Anthrax has been reported and described since
ancient times by Hindus, Greeks and Romans. The association of infection in man
(intestinal form) with eating the meat of infected animals was reported in pre-Christian
writings. The first US outbreak of anthrax was reported in Kentucky in 1824.
The Bacillus anthracis bacterium was discovered in sheep in 1850. Koch isolated the bacterium in 1877 and recovered it from experimentally
infected animals. Louis Pasteur produced the first effective
animal vaccine in 1881.
Human disease is primarily limited to those working
with infected animals or individuals in third world countries exposed to infected,
unvaccinated animals. Over 10,000 cases were reported in Zimbabwe from 1979 to 1985.
Approximately 2000 cases occur annually worldwide. Only 224 cases of
cutaneous anthrax were reported in the US in the fifty year period ending in 1994.
Even more rare, only 18 human cases of the inhalation form were reported in the US this
century.
Accidental and intentional releases of biological
weaponized forms of anthrax have been reported recently. In 1979, at least 68 deaths
and 79 cases due to accidental release and downwind contamination from a Soviet military
biological weapons production facility in Sverdlovsk,
Russia. For a complete description from an on scene investigator, see the book by Professor Jeanne Guillemin. There have been at least
eight intentional releases of anthrax as a domestic bioterrorism agent by the Japanese
organization, Aum Shinriyko, although no deaths or infections have been reported.
There have been seven alleged threats or uses of anthrax in the US in the last two months
of 1998 reported to the Centers for Disease Control. The CDC published "Interim
Guidelines for Management of Domestic Bioterrorism Alleging use of Anthrax" in the Feb 5, 1999 issue of Morbidity
and Mortality Weekly Report.
Domestic bioterrorism in the United Stated directed
against media sources and political figures using the US Postal Service as a delivery
vehicle yielded a death rate of just under 45% (11 deaths in 23 cases) in 2001.
Reportedly, weapons grade anthrax spores were used. The first
case/death gained national attention after a brilliant diagnosis made locally in Florida
and confirmed by the CDC. Subsequent awareness, precautionary measures and
biological testing allowed early intervention and intensive supportive care in a number of
cases. Tens of thousands of antibiotic courses were given, many discontinued because
of side effects. A number of "emergency first responders" requested and
received the anthrax vaccine. None of the victims received pre-exposure vaccination
or antibiotics.
For comprehensive resources on bioterrorism, the
St. Louis
University School of Public Health's Center for the Study of Bioterrorism and Emerging
Infections. A commentary
in Aviation Week and Space Technology by former Senator Sam Nunn addresses
the threat of bioterrorism in the US. Medscape, a resource for physicians
that requires free registration, has posted a resource
for bioterrorism with dozens of articles and news links that are updated regularly.
Recommendations for preventing anthrax in
"at-risk" individuals focus on pre-exposure vaccination. Treatment for the
disease is based on successful early identification, use of antibiotics and post-exposure
vaccination.
WHAT IS ANTHRAX?
Anthrax is a deadly spore-forming
bacteria that multiplies if it enters the body. It can infect humans
through inhalation or breaks in the skin (and what would one call it
inoculating it through the skin?). The spores release a toxin into the bloodstream and the
toxin starves tissues of oxygen resulting in respiratory and heart failure.
The anthrax vaccine was licensed by the
Division of Biologic Standards at the National Institutes of Health in 1970. At the
time, data for safety and efficacy was extremely limited.
Several years later, the FDA began licensing
vaccines. It was at this time that tha anthrax was licensed requiring no
demonstration for efficacy in humans. It was only approved for two markets:
Workers exposed to imported animal products, and lab investigators using anthrax. In the
studies, efficacy was only demonstrated for cutaneous anthrax, not for inhalation anthrax.
Below is the 1960 paper by Brachman et al which used
a different, earlier vaccine. This is the
only efficacy study of an anthrax vaccine ever published, and this is what has been used to justify vaccine effectiveness.
A New Hampshire goat hair mill had nine anthrax
cases in persons who were not vaccinated. But only ¼ of the mill workers had received the
vaccine, and it was found that the vaccinated workers worked in areas of the plant where
there were lower spore counts, so they were at lower risk for anthrax than the placebo
group.
Two years later the same authors published another
evaluation of the vaccine using the same study population but this time included three
additional mills. There were a total of 26 cases of anthrax at the four mills during the
study. Five cases occurred in persons who had received some doses of vaccine and fifteen
cases in persons who received placebo vaccine. Six cases occurred in workers who chose not
to participate in the study.
However, the authors now reported that the vaccine
was highly effective, and in performing the statistical analysis, they threw out four of
the five anthrax cases in vaccinated workers for not having received enough doses of
vaccine, to calculate a vaccine effectiveness of 92.5%, rather than an effectiveness of
about 65%, had they included the other four cases. This 92.5% statistic, fallacious back
in 1962, and generated by an older vaccine, has been used ever since to justify the
anthrax vaccine program.
This is a table from the 1960's CDC observational
study of the current vaccine, which was required to demonstrate safety so the vaccine
could be licensed. There are several interesting things about this study. First, the
investigators performed active surveillance for local vaccine reactions only, at 24 and 48
hours after giving the vaccine. They were careful to record local reactions, but paid only
cursory attention to systemic reactions, and did not perform active surveillance for
systemic reactions. In fact, at one mill a large number of systemic reactions were
reported, but this was blamed on an over zealous nurse.
The physician working at that mill pointed out that
the reaction rate was no greater than with other vaccines such as typhoid. No one noticed
that typhoid was the most reactogenic vaccine in use then. Also, notice that the reaction
rates are highly variable from one series to the other, which may suggest a large
difference between the lots, or a major difference in the recording of the effects by the
observers. Note also that they used both the old vaccine, used in the earlier trial, and
the current anthrax vaccine, despite the fact that the old vaccine was 16 years old at the
time the study was done.
Over the next 20 years, from 1970 to 1990, only a
small number of persons were vaccinated with this vaccine: between 200 and 2,000,
according to Dr. Kwai Chan's GAO report to Congress. “In our discussion with
scientists at Fort Dietrich, the estimates of number of people who may have received this
vaccine over a 30 years period range from somewhere between 200 to about 2,000 at the
most. And we don’t know who those individuals are. There has been no follow
up…” Vaccine recipients were never studied systematically and as far an anyone
knew the vaccine was safe.
In 1985 the FDA was reviewing a number of products
that had been licensed prior to the more stringent regulations, and anthrax vaccine was
reviewed by an expert panel. FDA concluded, “Immunization with this vaccine is
indicated only for certain occupational groups with risk of uncontrollable or unavoidable
exposure to the organism". They also pointed out that “Inhalation anthrax
occurred too infrequently to assess the protective effect of vaccine against this form of
the disease.” Despite these qualifications the decision to vaccinate US troops
against anthrax was made as we developed Operation Desert Shield and Operation Desert
Storm.
A number of things were not taken into account then,
and have yet to be taken into account, although 2.5 million military service members:
active, reserve and Coast Guard are in the pipeline to be vaccinated, with 450,000 having
already begun the series.
The anthrax vaccine is an inactivated (killed),
cell-free filtrate type vaccine. The vaccine stimulates immunity by triggering
antibodies to one of the three toxic protein factors associated with the anthrax
bacterium. This antibody stimulation is caused by the Protective Antigen in the
vaccine derived from the culture filtrate of an avirulent (non-disease causing) strain of B.
anthracis. It is not possible to contract anthrax from the vaccine. Live,
attenuated viral vaccines, such as rubella, can cause disease.
The vaccine uses aluminum hydroxide as an adjuvant
to boost the immunogenicity effect. Preservatives are 0.02% formaldehyde and
0.0025% benzethonium chloride. These components are used in many of the vaccines
used routinely worldwide.
The vaccine was first researched on animal mill
workers in the US in the 1950's. The studies concluded that the vaccine was
92% efficacious. The study by
Brachman published in 1962 is considered the first comprehensive study in humans. The
Centers for Disease Control (CDC) submitted an Investigational New Drug (IND) request for
the licensing of the vaccine in April 1966. The Michigan Department of Public Health
produced the vaccine. 16,000 doses of the vaccine were given to 7,000 individuals
under the protocol approved by the Division of Biologics Standards of the National
Institutes of Health.
Rates of adverse reactions were documented and
compared favorably to other vaccines approved for human use. Because of the small
portion of the population at risk and relatively small number of vaccines given, anthrax
vaccine studies are not as robust as those vaccines for much more common diseases
administered to very large numbers of people over extended periods of time.
Therefore, it is difficult for scientific studies of the effectiveness of the anthrax
vaccine to achieve "statistical significance" or firm conclusions based on
smaller numbers studied.
In November 1970, the Division of Biologics
Standards (NIH) approved the vaccine for human use in the United States. This
approval function now is in the Center for Biologics
Evaluation and Research under the Food and Drug
Administration. The Michigan Department of Public Health production facility
changed its name to the Michigan Biological Products Institute in 1996. The
production facility was bought by BioPort
corporation in September 1998. (see chronology of ownership)
This facility is the sole source manufacturer for the approved human anthrax
vaccine in the US. See the October 23, 2001 GAO Report to Congress on "Anthrax Vaccine - Changes to the
Manufacturing Process."
The FDA approved schedule for the vaccine includes
six doses in the primary series. The first three doses are given at two week
intervals followed by three doses at six month intervals from the initial vaccination.
Annual vaccines are then required to maintain high levels of immunity.
Approximately 68,000 doses were given to civilians, mostly veterinarians, from 1970 to
1989. The initial mass immunization of the military began during Operation Desert
Shield when over a quarter of a million doses were administered to approximately 150,000
people, but exact numbers of individuals immunized and number of doses per individual are
not known due to administrative lapses. Since 1998, over 1.98
million doses have been given.
One article from opponents of the
military anthrax vaccine program and congressional
testimony from the Director of the Center for Biologics Evaluation and Research of the
FDA inquiry to the anthrax vaccine program provide more information on the vaccine testing
and production process. The American Gulf War
Veterans Association has expressed opposition to the anthrax vaccine, but has listed
full text reprints of testimony before Congress from many interested parties representing
all sides of the argument on its web site. See testimony before the subcommittee on
National Security, Veteran Affairs, and International Relations, April 29, 1999.
What was not considered when the
decision to vaccinate troops against anthrax was made?
First, long-term safety of the vaccine has never been established.
- Second, the old efficacy rate was fallacious and came
from an older vaccine -- no one knew how effective this newer vaccine would be.
- Third, the stockpile was old and many lots had
expired but been re-dated, as if they were new, with only a retest of potency.
- Fourth, the lots were extremely heterogeneous, with
variable side effects and potency.
- Fifth, the manufacturer was far out of compliance
with good manufacturing practices, and had never had its anthrax line properly inspected.
Sixth, use for prophylaxis against biological warfare was not an FDA approved indication.
Even if the efficacy rate for this vaccine in mill
workers were known, it would probably bear very little relationship to efficacy in a bio
warfare setting, where spore counts would be much higher and anthrax strains would be
specially selected for virulence. The fact that genetically engineered anthrax had been
shown to evade vaccine protection was ignored. Monkey data were cited but guinea pig data,
which showed very poor efficacy against virulent strains, was ignored.
Although the stockpile was old there was no FDA
approved standard operating procedure for re-using expired lots, and no retesting for
degradents, preservatives or sterility took place before approving the use of expired
vaccine. It is now known that the potency test is unreliable and unreproducible. Finally,
there had never been a protocol added to the vaccine license, which was required before
reusing expired vaccine, yet FDA had permitted the manufacturer to continually redate old
vaccine stocks since 1970.
This appears to have been no aberration. The
military had a policy of storing vaccines for very long periods. In fact, they knew that
if licensed vaccines were stored in bulk rather than
in small vials they would legally last indefinitely, and if
they were investigational vaccines they would never
expire, no matter how stored, according to FDA regulations.
It turned out that some lots were 40 times as potent
as other lots. The manufacturing process had never been required to demonstrate lot-to-lot
product consistency, although that is part of FDA’s normal requirement for vaccines.
The result is that studies performed on one lot might not be applicable to other lots, and
that problems and side effects from one lot could not be predicted from studies on a
different lot.
Although FDA was legally required to inspect the
anthrax portion of the manufacturing plant every two years, it did not fulfill this
obligation, and appears to have allowed the Army to perform its own inspections. When FDA
finally went in and did a thorough inspection one month before the current vaccine program
began, they found so many problems that they immediately quarantined 11 lots of vaccine,
and the manufacturer "voluntarily" shut down for major repairs and renovations.
Although those renovations have since been completed, the FDA has not allowed the
manufacturer to reopen, and new lots of vaccine that have been made in the last 15 months
remain under quarantine.
Because prophylaxis against biological warfare was
not an FDA approved indication for the vaccine, such use both during the Gulf War and
presently should only have been conducted using an investigational new drug protocol. This
would have required the informed consent of vaccine recipients. The Defense Department
actually did obtain an IND for adding inhalation to the vaccine indications in 1996.
Although they claim it does not affect the current
use, the IND's existence opens up an interesting legal question of whether troops
receiving vaccine to protect against inhalation anthrax should be covered by IND
protection. This will likely be resolved in the courts.
After the vaccine was used on 150,000 US troops in
the Gulf War one would expect that we would now have a good idea about safety of the
vaccine. However, that is not the case. The very large question of whether Gulf War
Illness is related to anthrax vaccination has not yet been resolved. Why is that?
Although the Defense Department
and Veteran’s Administration have spent over 150 million dollars sponsoring over 120
studies of Gulf War Illness, not a single one of these studies in the United States has
examined the relationship between anthrax vaccine and Gulf War Illness, although sixteen other Gulf War exposures have been studied. Instead the
Defense Department has used a different strategy. A number of expert scientific panels
were convened between 1994 and 1996. They were asked to comment on whether anthrax and
botulinum toxoid vaccines could perhaps contribute to Gulf War Illness. None of the panels
presented here, with the exception of the Presidential Advisory Committee, cited any
references.
In the absence of data they drew the following
conclusions: The NIH Technology Assessment Workshop said, “no long term adverse
effects have been documented”. The VA said “both vaccines, anthrax and botulinum
toxoid have been used for many years without adverse effects. All three review panels, The
Institute of Medicine, Presidential Advisory Committee and the Defense Science Board
Review panels all stated that no long-term adverse effects have been documented or would
be expected. Further study of the potential adverse effects of vaccines in this population
is not recommended by any of the three panels nor is it endorsed in this plan."
The Presidential Advisory Committee produced a
series of final reports as further information about Gulf War exposures continued to come
to light. In 1996 they said, “The Committee concludes it is unlikely that health
effects reported by Gulf War Veterans today are the result of exposure to the botulinum
toxoid or anthrax vaccines, used alone or in combination”. They cited five references
for this claim, all of which were to Defense Department briefers. The Institute of
Medicine said, “The Committee knows of no evidence of any chronic effect.” The
Defense Department attempted to sidestep any actual study of anthrax vaccine and Gulf War
veterans’ illnesses. They said it was
impossible to do a study because the Gulf War vaccination records have all been lost.
However, the document cited here indicates that the
Gulf War vaccine records had actually been classified rather than lost. It says “All
original records and documents used in identifying units and personnel immunized during
Operation Desert Storm are still considered classified information.” But Dr. Philip
Pittman at Fort Detrick studied the effect of booster doses of anthrax and botulinum
toxoid vaccines several years after the Gulf War. To do this, he was able to identify 400
service members at Fort Bragg who had received anthrax and botulinum vaccinations during
the Gulf War. Somehow, the names of vaccine recipients, the dates of vaccination and the
numbers of doses for all 400 participants at Fort Bragg were found.
The results of his study were interesting.
They showed that systemic reactions occurred in 44%
of the recipients of vaccine. However, subjects received
botulinum vaccine in one arm and anthrax in the other, so it is uncertain how many of
these reactions are due to the anthrax vaccine alone. This study also showed that after 30
days, 3% of the subjects continued to have adverse systemic reactions. Whether their
problems resolved is unknown. This appears to be an unprecedented rate of long term
reactions, but it was ignored.
What then can be said about Gulf War Illness
and anthrax vaccination? There has only been one study done and it was performed in
England on service members who had received the British anthrax vaccine, which is similar
but not identical to the one used on US troops. This study was published in the Lancet in
January of 1999 and the authors wrote, “vaccination against biological warfare and
multiple routine vaccinations were associated with this CDC multi-symptom syndrome, (which
is a definition of Gulf War Syndrome) in the Gulf War cohort”. An accompanying
commentary, written by Dr. Stephen Straus of the NIH, said “vaccination against plague and anthrax before deployment to the Gulf
correlated highly with illness.
The investigators speculate that these vaccines more
so than the routine ones given to service personnel had unanticipated effects.”
Therefore we do not yet know conclusively whether anthrax vaccine caused or contributed to
the development of Gulf War Illness, but we suspect it. Further evidence comes from the
large number of gulf era service members who received anthrax vaccine, but were never sent
to the Gulf, and subsequently developed typical Gulf War Illnesses. They all received more
than one vaccination so we can’t say which has caused their illness, but they had no
other Gulf exposures, so the vaccine connection is very significant.
Despite all these unanswered questions, the decision
was made to begin vaccinating all US service members against anthrax in early 1998. And
not only anthrax: vaccines against a number of other biological warfare threat agents are
in development. Recently the military's Joint Vaccine Acquisition Program, the umbrella
program under which all these vaccines will be developed, has talked about a total of
40-50 new vaccines for all service members. This program was initially funded in 1997 by
Congress with 322 million dollars, and it has subsequently received additional
appropriations.
There might be a relationship between
the military’s interest in vaccinating troops, and the pharmaceutical industry's
interest in vaccinating civilians. After
passage of a Federal law in 1986, which made vaccine manufacturers no longer liable for
adverse effects unless there was a production error, the financial climate for vaccine
manufacturers started to improve. Furthermore, advances in genetic engineering made it
much easier to create new antigens and microorganisms for vaccines. It is conceivable that
the military vaccine program will be developing new techniques and possibly new vaccine
adjuvants that will be tested on the military population and used later in civilian
vaccines.
I'd like to speak briefly about reporting and
reviewing adverse events. The anthrax vaccine program began vaccinating service members in
March of 1998. In eleven months 550,000 vaccine doses had been administered but only 39
VAERS (Vaccine Adverse Effects Reporting System) reports had been filed with the FDA. When
Congressman Shays asked the Defense Department about the vaccine program, because of the
large number of reports of serious illnesses that had reached Congress, he was presented
with this slide and was told that the total adverse reaction rate was only .007%, and that
anthrax vaccine was safer than childhood vaccines. What DOD did was to take the total
number of reports to FDA of adverse effects and call it the sum total of all adverse
events.
However, it turned out that the military had
instituted a policy to limit the reports of adverse events before the first vaccination
was ever given! Although normally physicians and vaccine recipients are encouraged to
report to FDA any adverse reaction they choose, military
medical personnel were told that only adverse reactions which resulted in hospitalization, or more than 24 hours of lost duty time could be reported to FDA. This kept the reporting rates remarkably low. When the difficulties in reporting adverse effects to FDA were reported in
Congressional testimony in July 1999, the policy immediately changed. There are now about
1500 reports of adverse reactions to anthrax vaccine received by FDA, and approximately
one in every three hundred vaccine recipients has officially reported an adverse reaction,
despite continuing stories of obstructions being placed in the way of reporting.
What kinds of reactions are being seen? Data from a
study conducted by Dr. Pittman in 1998 on Seventh Day Adventists who had served as human
guinea pigs at Fort Detrick in the 1960’s and the 1970’s. Many of these people
received anthrax vaccine and had never been followed up. However, 25 years after the
program, named “Operation White Coat” ended, all the alumni were invited back to
Fort Detrick for a weekend of fellowship, and asked to participate in the following study.
What questions were asked regarding their symptoms?
The following list of twelve symptoms was given to
each participant and they were asked to comment on frequency and severity. Please note
that all of these symptoms are what is seen in Gulf War Illness, and now these are the
chronic symptoms most commonly seen in those reporting problems after anthrax vaccination.
While I'm on this subject, vaccine recipients also report a variety of neurologic
disorders, especially tremors, and endrocrine disorders. We suspect these to have an
autoimmune basis. A recent autopsy of a vaccine recipient showed death to be due to
coronary artery vasculitis, or what appears to be a series of heart attacks occurring
shortly after vaccination, and due to autoimmunity.
With 1500 VAERS filed why hasn’t
FDA stopped the program?
Well, this is one page from a list of the VAERS
reports received by FDA that I got through the Freedom on Information Act. This report
lists seven people who have filed adverse event reports. You can see that it is extremely
difficult to tell what the severity of the symptoms is and what the duration is. Two of
these people report severe fatigue but fatigue is a very subjective symptom. The FDA has
not paid it a lot of attention, although chronic fatigue syndrome and fibromyalgia are
commonly seen in both Gulf War Illness and the post anthrax vaccine syndrome. FDA has its
own list of terms that are used to describe adverse reactions.
The system is called COSTART and the terms that are
used, tend to confuse, rather than illuminate the adverse reactions. For instance, the
term asthenia, used twice on this page, is one that has been out of use for a century. The
term " Immune system disorder," is not specific enough to be useful, and thus
likely to be ignored. I have reviewed hundreds of these VAERS reports and it is my belief
that this system makes it impossible to tell whether different people are reporting the
same types of illnesses, and it is therefore impossible to tell whether their reactions
are due to the vaccine.
The VAERS reports are received by a private company
working as a contractor for FDA, and put into this format, then reviewed by FDA personnel.
I think that the only way for FDA experts to get an accurate idea of vaccine reactions is
for them to review more detailed reports, contact treating physicians directly, or
investigate sufficient numbers of actual cases. Currently they are required only to
investigate deaths.
The Defense Department did initiate its own
study to resolve the question of long-term safety of the vaccine in September of 1998
amidst all of the controversy. This was done at Tripler Army Medical Center and 603
medical personnel were enrolled in an observational study. These data were presented in
April 1999 to Congress. 43% of vaccine recipients
had mild systemic reactions, and 5% had moderate or severe systemic reactions after one of
the first four vaccine doses
This is a later GAO report to Congress, from July of
1999. It shows that over 60% of males reported muscle soreness after each vaccination and
60-80% of females reported the same thing. It shows that 2-5% of males and 4-14% of
females sought medical attention after one of their first three vaccinations, and that
1-2% of males, but 4-5% of females missed at least one shift of work after receiving a
vaccine dose. This vaccine causes adverse reactions in females at three times the rate of
males. However, followup information on this study has not been released, so even though
the Defense Department knows what happened to these 603 people, Congress and the rest of
us have no information.about any persisting medical problems, which was the question this
study was designed to resolve.
In March 2000, at the request of the Defense
Department, an Institute of Medicine Committee investigating Gulf War Illness exposures
reported on the evidence for safety of the anthrax vaccine. They said, “The Committee
concludes that in the peer reviewed literature there is inadequate, insufficient evidence
to determine whether an association does or does not exist between anthrax vaccination and
long term adverse health outcomes. This finding means that the evidence reviewed by the
committee is of insufficient quality, consistency or statistical power to permit a
conclusion regarding the presence or absence of an association between the vaccine and a
health outcome in humans."
Does vaccination of troops against
biological warfare agents even make sense strategically?
This slide from DARPA, the military's Defense Advanced Research Projects Agency, lists
over 65 known biological warfare agents, which are naturally occurring. In addition, there
are an infinite number of microorganisms that may be created using genetic engineering.
There are less than 10 vaccines effective against these agents. It takes an estimated ten
years, once one is aware of a microbial pathogen, to develop an effective and safe vaccine
against it.
The fact that we did not have an effective and safe
anthrax vaccine at the time of the Gulf War, and now 10 years later we still do not have
one, makes this perfectly clear. Furthermore, if we vaccinate against anthrax, an enemy
can just pick a different microorganism to use. If an enemy genetically engineers a new
virulent organism, we will not even be able to begin developing a vaccine against it until
after it has presented itself -- in other words, after if has been used. For these simple
reasons, the use of vaccines against the threat of biological warfare will never provide
an effective defense.
Dr. Ken Alibek, formerly the number two man in the
Soviet Union’s biological warfare program, has made this perfectly clear. “We
need to stop deceiving people that vaccines are the most effective protection and start
developing new therapeutic and preventive approaches and means based on a broad spectrum
protection.”
How has the FDA responded to the question of
vaccines for the biological warfare threat? They have bought into the Defense
Department’s plan completely. In fact, FDA itself is helping to develop newer
vaccines against anthrax and other threat agents.
This new DNA plasmid encoding anthrax vaccine was
developed at the Center for Biologics Evaluation and Research, FDA’s center for
vaccine oversight. How can FDA provide proper oversight for vaccines developed by its own
staff? Shouldn't FDA's scientists be helping the Defense Department to understand that
vaccines are not "the answer", rather than helping them stitch together the
emperor's new clothes?
Katherine Zoon, the Director of the FDA's CBER, the
woman in charge of vaccine oversight for every vaccine used in the United States, has
served on an Advisory Board for Biological Warfare for DARPA and has advocated rapid
approval of new biological warfare vaccines. In this recently published article, she
implies that the FDA review process may be limited to only six months for such products.
She also says, “After these vaccines are licensed and administered, the safety and
adverse reactions of these vaccines should be assessed.”
Ignoring Federal law, Dr. Zoon is suggesting that
biowarfare vaccines be licensed and used on humans and only afterwards should their safety
profile be ascertained. We have already learned that for the current anthrax vaccine, post
marketing surveillance is essentially limited to VAERS reporting, and VAERS reporting is
close to useless. Should the military be given carte blanche to field biowarfare vaccines
and then determine whether they cause adverse reactions? Clearly, if the case of anthrax
vaccine is any example, the military will do their best to prevent meaningful oversight
and cover up adverse reactions.
Dr. Katherine Zoon, Director of the Center for
Biologics Evaluation and Research at FDA, who is in charge of assuring that federal laws
are followed and that public health is protected with respect to vaccines, has forgotten
where her primary responsibilities lie. For
advocating that vaccines be administered before their safety and adverse reactions are
known she should immediately lose her job.
The FDA has focused more on assisting the Defense
Department, than in assuring the public health. It is critical that FDA’s priorities
be immediately turned around, or the repercussions will have grave effects on the health
of both our military and civilians of the United States.
Original post: http://www.anthraxvaccine.org/
Deaths, stillbirths, miscarriages,
physical defects and sicknesses are all being blamed on the anthrax immunizations that
were given to the soldiers who served in Iraq. Britain experts now fear the thousands of
British troops who received the vaccinations will face difficulties with having children.
I find it absolutely amazing that this vaccine
was ever approved for our troops. The only way they were allowed to give this was because
they were in the military and therefore lost all of their constitutional rights to be able
to refuse it.
Since the war was declared, at least seven young
couples linked to 33 Field Hospital have experienced pregnancy complications often
resulting with tragic consequences. Unlike the first Gulf War where women soldiers were
warned not to conceive within 12 months of various vaccinations, members of the 33 Field
Hospital didn’t receive any warnings about anthrax jabs.
The controversial vaccine administered to the
soldiers involved anthrax bacteria that initiated an immune response to the disease.
Findings from research showed that children of Gulf War veterans have been more prone to
birth deformities.
http://www.mercola.com/2000/oct/29/anthrax.htm
Page 4
