Section Two

The Stonewalling and Obfuscation

• March, 1999            GAO presented to Metcalf their findings (GAONSIAD-99-5).
  GAO recommended DOD not wait for the peer-review and publication process,
  but take immediate action to: "conduct researeh designed to replicate or dispute the
  independent research results that revealed the presence of squalene antibodies in the
  blood of ill GulfWar-era veterans.''  Surprisingly, DOD's comments regarding the GAO
  recommendations, contained in the report, accused GAO of being ''scientifically and
  fiscally irresponsible," even though their own officials had stated there was no
  reason to wait for publication. (14) The GAO report stated, "Safety concerns have been
  cited regarding the use of novel adjuvant formulations in vaccines, including squalene, and
  the associated adverse reactions. It has also been suggested that the safety of vaccines
  containing these formulations must be evaluated in conservative ways."
  (GAO/NSIAD-99-5 Page 3)
  
  
• May 13, 1999              Congressman Metcalf wrote Secretary of Defense
  William Cohen challenging DOD's refusal to carry out the GAO recommendations,
  and encouraging DOD to get to the truth by doing the research necessary to validate or dispute the Tulane test resnits. (Appendjx 4)
  
  
• May 24, 1999               Dr. Carl Alving called Dr. Robert Garry of Tulane, and
  indicated his "purely scientific" interest in Dr. Garry's work. Dr. Alving also asked
  to review a draft of the manuscript on anti-squalene antibodies which was subsequently
  published. Dr. Garry agreed to fax him a copy of the inprogress work for his personal
  review, requesting that he not circulate the copy. Dr. Garry was not made aware of Dr.
  Alving's intent to circulate the paper and publicly subject it to scathing reviews as
  published on the DOD website prior to publication. (Appendix 5)
  
  
• May 25, 1999                  Dr. Russell Wilson of Autoimmune Technologies,
  Tulane's exclusive licensee for the anti-squalene antibodies technology, sent a letter to Dr. Carl Alving sharing information, and offering to provide information
  regarding the ASA (anti-squalene antibody) assay and research with DOD.
  (Appendix 6)
  
  
• May 28, 1999                  Dr. Sue Bailey, Assistant Secretary of Defense for
  Health Affairs, provided GAO the DOD's final response to the March, 1999 report. She stated, "Our position and the concerns expressed in our comments to the draft report have not changed ...The test methods proposed by the investigators at Tulane University need to be reviewed and validated by other scientists." DOD would not take action until the peer-reviewed publication process was complete. (Appcndix 7)
  
  
• Summer 1999                    An anonymously written DOD memo was obtained by
  the defense team representing five young Marines at Twenty-Nine Palms who werebeing court-martialed for their refusal of the anthrax vaccine.
  The six page document entitled, "Issues Relating to Antibodies to Squalene" was a
  scathing review by Dr. Carl Alving and Dr. Matyas of the unpublished work of Dr. Garry
  and his colleague Dr. Pamala Asa. It discussed the phone calls of May 24 and 25
  between Dr. Alving and Drs. Garry and Wilson. With absolutely no proof, it accused Drs.
  Garry and Asa of an apparent anti-military agenda. It concluded by stating "There is
  an obvious need for independent in-house research by the Army to examine the
  issues and implications, if any, of antibodies to squalene." Attached was a chart
  detailing a three year study, with a total cost of  $1,260,834.00. (Appendix 8)
  
  
• July 23, 1999                    Dr. Bailey responded to Metcalfs May 13, I999 letter
  to Secretary Cohen. Once agaan she commented, " The Department's position and
  concerns have not changed from those published as Appendix VI of the GAO report.
  (Appendix 9)
  
  
• September 27, 1999            Metcalf letter to Secretary Cohen. Metcalf replied, "...
  because of your department's years of research in this area, I ask that you reconsider and
  proceed with the GAO recommendations. Your current position of waiting for the
  completion of the peer review and publication process does not recognize the vast amount
  of research that the DOD has already accomplished regarding adjuvant formulations
  containing squalene. The men and women who served honorably and are suffering
  from Gulf War Illnesses deserve truthful answers and immediate action."
  (Apdx. 10)
  
  
• October 25, 1999                 Because of DOD's refusal to cooperate with GAO
  recommendations, Congressman Metcalf asked for congressional intervention. With the help of Congressman George Nethercott, the House Report to H.R 2561, the Fiscal Year 2000 Department of Defense Appropriations Bill, included language instructing
  DOD to develop and/or validate the assay to test for the presence of squalene antibodies.
  This legislative action was signed into law by the President on October 25. (Appendix 11)
  
  
• November 5, 1999               Metcalf received a reply to his September 27 letter from Secretary Cohen. While stating: "The Department's position has been consistent and
  remains unchanged," he went on to inform Congressman Metcalf that a DOD
  investigator has been funded to "pursue a study to determine the feasibility of developing
  a test for antibodies to squalene." (Appendix 12)
  Although Secretary Cohen did not identify the DOD invesfigator. GAO discovered that DOD had awarded the study to Dr. Carl Alving. The project was not designed
  to replicate or dispute the Tulane findings as had heen recommended by GAO, but
  to develop a different means of  testing for antibodies to squalene, (Appendix 13)
  
  
• January 2000                       DOD provided some members of Congress a report
  titled, "Development and Validation of an Assay to test for the Presence of Squalene Antibodies." It stated, "This Report has been prepared in response to a requirement of the 106th Congress ,House of Representatives, Report 106-244, 2000 Department of Defense Appropriations Bill." It acknowledged that DOD had funded a DOD researcher to "determine the feasibility of developing a test for antibodies to squalene."It did not suggest a collaborative effort with Dr. Garry and his colleagues at Tulane to save valuable time for those who are suffering from Gulf War Ilnesses, even though the researchers at Tulane had expressed their willingness
  to assist. (Appendix 14)
  
  
• January 31, 2000              Congressman Metcalf was joined by nine colleagues
  requesting DOD do an objective analysis of "Antibodies to Squalene in Gulf War
  Syndrome" - the peer reviewed article pubIished in the February 2000 issue of
  Experimental and Molecular Pathology by Drs. Asa, Cao and Garry. The question
  from Congress was clear, "Given the published article, it seems prudent to use
  the assay if it could help sick Gulf War era veterans. Do you agree?"
  (Appendix 15)
  
  
• February 25, 2000             Congressmm Metcalf sent a strong letter to Secretary
  Cohen asking for immediate action to remove misleading information from the
  DOD's official Anthrax Vaccination Inocalation Program (AVIP) website regarding
  the peer-reviewed, published article on squalene antibodies. Earlier in the week, the
  information had been discovered, prior to receipt of the DOD's official reply to the
  January 31 letter. (Appendix 16)
  
  
• February 28, 2000              The official DOD response to the January 31 letter
  was delivered to Congressman Metcalf's office. Most of the information provided was based on a review of the early draft, not the published study which included significant changes. The half-page critical analysis of the peer-reviewed article was anonymously written, with no indication of the author's professional credentials to conduct and provide the review. DOD did not address the congressional question regarding the potential use of the assay to help sick Gulf War era veterans. (Appendix 17)
  
  
• March 3, 2000                     Congressman Metcalf challenged Secretary Cohen to
  halt the obfuscation campaign that DOD was waging concerning the issues surrounding antibodies to squalene research. Metcalf provided ample: evidence
  to demonstrate his conclusion. (Appendix 18)
  
  
• March 27, 2000                    On behalf of Secretary Cohen, Dr. Sue Bailey responded to Congressman Metcalf's February 25 and March 3 letters. She acknowledged needed modifications on the DOD AVJP website to more objectively reflect the Tulane research. She also informed Metcalf that the Armed Forces Epidemiological Board (AFEB) would convene a subcommittee of experts to review and critique the published article in response to Congressman Metcalf's March 3 letter (Appendix 19)
  
  
• June 2000                          An exchange of letters in Experimental and Molecular
  Pathology. Dr. Carl Alving and Dr. John Grabenstein submitted a critique of the
  Tulane research, and Drs. Asa, Cao and Garry coauthored the response.  The
  journal Editorial Note made the following statement: "New findings require confirmation
  within the bounds of comparability. This is as true for methodology as it is for the data
  produced from a particular study. This exchange of letters ...relaces to methodology
  Drs. Alving and Grabenstein offer no data against the conclusions of Asa et al.
  (Appendix 20)
  
  
• Augusl 10, 2000                   Congressman Metcalf was presented the DOD
  'objective analysis' of the article, "Antibodies to Squalene in Gulf War Syndrome"
  by an Armed Forces Epidemiologicel Board subcommittee of experts. They
  concluded unanimously that the research reported in the paper does not support its claim
  that the laboratory test created by Dr. Garry at Tulane may identify persons ill with Gulf
  War Syndrome. However, on the last page of the report, they state, "Whatever the
  paper's flaws and since the AFEB cannot exclude the remote possibility that the
  authors have identified a laboratory means of distinguishing persons with possible
  Gulf War Syndrome (GWS) from all others, replicability becomes the major
  unresolved issue... Therefore we recommended that a suitable test of replicability be done in cooperation with the authors...)"  They go on to state, " ...We are trying to... get quickly and inexpensively to a more meaningful bottom line: does the ASA assay clearly, reliably and unequivocally distinguish people with GWS from all others, and, if so, with what specificity and sensitivity?" (Appendix 21)
  

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