IOM Hearing Testimony
Concerning an ongoing study, mandated by Congress, on the Safety
and Efficacy of the Anthrax Vaccine
April 18, 2001
My name is Dr. John Buck. I am a board certified Emergency Medicine physician in the U.S. Air Force. I am in the process of being court-martialed for refusing to be inoculated with the anthrax vaccine. I am the 1st physician to be put in this situation, but if this program continues in its present form, I am sure I will not be the last.
I found myself researching this issue because of concerns expressed by my patients. Initially, I set out to examine the published data regarding the safety and efficacy of this vaccine. However, my research and concerns soon extended beyond these two issues and deal largely with the legality and medical ethics of the mandatory program itself. Today, however, I would like to stay focused on safety and efficacy.
In my investigation, I tried to remove all of the emotion, politics, alleged corruption, and the fear of the threat itself. I wanted to look at the science pure and clean.
As I reviewed the literature surrounding the safety of this vaccine, I asked one simple question. "Does this research address the issue of safety?" Although some studies looked at the short-term side effects, none addressed the potential long-term effects and none addressed the issue of safety.
I then attempted to change my paradigm and look outside of the box. When one considers the safety, it is intuitive we must consider issues other than the narrow scope of side effects. I then reviewed the published FDA reports of the facility. According to the GAO, the FDA did not physically inspect the facility until 1993. Since that time, they have issued several very concerning reports and even threatened to revoke their license.
The reports include such things as contamination, inappropriate re-dating, inappropriate re-labeling, changes in the manufacturing process without FDA approval and a manufacturing process that has not been validated. All of which are blatant violations of good manufacturing practices and make a strong argument for an adulterated product. The facility has not released any new vaccine in over 3 years. The FDA recommended standard is a 2-year storage and 1 year shelf life.
My ultimate conclusion is the issue of safety is not adequately addressed in the literature and has been compromised by issues surrounding the sole source manufacturer. The longer this issue continues the greater the safety concern. We hold Coca-Cola to a higher standard. If this were one of their facilities, every ounce of Coke from that facility would be recalled and destroyed.
I would next like to address the issue of efficacy. Fact - There has not and will never be any human studies testing inhalational anthrax as expected in a biological assault. When we apply the principles of evidence based medicine to the question of efficacy the only sound conclusion is, "We do not know…we don't know who will be protected, for how long, or against what type of assault" We are forced to drift away from the facts of science and into the inconclusive realm of theory by relying on animal studies. Unfortunately, even the animal studies do not address the issue.
It is my personal opinion that all vaccines and medications that rely on animal studies should remain in the investigational category and require informed consent. If the President determines in the name of National Security the medication or vaccine is essential, then he has the ability to take responsibility and sign an executive order to waive the right of informed consent. This is not the responsibility of the FDA, the DOD, the Surgeon General or even The Secretary of Defense.
A lot of responsibility has been placed on the members of this committee. You in essence represent our entire medical profession. The DOD has chosen to use our profession as a tool to achieve it's military objectives and in doing so, I believe has severely compromised the practice of medicine. You have the ability to send a strong message that this will not be tolerated by the medical community. If the DOD would like to practice medicine, it must answer to the highest standards. If this is the foundation of the DOD's joint vaccination program, they have set the bar extremely low.
I pray you will all reach for the courage to do what you know to be right. You have the ability to affect the rights of millions of our troops for years to come.
I will leave you with 2 quotes. The first one is from Michael Cohen:
A study that relies on data gathered from subjects compelled to participate without informed consent should give the scientific community reason to pause.
The forced AVA vaccination program would then be best viewed as a poorly controlled large-scare clinical trial. Scientist should search elsewhere for sources of data and not enter into this unethical marriage with the military.
One final quote is from our Commander In Chief:
Let us all have the courage to right the wrongs of the past so that Our next generation does not have to endure them.
To learn more about Dr. / Capt. John Buck, visit: Dr.
John Buck.com
Contents Official Documents Congressional Testimony Position Papers Troop Experiences News Articles Government Contact Information Opinion Informative WWW Sites Benefit versus Risk
Last revised: May 2001