs work more effectively and faster. Such compounds are called adjuvants. Because these compounds can so powerfully affect the body, alum is the only U.S.-approved adjuvant for humans.
. . . . However, in the experimental fields of medicine, cutting-edge biochemical therapies are worked on every day, including alternative adjuvants to alum. Their use on humans is strictly controlled and only permitted with government approval in advanced scientific research. Squalene is one such experimental adjuvant. A powerful immune stimulant, it has been tested at Walter Reed and the National Institutes of Health for treatment of herpes, malaria and AIDS.
. . . . Indeed, Walter Reed not only is the only known U.S. government manufacturer of squalene, but it has been using squalene in secret anti-HIV tests in Thailand for a number of years. Yet when Insight first began probing squalene antibodies as a possible cause for some of the gulf-war sicknesses, the DOD and Walter Reed denied ever using squalene. They denied even knowing that such an adjuvant existed or that it was one of a series of high-tech experimental "medicines" undergoing tests by the military. Only after this magazine reported the preliminary test results on the sick vets -- without identifying the role of Tulane's medical laboratory -- did the DOD finally acknowledge its experiments with squalene. But for two years DOD officials steadfastly have denied that they ever administered any secret vaccines to gulf-war soldiers or that they administered anything not approved by the Food and Drug Administration, or FDA.
. . . . Despite repeated requests from this magazine and from interested lawmakers, DOD officials also have refused on the record so much as to investigate whether squalene antibodies have in fact been found in the sick soldiers. The response has been: We never used it, it's only a theory -- and therefore we don't need to pursue it. Moreover, DOD officials have waged a major behind-the-scenes campaign for the better part of a year to try to discredit Insight's initial reports about these matters. "They came in and briefed us and told us your story was full of shit," said a senior aide on the House Veterans' Affairs Committee. Rep. Chris Shays, a Connecticut Republican who chairs the Government Reform and Oversight subcommittee on Human Resources, says that when he tried to look into the issue he was assured there was nothing to it.
. . . . Shays and members of the Veterans' Affairs and Armed Services committees who had promised to pursue the mystery of the squalene antibodies all ran into the DOD's disinformation campaign. Also, the initial test results Insight reported were just that. Without a peer-reviewed paper in a scientific journal to confirm details or the name of the laboratory conducting the research, the DOD flacks managed to stonewall and cast doubt on the story.
. . . . Another and equally important reason the issue was dropped, according to congressional and DOD officials, was a campaign directed at a Tennessee immunologist named Pamela Asa. She was the first to advance the theory that one of the causes of so many unexplained illnesses in gulf-war vets might be an autoimmune dysfunction caused by immunizations. Because she is not a nationally renowned scientist like Garry, it was suggested that she could not be taken seriously by DOD and her theory was bunk. Behind the scenes, DOD secretly commissioned a "study" three years ago that, according to a high-level DOD medical scientist, was designed to bury the Asa theory when she became "a pain in our butt, calling around and causing trouble." That "study" lay dormant until Insight broke the initial squalene story. DOD officials then trotted it out as "proof" that not only was her theory wacky but there was no medical basis for claims that an "unknown adjuvant" might be one of the causes of so much sickness.
. . . . Contrary to the odd picture painted by the DOD, however, the Pentagon never did an exhaustive study on whether an experimental squalene adjuvant was used on soldiers, let alone the theory of adjuvants' disease. What DOD commissioned was a study concerning the plausibility of the theory that adjuvants could have had any role in making so many soldiers sick. Since the study's authors were told that only alum was used, the research paper concluded that Asa's theory was not plausible.
. . . . The DOD even put out press releases and Internet messages arguing that because it never used squalene in any immunizations during the Persian Gulf War, the Insight story must have been based on bogus test procedures that simply picked up molecular traces of the naturally occurring squalene.
. . . . Meanwhile, in the intervening year, Tulane's Garry and his team quietly continued to perfect their testing protocol and systematically eliminated possibilities put forth by DOD. Scientific literature reviewed shows that squalene could not be absorbed orally or topically. And Tulane determined that production of antibodies to a naturally occurring substance in the human body would be remote, if not virtually impossible.
. . . . "I think you would discover that life exists on Mars before you could believe these [antibodies] were naturally occurring," says Garry. "My God, the human body is a very tough customer from a cellular biological perspective. Even people who were exposed to radiation from World War II did not show basic changes in their molecular biology."
. . . . Rep. Jack Metcalf, a Washington Republican, dissatisfied with the shaky DOD responses, called on the General Accounting Office for an investigation. The yearlong GAO probe, though still confidential, has not found evidence that the DOD used squalene in immunizations given to gulf-war troops. But its investigators are troubled by the confusing and incomplete facts offered by DOD concerning the now-undeniable presence of squalene antibodies. In the as-yet-unpublished report, the GAO has recommended that Congress conduct hearings.
. . . . "The responses and documents obtained by GAO closely tracked what you at Insight got," says one of more than two dozen sources familiar with both the GAO probe and the medical tests conducted by Tulane's medical department. "First the DOD said they didn't have [squalene]; then they said they did but never used it; then they said they used it but only after the war; then they admitted they had manufactured it prior to the war but claimed they never used it; then it was confirmed that it has been used overseas in trials for a number of years; then, well, you get the picture," says one of these Insight sources.
. . . . Tulane's confirmation contains immense implications, according to several DOD, congressional and government scientists. "What this tells us is that something containing squalene was exposed to these patients," says Asa, who long has suspected that with good intentions but disastrous results the military administered an unknown experimental vaccine just prior to the Persian Gulf War.
. . . . No evidence yet has surfaced to confirm this scenario, say those who have investigated the mystery of the squalene antibodies. And a highly sensitive DOD often makes this point in response to media inquiries. However, based partly on the medical tests and partly on DOD's contradictory responses concerning squalene's uses in experimental sciences, a number of medical, military, laboratory and veterans groups now are skeptical -- and nervous -- about the possibility that something that went awry is being hidden.
. . . . Veterans' fears are not being assuaged by DOD's refusal to release records involving its experiments with squalene -- nor is there comfort in its refusal to release details of what its various vaccines during the gulf war contained. The FDA, reportedly at the request of DOD, has declined to provide any information whatsoever related to those vaccines -- even to the GAO.
. . . . "They have created an air of mystery by their actions that has certainly raised suspicions," a government official says. "Even if they are innocent, they have acted so guilty as to raise questions. It would be such a simple thing to just go and test for these antibodies." Indeed, to Garry, Asa and hundreds of gulf-war vets who have volunteered for strict double- and triple-blind tests for squalene antibodies as administered by Tulane's Medical School, these actions by the military are deeply troubling. "I don't understand their position," confesses Garry, who often has worked with DOD and other government agencies. "They could have taken our testing protocol and quickly determined if there was any validity to the allegation."
. . . . Many of the DOD officials interviewed by Insight, as well as those interviewed by the GAO, have gone to extraordinary lengths to distance the Pentagon from the issue of the squalene antibodies. One reason advanced by many of the veterans and their families may have to do with the way several hundred of the sick soldiers were treated immediately after the gulf war and ever since. Scores of them were placed in Walter Reed's special HIV ward and isolated even from their doctors by personnel brought in from special DOD units to conduct medical evaluations based on AIDS-related symptoms. Many of these patients not only never learned what the specialist teams discovered, or for that matter what they failed to find, but they were required to submit to further semiannual HIV-examination testing procedures for many years without explanation.
. . . . Metcalf says the reasons behind any stonewalling are not nearly so important as getting help to thousands of sick gulf-war soldiers. "I have been deeply concerned about this issue since it was first brought to my attention by veterans suffering from gulf-war illnesses," he says in a statement prepared for Insight. "They had read the news reports about blood samples of some Gulf War-era veterans containing antibodies to squalene. They want to know the truth about why they are sick."
. . . . Metcalf continues, "I believe that any legitimate research that could provide clues as to the nature and treatment of their illnesses must be pursued vigorously. I asked the GAO to look into the issue ... and to determine if there was any possibility that veterans had received squalene and to determine if the reported research was valid."
. . . . The magnitude of the problem is considerable. "With over 100,000 of our veterans suffering, the DOD history of foot-dragging and obfuscation on this issue is inexcusable," Metcalf says. "The GAO study tells us that we can spend just a few thousand dollars and possibly unravel the mystery of gulf-war illnesses. We have a moral obligation to stand with the honorable men and women who sacrificed for this nation in their search for effective treatment ... and I demand DOD act on the GAO recommendations." Calls to DOD for official comment were not returned.
. . . .
Anatomy of a Discovery: Leading University Confirms Suspicions
. . . . It was nearly seven years ago. By a quirk of fate, a shipping label accidentally was left on a batch of test tubes containing blood specimens taken from sick vets. The squalene mystery began to unfold.
. . . . At the time, U.S. soldiers returning home were complaining about strange illnesses. Defense Department and Veterans Administration officials said there were no medical reasons for their sickness. No chemical or biological weapons had been used in theater, nor were there nuclear-related reasons. But more and more veterans, initially those who served overseas and then those who never left the United States, complained of autoimmune ailments that had no known cause. And more and more the soldiers were told their illnesses were psychological or possibly related to a combination of desert heat and allergy to insecticides -- and not to worry. What was occurring behind the scenes, however, told another story, according to a two-year investigation by Insight into the discovery of antibodies to squalene in the blood of the sick.
. . . . As it worked feverishly in public to deny any link between the odd illnesses and symptoms reported by a growing number of soldiers who served during the gulf war, medical personnel inside the military and the VA were working quietly to determine whether something indeed was causing gulf-era soldiers to fall ill and, in a growing number of cases, to die for unexplained reasons.
. . . . While the Pentagon denied that a secret arsenal had been unleashed by Iraq on U.S. forces in theater, Walter Reed Army Medical Center was working on a variety of theories involving possible biological or chemical weaponry.
. . . . In one of many experiments -- conducted without the knowledge of soldiers, family and (in many cases) even the patient's doctors -- teams of medical specialists secretly obtained blood samples of sick veterans. In one case, blood collected from sick gulf-war soldiers was shipped to Johns Hopkins University in Baltimore, where specialists in environmental sciences were asked to determine if anything unusual could be detected in the samples. At the request of a doctor at Walter Reed who worked in the HIV experimental-sciences section, Johns Hopkins was asked to conduct unusual but very specific tests for an autoimmune disease -- notwithstanding that the DOD had denied it was searching for such a cause.
. . . . Enter Tulane University Medical School and Dr. Robert Garry. Unable to conduct the specialized tests requested, Johns Hopkins made arrangements with Garry, a noted retrovirologist, to test for HIAP (Human Intracisternal A-type Retroviral Particle), a medical marker associated with autoimmune diseases believed to be linked with HIV, the AIDS precursor. To conduct such tests, Tulane was sent blood samples drawn from sick vets. Garry initially believed these came from Johns Hopkins. It was not for several years, when checking a saved shipping label to answer a reporter's questions, that Garry and Tulane realized the blood samples had come via Hopkins from the Walter Reed physician who worked on HIV.
. . . . Garry examined the blood and reported negative findings to Johns Hopkins -- which, in turn, so informed Walter Reed. When he had finished his research for Johns Hopkins in the early 1990s, Garry called to determine what to do with the blood samples still on hand. He was told to do whatever he cared to: Since the tests were negative, Johns Hopkins said that neither it nor its client needed them returned.
. . . . Unknown to Johns Hopkins, as well as Walter Reed, Garry's laboratory froze the samples and locked them away until 1997, when Pamela Asa began looking for clues about the possible causes of Gulf War Syndrome. She had theorized that an unrevealed vaccine or vaccine component such as an adjuvant might be contributing to the illnesses reported by sick soldiers.
. . . . Over many months of testing, Asa zeroed in on squalene as an experimental adjuvant that the military might have used to protect soldiers from biological- or chemical-warfare agents. Knowing of Garry's work in the polymer sciences, she contacted the Tulane expert and they began a loose collaboration, sharing information and conducting tests on patients to search for clues.
. . . . When Insight began investigating Asa's theory of possible squalene-related causes, Garry had just begun working on a protocol test based on blood he obtained from sick soldiers. Remembering he had received similar samples a few years earlier via Johns Hopkins, he also started testing the older samples. It was then that the antibodies to squalene began to be detected -- Asa's theory was beginning to show promise.
. . . . Tracking doctors involved in experimental medicine at Walter Reed, Insight came across the name of the military doctor mentioned by chance to Garry, who remembered the same doctor had shipped the Johns Hopkins blood samples to him. When the original shipping labels and medical-test orders were reviewed -- like the blood samples, the meticulous Garry had saved the shipping labels and instructions -- Garry's memory was confirmed: It was the same doctor, a medical specialist at Walter Reed's advanced-sciences section, who had been working for years on experimental AIDS vaccines in Thailand using squalene as a possible adjuvant. Further checks of confidential military records also confirmed that Walter Reed was the only known manufacturer of this experimental substance on record.
. . . . Working with his forgotten but now invaluable consignment of early vet blood samples supplied by Johns Hopkins via Walter Reed, Garry and his team at Tulane went forward with their protocol to search for squalene. After months of testing using both natural and synthetic forms of the adjuvant, the protocol confirmed the presence of squalene antibodies in the blood of only the sick soldiers -- both those who served overseas and also sick veterans who served during the era but never got to the Middle East. The only link was that all got their full complement of immunizations.
. . . . Along the road to discovery, however, there were some bumps. At one point the Garry tests did not detect naturally produced squalene, only the synthetic form. This seemed odd and was pounced upon by DOD officials when Insight reported the initial test results. Over time, however, Garry realized that, unless it is very fresh, naturally occurring squalene will begin to break down at a molecular level. With fresh supplies of naturally occurring squalene on hand, the tests still came back positive, just as they had (and should have) with the synthetic squalene samples.
. . . . Garry began to refine his protocol and continued testing until both he and Tulane, along with Asa and her laboratories, were confident of the testing procedures and results. Because of the importance of the study, Tulane and Garry agreed to file a patent jointly with Asa and to submit their findings separately to peer-reviewed medical/science journals.
. . . . Once all these elements were put together, Insight was released from its pledge of confidentiality. In the next few days, supported by the General Accounting Office's separate investigation and the soon-to-be published results of the laboratory findings reported here, Washington Republican Rep. Jack Metcalf will be asking for full-blown hearings by the House Veterans' Affairs and Armed Services committees.