The General Accounting Office in a report released yesterday — but not immediately posted on the Internet — confirmed findings of independent researchers that antibodies of a chemical compound called squalene — a substance being tested in some experimental vaccines — have been found in the blood of a number of veterans of the Persian Gulf War and can be considered “a potential contributing factor” in the illnesses suffered by so many veterans.
The GAO report further recommended that the Department of Defense conduct research “to replicate or dispute the independent research that revealed the presence of squalene antibodies in the blood of ill Gulf War-era veterans.”
Specifically, Defense is urged to test the blood of all Gulf War veterans for the presence of the antibodies.
The report is titled: “Gulf War Illnesses: Questions about the Presence of Squalene Antibodies in Veterans Can Be Resolved.”
It had been requested by Rep. Jack Metcalf, R-WA, who was prompted by concerns that experimental, unlicensed vaccines might have been used on troops heading for the Persian Gulf to protect them from anthrax, botulism, and other diseases — and that it was these vaccines that caused the illnesses and symptoms referred to as Gulf War syndrome, from which so many veterans suffer.
The Department of Defense has steadfastly denied using any experimental vaccines on troops heading for the Gulf, but at the same time refuses to conduct tests on veterans to see whether the findings of the researchers are valid or not.
The GAO report emphasizes that it was not the office’s intention “to focus on how squalene antibodies might 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.”
Still for many the question is: how did squalene antibodies get into the bloodstreams of veterans? That’s what Metcalf is asking, and as the report’s title suggests, the matter can be resolved.
Squalene is a naturally occurring substance found in shark liver oil, some vegetable oils, and the human liver. It can also be manufactured through chemical engineering.
Beginning in the 1980s, scientists at the Department of Defense and the National Institute of Allergy and Infectious Diseases (a branch of the National Institute for Health) have been looking for ways to induce a rapid response to certain vaccines using squalene as part of an adjuvant — that is, a substance added to a vaccine to enhance, accelerate, or prolong a specific immune response.
As reported by the GAO: “According to the National Institute of Allergy and Infectious Diseases… a new generation of novel adjuvant formulations are being developed. These formulations are intended to enhance and optimize immune responses to vaccines; enable easier deliver of antigens (substances that stimulate production of an antibody), and reduce the amount of antigen and the number of immunizations required for protective immunization. Squalene is a common component of these new formulations.”
In other words, if an adjuvant were formulated and added to a vaccine — such as one for anthrax or HIV (the AIDS precursor) — it would make that vaccine more effective. Since a full program of anthrax shots takes 18 months (six shots, one every three months), it would be of great benefit if an adjuvant could be found to cut the number of shots to, say, three.
At present, aluminum hydroxide (alum) is the only adjuvant used in vaccines licensed by the Food and Drug Administration in the United States. Although considered safe, it provides only a limited boost in the immune response, and scientists have stressed the need for more effective formulations. Hence the attention presently paid to squalene and other potential adjuvant components.
The Department of Defense conducted such research, but DoD officials say it was decided not to use vaccines with any adjuvant formulations — including those with squalene — to protect the troops. They further deny that “independent researchers” have proved the presence of squalene antibodies in the veterans’ bloodstreams.
The GAO report draws heavily on the work of these independent researchers. Though not cited by name, the institution where the research was performed was in fact the prestigious Tulane University Medical Center School of Medicine, with Robert Garry, lead scientist at the department of microbiology and immunology, heading the research team.
“We can say for certain now that these antibodies do exist in sick soldiers we’ve tested,” Garry told Insight magazine in an article published this week, which examines in depth the Tulane University findings.
Using a simple, inexpensive blood test, the Tulane scientists made several significant discoveries. As detailed in the GAO report:
Most veterans with Gulf War illnesses had the antibodies to squalene — regardless of whether they were deployed oversees 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.
Tulane researchers concluded that, “while the presence of the squalene antibodies remains unclear, the presence of these antibodies could potentially be a contributing factor to Gulf War illnesses.”
Department of Defense officials admit they could develop a test for detecting antibodies to squalene — and it wouldn’t be expensive or difficult to conduct. But the Pentagon “strongly disagrees with the GAO recommendation that the Secretary of Defense should test for antibodies to squalene in the blood of sick Gulf War-era veterans.”
In a response to the GAO report, Defense claims:
There is no basis for believing that the Gulf War-era veterans were exposed to squalene-containing vaccines;
The assay (test) for anti-squalene antibodies developed by the independent researchers has not been validated through peer review or publication in the scientific literature;
The presence of anti-squalene antibodies in the blood of Gulf War-era veterans would not establish an association of squalene or squalene antibodies with illnesses among Gulf War veterans;
The hypothesis that squalene antibodies may be a contributing cause to the illnesses of the gulf War-era veterans and any experimental design to test that hypothesis must be evaluated for scientific merit through independent peer review.
Is the Department of Defense stonewalling? The department went so far as to press the GAO to title its report: “Gulf War Illnesses: Gulf War Veterans Did Not Receive Vaccine Adjuvant Formulations Containing Squalene.”
But as noted by the GAO, the research has been peer reviewed and is awaiting publication. Since that is a lengthy process, the GAO recommends that the Secretary of Defense review the Tulane University research, and rather than making derogatory statements, actually take a look at the evidence.
Metcalf, while applauding the GAO report which he requested, deplored the decision of the Department of Defense to ignore the findings and turn its back on a problem, and urged officials to “aggressively pursue the GAO’s recommendations” and find the answers to the questions.
“Given the fact that the federal government has spent more than one hundred million dollars on research and investigations into Gulf War illnesses with so little success, it is unconscionable that they would be unwilling to spend a few thousand dollars to replicate or dispute independent research results,” said Metcalf. “The time to act is now.”
As a result of the findings of this initial report, Metcalf is asking the GAO to continue its investigation into the relationship between the presence of squalene antibodies in veterans and the Gulf War illnesses.