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Gary M- Author

PostPosted: Thu Nov 18, 2004 3:39 am    Post subject: FACTUAL ERRORS IN SLATE REVIEW OF VACCINE A Reply with quote

TO THE EDITOR OF SLATE, RE: “ANTHRAX SCARE: Did the military secretly doctor its anthrax vaccine?”

Dear Sir:

I would like to correct the following errors in Mr. Cohen’s review of my book VACCINE A: The Covert Government Experiment That’s Killing Our Soldiers and Why GIs are Only the First Victims. Jon Cohen’s text is highlighted:

Paragraph Four: “Although it is not currently in any FDA-licensed vaccines and has caused autoimmunity in some animal experiments, it is, as we learn two-thirds of the way into the narrative, in a flu vaccine that’s licensed in Europe and has been safely injected into tens of millions of people.”

Correction: Cohen incorrectly attributes to me the assertion that the squalene emulsion flu vaccine, FLUAD™, has been safely injected into “tens of millions of people” in Europe. Mr. Cohen may have gotten this figure from some other source, but not from my book, and not from the reference that he cites in his review. The only figure that I have seen (published in a scientific paper on FLUAD™) puts the number of recipients of this vaccine the late 1990s somewhere around 600,000. The weblink in the body of his text, provided by Cohen to support the assertion that “tens of millions of people” have been safely injected with FLUAD™, connects SLATE readers to a Chiron Corporation (Chiron makes FLUAD™) press release, which says nothing about the number of people injected with FLUAD™. The phrase “tens of millions” or even the word “millions” does not appear anywhere in this document.

Paragraph Eight: “the trace amounts, they suggested [FDA officials], could have come from a technician’s fingertip.”

Correction: When FDA officials disclosed in September 2000 that they found squalene in anthrax vaccine, the agency’s Mark Ellengold suggested to Congress that the trace amounts of squalene probably came from the organism. They did not suggest that it could have come from someone’s fingertips. I clearly state this in the book. What’s more, I interviewed the FDA scientist who performed the GC/Mass spec analysis of seven lots of vaccine (five anthrax lots, one diphtheria and one tetanus); he said he wore gloves, which is standard operating procedure in this lab when running a GC analysis. He also ran “blanks” (plain water); these blanks did not contain squalene. Thus no one’s skin came in contact with the vaccine, or the water in blanks, or the glassware.

Suggesting that the squalene contents of anthrax vaccine is a result of fingertip contamination, an assertion for which FDA provides no supporting data. It is also, on the face of it, a counter-intuitive assertion; given squalene’s hydrophobicity (it repels water and won’t go into solution without being turned into micro-droplets, which must then be treated with a surfactant, a kind of detergent, to remain in suspension).

Greasy fingertips are just the latest in a long series of unsupported explanations for squalene contamination in anthrax vaccine from DOD and FDA. In 1998, the year the NIH formed the NIH Working Group with DOD and FDA to “fast track” the licensure of the new vaccine, FDA officials suggested to Senate investigators that any squalene in the vaccine could have come from eggs because many vaccine antigens are grown in eggs and eggs are rich in cholesterol (and theoretically the cholesterol precursor, squalene). In fact, anthrax is grown in a non-protein broth which contains no eggs or egg products. Later, DOD stated correctly, but misleadingly, that squalene is found in many plants and animals. Still later, both DOD and FDA stated for several years that squalene is “probably” found in the organism. Squalene is, indeed, found in many plants and animals. One place it is not found, however, is in Bacillus anthracis. Bacteria do not biosynthesize lipids as complex as squalene. This has been demonstrated with atomic precision. According to GC/Mass spec analyses of bacteria, they do not make lipids with more than 17 carbons atoms and are monounsaturated (1 double bond); squalene contains 30 carbon atoms and polyunsaturated (6 double bonds).

Paragraph Ten: “Wyeth made an FDA-licensed tetanus vaccine until it dropped out of the business in 2001, and Connaught is part of what’s now called Aventis Pasteur, which has an FDA licensed diphtheria vaccine.”

Correction: In this one sentence alone, Cohen makes three errors:

(1) Wyeth did not make an FDA-licensed tetanus vaccine;
(2) Wyeth did not drop out the vaccine business;
(3) Connaught did not make an FDA-licensed diphtheria vaccine.

We both made errors here. I had a dyslexic moment and transposed Wyeth diphtheria and Connaught tetanus; I referred to Wyeth tetanus and Connaught diphtheria. Cohen did the same thing. As he a result, he made three errors in one sentence (I made two).

In my book, I erroneously state that the FDA found trace quantities of squalene in an unlicensed Wyeth tetanus vaccine and an unlicensed Connaught diphtheria vaccine. In fact, the FDA tested an unlicensed monovalent diphtheria vaccine from Wyeth, which is still in the vaccine business. Cohen would have been correct had he stated that Connaught made an FDA-licensed tetanus vaccine, and was later bought out by Aventis-Pasteur.

As Cohen neglects to mention in his review, I cite several peer-reviewed studies that report data showing that bacteria (including Bacillus anthracis, Corynbacterium diphtheriae and Clostridium tetani) do not biosynthesize complex lipids like squalene. As stated previously, and I think it bears repeating here, there is, in fact, atomically precise evidence that bacteria do not make lipid molecules containing more than 17 to 19 carbon atoms, and have more than 1 double bond. Squalene is a 30-carbon molecule with 6 double bonds. I report this in my book. He also omits from his attack any reference to the incontrovertible evidence that bacteria do not make squalene. In light of this peer-reviewed data, repeatedly in other laboratories, I have argued in my book that it is incumbent upon the FDA to explain how it found squalene in the seven lots of vaccine (five anthrax, one diphtheria and one tetanus) that it tested in June 1999.

Paragraph Eleven: “He [Matsumoto] writes that “by questioning the safety of squalene, Asa imperiled more than 80 percent of the existing NIH-sponsored clinical trials to prevent HIV. This is fiction. Here is a list of 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 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.”

Correction: Cohen’s assertions, once again, are incorrect. In making this particular attack, he takes what I have written in Chapter Eight (pg. 145) out of context. He refers in this paragraph to information specific to a period in time, 1991-1997, not 2001. From 1991-97, the GAO reports there were nineteen clinical studies with HIV vaccines, sponsored by NIAID and AVEG (AIDS Vaccine Evaluation Group), or NIAID and DIR (Division Intramural Research). GAO investigators got their information directly from NIAID officials. This information can be found in the GAO report, GULF WAR ILLNESSES: Questions About The Presence of Squalene Antibodies in Veterans Can Be Resolved (GAO/NSIAD-99-5, pg. 21). According to the GAO, there were nineteen trials with prototype HIV vaccines in this time period. All of them contained Chiron’s squalene emulsion adjuvant MF59. That’s 100 percent. If anything, then, based on the GAO’s reporting, me saying Asa’s antibody evidence “imperiled more than 80 percent of existing NIH-sponsored clinical trials to prevent HIV” was a rather generous underestimation. The GAO Appendix, citing data provided by NIAID and AVEG, not only specifies nineteen different NIAID clinical trials with an HIV vaccine emulsified in MF59 (a squalene emulsion), NIAID provided the GAO with the dates of each trial, the IND numbers for each trial, and the number of subjects in each.

When I informed Cohen of the GAO’s information during a telephone on Wednesday, November 18th, Cohen, without seeing the GAO report, flatly declared the GAO “wrong.” An unwillingness to review a document before declaring it wrong is, to me, a clear demonstration of bias.

In a weblink, Cohen directs SLATE readers to a 2001 survey paper on HIV vaccines, then misinforms readers when he writes, based on this paper, that “only one product, not yet tested in humans, uses squalene, and many don’t use adjuvants at all” (Johnston M, Flores J, Progress in HIV Vaccine Development, Current Opinion in Pharmacology, 2001(1): pg. 504-510) . To the contrary, in Table 2, the authors list Candidate vaccines in pre-clinical development. At least four of these vaccines, maybe more, rely on squalene emulsions:

(1) DNA, Sindbis replicons expressing multiple genes, novel recombinant envelope proteins [NIAID/Chiron];
(2) DNA expressing multiple HIV genes, DNA expressing cytokine gene and peptide boost [NIAID/Wyeth-Lederle];
(3) Vaccinia-env and envelope proteins [NIAID/St. Jude];
(4) Gp120 and regulatory proteins in novel adjuvants [GlaxoSmithKline].

In a cursory search of NIAID databases for current HIV vaccine trials involving a prototype HIV vaccines emulsified in squalene, I found several of them in quick succession:

(1) A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59, Sponsor: NIAID/Biocine, Study ID Numbers: AVEG 005C, Identifier: NCT00000632 [Study Completed ca. 2002];
(2) Safety and Immune Response to a Combination HIV Vaccine Regiment in HIV Uninfected Adults, Sponsor: NIAID, Clade B Recombinant, Oligomeric gp 140/MF59 Adjuvant, Study ID Numbers: HTVN 049, Identifier NCT00073216 [Currently recruiting];
(3) Safety of and Immune Response to a New HIV Vaccine HIV CTL MEP, Sponsor: NIAID, HIV CLT MEP administered with RC529-SE adjuvant, Study ID Numbers: HTVN 056, Identifier: NCT00076037 [Currently recruiting].

Additionally, in a cursory search of PubMed, the data for the National Library of Medicine, I found many recently published papers on HIV vaccines emulsified in squalene. Here’s just one of them, concerning a Duke University pre-clinical trial with a HIV vaccine and squalene administered to monkeys:

(1) Egan MA, et al., A comparative evaluation of nasal and parenteral vaccine adjuvants to elicit systems mucosal HIV-1 peptide specific humoral immune responses in cynomolgus monkeys, Vaccine, 22 (2004), pgs. 3774-3788. (These particular researchers were at Duke University).

That NIH-funded HIV vaccine investigators rely on squalene emulsion adjuvants to create viable HIV vaccine prototypes is extremely well documented, and easily verifiable.

Cohen incorrectly asserts that I wrote “fiction.” Contrary to the impression that he tried hard to convey in this paragraph, replete with a weblink, Cohen’s reference does not support his assertion. I can provide you with hard copies of all the above documents.

Paragraph Twelve: “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 different 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.

Correction: Cohen takes this information out of context, omitting the critically important data that immediately follows the sentence that he quotes in order to bolster his case against my book and its allegedly “shaky premise.” Asa and Garry state: “Further analysis revealed that ASA [anti-squalene antibodies] were associated with specific lots of vaccine. The incidence of ASA in personnel in the blinded study receiving these lots was 47% (8/17) compared to an incidence of 0% (0/8; P < 0.025) of the AVIP participants receiving other lots of vaccine. Analysis of additional personnel that in all but one case (19/20; 95%), ASA were restricted to personnel immunized with lots of vaccine known to contain squalene. Except for one symptomatic individual, positive clinical findings in 17 ASA-negative personnel were restricted to 4 individuals receiving vaccine from lots containing squalene. ASA were not present prior to vaccination in preimmunization sera available from 4 AVIP personnel. Three of these individuals became ASA positive after vaccination. These results suggest that the production of ASA in GWS patients is linked to the presence of squalene in certain lots of anthrax vaccine.” [from Abstract]

(Asa PB, Wilson RB, Garry RF, Antibodies to Squalene in Recipients of Anthrax Vaccine, Experimental and Molecular Pathology, 73; 2002, pgs. 19-27).

SUMMARY:Cohen makes an astonishing number of factual errors in a scant four pages. In at least two instances, he imputes information to me that I did not report. To support his argument, he selectively reports facts taken out of context, from my book, as well as from other sources. The references that I single out for criticism above do not support his assertions.

It is Cohen's prerogative to embrace DOD’s unsupported ex cathedra pronouncements on the amount of squalene required to initiate an immune response (the equivalent of “2000 pounds of mayonnaise”—relative to what the FDA found in anthrax vaccine), but I have quoted many scientists in the book who have concluded otherwise; not to mention Chiron Corporation, the manufacturer of the squalene emulsion licensed for use in flu vaccine in Europe, MF59. According to Chiron’s published data, its scientists have initiated an immune response in animals with 80 ppb concentration of MF59. Anthrax vaccine lot FAV 047 contained 83 ppb.

Cohen is entitled to disbelieve my book, and there’s no mistaking that he does, but he’s not entitled to invent facts, or misrepresent them, in order to persuade others to share his disbelief. Please make the appropriate corrections. If you require hard copies of documents to verify my corrections, please contact my publicist, Jamie Brickhouse, at Basic Books. His number is (212) 340-8000.

Thank you for your attention in this matter.


Gary Matsumoto
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Gary M - Author

PostPosted: Thu Nov 18, 2004 3:43 am    Post subject: P.S. TO SLATE ON SQUALENE EMULSION RC529-SE Reply with quote

RC529-SE is a squalene emulsion from Corixa Corporation. RC529-SE’s squalene contents can be confirmed in two patents: (1) U.S. Patent 6,303,347 (Oct. 2001), and (2) 6,764,840 (June 2004).

Gary Matsumoto
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John F. Sorg

PostPosted: Sat Dec 04, 2004 2:42 am    Post subject: Book Promotion and Refuting Disinformation Reply with quote

Mr. Matsumoto,

I humbly offer help in promoting your book. Additionally, I would like to give you an additional forum where you can post your side of the story.

You can find my site at:
Anthrax Vaccination Immunization Program EXPOSED

In any case, thank you for your contribution,
John F. Sorg

I hope this offer does not offend the readership in any way. My appologies if this is considered an inappropriate forum for this posting.
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