-Caveat Lector- Q: I want to go back to your statement that you planned to shut down the plant. The GAO testified at the congressional hearing that the state decided to get out of the anthrax business when FDA came in and inspected them and they weren't prepared to make the financial commitment to make the improvements that were necessary. A. “There's been a great deal of confusion about that … There were no issues that FDA had with the purity, the strength, any of the things that they want when that vaccine rolls out at the end, but there were bookkeeping difficulties…” Comment: Contrary to the assertions of this anonymous senior military officer, a 29 Apr 1999 GAO report found: “The FDA inspections of the facility where the licensed vaccine was manufactured uncovered numerous problems. The facility received warning letters from FDA, including one in March 1997 stating its intent to revoke the facility's license.” The GAO report also described manufacturing deficiencies found by the FDA “that could compromise the safety and efficacy of any or all batches.” In fact, Bioport’s Chief Operating Officer admitted to Congress that, “immediately after receiving the [warning] letter, we met with our clients, including the DoD, to rapidly develop and execute a comprehensive plan to resolve FDA concerns about our operation.” However, despite his actions, a 20 Feb 1998 the FDA inspection report found, “the manufacturing process for Anthrax Vaccine is not validated.” The report specifically criticized the vaccines’ purity, potency, sterility, and stability. All vaccine used to-date was manufactured under this non-validated process. Q: You're still using the untested vaccine? A: No, as the gentleman said, this vaccine has been tested and this contract change does not affect that. Comment: When the vaccination policy was announced, SecDef Cohen set four conditions before the policy was to be implemented. One of those conditions was “supplemental testing to assure sterility, safety, potency and purity of the vaccine.” DOD allowed Bioport to perform the testing even though the FDA had threatened the vaccine manufacturer in March 1997 with a revocation of their license. DOD hired a non-pharmaceutical defense contractor to oversee testing by the manufacturer. In his April 1999 testimony, the anthrax vaccine program manager, BG Eddie Cain, admitted to “inconsistencies” in the supplemental testing procedure. He stated: “based on this inconsistency, JPOBD suspended supplemental testing and sent a "Tiger Team" of subject matter experts to help resolve the problem. Corrective action is being implemented. We expect to resume testing within six months.” This admission of “inconsistencies” by DOD’s program managers means that the supplemental testing performed on anthrax vaccine used on servicemembers is of questionable value. Additionally, on 29 Apr 99 the GAO reported to Congress that anthrax vaccine “quality cannot be guaranteed from final tests on random samples but only from a combination of in- process tests, end- product tests, and strict controls of the entire manufacturing process.” Therefore, supplemental testing, even if without “inconsistencies” admitted to by DOD, cannot compensate for a flawed manufacturing process revealed by FDA inspections and documented by the GAO. Q: Are there other strains of anthrax that you can -- as a weapons designer -- you slightly alter that and therefore bypass your vaccine? A: There are a couple of answers to that. One is, it's theoretically possible to alter anthrax so that our vaccine would not be effective against it. It's theoretically possible. Nobody has one that we know of. Comment: On 5 Apr 1999 the New York Times reported on a recent book by a defector and former deputy director of the Soviet germ-warfare program, Ken Alibek. He stated anthrax “was genetically altered…to resist five kinds of antibiotics.” Additionally, a November 1998 Nation Magazine article reported, “at the end of 1997 Russian scientists had published a paper in the British medical journal Vaccine describing the creation of a genetically engineered anthrax strain that was resistant to standard Russian anthrax vaccine.” Alibek stated in another interview: “Vaccines are not the answer.” Q: Are there more severe [reactions] than that? Are there people who are crippled because of this? Are there people who... A: We're not aware of anyone who's crippled...It's on the order of three to five people. Comment: This admission contradicts statements about the vaccine by Mr. Bacon, who said last January, “It’s safe and reliable…It works and has no side effects.” This admission also contradicts DOD’s anthrax website, which states: “No reports of serious adverse effects have been received by the manufacturer” – unless DOD is not reporting adverse reactions to the manufacturer. If DOD is not, then it is in violation of federal rules (21 CFR 600.80), as is the manufacturer, if it does not promptly report adverse reactions to the FDA. Further, servicemembers are getting seriously ill – and some have testified before Congress. Q: So what percentage of the people who are getting the shots are coming up with some sort of reaction on their arm? Twenty percent, 40 percent? A: The data I'm aware of would say closer to the order of 40 to 50 percent would have something. They'll have some soreness, redness. The number that are going to have systemic illness with fevers, they're going to have to be hospitalized, are still extremely small. Much less than 40 to 50 percent. Q: So 100, 1,000 people out of your million shots, out of your 320,000? A: I don't have a number for you of that order. We looked at two small subsets. The numbers that have got fevers were probably in the 7 to 10 percent... Comment: DOD’s vaccine tracking system does not track adverse reactions – they rely on servicemembers to send a form to the FDA. In March, the Assistant Secretary of Defense for Health Affairs testified, “there have been 42 Vaccine Adverse Event Reporting System (VAERS) reports submitted to the FDA and CDC (an adverse reaction rate of 0.007 percent).” However, low reporting of adverse reactions may be because “initially patients who reported their illnesses as potentially related to the anthrax vaccine were viewed as "malingerers", "whiners"," liars" and "hypochondriacs,” according to Congressional testimony by a career medical officer in June. At the 5 Aug 1999 briefing, senior officers admitted, “as we have gained experience, we have found that those sort of local, self-limited, and actually harmless reactions are much higher than we thought.” Despite characterizations of reactions as “harmless”, the briefing made clear that DOD implemented the anthrax vaccination policy without ever having studied the long-term effects of the vaccine on servicemembers, and therefore they have no statistical basis of asserting a vaccine reaction is “harmless.” Q: What is your latest statistic on how many servicemembers have refused the vaccine? A: We don't have a formal tracking mechanism where we query and require commanders in the field to report back to us the numbers. [and later] Mr. Bacon: The answer is I'm not aware that any specific... We have approximately 200 people out of 320,000 who have received this vaccine have come into the disciplinary system. It's a small number. Comment: After an admission by a military officer that DOD has no way to track refusals or the retention impact of the anthrax vaccine policy, Mr. Bacon gave a very carefully worded follow-up by limiting his response to address only those servicemembers who “have come into the disciplinary system.” This omits discussion of those who are forced out of the military with a less than honorable discharge in lieu of a court-martial, and those who transfer, resign or retire before they have to refuse. Mr. Bacon: There is some indication that, in fact, some soldiers have said that they refused to take the vaccine because they didn't want to deploy to some place such as Korea where they would be required to have this vaccine. Comment: Mr. Bacon has made similar assertions before. Yet DOD has never presented any evidence to support this claim which ignores that fact that many of the servicemembers who have been punished for refusing the vaccine were already deployed overseas, including Marines on Okinawa and sailors aboard the USS Constellation. Mr. Bacon did not explain why hundreds of reservists, who as volunteers can resign at any time, and who have served repeated overseas tours in the past, have chosen to leave specifically when their units have required the anthrax vaccination. Mr. Bacon’s comment appears to be part of a Pentagon effort to ridicule or impugn loyal servicemembers, including combat veterans, who have volunteered to serve their country. The official DOD anthrax website newsletter states: “Much of the hand-wringing and bizarre allegations about the vaccine is coming from a vocal minority of people who think the "field" is where a farmer works and "Gortex" is one of the Power Rangers.” In fact, many of those opposed to the anthrax vaccination policy are combat veterans. Q: ...on the Hill. You've got two pieces of legislation... Mr. Bacon: We're not disciplining the people on the Hill. Q: But you've got to deal with them. There are two pieces of legislation introduced in the House, a growing number of cosponsors. And they're holding more and more hearings… Mr. Bacon: …To make vaccine use voluntary would be irresponsible … Comment: Apparently, more and more “irresponsible” Congressmen disagree with Mr. Bacon. Rep. Walter Jones (R-NC) has introduced H.R. 2543 seeking to make the vaccine voluntary. Rep. Benjamin Gilman (R-NY) has introduced H.R. 2548 seeking a halt to anthrax vaccinations pending an investigation by the National Institutes of Health. Rep. Gilman’s bill had 17 cosponsors as of late August. Rep. Jack Metcalf (R-WA) has written SecDef Cohen requesting DOD fund research into possible links between the anthrax vaccine and Gulf War Illness investigated by the GAO and reported in Insight Magazine. More Congressmen are getting involved because they are hearing from their constituents. If you have an opinion about the DOD mandatory Anthrax Vaccination Immunization Policy we urge you to contact your Congressional Representative and Senators now to let them know your thoughts. Congressional staffers inform us that letters and telephone calls are taken more seriously than email messages. ---------------------------------------------------- **COPYRIGHT NOTICE** In accordance with Title 17 U. S. C. 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