Squalene Presence Confirmed by FDA

Since July 1997 Insight has been reporting on the presence of antibodies to a substance called 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 statements by Department of Defense (DOD) officials, has been a simple one: How and why does something 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 personnel, 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 Tulane 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 get the technique patented. But DOD bizarrely said that patenting the test undermines Tulane's integrity.

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 science to be a promising new adjuvant to help speed the absorption and potency of various vaccines under 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 nearly 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 in cutting-edge medical experiments using investigational new drugs (INDs).

Meanwhile, one of the leading experimenters with squalene has been DOD. When Insight first 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 U.S. 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 whose common denominator has been that they received a full complement of shots (or nearly all of them) just before, or shortly after, the gulf war began?

Besides its denials, DOD also has argued variously that the Tulane research was faulty, that it 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 university, 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 bipartisan members of Congress, including Republican Rep. Jack Metcalf of Washington state. If Tulane's test was so bad, why not simply replicate it, or take Tulane's own "kits" and expose the Garry research 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 FDA 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 determine whether squalene ever was mixed with such medicines. With prodding from GAO and Metcalf, FDA ultimately did its own tests -- and found trace amounts of squalene. This raised questions about tests 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 era. 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 playing 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?