[Gary M - Author]

Jonathan D. Moreno, Ph.D.
Director, Center for Biomedical Ethics
University of Virginia
Member, Board on Health Sciences Policy
Institute of Medicine


Dear Dr. Moreno:

The pernicious effects of injecting squalene have been proven by scientists affiliated with more than 10 laboratories around the world, including the Karolinska Institute in Stockholm and the University of Florida Medical School. Four different animal species, inoculated in various parts of their anatomy - the temporomandibular joint, the tail and the ear - have developed the animal versions of multiple sclerosis and rheumatoid arthritis, and severe neurological damage.

Over the past two years, the University of Florida has demonstrated that injecting squalene can induce autoantibodies in mice that are specifically associated with systemic lupus erythematosus. The identical diseases have occurred in military personnel injected with anthrax vaccine from lots proven by the FDA to contain squalene. The autoimmune diseases diagnosed in U.S. troops correlate with the squalene-tainted vaccine lots.

All this has been published in peer-reviewed scientific journals. So I think it's fair to say that the concerns about squalene's toxicity, extensively documented in peer-reviewed scientific literature, constitute a bit more than, as you put it in your review, "scientific doubt." Yet you omit all these facts from your book review.

I maintain that military personnel in particular, a specific population of Americans that has been repeatedly subjected to unethical medical experimentation in the past, deserve to know all the facts about squalene, not just some of them.

You state that squalene's presence in the body is "a problem" with my theory. To the contrary, as I explain at great length in Vaccine A, squalene's presence in the body is precisely why it is a problem. Loss of tolerance for a self-molecule is the essence of autoimmunity. The risks of autoimmunity by injection with self-constituents (a frequently expressed concern with regard to oncology vaccines) are well known in immunology.

I have supported every attack that I made in my book, and I made many, with peer-reviewed scientific data and declassified military documents. You have attributed all this evidence contradicting DOD, FDA and IOM on this matter only to me. I am sorry; this is not only misleading, it is incorrect. I did not manufacture the data on squalene's toxicity (there are now twenty-six papers published in peer reviewed journals showing this). I did not write the papers on the neurotoxicology of sarin. I did not write the declassified Army documents spelling out the Defense Department's planned experiments for Desert Storm, or the Defense Intelligence Agency's dismissal of nerve agents as a potential cause of GWS.

Over the past fourteen years, the "no-stones-unturned" attempts to determine the nature of the allegedly mysterious malady, Gulf War Syndrome, have suffered from conspicuous omissions. As a result, we have, after untold federal panels have dismissed GWS as a mostly psychological disorder, a belated admission that many sick Gulf War veterans suffer from neurological injury (not to mention the twice of risk of developing ALS).

The panels concluding the non-existence of GWS include those organized by the IOM. The IOM has not only concluded that licensed anthrax vaccine is safe and effective, it has been an open proponent of the second generation anthrax vaccine. This vaccine has contained squalene since 1987. The IOM specifically recommended a "vigorous national effort" to "develop, manufacture and stockpile an improved anthrax vaccine" ("Chemical and Biological Terrorism," IOM, 1999). To do this, IOM urged a "well coordinated" DOD/DHHS effort to achieve this goal.

In this context, it is a troublesome fact that DHHS has the power to grant waivers of informed consent to the administration of IND vaccines to military personnel. General Phillip Russell, the USAMRDC Commander who oversaw the creation of the new vaccine, and a doctor who has advocated the new vaccine's adoption while in a position of considerable influence at John Hopkins School of Public Health and DHHS, was a member an IOM panel on Gulf War Illness ("Health Consequences of Service During the Persian Gulf War: Initial Findings and Recommendations fo Immediate Action," IOM, 1995).

In 1998, the NIH formed the NIH Working Group to "fast track" the second generation anthrax vaccine that contained squalene. This working group included DOD and FDA - another agency of DHHS. One year later, anthrax vaccine containing serial dilutions of squalene - an adjuvant that Chiron Corporation developed in conjunction with the NIH and DOD - was administered to troops.

Yes, Occam's Razor - all things being equal, the simplest explanation is probably correct - applies here. A large body of clinical and forensic scientific evidence now exists to support the allegation that DOD and DHHS did precisely what the IOM recommended. Contrary to DOD and DHHS's protestations, the scientific evidence is consistent with DOD's unambiguously delineated plans to test experimental vaccines on troops during Desert Storm, and the long-standing DHHS/DOD Memorandum of Understanding for waiving informed consent for the administration of investigational new drugs to troops in classified clinical trials.

It is also consistent with the contents of military documents, now declassified, that explain DOD's rationale for the routine testing of new medical products on troops in "a real operational setting." Every deployment is considered a "research opportunity." In other words, troops deploying to an AOR (Area of Responsibility) are especially vulnerable to a dubious practice that has been, in the past, officially sanctioned by the U.S. public health establishment. So I believe this allegation - concerning the deliberate administration to troops of an oil adjuvant that the NIH has touted as safe for almost two decades, and one that has been incorporated into every prototype of the Army's new anthrax vaccine - is entirely appropriate, and logical.

That oil adjuvants induce autoimmune disease is an uncontested fact that has been documented, repeatedly, over the past half-century. If the pathology in military personnel is autoimmune, and BioPort's own package insert for anthrax vaccine shows that it is, then an oil adjuvant is the most likely culprit. Whether by accident or by design, troops have been injected with nanomolar quantities of a known oil adjuvant, squalene. These injections are arguably the simplest explanation for why troops inoculated with squalene have subsequently developed autoimmune disease, post-immunization. Occam's Razor.

Despite all this - and probably knowing, given your long list of media credentials, that we live in an era when journalists are hampered by corporate timidity - you use the pejorative term "conspiracy theory" to describe this work. While it is true that I am asserting that various individuals in the U.S. public health establishment have conspired to suppress information about squalene's toxicity and its use in the second generation anthrax vaccine, characterizing these facts as a "conspiracy theory" makes it sound like it is the product of some sinister cabal. To the contrary, historically, this activity has taken place, without apparent remorse, and in most cases without apology, out in the open. In this particular case, I am saying it is less open, but the trail of evidence is almost ostentatious. Hence, I prefer to see this as another example of well-meaning but wrong-headed Beltway "group think" - the same phenomenon that led us into our current war in Iraq. A bevy of reputable Washington officials argued passionately for a war based on flawed intelligence, specifically, the supposed threat to the U.S. national security from Iraq's all-too-elusive WMD.

Regrettably, because we are flawed creatures with astonishingly short institutional memories - a kind of communal ADD, especially when it comes to unpleasantries such as unethical medical experimentation - past is, indeed, prologue.

Here are the facts about NIH's and IOM's past conduct in such matters. Both the NIH and IOM have participated in medical experiments in which unlicensed an oil adjuvant (Incomplete Freund's Adjuvant) was administered to tens of thousands of military personnel (possibly more) without informed consent. This was done, several times, at the express recommendation of another civilian-run panel: The Armed Forces Epidemiological Board.

Given NIH's and IOM's documented participation in unethical medical research on U.S. military personnel, specifically in pursuit of an oil adjuvant for vaccines; given NIH's efforts to promote the use of squalene emulsions in an entire range of genetically engineered vaccines, and given NIH's and IOM's open advocacy of the second generation anthrax vaccine, I believe the following response would have been appropriate:

At a minimum, to avoid the appearance of cronyism, and because of the magnitude and inflammatory nature of the allegations in Vaccine A, I believe you should have disclosed your close affiliations with both NIH and IOM in your book review. That, I think, would have been the ethical thing to do.

Sincerely,

Gary Matsumoto
Author
Vaccine A

[Eric]

GAry M can I publish this tesponce on my site? Thanks I think it will be very informative and helpful.

Eric

[Gary M - Author]

Dear Mr. Matsumoto,

Thank you for your message. I gave your book a fair review though evidently not the review you would have preferred.

The pro bono work I have done on IOM and NAS committees are not "close affiliations" as I am not a member of either the IOM or the NAS. I am not now nor have I ever been an NIH employee.

As you may be aware, like you I am a passionate advocate of the interests of soldiers and veterans. I served for a year and a half on a committee to review the DoD's dose reconstruction program for the "atomic soldiers." These are not "conflicts of interest" as you imply in the subject line of this message. I received no payment for this work or my current volunteeer efforts to advance public policy on stem cell research.

We are not on opposing sides and I regret that you have decided to see it this way.

[Gary M - Author]

Dear Dr. Moreno:

Thank you for taking the time to respond. In fairness to you, and in the interest of accuracy, I am going to post your objections to my email on the [i Vaccine A[/i] website.

I assumed that being a member of the "Board on Health Sciences Policy of the Institute of Medicine (National Academy of Sciences)" and a "Special Expert in the Department of Clinical Bioethics at the Warren Magnuson Clinical Center of the National Institutes of Health in Bethesda, Maryland" constituted "close affiliations." While that's close enough for me, I will no longer use the adjective "close" when referring to your ties to these agencies.

That being said, I believe paid consultancies are not the only things that can interfere with one's objectivity.

I do not necessarily see us on opposing sides, but I think it's fair to say that you gave fifty-seven pages of footnotes and bibliographic references rather short shrift by devoting so much space in a review (with limited column inches) to your perception that my pointed attack on Trevor Butterworth and virtually non-existent criticism of General Russell were simply injudicious paybacks.

DOD used Trevor Butterworth's irresponsible criticism of my 1999 Vanity Fair article to short circuit any discussion on this matter. DOD circulated Butterworth's critique to members of Congress (GAO officials told me it was sent to every member of the House). Rebutting his analysis is not a matter of personal vanity; Butterworth's errors, disseminated to members of our elected government, and posted on the Defense Department website for years, has had potentially harmful consequences for military personnel and, now, as I maintain in Vaccine A, for millions of U.S. civilians.

Contrary to what wrote in your review, there is, in fact, barely a trace of "scientific doubt" about squalene's safety in U.S. public health circles. Conversely, there is barely a trace of "scientific doubt" about squalene's dangerous properties among laboratories overseas - some of them as prestigious as the Karolinska Institute in Stockholm. Thus, there is a patently Manichean split in scientific opinion on squalene. If there is any doubt that squalene's safety at NIH or DOD, I have never seen in it print. It's as if scientists working with squalene are laboring in parallel, but polar opposite universes.

I have no doubt that General Russell meant well when he presided over the creation of the new vaccine, and later advocated its adoption. I have no doubt that Trevor Butterworth meant well when he thought he was sparing the American public the misguided reporting of a "susceptible journalist." Likewise you. I believe your intentions are honorable, as are mine.

Assuming that none of us is guilty of deliberate error propogated to mislead, I think any fair-minded person would agree that error can also be the result of bias arising from all sorts of things besides money.

I believe I have documented such well-meaning bias in my book. The question is when mere bias became an attempt to cover one's opulently exposed backside.

For almost eight years now, squalene has been dismissed as inconsequential by the very DOD and FDA officials who have been developing the second generation anthrax vaccine containing squalene. In their dismissals, these officials have made zero mention of the new anthrax vaccine or the numerous papers documenting squalene's toxicity. Given the deep involvement of both agencies in expediting the development and licensure of the new vaccine, and DOD/DHHS's long track record of collaboration in experiments run on U.S. military personnel - including several experiments expressly organized to develop an oil adjuvant - I think it is also fair to say that, at a minimum, the evidence reported in Vaccine A merits rigorous public debate. In my opinion, your perhaps well-meaning but patronizing review, which trivializes the evidence of unethical experimentation with squalene on military personnel, discourages such debate in the very community - Washington D.C. - where it must take place.

If, as you maintain, we are not in principal on opposite sides, then I think it is incumbent upon you and other bioethicists to give careful review not only to the scientific evidence for squalene's toxicity, but also the declassified DOD documents on biomedical defense from the first Gulf War. I daresay that even Henry Beecher would conclude that at least one of experiments planned for Desert Shield/Desert Storm - the one for leishmaniasis - was patently unethical. And this is only the experiment that we know about.

Were there others? The clinical and forensic scientific data is evidence that there were. Yet, no one in government has made a single reference to these plans - in any federal or military investigation conducted on Gulf War illness - since veterans first reported illnesses back in 1992. Reputable scientists daring to report such data have had their work smeared as "junk science."

Physicians and scientists on medical school faculties at UCLA, University of Florida, Baylor, Tulane, the Karolinska Institute and hospital, RIVM in the Netherlands and the University of Queensland and Australia - and others - have all documented the occurence of severe adverse reactions if not fully manifested autoimmune diseases in animals and humans injected with squalene emulsions, or squalene alone. Yet DOD, IOM, FDA, NIH and AFEB continue to omit any references to this data in their refutations of these allegations. It's as if it doesn't exist. These alone, are inexcusable lacunae given that NIH has already presided over numerous clinical trials with squalene. Were NIH's test subjects informed of the risks? Have they been notified after the fact?

Any "fair and balanced" (to borrow a former employer's slogan) review of the evidence would discuss the extensive toxicology data on squalene, DOD's planned clinical trials for Desert Shield, the fact that most of the prototypes of the second generation anthrax vaccine contained squalene, and that NIH, FDA, IOM and AFEB have all promoted the adoption of the new vaccine, which was originally slated for the approved administration to U.S. troops as early as 1996. What's more, General Russell worked for DHHS in 1999 when six lots of anthrax vaccine containing squalene were given to troops; several scientists who either helped develop the new vaccine or worked on Project Badger are now on staff at NIH.

Dr. Moreno, I believe you are an honorable man, and that you have criticized my book in good faith.

Under the circumstances, however, and good intentions notwithstanding, avoiding any mention of a possible "cover-up" with regard to some of your NIH and IOM colleagues, in my view, would be excessively generous.

Sincerely,

Gary Matsumoto

[Gary M - Author]

Eric:

By all means, put these communications on your blog. Thanks.

Gary

[Trebor]

Not "conspiracy theory", conspiracy de facto--you're book Gary is by no means a novel. If it were, I would have dropped it in the box after "Footprints in the Snow" (chap 1). You could have made it that way, as a novel...but you chose to take the hard road--to show us--the military folk, what's happening--the documents--the whole nine yards! So when the term conspiracy "theory" is used, I wouldn't be so sure that's so correct. Your book is a roadmap. You can draw your own conclusions with the data. "Bald and unilluminating statements" just aren't your style I've seen. The research is very strong, very substantiated. When will someone use facts to prove the contrary--not personal opinion--facts. Thanks for publishing this communique on the message board. I've seen you back down at times in your book for those unfounded premises--you've got integrity--you know what's real and what's theory--you point that out very clear. It's all about a roadmap--some just down like where it takes them -Trebor