Section One

The Investigation: A Pattern of Deception

• September 1997 - March 29, 1999 General Accounting Office (GAO) investigators initiated their study and completed the report "GULF WAR ILLNESSES: Questions About the Presence of Squalene Antibodies in Veterans Can Be Resolved"
  (GAO/NSIAD-99-5) The investigation was significantly slowed by government officials withholding or presenting incomplete information leading GAO investigators to document their concerns questioning a "pattern of deception. " (1) The following six dated entries are found in the background material for the GAO report. They illustrate the pattern of deception that clouded the investigation.
  
  
  
  • November 14, 1997     GAO entrance conference with Department of Defense (DOD) officials. GAO notes state,
    1) "They said DOD had not performed or sponsored any research on synthetic
    or natural squalene or squalene until after the Civil War. The sponsorship was
    through  two CRADAs [Cooperative Research and Development Agreement]. However, they could not. tell us who the CRADA's were with, what stage they were in, or what tests had been performed.
    2) "Squalene was used in two experimental adjuvants; after the war and involving
    fewer than 100 subjects. These were for HIV and Malaria vaccines. They said NIH
    had also used in some of their research protocols. DOD officials also stated that
    DOD was involved after animal testing stage." (2)
    In background papers, GAO investigators stated, "However, GAO found evidence of several other studies in our searches of publication databases, references and articles. Various DOD officials gradually acknowledged on a piece meal basis that their clinical research had started before the war, that they had conducted 5 clinical studies with squalene and had planned a sixth, that the size of these studies was increasing and now has involved 572 human subjects, and that some of these studies were pureli\y their own investigational New Drug (IND) Studies. Moreover they had conducted numerous animal studies, particularly to develop a modern vaccine for anthrax. In fact, in most cases they only admitted to conducting research after we had discovered it in public records. On three occasions people attending a meeting did not report their own research on squalene adjuvants. (3)
    
    December 10, 1997       GAO entrance conference with Food and Drug Administration (FDA) officials. GAO investigators noted that it was a very
    productive meeting and recorded:
    1) "The purpose of developing new adjuvants, even though alum is safe, is to use fewer inoculations, get a better response, and to check unconquered antigens.
    Earlier adjuvant ran into problems in animal testing... Most of DOD's work has been with Ribi Detox for malaria. Their person most interested in developing own adjuvants at WRAIR [Walter Reed Army Institute of Research] is Carl Alving.
    2) "Allied had concerns about the quality of our vaccines. Michigan had some manufacturing problems.
    3) "Karen is sure DOD used plague vaccine. They pushed it. She confirmed that
    squalene was used in placebos.
    4) "FDA testing of drugs and vaccines: Good Manufacturing Practices inspection every 2 years. Test each lot released. No routine random sample. For bot tox [botulism toxoid] they also checked for safety and sterility, but not the makeup of the compound. DOD should have reserve samples. Required to have them for each lot. Squalene should not be there." (4)
    NOTE: See Appendix 25 regarding the discovery by IDA in 1999 of trace amounts of squalene found in limited testing of Anthrax Vaccine Absorbed in the lots tested.
    
    March 30, 1998    GAO interview with Donald Burke, Director of AIDS research for DOD during the Persian Gulf War. GAO recorded, "Burke said
    he was involved with AIDS trials at time of war and purposely chose not to get involved in BWD [biological weapons defense] issues at that time... In his AIDS work he experimented with MF59 [an adjuvant containing squalene] because alum was destructive to HIV proteins. He has had good cooperation with NIH [National Institutes of Health]. He recounted various studies, including a large one with 300 subjects getting MF59. .. He suggested we talk to . .. Carl Alving about DOD adjuvant research." (5)
    GAO investigators noted, "Don Burke the former director of DOD's HIV research and Debbie Birx, the current director disagreed on the existence of a large early HIV trial with squalene with over 600 volunteers. She said he was thinking of an NIH trial. However, NIH reported no trial of that magnitude. (6)
    
    
    April 6, 1998       GAO Inteniew with Dr. Carl Alving. DOD's top adjuvant researcher. GAO stated,
    1) "Alving opened by saying be didn't know anything about Operations Desert Storm and Desert Shield (ODS) and the vaccines that were used. He is a researcher, and an expert, but not in the policy loop.
    2) "GOA pressed why he was not consulted about gulf war inoculations given his world class expertise. He admitted that just prior to gulf war he was asked if he could develop an anthrax vaccine on a crash basis. He stated that WRAIR has
    manufacturing capability, Ft. Detrick does not. He could have done it in 3-6 months but never received a follow on phone call to formally authorize the work. If askcd, he could have done it but would have recommended MP59 for anthrax because Chiron had the manufacturing capacity and the desire to market it. Ribi, Chiron and Hunter were the adjuvant leaders at the time. .. He was subsequently asked again (by DOD?) to develop an anthrax vacine using liposomes, but it and all others. .. tested failed to protect monkeys with a single shot, which he thought was an absurd criteria. But he thought commercial considerations may have driven the criteria.
    3) "He also said that as the world's foremost expert on lipids he knew quite a bit about cholesterol and its precursor, squalene. He doubted that a vaccine with squalene would produce a.meaningful antibody response.
    4) "Analysis; Overall, the commercial links appear to be crucial to the course of DOD vaccine R&D" (7))
    GAO investigators recorded the following observation in a section titled, DOD officials were less that forthcoming about their role in Gulf War vaccine decision making: " Carl Alving, DOD's top adjuvant researcher was not included in our meetings at WRAIR where he worked, nor even mentioned as someone we should interview. However, both NIH and FDA had said he was the person at DOD most involved with admuvants. We subsequently met and while he acknowledged that he was probably the army's best expert and adjuvants he at first denied having any role in the gulf war vaccine deliberations. After Kwan Chan left, Sushil Sharma pressed him on this, asking how could it be that they would discuss these issues without their principle expert. He then remembered that he had been called by someone from the army's biological warfare defense program at USAMRID. [United States Army Medical Research Institure of Infectious Diseases], who asked if he could develop a new, more potent anthrax vaccine on a crash basis to use in the Operation Desert Shield. He worked on it and thought he could do it, but no one ever called him back. He wouldn't say who called from USAMRID or why he just didn't return the call." (8))
    
    April 19, 1998       Interview with Dr. Anna Johnson-Winegar, Director Environmental and Life Sciences, key participant in the tri-service committees advising on the science and vaccine production issues.
    1) "Project Badger. [Tri-Service Task Force established prior to the Gulf War, (9/90) to investigate ways to increase production of biological warfare vaccines.] Badger was a discussion about the scientific issues involved in improving troop vaccine coverage. Discussions were wide-ranging and interesting, e.g. nonspecific immune enhancements, but there was not much, data. Carl Alving was our in-house adjuvant expert, and a participant in our discussion. [Dr. Alving first told GAO he did not have any role in the gulf war vaccine deliberations, then minimized his involvement.] We discussed using liposomes, but they didn't have enough .You
    have to go to war with what you have, not novelties that don't have your full confidence.
    2) "Adjuvants discussion and recommendations. Discussion of adjuvants was
    limited. It's one thing to discuss interesting phase 1 research, quite another to apply
    it to short term shortages. In the long run they can be of potential use. But scientific inference doesn't lead to immediate military operations. Some in the group were willing to jump out and use everything. (She refused to say who.) Our group advised the Surgeon General who in turn worked with the JCS. There was not any data on what happens to people getting the anthrax and botulism vaccines at the same time. But we had to do it.
    3) "Safety issues. There was little discussion of long term safety issues. They were
    thinking short term and immediate. Generally inactive vaccines don't have a problem.
    They used inactive antigens. But there were a lot of discussions regarding GMP
    [Good Manufacturing Practice] issues. For instance, they had trouble finding the exact same fermenter. Getting approval for a new one could take FDA 30 months. They went ahead started production with it and got retroactive approval. Anthrax vaccine is stable for up to 20 years if kept at right cool temperature." (DI-9)
    NOTE: In a DOD Badger document File120396 Sep96 decls10 002 txt, Subject: Desert Shield Biological Warfare HOC Working Group, the following statement is found,
    "It was reported that the individuals from logist__USAMRIID were expected back from theater today with the ____ anthrax and botulinum vaccines, antitoxin, ribavirin and centoxin. While in theater the items were under refrigeration, however, there was a report that the refrigerator failed to operate for a period of time and possibly these items were damaged. The items will be re__ to USAMRIID and a determination made with regard to the disposition." (Appendix3)
    
    GAO notes state, "Anna Johnson-Winnegar played a major role in Project Badger, leading the effort seeking the urgent assistance of vaccine manufacturers. She sat in on most of the Project Badger meetings addressing BW defenses. Our interview with here revealed several contradictins. At first she said they had limited discussion about adjuvants, but then added that discussions were wide ranging and interesting,  e.g. nonspecific immune enhancements, but there was not much data to base a decision. Alving, she said, was their in-house adjuvant expert, and a participant in their discussions. Some in the group felt it was one thing to discuss interesting Phase I research quite another to apply it to short term shortages, but others were willing to jump out and use everything. She declined to tell us who advocated pushing forward the use of experimental vaccines." (10)
    
    
    April 23, 1998       GAO meeting with General Ronald Blanck, Surgeon General of the Army, a discussion on the deliberations, decision making of DOD on vaccine production and administration for the Persian Gulf War. GAO summarized Gen Blanck's rtcollection:
    
    1)"One manufacturer, Michigan for both botulism and anthrax vaccine. We had a
    fair amount of anthrax vaccine but only a small amount for botulism (BT). However,
    we found Iaqis might have F and G strains so we contracted with Porton to make
    them. To best of his knowledge none ware administered. We got it but didn't use it.
    Everything we used was from Michigan. Salk at Swiftwater had the capacity to help
    produce, but got nothing from them. He got NIH to approve NCI use.
    
    2) "Novel Adjuvants Use. Blanck recalled no discussion of boosting immunogenicity with novel adjuvants. He was certain nothing was added to the products at Michigan. They decided to not do anything outside of the FDA The anthax vaccine used alum as an adjuvant.
    3) "Who else should GAO interview. We should talk to Winnegar and Collis as planned. Collis headed oversight for Badger and vaccine efforts... " (11)
    
    The following GAO statement summarized the failed attempts to interview Peter Collis. "Peter Collis, the chairman of the tri-service task forc, Project Badger, repeatedly declined to talk to us. First he said he could not meet unless he had the classified project summary to ensure his recall was accurate. We said we could provide those. "Then he said as a civilian without a clearance he could not look at the notes [GAO] could proceed with process to obtain a temporary clearance for him.] Then he called declining one last time saying he really didn't know much. However, the Project Badger notes clearly show him to be at the hub of all the discussions, and that he conducted the briefings about the committees recommendations." (12)
    
    
• September 11, 1998              GAO exit Conference with DOD offcials, GAO
  investigators record:
  1) "We presented a summary our principal of our job on Squalene and Gulf War
  Illnesses, 713014. DOD officials stated that if the independent researchers have
  developed a good test for squalene antibodies, there was no reason to wait for
  publication. The researchers could share it with DOD and they could cooperate on
  further research and development concerning squalene and GulfWar illness. This
  could be done through a CRADA which would protect the rights of the independent
  researchers. DOD would like to validate the test, particularly its specificity.
  2) " DOD officials again acknowledged that they had the know how to develop such an
  assay and could have tested for squalene antibodies but did not... They stated that DOD
  could do the screening antibodies to squalene for veterans who are ill along with a
  larger battery of tests, but they would have to think through the health administration consequences because they didn't want to do screening if they were not prepared to
  act on the results. Colonel Takafuji concluded that the questions raised by the
  independent researchers are going to come back to DOD." (13)

Next:  The Stonewalling and Obfuscation

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