In the March 4, 2002 article, The Argument of Anthrax Vaccine, by Mary Krystine, R.N., BSN, Ms. Krystine took the Anthrax Vaccine Network to task over a number of issues. This is our point-by-point reply. Kathryn D. Hubbell, President, Anthrax Vaccine Network Major Russell E. Dingle, Connecticut Air National Guard This reply is formatted so that the points Ms. Krystine makes come first in gray, with our reply under each point in white. You may find further documentation for our points at http://www.majorbates.com and http://www.anthraxvaccine.net
Inhaled Bacillus anthracis has a 95% fatality rate.
This is absolute conjecture. Of those persons identified with inhalation anthrax, 95 % have died. However, there has never been any attempt to quantify the total number of people that have inhaled anthrax spores. Two examples are sufficient to consider this number as speculative at best. The first example is the long history of exposure to anthrax in goat hair and other processing mills for the textile industry. This was widely known as "wool sorter's disease" because it was largely confined to those who worked in the textile industry. Of particular note in this area is the work done by Phillip Brachman and others in the late 1940's through the 1960's. Their record clearly indicates that most if not all the workers in these facilities were exposed to anthrax spores at regular, if infrequent, intervals. In fact, it was recognized that many workers had developed immunity to anthrax spores over the course of their employment. Likewise, based on the environmental conditions in these facilities, it is also logical that these workers could not have possibly been susceptible to cutaneous exposures alone. In many cases, ventilation was non- existent or poor at best. Airborne dust was particularly troublesome in carding and combing departments. It is statistically impossible for anthrax spores to be absent from all that dust, in all those facilities, over all those years. I will let you calculate the total number of persons in those facilities over the years and the number of hours of exposure to the airborne dust that may or may not have contained anthrax spores. To date no one has done so. More importantly though, no one, including P. Brachman ever attempted to quantify the regular and recurring exposures to anthrax spores in general, or airborne spores in particular. He has written about the man- hours spent in the various departments, but he did not conduct any studies to determine the exposures, if any during those times. There was no attempt to identify the strain or the quantity of spores. Evidence of this lack of quantification is in the often-referenced "Brachman Study". Brachman never attempted to quantify the exposure of his subjects to anthrax spores. He did not know and therefore could not calculate the true efficacy of the vaccine, or the fatality rate of those who inhaled anthrax spores. The second example is the 1979 Sverdlovsk accident. While it is true that many people died of inhalation anthrax, there was no attempt to quantify the total population who inhaled the wayward anthrax spores, nor is there any indication of the total volume or number of spores that were released. In both these examples it is evident that the true susceptibility to inhaled anthrax spores is unknown. More than likely, young healthy adults in Sverdlovsk survived a large exposure, while Ms. Lundgren (CT, 2001) died from a very small exposure. But this too is mere conjecture, not unlike the 95% fatality rate.
No troops, indeed no person in the US, can be given investigational medications or vaccines without freely given informed consent.
This is not true. In the Gulf War many servicemembers were inoculated with the experimental botulinum toxoid vaccine with no offer of informed consent. Additionally Pyridostigmine bromide was given to many servicemembers without their informed consent. The Department of Defense obtained a waiver of informed consent from the FDA. Read the history on this for a more complete understanding of how this came to be. (I can give you the Federal Register entries as well as some of the correspondence between the parties if you like.)
Similar to Tetanus Toxoid Vaccine, AVA is a filtrate that contains neither bacteria nor cells.
In the 3rd edition of Vaccine that you reference you will also note that there has never been any attempt to ascertain whether or not any organic material is in the final product. The fact that the manufacturer states that there are neither bacteria nor cells in the finished product has never been demonstrated nor investigated. In addition the FDA cited the manufacturer for a faulty filter system that had been designed to extract the bacteria and cells from the final solution.
In response to questions of safety and efficacy, the Department of Defense cites 18 studies that indicate AVA is both safe and effective in preventing cutaneous and inhaled anthrax.
Please take the time to review these eighteen studies. 15 were conducted after the mass immunization program began and most are scientifically laughable. As a research scientist, please review these 15 studies and tell me how they meet the most basic level of achieving scientific validity. Two of the three studies that were conducted prior to the mass immunization program were observational studies of the health of military researchers who had received many more inoculations than just anthrax vaccine adsorbed. So while the safety numbers generated from these two studies is substantive, it does not meet the federally mandated requirements of a clinical study. The final study in the group of 18 is the "Brachman" study. It is critical to note that this study was conducted with a version of the anthrax vaccine that differed in formulation, manufacturing process, and strain. Also note that this study would not meet the requirements of a valid clinical trial for the purposes of gaining a FDA approved license.
In written testimony submitted to Congress in November 1999, Melinda K. Plaisier, associate commissioner of legislation for the FDA, defended the FDA inspection of BioPort (AVA's manufacturer) and the approval of anthrax vaccine lots. She wrote: "Because of the complex manufacturing process for most biological products, each lot of the product undergoes thorough testing for purity, potency, and sterility. Manufacturers may release lots of product only after testing is documented. FDA may require lot samples and protocols showing results of applicable tests to be submitted for review and possible testing by the Agency. The anthrax vaccine manufactured by BioPort is subject to lot release, under which a manufacturer may not release a lot of product until CBER [Center for Biologics Evaluation and Research] releases it."
Ms. Plaisier is absolutely correct. What you need to understand is that the anthrax vaccine manufacturer was faulted in numerous inspections for violations to the very requirement that Plaisier points out. The FDA cited the manufacturer for failing in insure the purity, potency and sterility. The citations are too numerous to list here. Please go to the AVN website or ask the FDA for their inspection reports. A key point that I will make, though, is that the FDA cited the manufacturer for failing to keep adequate records of the testing for the purity, potency, and safety. Turns out that the manufacturer destroyed the working records after transcribing them to the official record and that this was done with no witnesses. That leaves the veracity of the official record in serious doubt.
The Department of Defense has identified at least seven nations suspected of researching, developing, and weaponizing anthrax.
This number varies from press briefing to press briefing and from congressional testimony to congressional testimony. Its validity is suspect and potentially misleading.
It claims hundreds of tons of anthrax were manufactured in the pre-Cold War Soviet Union and much is unaccounted for now.
To our knowledge this was all of a liquid nature, not the dried version. It is far less lethal.
The low numbers of postal workers who opted for the vaccine was disturbing to Philip Brachman, MD, an anthrax expert at Emory University's Rollins School of Public Health in Atlanta. Referring to anthrax vaccine he stated: "We've not done the proper informational job to acquaint people with its safety and efficacy. That's a major problem.
With all due respect to Mr. Brachman, the problem isn't that the people haven't been informed, it's that scientifically and clinically valid studies to determine the safety and efficacy of the vaccine have not occurred.
This decision is further complicated because the risk assessment is based on military rather than public health data. Trying to determine what is valid in the vast array of opinion and conjecture can be very confusing.
Based on the military's history of medical malfeasance it is amazing that they continue to be taken at their word, with no scientifically valid evidence to support their claim. It is truly a daunting task to determine the validity of what has been a military vaccine, used only in the military by the military, and on the military.
The Centers for Disease Control, the FDA, multiple studies, and many civilian reviews indicate AVA is as safe and perhaps safer than many vaccines currently in use.
Would it be possible for you to give me a list of these studies that you reference? I have seen the reviews, which are nothing more than a regurgitation of the studies reviewed. I have also read the MMWR article by CDC, which is not peer reviewed and contains references to unpublished data to support its position. I would argue that the only "studies" on this vaccine have been conducted by the military. If there are others I would like to read them. With respect to AVA being as safe or safer than many vaccines in current use, let me ask you to compare "apples to apples" here. You mentioned the adverse reactions rates of tetanus as an example. What are the adverse reaction rates from tetanus among the population that receives the anthrax vaccine? Neither infants, children, the elderly nor the infirm receive the anthrax vaccine, only the young and healthy population that makes up the military. Another window into the adverse reactions rates of various vaccines is the Vaccine Adverse Event Reporting System, or VAERS. If you extrapolate the number of adverse events reported with the anthrax vaccine in the military to the population at large, you would have an annual incident rate of just under one million, a far larger number than the annual total of between 11,000 and 12,000 for all vaccines combined that VAERS is currently experiencing. And finally, you mentioned the reaction rates for the lyme vaccine. The license for this vaccine was recently withdrawn by the manufacturer for "economic" reasons, however the reactions that did occur were severe so that the "economic" reason just may be that of not wanting to be sued.
Efficacy following initial dosing has been demonstrated in both human and animal studies.
Which efficacy are you discussing here? It is widely acknowledged, in the Defense Department, at the CDC, within the FDA, etc. that the efficacy against inhalation anthrax is unknown. Do you know of any method for correlating efficacy in animals to efficacy in humans that has been accepted in the scientific and regulatory communities? The answer is that none exist. In fact, the fundamental question of how immunity is conferred is still unanswered, whether you are talking about animals or humans.