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炭疽菌ワクチンの凄まじいデタラメ1：米軍２４０万人に強制接種予定：白昼の大虐殺？
次の文献の要部を訳しました。
長いものですが、細部に至るまで深い味わいがあります。
この世のからくりが良く判ります。
こんな「面白い」文献ないですよ。
長いので、２、３回に分けて投稿します。
リンク切れの可能性があるので、英文も付けておきます。
「DEATH OF THE ANTHRAX VACCINE PROGRAM
Did this and other DoD vaccines cause Gulf War Illnesses?
Prof. Garth Nicolson and Mike Williams」
リンク
http://www.immed.org/reports/gulf_war_illness/AVIP-SOF-00118.htm
今回の要点：
米軍兵士２４０万人に炭疽菌ワクチンを強制的に接種する計画が進行中
ワクチン接種直後から続く慢性症状が頻発しているが（軍医の報告）、
国防総省は（慢性症状の存在）それ自体を否定し、
統計をとらない。
そもそも使用中の炭疽菌ワクチンは、
もともと認可を受けたワクチンとは異なる。
つまり無認可のままで製造使用している。
炭疽菌ワクチンの製造プロセスは不良として食品医薬品局にたびたび指導を受ける。
しかし、炭疽菌ワクチンの製造業者は国防総省と癒着し、
食品医薬品局の規制も指導も法令も蹴飛ばした。
ワクチンの安全性、純粋性、効能等についての試験はまともに行われていない。
「期限切れワクチンの再使用」は日常茶飯事であり、
食品医薬品局も公式に見逃している。
ワクチンの一部ロットを検査すると（簡略検査）、
ほとんどは不合格となった。
しかし接種は継続。
英国は、炭疽菌ワクチンの一部に「未知の微生物汚染」と記録し、リストアップした。
英国復員軍人、カンサス州復員軍人の疫学的研究によると、
炭疽菌ワクチンの投与と、その後からの湾岸戦争症候群の発病との間に、
統計的に有意な相関が確認された。
要部翻訳文：
「１９９７年１２月１５日、国防総省長官Ｓ．コーエンは、
米軍人員２４０万人に対して炭疽菌ワクチンを接種して免疫化する計画を認可した。
これには、百万人以上の予備役および国防軍人員も含まれる。
この命令が正当とされたのは、
敵性国からの脅威増大と、テロリスト集団とが、現在または将来において、野戦での生物兵器使用能力を、炭疽菌胞子の兵器という形で所有できそうだからである。
炭疽菌ワクチン免疫化計画は、４つの条件を満足することに成功してから後で、実行されるはずであった。
それは、炭疽菌ワクチンが、無菌、安全、能力が高く、純粋であることである。
実際には、これらの４条件が満たされたことはない。
国防総省は、炭疽菌ワクチン免疫化計画を実行するときに、
コーエン長官が指定した４条件を守ろうという意図を持たないことを示す証拠が幾つかある。
生物的防衛のための共同計画局が発表した文書が示すところでは、
国防総省は、コーエン長官指定の４条件を満足するために必要な連邦食品医薬品局の試験を実施する意図はまったくない。
国防総省は、正式の炭疽菌ワクチン免疫化計画ウエブサイトにおいて、
炭疽菌ワクチンが安全であり、炭疽菌兵器に対して有効であると主張している。
本当だろうか？
米国下院で医学熟練者が行った証言、欧州と米国からの学術文献、炭疽菌ワクチン免疫化計画を熟知する専門家のインタビューは、反対の結論を示している。
炭疽菌ワクチン免疫化計画は、１９９８年に全面実施段階に入ったが、
約４０万人の軍人がワクチンを接種したところで、ストックがなくなり始め、中断した。
炭疽菌ワクチン免疫化計画の全面実施が始まるか否かは不明である。
（注意：この文献は２００１年に書かれたものです）。
（炭疽菌兵器とは何か？）
（炭疽菌兵器への対策）
は、一般的な話なので略します。
（炭疽菌ワクチン免疫化計画の安全性）
国防総省の炭疽菌ワクチンが、炭疽菌胞子兵器が空気中に致死量放出されたときに、それを止める能力を持つかどうかは、証明されていないままである。
ワクチンの安全性については根本的な問題がある。
メリーランド州フォートデトリックの米軍感染症医学研究所によると、
軍が使用する炭疽菌ワクチンは安全であると決定され、
副作用は、５００００回にわずかに一度（０．００２％以下）の割合でしか起こらないと述べられている。
この割合は、現在では０．０２〜０．２％に改定されている。
しかし、国防総省自身の研究では副作用の割合はもっと高い。
メリル ナスＭＤ（民間の炭疽菌研究者）が国立科学アカデミーで行った証言によると、
米軍感染症医学研究所による炭疽菌ワクチンの安全性と副作用の割合とは疑問がある。
例えばドーバーＡＦＢでの研究では、
炭疽菌ワクチンを接種した後の長期敵な健康問題の割合は７％に及ぶ。
米軍感染症医学研究所が公式に発表した副作用割合と、ドーバーＡＦＢでの健康問題の割合とが相違しているのは、
前者は、「接種直後」の反応だけに限っているからである。
公式的な国防総省の立場は、
「炭疽菌ワクチンが慢性，あるいは長期間にわたる反応を引きおこすことはない」というものである。
しかし、現場から軍医が行ってきた報告では、まったく異なる。
フォートブラッグ基地からフィリップ ピッツマンＭＤが報告するところによると、
炭疽菌の接種を受けた人員のうち４４％、およびボツリヌス菌毒素の接種を受けた人員のうち３．２％が、
ワクチン接種後１カ月経過後においても、症状が続いている。
ドーバーＡＦＢでの研究では、
調査した人員のうち少なくとも３２％が、炭疽菌ワクチンに対して全身にわたる反応をひき起こしており、わずか１１％だけしか、数日間に症状が治癒していない。
ＧＡＯによると、炭疽菌ワクチンを接種した軍人のうち８６％は、何らかの副作用を経験しており、
６％は極度の疲労を訴え、
７％は、数日よりも長期間にわたって継続する関節痛を報告している。
このように、炭疽菌ワクチンは、長く続く全身性の反応を高い割合でひき起こしているのである。
興味深いことに、炭疽菌ワクチンによって生ずる長期にわたる症候と症状とは、湾岸戦争症候群の症候および症状と似ている。
ガース・ニコニソンが１９９７年６月２６日、１９９８年７月１６日に下院で（および１９９８年１１月１９日に化学および生物事故に関する国防総省調査の特別監視委員会）で行った証言によると、
湾岸戦争で使用された複数のワクチンが、湾岸戦争症候群の原因の第一の原因として列記されている。
湾岸戦争症候群には、化学的および他の毒物によって生ずる疾患も含まれるけれども、
復員軍人のうち４０％もの多くが、その疾患を感染と国防総省のワクチンまでさかのぼることができている。
炭疽菌ワクチンを評価するのに際して重要なことは、ワクチンの副作用がどのように報告されていたかである。
炭疽菌ワクチンの副作用に苦しむ軍人の多くは、医学的治療を進んで求めることには消極的である。
なぜなら、症状が、うつ病やストレスということにされてしまうのを見てきたからである。
また、現役軍人としての地位を失うかもしれないというおそれもある。
方々の基地で、多数のパイロットが、炭疽菌ワクチン接種後に始まった未診断の疾患のために、現在、飛行以外の地上勤務についている。
軍のワクチン接種計画の責任者であるランディ・ランドルフは、
炭疽菌ワクチンを含むすべてのワクチンが副作用を生じさせるのに遭遇した（例えば注射部位の痛み、赤斑、かゆみ、腫脹、腫れ物）。
男性のうち３０％、女性のうち６０％が、これらの短期的な局所反応を報告した。
しかし，ワクチン接種した人員のうち５〜３５％は、注射部位での初期局所反応が消失した後に、
筋肉痛、関節痛、頭痛、発疹、悪寒、発熱、下痢、食欲不振、倦怠感、および関連の症状を報告している。
民間の医者と軍医との間で、何によって炭疽菌ワクチンの副作用がもたらされているかという意見が相違しているのは、
ワクチンが、国防総省の定めた副作用の報告期間（数日）が経過した後で、疾患が生ずることを受け入れるかどうかにかかっている。
（後略）
（炭疽菌ワクチンの出所）
炭疽菌ワクチンの安全性に取り組むにあったて最も困難な問題点は、
炭疽菌ワクチンの特定情報を得ることであり、ワクチンがなぜ安全と決定されたかを知ることである。
米国のワクチンのほとんどは、単一生産者から供給されている。
食品医薬品局が認可したワクチンの場合には、
多数の厳格な生産および安全基準が達成されなければならず、
ヒトにおける有効性の立証が食品医薬品局へと提示して、
生産販売の商人を受ける必要がある。
しかし、炭疽菌ワクチンの場合には、
このような基準手続は守られていないようである。
炭疽菌ワクチン免疫化計画用の炭疽菌ワクチンの単一生産者は、
ミシガン バイオロジック プロダクツ研究所（ＭＢＰＩ）である。
これは州政府所有の会社であり、政府のワクチン認可を、国立衛生研究所の生物局を通して１９７０年に得ている（食品医薬品局の認可が必要な２年前）。
このライセンスの請求時には、長期安全性のデータは提供されていない。
また、食品医薬品局にも何も提出されていない。
炭疽菌ワクチン免疫化計画で使用された炭疽菌ワクチンは、１９７０年に認可されたワクチンとは違っている。
新しい製品や製造方法の変更があったら、食品医薬品局の試験と認可とが普通は必要である。
しかし、食品医薬品局は、明らかに、現在使用中の炭疽菌ワクチンになされた変更を試験しておらず、認可もしていない。
重要なことに、炭疽菌ワクチン免疫化計画で使用中の炭疽菌ワクチンの認可は、経皮（皮膚）曝露への保護に基づくものであり、炭疽菌胞子の吸引に基づいていない。
炭疽菌ワクチンを製造する唯一の認可施設はであるＭＢＰＩは、１９９８年にミシガン州衛生局が購入した。
このライセンスと設備との新しいオーナーはバイオポート社である。
この会社を所有する投資家を率いるのは、
ウイリアム クローエ ジュニア提督（海軍大将？）（国防総省出身）と
ファウド エル−ハイビリ（米国市民権を得たレバノン系のドイツ市民）である。
クローエ提督は、バイオポート社の１１％を所有しており、取締役会の議長である。
設備は、国防総省が、炭疽菌に対して軍人全員をワクチン免疫化するという決定をした後で、クローエ提督に売却された。
最近、バイオポート社は財政的問題に直面している。
しかし、国防総省が救援にかけつけた。
バイオポート社は、国防総省との契約に一連の変更を施し、
国防総省に供給する炭疽菌ワクチンの１用量当たりの価格を３倍に引き上げることに成功した。
１９９９年には、バイオポート社は、
国防総省から１８００万ドルの前払いを受け取り、手元流動性を維持した。
バイオポート社は、さらなる費用として毎月２００万ドルを受領し続けている。
これらの問題点は、国防総省とクローエ提督およびバイオポート社の創業者との間の利益相反について、議会の調査を招くこととなった。
下院の調査は、共和党のウォルター・ジョーンズ ジュニア（下院軍事委員会）によって開始された。
更に、ミシガン州の議員リング ブリュアーは、バイオポート社の従業員が、虚偽記録にかかわり、炭疽菌ワクチンのバッチを国防総省へと販売できるようにしたと述べた。
ボブ マイアーズ（バイオポート社の主任科学部長および株式所有者）は、この疑惑を激しく否定した。
何年にもわたって、食品医薬品局は、ＭＢＰＩにたいして、ワクチン製造のライセンスを取り消すと警告してきた。
なぜなら、ワクチンの生産および試験方法に法令違反があり、
クローエ提督のバイオポート社においても違反が続いていたからである。
１９９５年および１９９７年には、ＭＢＰＩは、食品医薬品局から正式書面を交付された。
これによると、ＭＢＰＩは、食品医薬品局が義務づけている好適製造実務に沿っていなかった。
食品医薬品局は、工場を閉鎖すると脅した。
１９９８年には、食品医薬品局は１１頁の報告書を発行し、炭疽菌ワクチンのみに対して、好適製造実務に違反していると述べた。
しかし、ＭＢＰＩが炭疽菌ワクチンの唯一の製造業者であったために、
免除特権を与えられ、食品医薬品局の指導遵守は引き延ばされ、操業を続けることができた。
このとき、炭疽菌ワクチンのロットが軍に引き渡された。
これらが炭疽菌ワクチン免疫化計画用炭疽菌ワクチンの品質に影響したのだろうか？
１９９８年には、炭疽菌ワクチンの１９のロットを、無菌性および効能について再試験したところ、
８ロットしか、初期の補助試験を合格しなかった。
次いで、他のワクランロットを再試験したところ、
３１ロットのうち、６ロットしか、食品医薬品局の試験に合格しなかった。
再試験したワクチンのほとんどは、有効期限を過ぎており、
起源経過後、更に３年あるいは６年間、有効期限が引き延ばされた。
炭疽菌ワクチン使用に必要なコーエン長官の出した４条件を満足するためには、
ワクチンが無菌、安全、効能あり、かつ純粋であることを証明するために、
追加試験が必要である。
しかし、コーエン長官の条件を実行する責任のある役所（ＪＰＯＢＤ）は、
炭疽菌ワクチン使用のためのこの条件を曲げた。
ＪＰＯＢＤのマイク ガルブレイス博士からジョン クシックへと当てた情報文書において、
追加試験は技術的、規制上、ほとんど有用性がないが、国防総省に指示されたように行ったと述べた。
また，彼は、食品医薬品局が許可したロットは、製品品質と一体性との点で高度の自信をもって、追加試験なしに使用できると述べた。
この宣言は証明が必要であるが、
しかし，起源切れの炭疽菌ワクチンロットを、日付を新しく変えて使用する結果をもたらしたのかもしれない。
不幸なことに、１９７０年以降、食品医薬品局は、期限切れの炭疽菌ワクチンロットの日付変更を許可してきており、
連邦規則を直接に破ってきている。
主要な問題点が浮かび上がる。
期限切れの、あるいは不良なワクチンロットが、湾岸戦争時に軍人を免疫化するのに使用されたか否かである。
湾岸戦争で使用された炭疽菌ワクチンの追加試験は実施されておらず、
これらのロットは明らかに既に期限切れになっており、
有効期限を変更されている。
何人は、期限切れのワクチンを接種されたのかもしれず、
更に悪いことに、汚染されたワクチンを接種されたのかもしれない。
米軍が汚染ワクチンを接種されたかどうかについて、まだ情報はない。
しかし、英国の湾岸戦争復員軍人の報告によると、
湾岸戦争時のいくつかのワクチンロットは、未知の微生物によって汚染されているという記録があった。
従って、湾岸戦争中および後に既に使用された炭疽菌ワクチンに関連する健康問題のうちいくらかは、
汚染ワクチンによるものかもしれない。
２０００年１月の英国医学開始の文献は、国防総省が資金を出した研究に基づいている。
キャサリン アンウインと同僚は、英国復員軍人において、
炭疽菌ワクチンの接種と、続くワクチンの発病との間に、
統計的に有意な関係があることを発見した。
同様の発見は、カンサス州の湾岸戦争復員軍人について、
リー スティール博士（カンサス州の疫学者）から報告されている。
この問題は後で議論する。
（つづく）
炭疽菌ワクチン関連の他の文献です。
（ANTHRAX VACCINE
Controversy over Safety and Efficacy）
http://www.immed.org/publications/gulf_war_illness/anthrax3-18-00.html
（THE ANTHRAX VACCINE CONTROVERSY
Questions about its Efficacy, Safety and Strategy）
http://www.immed.org/publications/gulf_war_illness/anthrax2-3-18-00.html
（Anthrax Vaccine: Historical Review and Current Controversies）
http://www.immed.org/publications/gulf_war_illness/2JNEM_Nass_Nicolson2002ss.html
以下は英文です（リンク切れの可能性があるので）。
「Soldier of Fortune Magazine2001
DEATH OF THE ANTHRAX VACCINE PROGRAM
Did this and other DoD vaccines cause Gulf War Illnesses?
Prof. Garth Nicolson and Mike Williams
The Institute for Molecular Medicine, Huntington Beach, CA
MAJ Sonnie Bates stood up to the U.S. Air Force when ordered to take the anthrax vaccine that is suppose to protect U.S. Armed Forces personnel against weaponized anthrax spores. The C-5 pilot with more than 14 years and over 3,200 flight hours in the Air Force was convinced that the Anthrax Vaccine Immunization Program (AVIP) caused chronic health problems in 12 members of his Dover AFB squadron alone, including neurological problems, muscle and joint pain, severe headaches, sleep difficulties, memory loss, seizures, among other problems. This is a scenario that has been repeated around the world at U. S. bases where the AVIP is being administered.
MAJ Bates was grounded in December 1999 and then was faced with the prospect of a court-martial and up to five years imprisonment for refusing to take the anthrax vaccine. At the time Sonnie Bates was the highest-ranking American officer who faced a court-martial for refusing the AVIP, but he was certainly not the first to face discipline over the AVIP. MAJ Bates received a general discharge and $3,200 fine rather than take the anthrax vaccine. In the Air Force alone, more than 100 reserve pilots have resigned their commissions rather than be subject to the AVIP, and the number is growing. According to an 11 October 2000 report from the General Accounting Office (GAO), the investigation arm of Congress, since September 1988 an estimated 25% of the pilots and air crews of the Air Guard and Reserve have moved to inactive status or left the military with another 18% indicating that they will leave within the next 6 months. The AVIP was cited as the most important factor in their decision to leave.
On 15 December 1997 Secretary of Defense William S. Cohen approved the plan to administer the AVIP to 2.4 million U.S. Armed Forces personnel, including more than one million reserve and National Guard members. This order was justified to counter an increasing threat from hostile countries and possibly terrorist groups that now or in the future will likely possess the capability of fielding Biological Warfare (BW) in the form of weaponized anthrax spores.
The AVIP was to be implemented after the successful completion of four conditions that were designed to prove that the vaccine was sterile, safe, potent and pure. In fact, these conditions were never met, and there is some evidence that indicates that the DoD had no intention of following the four conditions set forth by SecDef Cohen before implementing the AVIP. The documentary evidence from the Joint Program Office for Biological Defense (JPOBD) indicates that the DoD never intended to perform the supplemental FDA testing required to fulfill SecDef Cohen·s four conditions. The DoD concludes on its official AVIP website that the anthrax vaccine is safe and effective against anthrax BW. But is it? U.S. Congressional testimony of medical experts, medical publications from Europe and American and interviews of professionals who know about the AVIP indicate otherwise. Although the AVIP got into full swing in 1998, it has run out of steam after approximately 400,000 Armed Forces personnel received the vaccine and stocks became depleted. It is unclear whether the AVIP will ever be fully implemented.
What is Anthrax BW?
Anthrax is a relatively common spore-forming soil bacterium that is rarely found in the North America but more commonly found in some areas of the world as an infectious agent. Inhaling a lethal dose of anthrax spores can cause death within six days of exposure. Anthrax spores are tough, relatively inactive, compact forms of the bacterium that can survive for long time periods in soil or sand and are much more resistant to sunlight, heat, dryness and chemicals than the replicating microorganism. But when they come in contact with the moist environment of the lungs and sinuses, anthrax spores come alive and begin to multiply and produce toxins. It is the anthrax toxins in the right concentrations that cause a fatal illness.
To be effective as a BW agent a microorganism must be highly infectious, very pathogenic (causing illness at low concentrations) and stable in the air and environment for the period of time needed for dissemination and infection of large numbers of people. Spore-forming bacteria like anthrax are ideal for this purpose, and ·weaponized· versions of anthrax spores are more pathogenic and survive better than naturally occurring anthrax spores.
Although weaponized anthrax spores are among the most easily manufactured BW weapons, they are only one of dozens of lethal and incapacitating (causing nonlethal sicknesses) BW agents that have been produced in large quantities suitable for BW deployment and tactical use. Anthrax is also one of the few BW agents for which a vaccine exists that is capable of preventing some (but not all) lethal infections. Of the dozens of microbial candidates for BW that have been produced in various quantities by several countries, such as bacteria, toxins, viruses and miscellaneous incapacitating BW candidates, such as Brucella and Mycoplasmas, a primitive bacterium found in ~40% of sick Gulf War veterans, weaponized anthrax is considered one of the greatest threats because of the ease of its production, storage and dissemination as lethal spores that can survive in the environment for years.
Countering Anthrax BW
There are basically three methods to counter anthrax BW: immunization using vaccines, immunization by administering antibodies against the anthrax bacterium and immediate use of antibiotics that inhibit the growth or kill the bacterium. Antibiotics have to be administered shortly before or after exposure, otherwise they won·t be effective, and they cannot prevent a lethal infection once anthrax has produced signs of illness. Immunization with antibodies against the BW agent requires quantities of antibodies not currently available, and they cannot usually be administered in the field. Immunity using vaccines on the other hand can be administered years before exposure as long as immunity is maintained. Thus vaccines can be effective as long as they can neutralize the BW agent before it starts rapidly replicating and producing lethal toxins. From a practical standpoint, only antibiotics administered immediately after a BW attack and vaccines administered well before an attack can protect the large numbers of people exposed in an organized BW attack.
Is the AVIP then a reliable program for protecting against anthrax BW? Not necessarily. Although the anthrax vaccine used in the AVIP can protect against exposure of relatively small doses of anthrax spores that infect skin wounds, such as encountered occasionally in meat processing, it remains unproven whether the DoD·s anthrax vaccine will actually protect deployed forces against a lethal airborne dose of inhaled anthrax spores of the weaponized variety. This is especially true if mixtures of BW agents are used instead of single BW agents. Unfortunately, any nation or group that has the expertise to field such weapons knows this basic information about BW agents and their effective use.
Safety Concerns about the AVIP
The DoD·s anthrax vaccine remains unproven in its ability to stop a lethal airborne dose of weaponized anthrax spores, and there are serious questions about its safety. According to the U. S. Army Medical Research Institute for Infectious Disease (USAMRIID) at Fort Detrick, MD, the anthrax vaccine used by the military was determined to be safe, and adverse reactions were stated to occur at the rate of only one per 50,000 doses (less than 0.002%). This has now been revised to a rate of 0.02-0.2%, and it is much higher according to the DoD·s own studies.
In recent testimony , to the National Academy of Sciences by Merryl Nass, MD, a civilian anthrax expert, the safety of the anthrax vaccine and the rates of adverse reactions released by the USAMRIID were questioned. Using Dover AFB as an example, the rate of long-term health problems after receiving the anthrax vaccine may be as high as 7%. The difference in the official USAMRIID rate and the rate of health problems found at Dover AFB is that the USAMRIID rate is for immediate reactions only. The official DoD stance is that the rate for anthrax vaccine chronic or long-term reactions is zero; however, reports by military physicians in the field are quite different. At Fort Bragg LTC Philip Pitman, MD, reported that 44% of personnel given doses of anthrax and botulinum toxoid vaccines had system-wide reactions, and 3.2% had symptoms lasting over a month after vaccination. At Dover AFB at least 32% of those surveyed had a system-wide reaction to the anthrax vaccine, and only 11% indicated that the symptoms resolved within a few days. According to the GAO, 86% of Armed Forces personnel that received the anthrax vaccine had some type of adverse reaction, 6% reported extreme fatigue and 7% reported joint pain lasting more than seven days. Thus the anthrax vaccine causes a high rate of system-wide reactions that persisted for some time.
Interestingly, the signs and symptoms of the long-term reactions caused by the AVIP resemble the signs and symptoms of Gulf War Illnesses (GWI). In the testimony of one of us (G.N.) to the House of Representatives on 26 June 97 and 16 July 98 and to the Special Oversight Board for DoD Investigations of Chemical and Biological Incidents on 19 November 98 the multiple vaccines used in the Gulf War were listed as the number one possible source of GWI. Although GWI includes illnesses those caused by chemicals and other toxic exposures, as many as 40% of the veterans may eventually have their illnesses traced to infections and the DoD·s vaccines.
In assessing anthrax vaccine safety it is important to know how vaccine adverse effects are reported. Many servicemen and servicewomen suffering from adverse anthrax vaccine effects are reluctant to step forward to seek medical care, because they have seen these problems dismissed as due to depression or stress. There is also a fear that they could lose their active duty status, as a number of the pilots and airmen at various bases are now on DNIF (duties not including flying) because of undiagnosed illnesses that began after they received their anthrax vaccinations. LTC Randy Randolf, director of the Army·s vaccination program, counters that all vaccines, the anthrax vaccine included, can produce adverse effects, such as soreness, redness, itching, swelling, and lumps at the injection site. About 30% of men and 60% of women report these short-term local reactions. However, 5-35% of vaccinated personnel have reported muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise, or related symptoms long after the initial local reactions at the injection site subsided.
The difference between what military and civilian physicians conclude about adverse reactions caused by the anthrax vaccine is based on whether you accept that vaccines can cause illnesses beyond the initial few days reporting period of vaccine adverse effects used by the DoD. The high incidence of unusual long-term health problems from the AVIP include system-wide signs and symptoms, such as vomiting, diarrhea, muscle and joint pain, fever, memory loss, weakness and numbness and other problems, and these occurred well after the usual DoD reporting period for vaccine adverse effects. Even more serious, some anthrax vaccine recipients had seizures with complete loss of consciousness. Because these types of reactions have rarely been identified with other vaccines and because few of those reporting illness have had an exhaustive medical evaluation, exactly how the anthrax vaccine may be causing illness is unknown. Even in the face of contrary evidence, most military physicians continue to deny that the anthrax vaccine can cause long-term illness.
The Anthrax Vaccine Source
One of the most difficult problems in dealing with anthrax vaccine safety is obtaining specific information on the anthrax vaccine and how it was determined to be safe. Most military vaccines in the U. S. are from ·sole-source· manufacturers. In the case of FDA-approved vaccines, a number of strict production and safety requirements must be fulfilled, and evidence for effectiveness in humans must be presented to the FDA before approval for production and release. However, in the case of the anthrax vaccine these standard procedures appear to have been violated.
The sole producer of the anthrax vaccine for the AVIP was Michigan Biologic Products Institute (MBPI) a state-owned corporation that obtained Government approval for the vaccine through the Bureau of Biologics of the National Institutes of Health in 1970, two years before FDA approval was required. Long-term safety data were not supplied with the license application, and none has yet been supplied to the FDA, and the anthrax vaccine used in the AVIP is a different vaccine from the one approved in 1970. The usual requirement is that any new product or modification in preparation must be examined and approved by the FDA, but the FDA has apparently not examined or approved of the modifications made to the current anthrax vaccine. Importantly, the approval for the anthrax vaccine used in the AVIP was based on protection to cutaneous (skin) exposure, not inhalation of anthrax spores.
The only licensed facility producing the anthrax vaccine, MBPI, was purchased from the Michigan State Department of Health in 1998. The new owner of the license and the facility is Bioport, Inc., a company owned by a group of investors lead by Admiral William Crowe, Jr., former head of the Joint Chiefs of Staff, DoD, and Faud El-Hibri, a German citizen of Lebanese descent who has since obtained American citizenship. Admiral Crowe owns approximately 11% of Bioport and is the Chairman of its Board of Directors. The facility was sold to Admiral Crowe·s investor group after the DoD decided to vaccinate all of its servicemen and servicewomen against anthrax.
Recently Bioport ran into financial problems. However, the DoD has come to its rescue, and it was able to negotiate a series of changes in its DoD contract that increased three-times the per dose price of the anthrax vaccine supplied to the DoD. In 1999 Bioport received an $18 million cash advance from the DoD to help keep the company solvent, and it continued to receive $2 million each month for additional expenses. These and other problems have resulted in a congressional investigation into the financial conflict of interest relationship between the DoD and Admiral Crowe and the new owners of Bioport. The House investigation was initiated by Rep. Walter Jones, Jr. (R-NC), a member of the House Armed Services Committee. In addition, Michigan State Representative Lingg Brewer (D-Holt) has alleged that Bioport employees were involved in falsifying records so that a batch of anthrax vaccine could be released to the DoD, a charge that Bob Myers, Bioport·s Chief Scientific Officer and part-owner, hotly denies.
For years MBPI had been warned by the FDA of intent to revoke their license to produce vaccines because of violations in the production and testing of their vaccines, and this has continued with Admiral Crowe·s Bioport. In 1995 and 1997 MBPI received formal written notification from the FDA that they had not complied with FDA-mandated requirements of good manufacturing practices, and they threatened to close the facility down. In 1998 an 11-page FDA report cited breaches of good manufacturing practice for the anthrax vaccine alone. However, since MBPI was the only manufacturer of anthrax vaccine, they were given a waiver and allowed to remain open, pending FDA compliance. During this time anthrax vaccine lots were distributed to the military. Has any of this affected the quality of the anthrax vaccine for the AVIP? In 1998 19 of the anthrax vaccine lots in the AVIP were retested for sterility and potency, and only 8 lots passed initial supplemental testing. Subsequently other vaccine lots were retested, but only 6 of 31 lots passed FDA testing. Most of the retested vaccine lots had expired or had been redated for an additional 3-year period once or even twice. In his testimony to the House of Representatives on 29 April 97 General Eddie Cain admitted that 21 lots of the original stockpile of anthrax vaccine remained quarantined pending resolution of supplemental testing and FDA regulatory issues.
To fulfill the conditions of SecDef Cohen for the use of the anthrax vaccine supplemental testing is necessary to prove that the vaccine is sterile, safe, potent and pure. However, the office responsible for implementing Secretary Cohen·s conditions, the JPOBD, has circumvented the conditions for use of the anthrax vaccine. In an information paper from Dr. Mike Gilbreath of the JPOBD to LTG John Kusick he stated that ·supplemental testing has little technical or regulatory utility, but is being done as directed by DoD.· He also indicated that ·the FDA-approved lots can be used without supplemental testing with a high degree of confidence in the product quality and integrity.· This remains to be proven but may have resulted in the redating of expired anthrax vaccine lots to allow their use after they had expired. Unfortunately, since 1970 the FDA has allowed the redating of expired anthrax vaccine lots in direct violation of the Code of Federal Regulations.
A major question has been raised whether expired or failed vaccine lots were used for vaccinating military personnel during the Gulf War. Since supplemental testing of anthrax vaccines used in the Gulf War was not undertaken, and some of these lots apparently also had previously expired and had been redated, some personnel could have received out-of-date vaccines, or worse, contaminated vaccines. Information is still not available on whether U. S. Forces received contaminated vaccines, but the British Gulf War veterans report that several vaccine lots from the Gulf War were listed as contaminated with ·unknown microorganisms.· Thus some of the health problems associated with the anthrax vaccine used before, during and after the Gulf War could have resulted from contaminated vaccines. In a January 2000 publication in a British medical journal on a study that was funded by the DoD Dr. Catherine Unwin and colleagues found that there was a statistically significant relationship between receiving the anthrax vaccine and subsequently developing GWI in British veterans. Similar findings have been reported for Kansas veterans of the Gulf War by Dr. Lea Steele, a Kansas state epidemiologist. This issue will be discussed again.
Is the Anthrax Vaccine Safe?
Problems with the anthrax vaccine have raised questions about previous vaccine programs. The former commander of the USAMRIID, Dr. Phillip Russell, admitted in an infectious disease medical journal in 1990 that unlicensed anthrax vaccines were used on Armed Forces personnel before the Gulf War. There is, of course, no record of safety available for unlicensed vaccines. In fact, there were no ·available· studies of safety or efficacy for the current anthrax vaccine until very recently, well after the decision was made to start the AVIP. A recent brief publication from the USAMRIID in the Journal of the American Medical Association provides some safety information about the anthrax vaccine, but it refers to previously unpublished data that are not available for evaluation. Dr. Kwai Chan of the GAO in his testimony to the House of Representatives on 29 April 1999 indicated that ·the long-term safety of the vaccine has not yet been studied, and therefore one cannot conclude that there are no known long-term effects [caused by the vaccine].·
The normal procedure for determining vaccine safety and evaluation of potency requires that the FDA must review adverse vaccine reactions collected through the Vaccine Adverse Event Reporting System (VAERS). Using the VAERS system adverse events are usually collected independently by a FDA-approved contractor. The contractor sends its information to the FDA, and the FDA assembles a committee that then evaluates adverse events for the likelihood that the vaccine might have caused them. And it can recommend further study of the vaccine before it can be used in massive immunization programs. However, in the case of the anthrax vaccine, military physicians were instructed that only certain adverse effects could be vaccine reactions, such as classic immediate allergic reactions that occur soon after inoculation, and others, such as fevers, joint pain, memory loss, etc. that develop more slowly were not due to the vaccine and should not be reported. Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs, provided testimony to Congress that there were only 46 VAERS reports on the AVIP submitted to the FDA for an adverse reaction rate of approximately 0.007%. The VAERS system, unfortunately, does not yield adverse reaction rates, it gives a rate of VAERS reporting, and most civilian studies reported to the FDA indicate that it probably underreports adverse events by a factor of 100. Dr. Meryl Nass in her 30 September 1999 testimony to the House Armed Services Committee indicated that military physicians were specifically directed not to report VAERS on the anthrax vaccine, unless one of three relatively uncommon conditions have been met. This may explain the paucity of VAERS reports on the anthrax vaccine.
Military physicians treating patients that became sick after their vaccinations did not have access to any published information on anthrax vaccine side effects, and there is no entry for the anthrax vaccine in the Physicians Desk Reference (PDR), the most widely used physicians· source for information. The package insert for the anthrax vaccine is supposed to give information on possible adverse reactions and other potential problems, but in the case of AVIP the information was based on data collected from an earlier anthrax vaccine, and it does not list the range of possible reactions that could occur. Thus until recently none of the long-term chronic effects of the vaccine were even reported by medical personnel.
In the case of the AVIP, only reactions that result in hospitalization or immediate loss of 24 hours of duty time are reportable to a military clearing-house for vaccine reactions. Although this appears to have changed recently and adverse vaccine effects will be entered in the medical records of patients, it remains unclear whether adverse events will be reported to the FDA. It is very important that traditional and accepted methods of FDA vaccine evaluation be implemented for military vaccines, just as they are required for civilian vaccines. Only then can the safety of the anthrax vaccine be evaluated. The vaccine used in the AVIP should be treated just like any other commercial vaccine and not given special waivers or treatment in the evaluation process. In the case of the anthrax vaccine, two Congressional reports indicate that it should be considered an ·Investigational New Drug· or IND. Under Federal law, presidential executive order, FDA regulations and armed service regulations, it is illegal to administer IND vaccines or drugs unless proper written informed consent is given. In fact, no written informed consent was ever given to participants of the AVIP, and we and others are not satisfied that the current anthrax vaccine is safe.
Military Vaccines and Gulf War Illnesses
Before or during deployment to the Kuwaiti Theater of Operations (KTO), Armed Forces personnel had to pass physical examinations and be fit for active duty. As a part of this process, they received several types of vaccinations, mostly with commercially available vaccines. In the KTO this was usually done by administering as many as two dozen vaccine doses over a period of a few days. Most of the vaccines are required to be given over a course of several months to well over a year. In contrast to previous wars, service personnel were not allowed to keep a record of these vaccinations, and according to the DoD the shot records of hundreds of thousands of deployed personnel have since disappeared or have been classified and are not available.
Some health personnel administering the vaccines were warned that they would be courts-martialed if they kept any record of vaccines given to military personnel. According to nurses that took part in the vaccination program, many soldiers became sick after the vaccines were given, but few were allowed to report any adverse effects of the vaccines, unless they were immediately hospitalized. Most had to return to active duty, even if they suffered adverse effects directly attributable to the vaccines. The records of these adverse effects are for the most part also missing or classified.
Administering multiple vaccines all at once or within a few days can result in depression of the immune system and leave individuals susceptible to opportunistic infections, such as the types of infections that the vaccines were supposed to protect against. To be effective, the vaccines used in the Gulf War should have been given in several steps, the initial vaccination followed by several boosters given over months to over a year to maximize immunity. If given all at once, these vaccines are more likely to cause adverse reactions and produce diminished immunity. Thus they were probably useless in protecting an individual, and they may have even made the vaccinated personnel more susceptible to opportunistic infections due to suppression of their immune systems.
Gulf War Illnesses and Vaccines
Between 100,000-200,000 veterans of Desert Storm in 1991 now have GWI, characterized by complex, multi-organ chronic signs and symptoms. These include chronic fatigue, headaches, memory loss, nausea, gastrointestinal problems, vomiting, diarrhea, joint and muscle pain and soreness, fevers, organ tenderness, among other signs and symptoms. Often these patients show the appearance of rheumatic (Rheumatoid Arthritis) and other autoimmune signs and symptoms. The signs and symptoms of GWI overlap with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis (ME), and GWI patients often they meet the criteria for the diagnosis of Fibromyalgia syndrome (FMS), where the distinguishing feature is the presence of chronic fatigue and widespread muscle pain and tenderness. Often included in this complex clinical picture are increased sensitivities to various chemicals and enhanced allergic responses. There are also other clinical problems in these patients, including impaired cardiac function, hormonal problems, increases in spontaneous abortions and other chronic signs. The signs and symptoms reported by anthrax vaccine recipients that have long-term health problems overlap with those reported for GWI.
In some cases GWI has spread to immediate family members. Although incomplete, a May 1994 report by investigators of the U. S. Senate Banking Committee found after contacting approximately 1,200 GWI families that ~77% of spouses and ~65% of children born after the war developed the chronic signs and symptoms of GWI. Although officially denied by the DoD and British Ministry of Defence, this indicates that at least a subset of GWI patients have an illness that is being passed to spouses and children. Since some of the GWI patients have an illness that is transmissible to family members and perhaps others as well, these GWI cases cannot be explained on the basis of chemical or other non-biological exposures, or an even more unlikely cause--battlefield stress and Post Traumatic Stress Disorder.
Although stress can induce some illnesses, the GAO after studying government and civilian data on GWI, concluded that the link between stress and GWI was not established. Of course, stress can exacerbate chronic illness but most military personnel indicated to us that the Gulf War was not a particularly stressful war, and they strongly doubted that stress was the origin of their illnesses. However, in the absence of physical or laboratory tests that could identify possible origins of GWI, many military physicians accept that stress was the cause of GWI or that it was caused by combinations of chemical exposure and stress. However, a recently published psychiatric study indicates that patients with GWI do not fit the classical picture of stress related illness.
If stress is added to multiple vaccines given at once, plus chemical and other toxic exposures encountered during the Gulf War, then immune suppression and opportunistic infections could be a likely outcome in at least a subset of the military personnel that subsequently came down with GWI. This would also explain in some cases the apparent transmission of illness to immediate family members and the occurrence of GWI in some vaccinated forces that were not deployed.
Vaccine Contamination and Gulf War Illnesses
Testing of commercial vaccine lots demonstrates that contamination can and does occur. A common vaccine contaminant found in one published study at a rate of ~6% is Mycoplasma species, primitive bacteria lacking cell walls and many of the genes found in bacteria that contain cell walls. Mycoplasmas have been implicated in a variety of chronic illnesses, including CFS/ME, FMS, Rheumatoid Arthritis and GWI.
When we examined thousands of GWI patients for evidence of blood mycoplasmal infections, we found evidence of mycoplasmas in about 40% of GWI cases, and in particular, one species of mycoplasma, Mycoplasma fermentans, was found in ~80% of mycoplasma-positive patients. These findings have now been confirmed in a large DoD/VA clinical trial. M. fermentans has been studied over the last decade or so by the Armed Forces Institute of Pathology for its role in causing a progressive, non-HIV AIDS-like fatal disease that has many of the hallmarks of GWI. The DoD also holds a patent on M. fermentans and its testing and role in causing various chronic illnesses.
Mycoplasmas like M. fermentans could be involved in the transmission of GWI to immediate family members. When symptomatic family members of veterans with GWI were tested for the presence of mycoplasmal infections in their blood, they were found to have the same species of mycoplasma as found in the sick veteran family member. In addition, most of these patients responded to the appropriate antibiotics and eventually recovered, albeit slowly, from their illness, similar to what we have seen in CFS/ME, FMS and Rheumatoid Arthritis patients with mycoplasmal infections. When recovered patients were retested for mycoplasmal blood infections, they were no longer positive for Mycoplasma species in their blood samples. This suggests that mycoplasmal infections could be causing at least some if not most of the signs and symptoms found in this subset of GWI patients, and these infections can be passed to family members who then develop similar illnesses.
Were the vaccines used in the Gulf War were the source of the mycoplasmas found in veterans· blood? The answer to this question is not known, and we have not been able to secure sources of vaccine to test this notion. A study reporting the presence of antibodies to an unlicensed vaccine adjuvant (squalene) in over 90% of the GWI patients evaluated was published recently in a pathology journal. Although the DoD has denied for years that squalene was a component of any vaccine used to immunize U. S. Forces, on 3 October 2000 the FDA admitted that squalene was indeed found in lots of the anthrax vaccine. This study and the FDA findings strongly suggest that experimental vaccines were used in the Gulf War. Experimental vaccines are unapproved vaccines without available safety and efficacy data.
Although listed as our number one possible source of the infections found in GWI patients, vaccines are not the only possible source of microorganisms from the Gulf War found in GWI patients. In our sworn testimony to the U.S. House of Representatives, one of us (G.N.) stated that there were several potential sources of chronic biological agents in the Gulf War. The Iraqis were known to have extensive stockpiles of BW agents and the potential to deliver these weapons offensively, at short range in modified Italian-made biological sprayers that deliver BW agents onto the sand to create exclusionary zones or 'biological minefields' and at long range in modified SCUD-B (SS-1) missiles with 'airburst' warheads or sprayers carried by aircraft. Many of the bunkers and factory facilities where BW agents were stored were destroyed immediately up to, during and after the Desert Storm ground offensive, releasing plumes containing these agents high in the atmosphere where they could be carried downwind ('blow-back' exposures) to our lines. These and other possible mechanisms of potential exposure must be carefully examined as well as the possible role of mycoplasmas and other chronic infections in GWI patients. Rather than attacking the scientists and physicians who raise embarrassing questions about the possible sources of GWI, the DoD should be funding our studies. Instead, most of the over $150 million allocated by Congress for GWI studies has been spent on psychological and stress-related research.
Terrorism and BW Attacks
If terrorists ever deploy BW agents in suicide attacks, many times the lethal (human) dose could be encountered in an aerosolized BW and chemical mixture that is designed to inhibit and overwhelm the body·s defensive abilities. These mixtures, called ·Russian Doll Cocktails,· contain microorganisms plus ·immune blockers· and other chemicals that are designed to impede the immune system·s ability to contain the infection by blocking defenses in the sinuses and lungs. BW use in the future will likely involve multiple BW agents, not just one or even a few agents.
Countries like Iraq operate under ·Soviet War Doctrine,· a battle strategy that stresses combinations of conventional and unconventional weapons. Thus combinations of multiple BW, CW (Chemical Warfare) or even NW (Nuclear Warfare) agents may be used together to heighten BW virulence and confuse the diagnosis and treatment of casualties. The rationale is to overwhelm a medical corps· ability to effectively manage large numbers of casualties with unknown or incomplete diagnoses. Iraqi Field Manuals found during the Gulf War described this strategy in detail. Unfortunately, BW can be developed and produced at a fraction of the cost of other weapons of mass destruction, making it likely that future terrorists will choose BW agents over other weapons for terrorist attacks.
The U.S. military·s strategy of defense against BW agents is prior immunization using multiple vaccines. Unfortunately, this can only be successful if the exact BW agents likely to be encountered are known in great detail and for some time in advance of exposure. For example, the vaccine used in the AVIP requires a rather lengthy immunization protocol, administering multiple vaccine and booster doses over more than a year. If multiple vaccines are to be administered, then they will have to be administered at different times to prevent immune suppression or excessive stimulation. Obviously, this strategy requires advance knowledge of the threat and careful long-term preparation against the threat.
To prepare for any new BW threat that arises will require some time, possibly years or over a decade. Recent reports have appeared indicating that the Russians have developed anthrax strains for which it is claimed protective vaccines do not exist. What is the evidence that our ·multivalent· AVIP vaccine will protect against all known anthrax strains? Unfortunately, there is none. In fact, the available evidence from the DoD indicates that the AVIP will not protect against multiple anthrax strains. In his statement to the House of Representatives on 29 April 1999 Dr. Kwai Chan of the GAO indicated that ·taking all the evidence into account, it·s likely that the vaccine does give some protection, but to what extent, against what amount of anthrax, against which strains and how long protection lasts, is unknown.·
How Do We Protect Against BW Attacks?
Other strategies besides the AVIP approach to BW defense can be successfully used. During the Gulf War the French forces elected not to use vaccines as a primary defense against Iraqi BW and not to use anti-nerve agents as a defense against Iraqi Chemical Warfare agents. Instead, they used prophylactic antibiotics to counter Iraqi BW agents, and they depended on protective suits to counter Iraqi chemicals. Interestingly, the French Armed Forces were the only Coalition Forces that did not report any cases of GWI, nor were there any illnesses reported in the immediate families of French Gulf War veterans. Although recently a few French veterans have complained of illnesses related to the Gulf War, the numbers are quite small compared to the rather large fraction of American, British, Canadian, Australian, Belgian and Dutch forces that have GWI. To our knowledge, all of these personnel received vaccines as a part of their force protection.
If antibiotics or antiviral agents are used for BW defense, can these be defeated in the field? Unfortunately, BW agents can be modified or ·constructed· using genetic modifications that have integrated antibiotic- or antiviral-resistance genes. Similar to the ·engineering· of more lethal BW agents to circumvent known vaccines and increase survival and pathogenicity, such microorganisms can be ·engineered· to resist specific antibiotic or antiviral agents. Interestingly, certain U. S. units were issued antibiotics like ciprofloxacin and doxycycline just before the ground offensive in the Gulf War. These antibiotics would be expected to be effective in preventing infections of at least two of the agents that we have identified in veterans with GWI (Mycoplasma fermentans and Brucella spp.). Examination of the numbers, deployments and types of casualties and their diagnoses in the units administered antibiotics before and during the Gulf War could tell us if the French approach to BW defense was more or less effective than our approach of administering multiple vaccines.
Although the demise of the AVIP has been predicted for some time, it is still important to admit that the AVIP is a failure in terms of force protection and safety. Instead of the massive ongoing cover-up that may be intended to protect certain individuals who have made bad decisions from close public scrutiny, continuing institutional support for this program will hamper implementation of more effective countermeasures to multiple BW threats.
Garth Nicolson, PhD, is the President, Chief Scientific Officer and a Research Professor at the Institute for Molecular Medicine in Huntington Beach, California. Mike Williams is a veteran of the U.S. Army, the Congolese National Army and the Rhodesian Army. For further information on BW and illnesses associated with vaccines and the Gulf War and how to obtain testing and treatment information, consult the Institute for Molecular Medicine website: www.immed.org.
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