From: JH88008@aol.com Sent: Wednesday, January 02, 2002 10:09 PM To: fdadockets@oc.fda.gov Subject: Copy of petition To: FDA cc Congressman Rick Boucher From John C. Hammell, President International Advocates for Health Freedom POB 625 Floyd VA 24091 FDA: In light of the points below, I agree with the Anthrax Vaccine Network http://www.anthraxvaccine.net/ and totally oppose the Anthrax vaccine. I would like the FDA to ban this dangerous vaccine and revoke Bioport's license to manufacture it. It is clearly a very dangerous drug. You cannot legally justify approving this drug for use by the public, and it is wrong that members of the military are forced to take it. I would like to know how you intend to handle this matter, and am forwarding this to Congressman Rick Boucher, my congressman, as well as to my email distribution list. I am also posting this letter to you on my website in the Anti Vaccination section. I regard you to be terrorists. Many other armed Americans also regard you to be terrorists. In light of the points below, how can we possibly come to any other conclusion? If you dispute this information, and feel that it is incorrect in any particular, I would like to know your specific views on this issue. Any lack of response on your part will be construed by me to be tacit agreement on your part that you are indeed terrorists, and that you are on a genocidal mission to kill as many Americans as you possibly can via this improperly tested, clearly dangerous vaccine. 1. The vaccine's manufacturer, Bioport of Lansing, Michigan, has never passed an FDA inspection. Numerous problems include lack of sterility, contamination problems, quality control problems, lack of consistency in manufacturing, falsification of the expiration dates on some lots of the vaccine (labels were switched), and the presence of squalene, an adjuvant which is illegal in the United States. 2. Adverse reactions to this vaccine range from 40% in men to 70% in women, according to an Army study. Yet when the program began the FDA-approved product label admitted to only a 0.2% adverse reaction rate; now it says 5-35%. Adverse reactions range from severe bone and joint pain, to loss of vision, severe skin problems, blackouts and loss of consciousness (crashing from a standing position leads to other injuries, of course), grand mal seizures, internal organ problems, ALS, multiple sclerosis -- and death. If this was a civilian vaccine, it would long ago have been taken off the market. 3. The current vaccine, licensed in 1970, failed to meet federal requirements to prove efficacy in humans prior to licensure; the required trials to prove safety were conducted, but were of limited scientific validity. The only trial of an anthrax vaccine in humans, in the late 1950's, was for a different vaccine and showed efficacy only for cutaneous, or skin contact. The Dept. of Defense wanted a vaccine against aerosolized anthrax - that which would be “weaponized” - and for mass inoculation, and in 1996 submitted to the FDA an Investigational New Drug (IND) application requesting permission to use it for this purpose. By law (10 USC 1107), an IND requires informed consent, or a Presidential waiver of that consent, neither of which currently exist. Absent either, a military order to take the vaccine is illegal. Yet, if troops refuse the vaccine, they are most often fined, court-martialed, jailed, and separated from the service under less than honorable conditions. 4. The General Accounting Office last year (October, 2000) came out with a report that in the the Air National Guard and Air Force Reserve units that were required to be vaccinated, 25% of its pilots resign rather than take it. 5. Even if this vaccine were not so dangerous, it may be of limited value in the short-term. The FDA-approved protocol for taking it calls for three shots each spaced 2 weeks apart; then three more shots at 6, 12, and 18 months, then annual boosters for life. (This is a copy of a petition that I am passing on in support of.)