Sunday, November 07, 2004

Communication between Author of Vaccine A and Washington Post reviewer, Dr Moreno.

The following are posts written to each other after Dr. Moreno reviewed Vaccine A on the Washington Post. These are actual words nothing has been changed. Read and determine for yourself.

Posted: Sun Nov 07, 2004 5:38 pm Post subject: Reply to Dr. Moreno's Follow-Up Response

Dear Dr. Moreno:

Please allow me to reiterate my belief that you are an honorable man and that your criticisms of Vaccine A were made in good faith. You are clearly an eminent scholar who is, even as we disagree on substantive issues concerning my book, doing important work in the service of U.S. military personnel. For your research on the DOE human radiation experiments, Project Shad and more, may I be among those who most loudly applaud your past and present efforts. I know that I am, along with the men and women in serve in the U.S. armed forces, a beneficiary of your work. All my nieces and nephews are now draft age; one nephew in is in the Marine Corps awaiting deployment to Iraq. If I have appeared ungracious towards Mr. Butterworth or Laurie Garrett in my book, then I apologize, but only about my tone. In general, it is not easy to criticize without such criticism appearing unduly harsh. However, criticize I must, because their errors were intentionally amplified by DOD's wide dissemination of their attacks on the Vanity Fair article, which were distributed to members of Congress and the media. Having spoken to Mr. Butterworth on more than one occasion, I believe that he, too, was well meaning in his attacks on Vanity Fair, and acted in good faith. Nevertheless, I believe his assertions, which are still being trafficked on the Internet, required rebuttal for the benefit of those people who've been injected with squalene in the past, and those at risk of being injected with it in the future. All this could be settled if selected DOD and DHHS officials be forced to answer, under oath, and before a committee whose members have no ties to the defense or pharmaceutical industries, these two questions: (1) Did DHHS grant DOD a waiver of informed consent for the testing of the second generation anthrax vaccine on military personnel, or, in a separate protocol, the testing of squalene emulsion adjuvants on military personnel?; and (2) Did DOD defy existing requirements for such a waiver and administer IND drugs and vaccines to U.S. troops with the best of intentions, but in error? Then, as with the DOE documents on the human radiation experiments, all the DOD and DHHS documents regarding the testing of oil adjuvants on troops (Incomplete Freund's Adjuvant and squalene emulsions), should be declassified and released, unredacted, to the public. It does not help if scholars such as yourself remain tepid on this issue; or worse, balk at it. Even GAO investigators, investigators with the Senate Veterans' Affairs Committee and members of the House Government Reform Committee have complained about DOD and FDA stonewalling and obfuscation on the matter of squalene. Because classified clinical trials on troops lack accountability and are open to corruption, I believe the practice of running such experiments without informed consent should stop. To inject accountability into this system, the Feres Doctrine should be reinterpreted or scrapped, and reparations should be paid to those military personnel who've been harmed by these injections.


Gary Matsumoto

Dear Mr. Matsumoto,

Thank you for your reply. I have never made any secret of my affiliations, paid or unpaid. I hope in your posting you will note that my work on the human radiation experiments controversy 10 years ago helped result in uncovering decades of federally supported research; that I published the first and only comprehensive history of government atomic, biological and chemical experiments since World War II; that I am the only bioethicist to have written about the exposure of sailors and soldiers to nerve agents during the 1960s ("Project 112" of SHAD); that my uncompensated service on the National Research Council's committee to review the Pentagon's radiation dose reconstruction has contributed to an overhaul of that program and fairer assessment of the veteran's' exposures; and that my current projects include a book on the threat that national security neuroscience research poses to our civil liberties and further threatens traditional limits on the exposure of civilians to weapons of war. I look forward to seeing this information on your website. I wish you best of luck in your work.

Post subject: Follow-up Reply to Dr. Moreno from G.M. on WashPost Review

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.
Gary Matsumoto

Post subject: Reply to G.M. from Jonathan D. Moreno, Ph.D.

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.

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. more

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