Squalene Presence Confirmed by FDA
Since July 1997 Insight has been reporting on the presence of antibodies to a substance
squalene that has shown up in the blood of sick U.S. soldiers of the Persian Gulf War era -- both
those who served overseas during the conflict and those who were called to service but never
deployed. The theme that has run throughout these reports, contrary to many erroneous
by Department of Defense (DOD) officials, has been a simple one: How and why does
that shouldn't be there show up in the blood of these sick people?
The DOD has spent a considerable amount of time -- and taxpayer dollars -- trying to spin
Insight's stories and the scientists involved in the squalene discovery. The DOD repeatedly has
claimed that, because it never used squalene in any of the vaccines given to gulf-war-era
there is no reason for it to pursue what it has called a kooky, wacky and flawed test.
The problem for DOD -- and, therefore, an allied problem for the General Accounting Office
(GAO) and a growing number of members of Congress on both sides of the aisle -- is that the
allegedly kooky testing procedure was developed at the prestigious School of Medicine at
University by one of it's leading immunologists, Dr. Robert Garry. Moreover, Tulane has been so
impressed with Garry's work in discovering a test to find antibodies to squalene that it helped to
the technique patented. But DOD bizarrely said that patenting the test undermines Tulane's
So what is squalene? And what's it got to do with sicknesses reported by tens of thousands of
U.S. military and civilian personnel? Squalene is a naturally occurring substance found in a wide
range of products and even in trace amounts in humans. It's also considered in experimental
to be a promising new adjuvant to help speed the absorption and potency of various vaccines
development. Notice we've said experimental medicine. That's because the only
government-approved adjuvant for use in humans is alum. It has been used as an adjuvant for
50 years and is considered safe by the Food and Drug Administration (FDA).
Over the years many scientists have been looking for a new and more efficient adjuvant, and
experiments often have focused on squalene as a promising replacement for alum. However,
because any adjuvant may trigger unwanted autoimmune dysfunctions in humans, testing of
squalene adjuvants has taken a long time and only in the last decade has it been licensed for use
cutting-edge medical experiments using investigational new drugs (INDs).
Meanwhile, one of the leading experimenters with squalene has been DOD. When Insight
began its now 3-year-old series of stories, DOD denied ever having used squalene in any form.
Period. Then it acknowledged experimenting with it in labs. Then on animals. Finally, DOD
admitted it even had begun limited IND tests using squalene adjuvant in human trials involving
immunizations to combat HIV and malaria. But never, ever, according to DOD, was it used on
troops or personnel prior to or after the gulf war.
Then how to explain antibodies to the substance showing up in sick soldiers and civilians
common denominator has been that they received a full complement of shots (or nearly all of
just before, or shortly after, the gulf war began?
Besides its denials, DOD also has argued variously that the Tulane research was faulty, that
wasn't peer-reviewed and therefore was shoddy. Then, when the Tulane study was peer-reviewed
in Experimental and Molecular Pathology, it went after the credibility of Garry and the
smearing the character and reputation of both, as well as the renowned journal.
This has been curious to us, as it has been curious to the GAO and the growing list of
members of Congress, including Republican Rep. Jack Metcalf of Washington state. If Tulane's
was so bad, why not simply replicate it, or take Tulane's own "kits" and expose the Garry
as false? But DOD wouldn't do that. It said this would be a waste of money and, besides, it never
used squalene in any medicine or vaccine administered to troops during the gulf war and the
has confirmed this.
Here's the rub: FDA says it has done no such thing. It confirms that it has approved a variety
of vaccines used by the military, but says that until recently it never tested on its own to
whether squalene ever was mixed with such medicines. With prodding from GAO and Metcalf,
ultimately did its own tests -- and found trace amounts of squalene. This raised questions about
DOD has widely claimed proved nothing was there -- especially since it appears that DOD's labs
used an improper testing method. The FDA used the proper test, the one recommended by the
federal Centers for Disease Control and Prevention.
What's troubling about the trace amounts of squalene FDA has discovered is that they were
found in the samples of anthrax-vaccine lots administered during the gulf war. And though
minuscule (parts per billion), an expert at Baylor University contacted by Metcalf is concerned it
might -- might -- be a factor in so much sickness reported by so many personnel of the gulf-war
Why? Because even at such small levels it could affect a human autoimmune system and lead to
unexplained illnesses similar to those reported by gulf-war era personnel.
Maybe squalene was added to the vaccines and DOD is lying. Maybe it wasn't added. Either
way, maybe Tulane has found an indicator to identify these sick people. But until DOD stops
war games we'll never know the answer to this question: Why does something show up in sick
gulf-war-era personnel -- those who served in theater and those who never left the United States?