Did the military secretly doctor the anthrax vaccine?

Health and medicine explained.
Nov. 16 2004 4:00 PM

Anthrax Scare

Did the military secretly doctor its anthrax vaccine?

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Matsumoto also notes the FDA's claim that it found similar trace levels of squalene in a tetanus vaccine made by Wyeth and a diphtheria vaccine made by Connaught. To the FDA, this simply showed that tiny amounts of squalene can contaminate many vaccines. To Matsumoto, this was a hot lead: Neither of these products is on the FDA's list of licensed vaccines, raising the prospect that they were actually experimental, unlicensed vaccines that also had squalene intentionally added to them. How could it be that the FDA researcher who presented these findings—"in one of those moments of almost cosmic irony, testifying to the House Committee for Government Reform," Matsumoto writes—omitted these details? Here's how: Matsumoto mistakenly wrote that the FDA tested Wyeth's tetanus vaccine and Connaught's diphtheria vaccine (it's actually Connaught's tetanus vaccine and Wyeth's diphtheria vaccine), and then did not note that Connaught is part of what's now called Aventis Pasteur, which has an FDA-licensed tetanus vaccine. Cosmic irony, indeed. *

But in Matsumoto's mind, the deception goes deeper: The DoD, the National Institutes of Health, and the FDA conspired to quash concerns about squalene because it was the magical ingredient needed to make future vaccines—not just against bioweapons, but against AIDS and cancer. He writes that "by questioning the safety of squalene, Asa imperiled more than 80 percent of the existing NIH-sponsored clinical trials for vaccines to prevent HIV." This is fiction. Here is a 2001 list of AIDS vaccines in clinical trials and in the pipeline. Only one product, not yet tested in humans, uses squalene, and many don't use any adjuvants at all. Chiron Corp. did use squalene in earlier human tests of an experimental AIDS vaccine, but that project crashed and burned because of the unimpressive results with the HIV ingredients in the vaccine, not the adjuvant.

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The shaky premise of Vaccine A falls apart completely when Asa and Garry—and, separately, military researchers—compare squalene antibody levels in people who received the anthrax vaccine and controls who did not. Logically, if the vaccine contained significant amounts of squalene, vaccinated people should have higher levels of squalene antibodies than the unvaccinated. Asa and Garry found the antibodies in eight of 25 vaccinated people (32 percent) and three of 19 controls (15.8 percent). "This difference is not statistically significant in this size sample," they reported in a 2002 paper. A military study tested for squalene antibodies in more than 700 people from three separate groups, one of which included 34 people who had received the anthrax vaccine. Each group had the antibodies, and there again was no significant difference between them. Matsumoto challenges the quality of the military data near the book's end, but at that point it's like listening to a Yankee fan at a bar who still can't accept the ump's interference call on A-Rod.

Vaccine accidents do happen, they do get covered up, and they deserve close scrutiny. One of the most famous vaccine accidents is the contamination of the first polio vaccines with a monkey virus, and a new book on the accident by Debbie Bookchin and Jim Schumacher, The Virus and the Vaccine, has many parallels with Vaccine A. But the research in this book is meticulous, and Bookchin and Schumacher's tone is so measured and thoughtful that my mind opens to their controversial thesis (that the monkey virus accidentally injected into people through polio vaccines causes human cancers). I'm not convinced that the monkey virus does, in fact, cause harm, but I am convinced that the question merits serious attention. Matsumoto, in contrast, with his sloppy errors, remote possibilities trumped up as facts, and outright dismissal of evidence that doesn't support his thesis, leaves me groaning.

Science is provisional. Data can surface tomorrow that overturns everything we think we know. But given the evidence to date, did the military spike its current anthrax vaccine with squalene and unintentionally cause Gulf War Syndrome? No. And part of my conviction comes from the fact that Matsumoto tried so hard to make this case and failed.

Corrections, Nov. 24, 2004: Jon Cohen did not intend to imply that the book Vaccine A stated that a flu vaccine licensed in Europe "has been safely injected into tens of millions of people." In fact, the book questions the safety of that vaccine, but does not explicitly state how many people it has been injected into. Cohen stated that the vaccine "has been safely injected into tens of millions of people." This figure was taken from the Department of Defense Web site; according to Chiron Corporation, the vaccine's maker, the vaccine has been safely injected into more than ten million people. (Return to the corrected sentence.)

Jon Cohen incorrectly wrote that Wyeth made an FDA-licensed tetanus vaccine, and Connaught made an FDA-licensed diphtheria vaccine. The error, however, was originally made by Gary Matsumoto in Vaccine A, and Cohen did not notice it. In fact, Wyeth made an FDA-licensed diphtheria vaccine and Connaught, which is part of what's now called Aventis Pasteur, made an FDA-licensed tetanus vaccine. (Return to the corrected sentence.)

Jon Cohen writes for Science magazine. Follow him on Twitter.

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