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Date forwarded: Tue, 7 Dec 1999 09:45:27 -0500
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Subject: SOLDIERS FOR THE TRUTH, Newsletter, December 7, 1999
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SOLDIERS FOR THE TRUTH
Newsletter, December 7, 1999
A BREAKDOWN OF RESPONSIBILITY
By: Wilma Hogle, Managing Editor
Email: [EMAIL PROTECTED]
When a man or woman joins the military they are asked to raise their
right hand and swear to defend the Constitution and protect this country.
If one thinks this is an idle promise, recall the rows of white crosses in
American cemeteries around the world.
There is no other organization which demands such a severe test of
loyalty and courage. In exchange for this oath, the Department of Defense
and we private citizens, the ultimate employer of all members of the
military, are obligated to make certain these men and women are provided
the best equipment, the best training and the best care available.
If we provide anything less, we have failed them.
Over the years there has been a major failure to put the welfare of the
troops first. It has happened so gradually that it has escaped the notice of
most of us. The Department of Defense has slipped into acceptance of the
practice of using soldiers as test subjects for substances which may, repeat,
may, enhance performance or offer some protection against biological warfare
attacks. And the record of giving proper treatment to those injured in such
experiments is abysmal. Examples of these programs and the results are many.
This is what one woman had to say about the experiences of her father
in 1945. "My father was a young sailor who was experimented on with mustard gas
and various other gasses in the U.S. Navy at the Great Lakes Naval Station. He
could not talk about it under threat of treason until it was declassified
recently.
"I've seen him suffer both emotionally and physically all my life, but
I never knew why until he was able to talk about it legally last spring.
It's the first time I have seen my father cry. He spent several months in
the hospital due to these experiments. In the beginning, he received
injections every two hours around the clock to save his life. He believes
he witnessed other young American sailors die in these experiments.
"My father has never been to a VA Hospital for medical treatment
because 'classified medical experiments' are treated by the VA Hospitals as if
they never occurred-thus any medical treatment needed must be at their own
expense by private providers if they can financially afford it."
During the 1950s there were experiments with LSD.
During the Vietnam War there was Agent Orange. Last month South Korean
veterans who fought in the Vietnam War met at the War Museum in Seoul to
commemorate the 35th anniversary of the nation's deployment of 320,000
South Korean troops alongside American soldiers in Vietnam.
Veterans' groups have estimated that 32,000 were exposed to Agent
Orange, which can cause cancer, deformities and birth defects. In an
out-of-court settlement in 1984, Dow Chemical and Monsanto, both of which
have business operations in South Korea, paid Australian, Canadian and New
Zealander veterans who served in Vietnam, and who had disabilities after
being sprayed by Agent Orange. Now, South Korean veterans are seeking $4.3
billion from Dow and Monsanto and are suing the U.S. government for $1
billion.
Stories are endless about the suffering of many American veterans and
their families from exposure to Agent Orange. Since this is a defoliant
sprayed by airplane it was obvious it would come in contact with civilians,
American troops, and enemy troops
In 1990-91 the drug pyridostogmine bromide, or PB, was distributed to
some 250,000 to 300,000 of the 700,000 soldiers in the Gulf War. PB was
given as an antidote to soman, a nerve agent.
More than 100,000 veterans have reported experiencing adverse symptoms
attributed to Gulf War syndrome, including memory loss, loss of balance,
sleep disorders, depression, exhaustion, joint pain, diarrhea and problems
with concentration.
The troops were lined up and watched while they swallowed PB. One woman
reported she began having reactions after the first dose. She returned from the
Gulf with the loss of control of bodily functions and has had to wear diapers
since 1991.
Two years ago the Department of Defense asked the Rand Corporation, a
non-profit research organization, to study PB and its effects. While this
work was going on, Assistant Secretary of Defense Sue Bailey was
supervising more than twenty committees formed to study various aspects of
Gulf War syndrome.
Most telling was the testimony of Dr. Beatrice Alexandra Golomb, who
led the Rand research, and was asked during a Senate hearing if, on a scale of
one to ten-one being a "yes" and ten a "no"- she would have taken PB had she
been in the Gulf War theater. Her answer was "a five or a six."
What is tragic is that, apparently, none of the appropriate testing and
evaluation had been done on PB before the decision was made to use it. To this
day the use of PB as an antidote to soman is regarded as experimental. Soman was
never detected during the Gulf War.
A Memorandum of Understanding (MOU) was executed between the
Department of Defense and the Food and Drug Administration. This had the
effect of the FDA allowing the DOD to bypass the safeguards normally
required before use of an experimental substance.
(Moral: When the FDA and the DOD are caught in bed together the proper
response is "Uh-oh.")
Within the last few days, two doctors at the University of Texas
Southwestern Medical Center in Dallas. using advanced magnetic resonance
techniques, were able to identify damaged and atrophied brain cells found
in Gulf War veterans. The doctors involved stated the disabilities were
consistent with the soldiers' exposures to chemical nerve gas, side effects from
PB tablets, insect repellants, and pesticides used in flea collars.
This finding sets the medical community on the road to developing a
treatment and possible cure, and gives hope to many seriously disabled
veterans.
The Texas study was funded by the U.S. Department of Defense and the
Perot Foundation of Dallas.
And now we come to anthrax.
Given the track record of the Department of Defense, logic would
dictate that any vaccine for mass inoculation of troops would be used
only after independent testing and assurance of its effectiveness and its
safety.
Forget logic.
Secretary of Defense William Cohen announced that the DOD intends to
inoculate all 2.4 million members of the American Armed Forces. Secretary
Cohen has made the vaccination of all troops against anthrax a major goal
of his tenure in the Pentagon. While no one would quarrel with the concept
of protecting our soldiers against biological weapons, it is the vaccine
that is the problem, and the heavy-handed manner in which it has been
forced on hesitant troops.
The anthrax vaccine was developed 23 years ago to protect veterinarians who
might come into SKIN contact with anthrax. The same vaccine is being given to
our troops as a prevention of INHALANT anthrax.
Dr. Michael Friedman, FDA Lead Deputy Commissioner, on March 13, 1997,
in a letter to Stephen Joseph, then Assistant Secretary for Health Affairs
acknowledged the "paucity of data regarding the effectiveness of the
anthrax vaccine for prevention of inhalation anthrax."
There are many strains of anthrax, and there is no assurance the
vaccine the Pentagon is using is effective against any, let alone all.
While the Pentagon claims the inoculation protects against all anthrax, as
does the manufacturer of the vaccine, BioPort, experiments at the Fort
Detrick Chemical and Biological Warfare Center in Maryland using guinea
pigs showed nine of the 27 anthrax strains tested killed 50 percent of the
vaccinated subjects.
And there is a problem with the sequence of vaccinations. In September,
Katheryn Zoon, Director of FDA's Center for Biologial Evaluation and Research,
wrote Assistant Secretary of Defense Sue Bailey, "It has come to the agency's
attention through congressional sources that some troops may not be receiving
the vaccine in accordance with the schedule found in the approved labeling. As
you know, the approved anthrax labeling states that full immunization involves
six doses of the vaccine to be administered following the first dose at two and
four weeks, six months, 12 months and 18 months, with yearly boosters
thereafter. This schedule is the only schedule approved by the FDA. Data
received by FDA from congressional sources indicate that a number of reserve and
active military personnel are receiving their anthrax vaccine significantly
later than the FDA approved schedule."
Dr. Kwai-Cheung Chan, the director of Special Studies and Evaluation,
National Security and International Affairs Division of the General
Accounting Office, testified before a House Government Reform Committee
that there have been no studies to "determine the optimum number of doses
of the anthrax vaccine."
It is difficult to determine the number of service men and women who
have had symptoms after taking the vaccine. The Department of Defense
maintains that only a small number of people are experiencing problems, but
there is information that personnel are discouraged from reporting symptoms, and
that many of the reports which are submitted are ignored. Outcries from those
who had symptoms after being inoculated and from those who were refusing to
accept the vaccine were sufficient to cause various Senate and House Committees
to hold hearings.
They got an earful.
Four members of the House, Walter B. Jones (R) North Carolina, Dan
Burton (R) Indiana, Christopher Shays, (R) Connecticut, amd Benjamin Gilman (R)
New York, after hearings, were so concerned that on November 3, 1999, they wrote
a letter to Jane E. Henney, M.D., Commissioner, Food and Drug Administration.
Parts of this letter are revealing.
"...despite the licensure of the anthrax vaccine in 1970, 23 years
passed before your agency physically inspected the anthrax-specific portion of
the manufacturing facility. In testimony before the House Government Reform
Committee, Dr. Zoon of the FDA, indicated that two inspections of the production
facilities in 1997 and 1998 revealed significant deviations from the Federal
Food, Drug and Cosmetic Act, FDA's regulations, and the standards in the
Michigan Biological Product Institute license. Inspection reports of the
production facilities following its purchase by BioPort revealed some progress
but many remaining deviations. In large part, the significant ongoing deviations
prompted the company to close the facility for remodeling rather than face the
likelihood of FDA revoking their license."
"Given the documented deviations from approved practices in the
manufacturing process, it is imperative that the FDA follow its own
prescribed regimen of thorough testing for purity, potency, identity and
sterility. As a prerequisite for approval of the license supplement, the
testing must reveal lot-to-lot consistency for the vaccine. Included within the
testing requirements, the FDA must ensure lot-to-lot consistency for the antigen
(any substance which stimulates the production of an antibody) level. FDA
mandated lot-to-lot consistency will ensure we can accurately measure the
efficacy of the vaccine. The lack of clinical data detailing the relationship
between antigen levels and the amount of protection provided argues strongly for
greater vaccine consistency data so correlates of immunity can be studied."
"We also urge that the FDA place the anthrax vaccine back under
Investigational New Drug (IND) status. As Dr. Zoon testified the vaccine
was licensed for use by a population of individuals at risk for cutaneous
(skin) spores to anthrax through infected animals or animal
products.......However, the Department of Defense is performing a large
scale inoculation for protection against inhalation anthrax. The scope of
the vaccination program and the form of exposure anticipated by the
Department of Defense were not addressed in the initial license."
Finally, "We are also concerned about reported re-dating or re-labeling of
current vaccine stock. There are numerous reports that BioPort, acting through
the Department of Defense, has re-dated a number of vaccine lots or vials to
allow their continued use. If that is the case, no amount of supplemental
testing can avoid the legal obligation to prevent the lots from being used".
Mr. Chan of the GAO on supplemental testing: "Quality can not be
guaranteed from final tests, but only from a combination of in-process
tests, end-product tests and strict controls on the entire manufacturing
process."
What do we have here?
We have a vaccine that has been in existence for 23 years, was intended to
stop anthrax spores through the skin, not through inhalation, was manufactured
by a laboratory with highly questionable quality controls and which may have
re-dated or re-labeled vaccine stock, and a Department of Defense which is
unable to meet FDA specs for frequency of inoculation.
Don't start the war, we ain't ready.
As the reports of soldiers reacting badly to the vaccine increased and
the Senate and House drew up bills calling for cessation of the anthrax
program, or at least a pause to permit testing, the Department of Defense
did what it knows how to do best-bring out the public relations specialists and
circle the wagons.
It soon became obvious that this was not going to stem the tumult from
units losing pilots, soldiers getting sick only after vaccination, and
National Guardsmen walking away from lengthy careers, so Commander in Chief
William Clinton issued Executive Order 13139 requiring military personnel to
receive experimental vaccines not approved by the FDA.
This removes any shield for any soldier who refuses to take the anthrax
vaccine. Refusal to obey a direct order may, and probably will, result in court
martial and a dishonorable discharge.
In direct contrast to the contents of this Executive Order, there is a
worldwide agreement put together by many nations called the Nuremberg Code. The
code itself is only a guideline, but subsequent derivative agreements lock in
member nations to abiding by specific standards of behavior involving scientific
experiments.
This is from the Nuremberg code: "The voluntary consent of the human
subject is absolutely essential. This means that the person involved should have
legal capacity to give consent, should be so situated as to be able to exercise
free power of choice, without the intervention of any element of force, fraud,
deceit, duress, over-reaching or other ulterior form of constraint or coercion;
AND SHOULD HAVE SUFFICIENT KNOWLEDGE AND COMPREHENSION OF THE ELEMENTS OF THE
SUBJECT MATTER INVOLVED AS TO ENABLE HIM TO MAKE AN UNDERSTANDING, ENLIGHTENED
DECISION."
"This latter element requires that before the acceptance of an
affirmative decision by the experimental subject there should be made known to
him the nature, duration and purpose of the experiment; the method and means by
which it is to be conducted. During the course of the experiment the scientist
in charge must be prepared to terminate the experiment at any stage if he has
probable cause to believe, in the exercise of good faith, superior skill and
careful judgement required of him that a continuation of the experiment is
likely to result in injury, disability, or death of the experimental subject."
The United States has approved the Nuremberg Code and subsequent
binding agreements.
Soldiers For The Truth, along with many other groups, has called for a
pause in inoculations so that the vaccine can be tested. The Executive
Order, of course, overrides efforts from all sources to achieve a pause for
testing or stopping the inoculations.
What is puzzling is that while Pentagon spokesmen reiterate assurances that
the vaccine is safe, the obvious course of inviting tests to prove their claims
has never been mentioned. Wouldn't you be inclined to say, "If you don't believe
me, test it yourself. Pick a good professional lab and let them collect samples
for testing."
Suddenly, on December 4, 1999, the Pentagon announced it is postponing
the second phase of its anthrax vaccination program because the Food and
Drug Administration has yet to re-certify the plant making the vaccine.
The postponement, which may last until late next year, will delay vaccine
shots for all soldiers, sailors, airmen and Marines who would be deployed
early during an overseas conflict. This will include personnel assigned to
many Navy ships, airborne units and fighter squadons, along with hundreds
of thousands of others.
Military officials say there is enough vaccine stockpiled for units and
personnel who may be headed to the Persian Gulf and Korea.
BioPort Corporation has been boosting production to meet future needs
but before the military can take delivery of new vaccine the FDA must
approve an amended license for the plant.
Now that there is to be a partial hiatus, the FDA should test older
versions of the vaccine being used now, and not just new production since
the plant restarted in May.
The fallout from the failure to listen to reports from the troops may
have disastrous effects far beyond what the DOD and the President
anticipate.
Morale is low. The armed forces are badly undermanned and commitments
are many. Any extra losses now when soldiers are scattered around the
world, overworked and exhausted, with longer and more frequent tours of
duty playing havoc on the home front, may translate into a huge problem as
many decide to walk away from their military careers just when they are
needed most.
The dollars to find and train replacements will cost us, the employer,
extra billions.
Overlaying all of this is a much more serious issue.
Most of us understand that during war time there is only one goal-kill
the enemy, win the war. Robert's Rules of Order are suspended. Soldiers are
given stupid orders, soldiers fail at their tasks, soldiers die needlessly, but
it is understood that this is an unavoidable part of fighting to win.
At what stage in the evolution of this nation did it become commonplace for
the military to use soldiers for experiments under circumstances that would not
be allowed anywhere else, and which, clearly, violate all tenets of our ethical
and moral heritage?
The United States takes pride in the protection of all its citizens,
yet we allow those trained to be obedient, those most loyal and most
vulnerable, and most essential to our defense, to be a proving ground for
ill-thought-out and careless research.
Worse, we have failed to hold accountable those responsible.
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