[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
THE ANTHRAX IMMUNIZATION PROGRAM
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
VETERANS AFFAIRS, AND INTERNATIONAL
RELATIONS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
MARCH 24, 1999
__________
Serial No. 106-17
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
57-559 WASHINGTON : 1999
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
JOHN T. DOOLITTLE, California (Independent)
HELEN CHENOWETH, Idaho
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Carla J. Martin, Chief Clerk
Phil Schiliro, Minority Staff Director
------
Subcommittee on National Security, Veterans Affairs, and International
Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois
ILEANA ROS-LEHTINEN, Florida TOM LANTOS, California
JOHN M. McHUGH, New York ROBERT E. WISE, Jr., West Virginia
JOHN L. MICA, Florida JOHN F. TIERNEY, Massachusetts
DAVID M. McINTOSH, Indiana THOMAS H. ALLEN, Maine
MARSHALL ``MARK'' SANFORD, South EDOLPHUS TOWNS, New York
Carolina BERNARD SANDERS, Vermont
LEE TERRY, Nebraska (Independent)
JUDY BIGGERT, Illinois JANICE D. SCHAKOWSKY, Illinois
HELEN CHENOWETH, Idaho
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Robert Newman, Professional Staff Member
Jonathan Wharton, Clerk
Cherri Branson, Minority Counsel
David Rapallo, Minority Counsel
C O N T E N T S
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Page
Hearing held on March 24, 1999................................... 1
Statement of:
Bailey, Dr. Sue, Assistant Secretary for Health Affairs, U.S.
Department of Defense; Lt. General Ronald R. Blanck, U.S.
Army; Deputy Surgeon General Todd Fisher, U.S. Navy; and
Lt. General Charles H. Roadman II, U.S. Air Force.......... 5
Rempfer, Captain Thomas L., Connecticut National Guard; Major
Russell E. Dingle, Connecticut Air National Guard; Pfc.
Stephen M. Lundbom, U.S. Marine Corps; Mark S. Zaid,
attorney at law; Colonel Redmond Handy, Reserve Officer
Association; and Lorene K. Greenleaf, Denver, CO........... 39
Letters, statements, etc., submitted for the record by:
Bailey, Dr. Sue, Assistant Secretary for Health Affairs, U.S.
Department of Defense, prepared statement of............... 7
Blagojevich, Hon. Rod R., a Representative in Congress from
the State of Illinois, prepared statement of............... 20
Greenleaf, Lorene K., Denver, CO, prepared statement of...... 99
Handy, Colonel Redmond, Reserve Officer Association, prepared
statement of............................................... 92
Lundbom, Pfc. Stephen M., U.S. Marine Corps, prepared
statement of............................................... 55
Rempfer, Captain Thomas L., Connecticut National Guard and
Major Russell E. Dingle, Connecticut Air National Guard,
prepared statement of...................................... 44
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut, prepared statement of............ 3
Zaid, Mark S., attorney at law, prepared statement of........ 65
THE ANTHRAX IMMUNIZATION PROGRAM
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WEDNESDAY, MARCH 24, 1999
House of Representatives,
Subcommittee on National Security,
Veterans' Affairs, and International Relations,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2154 Rayburn House Office Building, Hon. Christopher Shays
(chairman of the subcommittee) presiding.
Present: Representatives Shays, Ros-Lehtinen, Biggert,
Blagojevich, and Schakowsky.
Staff present: Lawrence J. Halloran, staff director and
counsel; Robert Newman, professional staff member; Jonathan
Wharton, clerk; Cherri Branson and David Rapallo, minority
counsels; and Earley Green, minority staff assistant.
Mr. Shays. Good morning. I would like to call this hearing
to order. This morning we begin the subcommittee's oversight of
the Department of Defense, DOD force-wide Anthrax Vaccine
Immunization Program [AVIP].
We begin with questions. Why now? Why this vaccine? Why a
mandatory program? And why would active duty, reserve and
National Guard personnel jeopardize their military careers and
even their liberty rather than take the vaccine?
After what has been described as a multi-year and
deliberative, but for the most part, closed process, DOD
launched the AVIP in 1997, but anthrax was a known threat in
the 1991 Gulf war. Vaccine development and acquisition against
biological threats have been an explicit element of U.S. force
protection policy since 1993.
Yet only now has anthrax been deemed the preeminent threat
requiring this additional medical force protection measure
unique to that single organism. If, as has been argued, it
would be irresponsible, even immoral, not to use the available
vaccine, what took so long?
To meet tomorrow's very real threat of biological weapons,
cocktails and genetically altered anthrax strains, DOD selected
the vaccine approved by the Food and Drug Administration [FDA],
almost 30 years ago. It has been described as crude and dated
medical technology. The sole production plan is under
renovation to address serious failures to follow good
manufacturing practices which, in turn, can affect vaccine
purity, potency and safety. Is that the best we can do?
The missing element of the mandatory anthrax vaccine
program is trust. Radiation testing, Agent Orange, the reckless
use of experimental drugs and mysterious Gulf war illnesses
have made military men and women understandably distrustful of
the Pentagon on medical matters.
Although DOD appears to acknowledge the problem, AVIP
brochures and websites still seem heavy handed and one sided,
glossing over legitimate concerns about the safety and efficacy
of that vaccine, minimizing adverse reaction reports and
blaming the internet for fanning dissent.
But it is what they do not find on the Internet that gives
many pause. There are no long term studies of anthrax vaccine.
Limited use by veterinarians in research since 1970 does not
provide the statistical weight to project the vaccine's effect
in 2.4 million young men and women. After vaccinating 150,000
Gulf war troops, DOD had a unique pool of subjects to study,
but due to poor recordkeeping, no large scale research has been
conducted.
So those being ordered to take the vaccine face a
profoundly personal choice, whether or not to put something in
their bodies they fear may do more harm than good. After
military service, the uniform comes off, but the anthrax
vaccine stays with you for life. It is just not the commitment
many dedicated men and women made to their country when they
volunteered for military service.
We arrive at this inquiry after traveling a road that began
for many Veterans in the toxic battlefields of the Gulf war
where they were exposed to multiple vaccines, experimental
anti-nerve agent pills and botulism toxoid vaccine, depleted
uranium, low levels of chemical warfare agents, pesticides, oil
fire smoke and more. We will follow it until we are sure
medical force protection means assuring the long-term health of
U.S. forces, not just short-term mission capability.
Again, thanks to all our witnesses for being here today. We
look forward to your testimony.
[The prepared statement of Hon. Christopher Shays follows:]
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Mr. Shays. I would like to acknowledge Ms. Lehtinen.
Ms. Ros-Lehtinen. Thank you so much, Mr. Chairman. I want
to congratulate you for spearheading this effort in Congress,
doing these hearings.
As a wife of a Vietnam veteran who had many of his friends
subjected to Agent Orange and having our military deny this
existence for many years, I want to commend you for being on
the cutting edge of this issue and I look forward to hearing
from our expert panelists to find out what the proper role of
this vaccine is in today's military forces. So thank you,
Chris.
Mr. Shays. Thank you very much. We have testimony in our
first of two panels: Dr. Sue Bailey, Assistant Secretary for
Health Affairs, U.S. Department of Defense; accompanied by and
I believe will be providing brief comments as well, Lt. General
Ronald R. Blanck, U.S. Army; Deputy Surgeon General Todd
Fisher, U.S. Navy; Lt. General Charles H. Roadman, II, U.S. Air
Force. We welcome all of our witnesses and as is the custom we
would invite you to stand to take the oath.
[Witnesses sworn.]
Mr. Shays. Thank you. Note for the record that all
witnesses have responded in the affirmative and let me say to
you Dr. Bailey before recognizing you, that we have very tough
questions. We have very real questions to ask, but this
committee has not concluded one way or the other about this
issue, so we have an open mind and we look forward to your
testimony. Thank you.
Dr. Bailey.
STATEMENTS OF DR. SUE BAILEY, ASSISTANT SECRETARY FOR HEALTH
AFFAIRS, U.S. DEPARTMENT OF DEFENSE; LT. GENERAL RONALD R.
BLANCK, U.S. ARMY; DEPUTY SURGEON GENERAL TODD FISHER, U.S.
NAVY; AND LT. GENERAL CHARLES H. ROADMAN II, U.S. AIR FORCE
Dr. Bailey. Thank you, Mr. Chairman, Ms. Lehtinen, other
distinguished members of the committee, anthrax has been
identified by the chairman of the Joint Chiefs of Staff as a
major threat to American forces. It is lethal. It is easily
made and it is easily weaponized. Our mission at Health Affairs
is to support force protection through force health protection,
specifically that means providing for protection from all
sources, including chemical and biological weapons.
The anthrax vaccine is a safe vaccine and it is
efficacious, but you should realize that it is not a medical
program, that this program is a line commander's program
supported by military medicine. It is their responsibility also
to provide for the safety of troops and as well, to complete
their military mission. Total force anthrax vaccine
immunization involved a deliberate and detailed process that
resulted in the decision by the Secretary of Defense in May
1998 to immunize the total force. Prior to that in December
1997 a total plan was approved by the Secretary upon four
conditions being met. Those conditions were that there was
supplemental testing above and beyond that of the production
facility and the FDA; that there was a service-wide plan for
implementation of the vaccine program as well as communication
to our forces, families and those concerned. The third
condition was that there was an information technology tracking
system to allow us an overview and a tracking of each of these
immunizations as they were provided, and fourth, that there was
an independent review provided. And that if all of these
conditions were met, we would proceed with total force
vaccination. In fact, all of those conditions were met and we
proceeded with total force immunization.
We are deeply committed at the Department of Defense to
force health protection. We are proud of the anthrax vaccine
immunization program which, as you see, has now provided
immunizations for over 223,000 of our troops with very few
adverse reactions. At this point the rate is 0.007 percent.
That is much lower than most of the vaccine immunization
programs that you may be well aware of, those for children and
infants, for instance, and for many Americans.
At this point, adverse reactions stand at 42 out of 223,000
individuals and a total of over 600,000 actual immunizations
given.
We believe the efforts that we have undertaken, in fact,
set the standards as we provide force health protection in a
new era of chem-bio weaponization and we are very fortunate to
have this vaccine, and in fact, it would be irresponsible were
we not using it at this time to protect our troops.
Thank you very much.
[The prepared statement of Dr. Bailey follows:]
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Mr. Shays. Thank you, Dr. Bailey. We will go first to you,
General Blanck and then to Surgeon General Fisher and then
General Roadman.
General Blanck. Mr. Chairman, distinguished Members, thank
you for the opportunity of appearing to deal with the issues
and concerns which I think in your opening comment you summed
up very well.
I believe the threat is real. I believe the threat is
greater today than it was 2 years ago, 5 years ago, 10 years
ago, though it existed then and we have a way to counter the
threat and to offer protection to the men and women in uniform
and it is the fully FDA approved anthrax vaccine.
Now certainly there are questions and concerns about the
vaccine. There must be, because it is not in widespread use.
Although it is a very similar vaccine manufactured exactly the
same way as tetanus to a very similar organism, has very
similar side effects, people know about tetanus and are
comfortable with it. By the way, before World War II, tetanus
vaccine was also made mandatory for the Armed Forces and during
that entire conflict there were only 12 cases of tetanus
despite all of the ordnance that was around the wounds suffered
by the men and women in uniform.
So this is not something that is particularly new. We know
about this vaccine. You alluded earlier to the Gulf war and I
think that is particularly pertinent because as Dr. Bailey has
described we have learned from the Gulf war. We have learned
that even though the vaccine is FDA-approved, we needed
supplementary testing so that we knew it met the standards for
on top of the FDA approval, safety, sterility, purity and
potency and we have done that testing on every lot of vaccine
that has been administered to our soldiers.
We knew that we had to have a way of tracking the
administration of the vaccine and the individuals who received
it, so that we could retrieve the data and so that we knew when
the next doses were to be given. I returned on Saturday from
Seoul, Korea. While in Seoul, I received my fourth anthrax
vaccination and we checked, today, I am in that automated
tracking system and so is the sailor who got it with me and the
other soldiers who happened to be there for their fourth shot
in Korea. So we have that system. It works very well for all
three services. And by the way, the sailor was getting his shot
in an Army clinic, so it was entered through our system. It
goes to the Defense Enrollment Eligibility Reporting System and
when he goes on board his ship, the Navy will be able to
download that information, see when he needs his fifth
immunization, know what lot he got and so forth and so on. So
we are doing that very well.
The independent review has already been mentioned. I would
like to spend a moment on something that I think we did very
poorly in the Gulf war and in following up on health issues and
that is risk communication, education, talking to people.
We have tried to do this to the best of our ability and
provide information. We have a goal in all of the services that
no one gets a needle in their arm without having been educated,
having been briefed, often having seen the leadership getting
their immunizations first and having had the chance to ask
questions and get pertinent and appropriate answers. So we have
really taken that very seriously and I would like, if I might
to take 2 minutes and show you a little film clip that has to
do with both the education effort, but I think it speaks to
safety and I will conclude with the safety.
If I could have the film clip, please.
[Film Clip.]
From the AFRTS News Center in Washington, this is the Two-
Minute Report. I am Jim Langdon. On this edition, anthrax.
Even a cute little guy like this could carry the deadly
biological agent. That is why Specialist Amber Stanley and the
other people who handle animals at the U.S. Army Medical
Research Institute of Infectious Diseases have had anthrax
vaccination shots. Specialist Stanley has worked at the
Institute for more than 2 years. She took her first anthrax
shot long before the vaccine became mandatory for all service
members.
``I did not mind it, considering the biocontaminant level
we were in. I figure at least it would give me a fighting
chance if something had happened.''
Specialist Stanley says everyone she works with at the
Institute has had anthrax vaccination shots.
``I have not met anyone who has had any problems, any
health problems, any health risks after taking the shots.''
Specialist Stanley has received six anthrax shots so far.
John Kondig probably cannot recall when he took his six
anthrax shots. He has been taking the vaccine here at the
Institute for more than 30 years.
``I trust it completely. I have no questions about its
safety whatsoever.''
But he says it is hard to talk about the vaccine's safety
to service members who have their minds set against the shots.
``I can understand their feeling, but my personal feeling
is that I think they should take the shots as a safety
precaution and I do not believe there is anything--there is any
danger involved in taking the shots.''
A tender arm is the only adverse reaction Mr. Kondig has
ever had to anthrax shots. He still runs into people he worked
with 30 years ago and says none of them have complained about
side effects from the anthrax shots they took.
That is the Two-Minute Report from Washington.
General Blanck. If we could turn off the tape, please.
Part of the education program, but it speaks to something
else. He is one of the individuals who since 1974, having
received anthrax, has been followed for long term health
effects and we followed those who received over 10,000 of the
immunizations over 1,000 individuals to see from 1974 to 1992
if, in fact, there were long term health effects and we found
none.
We also have done other studies in groups, for example, at
Tripler Army Medical Center to see what the real rate of even
minor side effects. As Dr. Bailey has pointed out, we have
those that are significant side effects, but somewhere
depending on the study between 4 percent and even as high as 30
percent, will have minor local reactions. For example, on my
second shot, I developed a nodule at the site of immunization.
So there are those kinds of things. But in every study that we
have done, in every study that others have done, we have found
the rate of adverse effects to be lower than those of other
mandatory vaccines. Tetanus comes to mind, Yellow Fever,
typhoid, Hepatitis A, Hepatitis B and of course, you know about
the DPT that is mandated by most States, in fact, by all States
before students start public school, with far greater adverse
reactions, or at least the rate of them. We believe this to be
a safe vaccine.
As far as efficacy, you know that there has only been one
human study and the numbers were in approximately wool sorters.
In the group that received the vaccine, none developed
inhalation anthrax. In the group that did not receive the
vaccine, four did.
The numbers, while significant, still are not large enough
to make a great deal of conclusion, though it was at least
partially the basis for groups such as the National Academy of
Pediatrics, the Food and Drug Administration and others to
conclude that this was efficacious against inhalation anthrax.
But we went further, of course, and did the animal studies that
I think you are aware of. The guinea pig model is not a good
one. It does not match our immune system or develop the disease
as in humans, so we have used two models that do, one, the
rabbit, two, the Rhesus monkey. And in those studies, which I
can answer in greater detail, we found the vaccine to be
protective in almost all cases, whereas all of the controls
died.
That concludes my remarks and I would be happy after the
others speak to answer questions.
Mr. Shays. Thank you, General Blanck.
Admiral Fisher.
Radm. Fisher. Thank you, Mr. Chairman, distinguished
Members. On behalf of Admiral Nelson, I would like to thank you
for this opportunity to provide information on the safety and
efficacy of the anthrax vaccination immunization program
[AVIP].
The Department's decision to vaccinate all Service
personnel with the anthrax vaccine was made only after careful
validation of the threat of weaponized anthrax and ensuring the
vaccine would provide safe and effective protection which you
have heard about.
We also in the Navy have great confidence in the safety and
the efficacy of the vaccine which has a long history, which you
have just heard about again, of safe use with remarkably low
incidents of side effects since its start of licensure by the
FDA in 1970.
I have received the vaccine and its side effects with me
are quite honestly less than what I experienced with the
tetanus-typhoid booster, so it is--you know that you got it,
but my arm is fine.
Our experience in the Navy has been very positive since we
began the anthrax vaccine immunization program in May 1998. As
of March 22, over 82,000 Navy and Marine Corps members have
been vaccinated, with only 8 reactions reported via the Vaccine
Adverse Event Reporting System, the VAERS system. All have been
returned to full duty.
Our reporting policy requires a VAERS report be submitted
when an individual is placed in quarters for longer than 24
hours, is hospitalized or contamination of the vaccine lot is
suspected. However, in our policy message, we emphasize any
adverse reaction can be reported and anyone may submit a
report, not just the provider.
There may be additional individuals who have experienced
some reaction to the vaccine that have not been reported,
however, I am confident all of the serious reactions have been
reported in our system.
Also, Navy Medical Department personnel are instructed to
provide Sailors and Marines this informational brochure before
they receive their first anthrax vaccine dose. This includes
valuable information about the vaccine and answers to often
asked questions, as well as giving the Internet address for the
Navy website on anthrax which also then identifies other
websites for information.
Our main concern is the safety and welfare of our Sailors
and Marines. This is why we are protecting them against the
threat of biological warfare, by giving them the anthrax
vaccine.
We are fortunate to have a time tested, safe and effective
vaccine to provide an important element of the body armor
needed to defend our personnel against weaponized anthrax.
Anthrax has now joined other immunizations received by our
Service men and women to protect against disease threats just
as important as wearing a gas mask or carrying a rifle when on
the battlefield.
Again, thank you for this opportunity to testify and I
would be happy to take specific questions.
Mr. Shays. Thank you very much.
General Roadman.
General Roadman. Mr. Chairman, members of the committee,
thank you for the opportunity to testify today.
I think that in my mind it is clear when it comes to
pulmonary anthrax there is one clear simple truth. If you are
not vaccinated, if you inhale the spores, you almost certainly
will die. As the Air Force Surgeon General, it is my duty to
protect the health of our airmen. This duty also requires me to
be Air Force's point man in the war to combat diseases which
are turned into weapons of mass destruction.
Our greatest and prime biological enemy today is anthrax.
And our strongest weapon against it is vaccination.
Now the Air Force so far has immunized about 65,000 people
using 200,000 doses and we have had 8, excuse me, 12 total
reports in the VAERS system; 7 systemic, which is, of course,
fever, muscle aches; and 5 local which is the local induration
and redness around the immunization site.
I personally have no doubts or concerns about the vaccine.
As a physician, husband and father, I would not ask anybody to
do anything I would not do myself. I have completed my anthrax
series which is a series of six and you would say well, why are
you at six and other people are at four? It looked like, Mr.
Chairman, a year prior to the decision we were going to have
the anthrax immunization approved and I had started it along
with the then Chief of Staff General Fogelman, started it as an
issue, once again of confidence and leadership. So I finished
my six and I have no worries about its safety and efficacy.
The reason I am convinced of the anthrax vaccine's safety
is because the science and the tracking over a long period of
time are long standing and credible. This is not a new
experimental vaccine.
As you pointed out, it has been FDA licensed for almost 30
years in both the civilian and military population. There has
never been a question of effectiveness and safety in its use.
What is being questioned is people's perceptions simply because
I believe this vaccine is relatively unfamiliar.
It is unfamiliar because we have a generation of people who
have forgotten about polio, diphtheria, tetanus, typhoid as
major public health issues. And the reason that we have had the
luxury of forgetting about those as public issues is because we
have had vaccines to be able to deal with them.
In short, I believe that this discussion is being framed
incorrectly. It is being framed as fear of an immunization when
I believe we have a weaponized agent that is uniformly lethal
and we have an effective immunization and we should not be
framing this as fear of the immunization. We should be framing
this as fear of the disease itself.
Unfortunately, the anthrax vaccine has been getting
unreasonable criticism in some circles. In particular, there
are, in fact, Internet and e-mail programs that I believe are
not putting forth all the information that is important.
Although their intentions may be good, I believe that these
critics build fear unnecessarily about this vaccine.
Yet, it is interesting to note that little is said in the
same publications about the devastating disease of anthrax
which, by the way, has the same mortality as the Ebola virus.
And so we need to put it into context as we are talking about
the disease itself.
Truly accurate information, and I believe, Mr. Chairman,
you are correct, our obligation is for truly accurate
information. I believe it will make it evident that we should
fear the disease, and not the immunization.
Now the Air Force, as an expeditionary Air Force, must be
ready to deploy any time and that means that in a moment's
notice our people must be able to get onto aircraft to execute
our mission and they must be fit and healthy. If our country is
going to send us into harm's way, we must be equipped with
every possible form of protection available. Losing life of
even one person when it could be prevented is inexcusable. That
is why it is mandatory for all service members to be
vaccinated.
In addition to the potential human cost, mass casualties
would degrade our military mission, military capability and
mission accomplishment. We would not send people into battle
without helmets and weapons. So we should also provide the best
armor against biological dangers that we can. That armor is
immunization.
We recognize that commanders, airmen and family members
must become informed about anthrax. We are working hard to
educate them through our websites, internal media forum and
individual counseling. The Air Force has recently established
an Integrated Process Team run by the Assistant Vice of the Air
Force to insure a comprehensive approach to the issue involving
personnel from across the Air Force. That is medical, line,
legal, public affairs and others. It has been framed as a task
force looking at the efficiency and effectiveness of the drug.
That is absolutely not what this is. It is looking at a large
system with a large immunization program and saying are our
processes, are our messages, coming across consistently and
clear? It is not a deviation by the Chief of Staff at all from
believing that we are on the right track. It is an initiative
and good management and strong leadership.
I believe that the message of the IPT is clear. The threat
is real. Anthrax kills. The vaccine will save your life.
Thank you.
Mr. Shays. Thank you, General. Let me ask the first
question to you, Dr. Bailey, and then any of you can respond to
it.
Why now? Why this program now? Why not 5 years ago? We have
known about it for 30 years.
Dr. Bailey. First of all, we did provide immunization to
over 150,000 people in the Gulf during the Gulf war. So this is
not something that is new. We also, as you have heard, have
tracked immunizations for some time. This is a threat that has
increased and that is why now.
Mr. Shays. Let me pursue that question in a second. But
first, I would like to--I realize I have been derelict in
letting you know who else is here. We are joined by
Congresswoman Biggert, Judy Biggert from Illinois, and also
Janice Schakowsky from Illinois as well, and also the ranking
member, Mr. Blagojevich. I would just ask if Mr. Blagojevich
would like to make a statement and then we will get back to the
questions.
Mr. Blagojevich. Thank you, Mr. Chairman. Speaking of
derelict, as the ranking member, I was a half an hour late. I
should confess to obvious dereliction.
I have a statement, and since I was late, rather than hold
up the testimony, I will submit this for the record.
[The prepared statement of Hon. Rod Blagojevich follows:]
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[GRAPHIC] [TIFF OMITTED] T7559.011
Mr. Shays. Thank you. And if I could, let me do some
housekeeping.
I ask unanimous consent that all members of the
subcommittee be permitted to place any opening statement in the
record and that the record remain open for 3 days for that
purpose. And without objection, so ordered.
I ask for the unanimous consent that all witnesses be
permitted to include their written statement in the record and
without objection, so ordered.
And I would invite our other members, if they would like to
make a comment before we go back to questioning.
General Blanck.
General Blanck. Yes. I think there is a combination of
factors. One is the increased recognition or assessment of the
immediacy of the threat, how serious it is, how likely it is to
occur. But I also think it has to do with how seriously we have
taken it in the past.
Up until 1990, we faced the Soviet Union and chem-bio was
almost in the too hard to do box. We knew that it was there. We
did not take it as seriously as we do now with the much more
evident threat nations, terrorist groups.
Second reason is, given what I have just described, it was
only in the late 1980's that we began a process to increase
through the Michigan Biologics Products Institute the
production of adequate amounts of vaccine so that we could
immunize the whole force. And in fact, we did not have that
amount earlier and it is one of the reasons we did not do more
immunization in the Gulf in 1990 and so as all of these
concerns were discussed and so forth, we came out with the plan
that you have heard described in the timing that you know.
General Roadman. Yes sir. There are, as you know, 10
nations that we believe or suspect have this capability and I
believe there is an increased recognition of the threat,
particularly as we look at an asymmetric type of threat in the
new world. As you know, the Aum Shirikio experimented with
anthrax prior to using sarin in the Tokyo subways. About 9
months ago there was a threat in Las Vegas of an individual to
sell anthrax. It did not turn out to be correct. About a year
ago, B'nai B'rith here in Washington, DC, received a package
stating it was in fact anthrax and there has been a flurry of
envelopes going to women's clinics across the country.
I think that as you look at both nation states and as Ron
Blanck talked about terrorist groups, most of us who look at
this consider it not a question of whether, but when we are
exposed to this agent. And I believe that it is therefore our
responsibility, particularly as the threat increases to provide
maximum force protection.
Mr. Shays. Let me just pursue the question. You used 150 of
our soldiers, our sailors and their men as well, it was a
mixture. Who were the 150,000 who received this vaccine?
General Blanck. Generally, these were the rear troops,
those in ports, airfields. They were not the front line because
this will not deter an initiated attack because it takes 2 or 3
days to begin working when symptoms appear. So this is the kind
of agent that we felt would be used to cripple the rear,
potentially, and so those were the troops that we tended to
immunize. Then the decision was in CENTCOM by General
Schwartzkopf and his staff.
Mr. Shays. You are saying that the impact is not felt
immediately. It is felt in a few days?
General Blanck. That is correct.
General Roadman. Mr. Chairman, may I just address that?
Mr. Shays. Sure.
General Roadman. Because I think we need to paint the
picture correctly. The initial symptoms of pulmonary anthrax
are flu-like syndrome, where you have a cough, you have muscle
aches and low grade fever. And as you would look at an
individual you would say you have the flu, unless you suspected
that they were exposed to anthrax. The difference between that
and the flu is that 3 days later they would be dead. And as a
matter of fact, as you look at the accidental release in
Sverdkovsk in the then Soviet Union, downwind there--we think
up to 100 people downwind who were exposed to a very small
release of anthrax and the--if you read the reports, the
physicians in the emergency rooms, in the civilian emergency
rooms started talking among each other saying are you seeing a
lot of flus? And they are saying well yes, we are seeing more
flu, but then the following question and are your patients
dying? And the fact of the matter is that once people develop
symptoms to this, antibiotic treatment in the animal models has
been ineffective and that the mortality rate is as we described
it.
So it is important to recognize that this is a public
health hazard, it is a military mission capability issue.
Mr. Shays. Is it not your testimony though you need six
shots?
General Roadman. You need six shots as required by the FDA
for the immunization.
Ron, I think you see after three, you see about 95 percent
immunization, but it is still given by the FDA protocol.
Mr. Shays. That is 95 percent established by whom?
General Blanck. By the antibody, demonstrable antibody
levels will occur, that we believe offers protection.
Certainly, it does in animal models. Actually, in a high
percentage after just two shots, 95 percent of patients will
demonstrate this antibody response after three.
Mr. Shays. And how much time do you have to wait from one
shot to the next to the next?
General Blanck. The protocol is 0, 2 and 4 weeks for the
first three shots. So a month.
Mr. Shays. Is that what we are doing right now?
General Blanck. We are doing that and then the fourth shot
is at 6 months, fifth is at 12 months, sixth is at 18 months
and then there are yearly boosters. Again, this is the protocol
established by the FDA on the basis of those earlier trials.
Mr. Shays. Now we determined that this would be Army
personnel that were not forward engaged? Was this Air Force,
Army, Navy?
General Blanck. All services.
Mr. Shays. Were the 150?
General Blanck. That is correct.
Mr. Shays. Now why are you not able to tell us who those
150,000 people are?
General Blanck. Because the record of their immunization
was entered into their medical record, rather than in an
automated system that would allow us to track them
individually.
Now we have by unit, been able to determine who has been
there and in fact, who should have received the immunization
and it was on the basis of that information that the National
Institutes of Health, Presidential Advisory Committee,
Institute of Medicine and so forth did the studies that failed
to show any correlation of Gulf related health problems with
the administration of the anthrax vaccine. That is what gives
us the information and the confidence that the anthrax vaccine
was not a cause of these illnesses.
Mr. Shays. I am going to go to Mr. Blagojevich, but I am
not clear of your answer. My understanding is that we have not
taken this 150,000 and seen--made a study exactly of the impact
on the 150,000.
General Blanck. That is correct because we do not know
individually who got it. What we have done is taken the
information from the comprehensive clinical evaluation program,
from the VA studies of those that are ill following their Gulf
war service and look to see if there were correlates with the
administration of the anthrax vaccine. And it was based on two
things. One was their own records or recollection of getting
the anthrax vaccine first, and second, on what unit they were
in.
Dr. Bailey. Let me add as far as the tracking goes, that if
you remember there were four conditions that Secretary Cohen
said. One of them was the tracking. That is one of the
overwhelming successful aspects to this program. We can track
down to the Social Security number, whether or not you are 2
days late for your immunization. Let me just say everybody
sitting at this table are the people responsible for this force
health protection mission and all of us have had our anthrax
immunizations.
That speaks to the safety, obviously, it is a leadership
issue as well. But each of us can tell you that if you are a
day late, it is known by our system. We have done an incredibly
successful job of tracking every individual and therefore will
have long term capability to review retrospectively as well.
Mr. Shays. Secretary Cohen told me he is under this program
as well.
Dr. Bailey. Right.
Mr. Shays. Mr. Blagojevich.
Mr. Blagojevich. Thank you, Mr. Chairman. Dr. Bailey, if I
can ask you a question or two. The concerns that have been
raised about the extension of expiration dates on the vaccine,
can you tell us whether the extension of expiration dates has
had any effect at all on the safety or efficacy of the vaccine?
Dr. Bailey. I can. Go ahead, I want to give you some
specifics, but go ahead, General Blanck.
Mr. Blagojevich. Yes, General, that would be great.
General Blanck. Thank you. If I may, when biologic products
are stored, whether they are anthrax vaccine or tetanus vaccine
or hepatitis A vaccine, et cetera, they have by FDA regulation
a 3-year shelf life. At the end of that 3 years, the vaccine is
again tested by the manufacturer, generally, but with the FDA
oversight to assure its potency. If the vaccine, in this case,
or other biologic products, still meets their criteria, then it
is certified for a further 3 years.
We, in addition to the FDA doing that testing in
establishing a new shelf life did the supplemental testing of
the safety, sterility, purity and potency, a separate and
distinct, actually more than the FDA requires to be absolutely
certain that there was no degradation in any way of this
product and that it was entirely safe.
Dr. Bailey. Let me also add that at no time have expired or
contaminated lots or vials of vaccine been administered to our
service member or shipped by any DOD, by the DOD to any
military facilities. That is the answer you specifically need
to know, but I wanted to give you some other specifics which is
that there was a lot number FAVO20 which was originally
approved for release by the FDA in 1994. As General Blanck
indicates, expiration dates do come up. In fact, there was an
expiration date on that of 1996. The manufacturer requested an
extension of the expiration date and they received an FDA
expiration date extension until 1999 and that is a common
practice.
Mr. Blagojevich. OK, now these have been tested by lot,
right, not by individual vials, is that right?
Dr. Bailey. By lot.
Mr. Blagojevich. Can you explain why that is the case?
Dr. Bailey. That is standard manufacturing and production.
General Blanck. Well, plus it is tested before it is put in
vials. We store it by lot, in bulk.
Mr. Blagojevich. I have one more question. When Secretary
Cohen announced the intention of the Department of Defense to
go ahead with total force vaccination, he listed four elements
as pre-conditions. Why were these needed?
Dr. Bailey. That was to assure the safety and efficacy of
the vaccine and that the program was in place in a way that
could be monitored. Specifically, you were not in the room, but
I know you know the four conditions: supplemental testing and
tracking and an implementation program and a communication
program to our service members, and finally, independent
review. And all of that was accomplished so that Secretary
Cohen could be comfortable that we moved ahead with the total
force program in the appropriate way.
General Blanck. If I can add to that, though and this has
to do with two things. One are lessons that we have learned
from the Gulf war. We are not going to do that again and have
that issue. I mean all of us are bound and determined to do
everything we can to prevent what went on there and that has to
do with recordkeeping and supplemental testing and so forth.
But it also has to do with credibility. It also has to do with
some of the things that the chairman mentioned as far as atomic
testing or Agent Orange or whatever it is that I think has
damaged the credibility of the Department substantially. And so
we had that independent review. We have the independent
testing. We have the FDA approval and so forth and so on, that
automated tracking system. We need to make sure that the men
and women in the armed forces have that confidence that what
they are getting is in, fact, a necessity and will save their
lives.
Mr. Shays. Thank you very much. Mrs. Biggert.
Mrs. Biggert. Thank you, Mr. Chairman. This is probably for
Dr. Bailey or General Blanck. You stated in your remarks that
there is only one producer of the vaccine which has recently
been acquired by somebody else, but it still is one company.
Are you comfortable with the fact that there is only one
producer?
Dr. Bailey. I am comfortable at this time that the program
that we have developed will provide safe and efficacious
vaccine throughout the total force which will take us to the
year 2006 and will include total force, active duty and
reserves. Yes, we will have safe, efficacious vaccine from that
production facility.
In general, I could share with you that I would like to see
us less dependent on any specific production capability
manufacturing site, with this vaccine or with any vaccine or
any medication we may need for force health protection.
Mrs. Biggert. Well, there is--it was shut down for a while,
renovation and inspection violations?
Dr. Bailey. It was not shut down because of inspection
violations. It was for renovation and in fact, is now beginning
production again.
Mrs. Biggert. Does the Department of Defense have----
Mr. Shays. Could the gentle lady just suspend for a second?
Would you elaborate on that answer just a bit as to the purpose
it went through renovation? Has the facility not received
critical review?
Dr. Bailey. While not manufacturing anthrax vaccine due to
the renovation, a number of deficiencies with the process were
cited. Now FDA observes and checks on all of the manufacturing
sites of any medications that are provided.
Mr. Shays. Right.
Dr. Bailey. For our forces, as well as other Americans.
None of the deficiencies were considered significant enough to
warrant plant closure or recall of the anthrax vaccine. In
fact, the FDA also found that significant progress had been
made toward meeting objectives under its strategic plan for
improving its manufacturing facility and processes.
While not required by the FDA, by the way, MPBI has
performed supplemental testing as General Blanck indicated.
Mr. Shays. Thank you.
Mrs. Biggert. To continue then, but were not some of the
lots actually quarantined, 11 lots that were quarantined with
questions about sterility and potency?
General Blanck. Yes, absolutely. And in some cases the
testing found that, in fact, they were fine and were released
by the FDA again to go through our supplemental testing to
doubly insure everything.
In at least two cases of which I am aware, we never did
release them and destroyed the lot. There was an additional
instance where we shipped vaccine to Germany, 200,000 doses and
on the basis of one vial having a little sludge in it, ice
crystals, that is, we feared the vaccine had been frozen, we
destroyed all of them.
We really are trying to bend over backward to make sure
that we have an absolutely 100 percent safe product.
Mrs. Biggert. When you do further testing is that using it
on animals or is that the process that you would determine?
General Blanck. Yes, it goes through of course the
sterility has to do with cultures and the purity with chemical
analysis. We know what is in there and then the safety and
potency on animal testing.
Mrs. Biggert. How do you dispose of anthrax vaccine?
General Blanck. I am afraid I do not know. I would imagine
that would incinerate it. That is the way you generally get rid
of biologics.
Mrs. Biggert. I was just curious. But the Department of
Defense has no interest in the company itself?
Dr. Bailey. No, absolutely not.
Mrs. Biggert. I mean there is no financial or----
Dr. Bailey. Let me just add, again, we have got answers,
but I want you to also have specific answers because we are
very confident about this vaccine.
Let me just back up a little bit and give you some details.
During a routine, quality control inspection--and by the way,
all the vials are checked visually prior to shipment, the
manufacturer detected the presence of a gasket or a stopper to
the vial, some of the material was in a number of the anthrax
vials in a specific lot. All those vials in that lot that
contained that material were discarded. Lot release data on
that particular lot was subsequently sent to FDA and upon
review, FDA did release the lot for use. So again, there is an
inert material that had gotten into the vial that was not in
the production or the safety of the vaccine or the sterility or
purity or efficacy, that there was any concern.
During the February 1998 FDA inspection, and these are
routine. They go on continually in vaccine production. The FDA
requested they be provided documentation on destruction of the
vials that contained the particulate matter. As a good
manufacturing practice, the manufacturer quarantined all their
remaining vials of that lot pending collection of the
documentation required by the FDA. No recall of vaccine of that
lot that had been shipped to DOD was instituted by the
manufacturer, nor was it requested by the FDA because all vials
had been FDA approved before shipment and had been visually
checked to insure that none of those had any particulate
material.
Mrs. Biggert. Just another followup on that. Are there any
other companies that have expressed any interest in the
manufacture of anthrax?
Dr. Bailey. Well, in that there are no others interested in
providing this vaccine except as is the program that we have
outlined here, there have not at this time.
Mrs. Biggert. One other question then. What is your
judgment that this vaccine will be effective if in case there
is a weapons grade where it is needed rather than just because
of a country that might have anthrax there.
Dr. Bailey. Again, we have looked at the immunogenicity of
the response, the antibody response to this vaccine and it is
very high.
As you heard, in fact, after your second immunization at
just 2 weeks, in that first month you have got antibody
response, high immunogenicity, so it is very, very effective.
Clearly, there have been for years, as you hear this has
been FDA approved vaccines since the 1970's, so we have almost
30 years that show this to be an effective vaccine. In fact,
there have been scientific studies that allowed the FDA to
approve the vaccine, starting back as you have heard here with
the wool sorters when this was a disease problem in the 1950's
and in fact, there have been aerosol challenges which is, of
course, of great interest to us because that is how these
spores would be weaponized. Those aerosol challenges in Rhesus
monkeys show us that, in fact, it is overwhelming protective
and that anthrax without the protection is incredibly deadly.
Mrs. Biggert. Thank you very much. Thank you, Mr. Chairman.
Mr. Shays. Thank you. Before recognizing my colleague from
Illinois, Dr. Bailey, do you have in your possession a letter
of March 11 that the FDA sent to the Michigan Biologics
Products Institute? Do you have it?
Dr. Bailey. I believe I do.
Mr. Shays. I do not want to swallow camels and strain out
gnats here, but the FDA issued a letter. I am reading from the
Center for Biologics Evaluation Research which is the FDA's
division. It has a headline, ``FDA warns Michigan Biologics
Products Institute of intention to revoke licenses.'' And it
says ``The FDA issued a letter to the Michigan Biologics
Products Institute, Lansing, Michigan, on March 11, 1997
warning that the Agency will initiate steps to revoke MBPI's
established and product licenses unless immediate action is
taken to correct deficiencies at the firm.'' And then further
on it goes and says, ``An FDA inspection of the MBPI conducted
between November 18th and 27th, 1996 documented numerous
violations in the following areas: organization and personnel,
buildings and facilities, equipment, control of components,
drug product containers and closures, production and process
controls, laboratory controls and records and reports. Some
examples are: failure of the quality control unit to approve or
reject all components, drug product containers, closures and in
process materials, packaging material, labeling and drug
products. Failure to have separate defined areas or other
control systems for manufacturing and processing operations.
Failure to assure that the equipment used in the manufacturing
processing packaging holding of a drug product is appropriate
design of adequate size for its intended use and for its
cleaning and maintenance. Failure to properly store and handle
components and drug product containers and closures. Failure to
calibrate instruments, apparatus, gauges and record devices at
suitable intervals and failure to record the performance of
each step in manufacturing distribution of products.'' That
seems a little more significant than the way I had been led to
feel, based on your answer to Mrs. Biggert.
Dr. Bailey. In fact, there were a number of deficiencies
with the manufacturing process that were cited.
Mr. Shays. Could you move the microphone a little closer to
you and push it down.
Dr. Bailey. In fact, there were a number of deficiencies
with the manufacturing process that were cited.
In February 1998, the FDA inspected the facility, however,
and none of the deficiencies were considered significant enough
to warrant plant closure or, in particular, any recall of the
anthrax vaccine and in fact, the FDA also found that
significant progress had been made toward meeting objectives
under its strategic plan for improving the manufacturing
facility and processes.
I would also say that we are pleased to report that there
has been a renovation of that plant and that many of these
things have been taken into account.
Mr. Shays. That was the whole point. The implication was
that the plant was being renovated to deal with these problems
and your implication to us was that you did not need to make
those renovations to take care of those problems.
Dr. Bailey. And the FDA did not require that there was that
renovation.
Mr. Shays. I know they did not.
Dr. Bailey. I understand what you are saying.
General Blanck. The renovation was planned long before
these problems were brought to our attention. The 1997 letter
had to do with production lines of vaccines other than anthrax.
They had not looked at that, though the 1998 inspection, while
it acknowledged progress, certainly did continue to find some
problems with the anthrax line by which time we had shut it
down or Michigan had shut it down.
Mr. Shays. The record will show, Dr. Bailey, that your
answer was accurate. I mean, we are not disputing the fact that
there was not a recall and the plant was not asked to shut
down. But I think the record will also show tremendous concern
by the FDA revoking a license is not something that is done
lightly or suggested that it will be done lightly and there
were significant reasons and I am gathering your testimony is
that you feel that this has been dealt with?
Dr. Bailey. I do and I should also state that the JPO is
going to testify later on bioport specifically and that I think
you can obtain greater information there as that is an
acquisition and procurement area, which is outside of my
medical purview. I obviously have great concern about safety
and efficacy and therefore manufacturing processes.
Mr. Shays. Thank you. Thank you for your patience,
Congresswoman Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman, and it is really a
pleasure to be on this committee and on this subcommittee.
Thank you.
I have a number of questions in other areas but I want to
followup a little bit on this area of production. Is it true
that the Department of Defense is paying for that renovation?
Dr. Bailey. Again, this is outside the affairs of Health
Affairs, and so I would suggest that would more directly be
related to JPO and questions referred there. I would be happy
to take the question, however, for the record.
Ms. Schakowsky. I am looking at the brochures that were
issued to service members and their families. Under the
question, ``What if I am pregnant?'' this is to service
members. ``Pregnant women should not receive this vaccine. If
you are or believe that you may be pregnant, you should inform
your health care provider. The vaccination program will be
deferred until the pregnancy is completed.'' And then further
in the one that goes to families, it says, ``There is also no
scientific evidence to suggest that future pregnancies by
service members or their spouses will be affected by the use of
this vaccine.''
First of all, what was the basis for deciding that this was
not a vaccine safe for pregnant women?
Dr. Bailey. There are no vaccines to my knowledge that are
recommended to be given or very few, recommended to be given to
women who are pregnant. It is generally a safety generalization
for women who are pregnant. Although again, there is no
evidence at this time that there is any concern to the fetus of
a pregnant woman.
It is our policy, however, if anyone is pregnant or feels
they may be pregnant, that they step out of line, that they
acknowledge that and that their vaccine would be therefore not
given until the completion of the pregnancy.
General Roadman, you wanted to----
General Roadman. Well, I am an obstetrician so I can talk
to that and that is we do not--I can verify, we do not give
immunizations just on a basis of common sense of not exposing a
fetus to anything external, but there is no scientific evidence
to document damage to fetus by vaccines.
General Blanck. We have had, if I may add, several
individuals who received the vaccine at our laboratories become
pregnant and have had no problems. This is not a vaccine,
again, like tetanus, like any of the other vaccines which have
similar constraints on them that would cause any problems
during the pregnancy.
The FDA does not do testing of vaccines during pregnancy,
as again, a common sense measure, we recommend against giving
it.
Ms. Schakowsky. Well, then in terms of long term effects,
have there been any tests on Rhesus monkeys or otherwise on the
potential long term adverse effects of the vaccine? Saying that
there is no evidence that it is a problem is not quite the same
as saying we have data to show that there is, in fact, no
problem.
Dr. Bailey. We have a program underway now, Tripler Army
Medical Center, in Hawaii where we are looking at a long term
study so that we will be able to track the vaccine that we are
giving today. That will be a prospective study to be
accomplished over the upcoming years.
General Blanck. Yes, and we have specifically tracked the
individuals since 1974 at our laboratory who have received the
over 10,000 immunization doses of the vaccine and as late at
1992 have found no long term health effects. Plus, the Michigan
plant has since 1972 distributed over 68,000 doses of the
vaccine between the early 1970's to about 1994 and those have
gone to Centers for Disease Control to universities to
veterinarians working with the organism and so forth.
If there are side effects or long term health effects, it
is reported to the FDA. They have no such reports.
Ms. Schakowsky. You mentioned the CDC. Earlier, it was
stated that should someone become ill from anthrax that there
really was not any antibiotic protocol that would address that.
The CDC says doctors can prescribed effective antibiotics.
Usually, penicillin is preferred, but Erythromycin,
tetracycline or another one that I cannot pronounce can also be
used. To be effective, treatment should be initiated early. If
left untreated, the disease can be fatal.
So the CDC is saying that should someone contract anthrax
that it is treatable.
Dr. Bailey. In fact, I think that is probably referring to
cutaneous and not aerosolized anthrax. Weaponized, aerosolized
anthrax, if you are unprotected, without vaccine, you will die
within 24 to 36 hours.
Now there are treatments that are undertaken before you
have symptoms. If you have symptoms of anthrax and as you have
heard here today, by the time we know we have been attacked,
people are coming forward with flu-like symptoms. If you have
got symptoms, you are going to die 99 out of 100 times
regardless of what treatment we would provide.
I would also add that it is very difficult to determine
exactly what it is that we are dealing with. In order to even
know that it is anthrax, we have to do things like a chest
xray. We have to do a gram stain on blood products. By that
time, you can imagine if our troops are, in fact, in harm's way
and have been attacked, that we have a major combat casualty
situation on our hands.
Now we do treat. We will, in fact, treat those with Cipro,
Doxycillin, penicillin, but what you are commenting on, I
believe, is cutaneous anthrax as reported by CDC.
Ms. Schakowsky. Do we have any noncompulsory vaccination
programs or are all of our programs in the armed services
mandatory?
Are there lots of service members who are seeking to be
excluded from this program?
Dr. Bailey. We are, at this time, not specifically
tracking, although we are looking at a policy, given our
concern about those who may refuse this particular vaccine.
However, that is the refusal of a direct order and that is
something that is a command issue, dealt with as a line
commander issue.
At this point, it is our understanding that we have over
223,000 people that have been immunized with less than 200 who
have refused the immunization.
Ms. Schakowsky. Is it true that in Great Britain that it is
an optional program?
Dr. Bailey. That is true, but it is also true that there
are ships at sea in the British Navy where no one is protected,
so again, it is a concern of ours that this is a much higher
threat than it has ever been before and we do not want to see
our sons and daughters going into harm's way unprotected.
Ms. Schakowsky. Let me ask one other question about this
issue of protection. Other than the vaccine, are there other
strategies, safeguards that are encouraged, clothing, masks, et
cetera?
My concern here is that is there any way in which this
vaccination program could be somewhat counterproductive, that
is, that will people who are vaccinated feel that they do not
need to take other kinds of precautions?
Dr. Bailey. Let me just share with you that 4 weeks ago I
was in the Persian Gulf and I was both on an aircraft carrier
at sea and in the desert with our troops and I slept 1 night in
a bunkered area and although sitting in the Pentagon there are
times where one would wonder why you may need anthrax
immunization, it was no doubt in my mind that I was in harm's
way, and that being responsible for all those around me that I
was pleased that we had a very robust vaccine program there in
the desert and anywhere else where it is considered a high
threat.
General Blanck. If I could add something because I think
you are hitting on a very important point and it has to do with
other protective measures.
The MOPP gear we have, the protective gear for chemical and
biologic, in fact, does protect against not only chemical, but
biologic agents such as this. The difficulty is that an enemy
would probably use this before the start of hostilities.
For example, as we were building up in the rear areas and
that kind of thing, and we would not know it because we do not
have real time detectors. By the time we would know about this,
it would be far too late to put on those protective measures
and certainly this is not something during a buildup that
people would be using 24 hours a day. It is very difficult to
work in and so forth and so on.
So would they at a time of other threat take, put on this
measure even though they had the vaccine, absolutely. Why?
Because of other biologic and certainly the chemical agents for
which the suit is good protection.
This is so deadly, not only because of the illness it
causes, but because it can be dispersed, it can be spread, we
can all be exposed without anybody knowing it until 2 or 3 days
later and then it is too late.
Ms. Schakowsky. Thank you. Thank you, Mr. Chairman.
Mr. Shays. Mr. Blagojevich.
Mr. Blagojevich. Thank you, Mr. Chairman. I would like to
get the chronology straight if I possibly can and this is a
question for whoever wants to answer it.
The Secretary announced the program in December 1997. He
included the four conditions to be met prior to going forward.
You stated that he certified these conditions were met the
following May 1998. Is that right?
Dr. Bailey. Yes.
Mr. Blagojevich. But did you not go ahead before May with
the accelerated program for Southwest Asia?
Dr. Bailey. Yes. In Southwest Asia the concern that the
threat had become so great that it was important for us to go
ahead and immunize those who were early deployers into that
area of high threat.
Mr. Blagojevich. As I understand it, there is no uniform
consistent form of discipline for service members who refuse
the vaccine.
Is that a fact?
Dr. Bailey. Correct. It is a decision that is made service
by service.
Mr. Blagojevich. Is there any risk that individual
commanders may discipline differently and cause a disparity
that might foster favoritism or in the alternative resentment?
Dr. Bailey. Again, that is a line command issue and I would
ask----
Mr. Blagojevich. General, could the General address that?
General Roadman. With everything under the Uniform Code of
Military Justice, it is the line commander, it is the commander
on the ground that is in control of that. The line commander is
responsible to begin with education, to get the information out
to all of the troops. After that information is given and if
there is somebody who refuses, particularly in the Air Force,
we have medical counseling and if it is a religious issue,
counseling by the clergy. If it is not a religious issue, then
a direct order is given to get the immunization. And then there
is a choice that the individual has about whether to comply
with a lawful order or whether to enter the Uniform Code of
Military Justice.
This is, in many ways, a good order and discipline issue
because in a military you cannot decide which order you are
going to obey and which order you are not going to obey. It
just does not work that way.
And I have been asked the question well, would not a
civilian have a choice of doing that? And the answer is, of
course, a civilian would have a choice of doing it. That is
what differentiates us from a civilian organization. And the
fact of the matter is that we put our people in harm's way and
they do not have a choice of where they go and therefore we
need to protect them. That is why the local commander is in
charge of that because he is responsible for the protection of
the troops, as well as the military mission.
I do not believe that as we look at the Uniform Code of
Military Justice that there is an issue of favoritism. I cannot
talk about the resentment issue because any time you are in
trouble, you have a tendency to resent that.
Radm. Fisher. And that is very similar, the same situation
in the Navy in regards to the commanding officer on board the
ship, the commander of Marines. They have the responsibility
for their troops and the authority and responsibility rests in
that individual. So whether there is favoritism or not, I have
no idea. But I know that the leadership takes this issue very
seriously and acts accordingly.
General Blanck. General Kirwin, when he retired as the Vice
Chief of Staff of the Army many years ago, gave a speech that
stuck in my mind and it said, it is very interesting that to
protect the rights of those in this society, we who wear the
uniform give up certain of our rights. It is a term of
employment, that, in fact, you follow lawful orders. And you
cannot choose which orders to follow as General Roadman said.
So this really is not in that sense a medical issue. It really
is a command issue, a good order and discipline issue. And in
my view, those that choose not to follow the order, have broken
their term of employment and should be separated from service.
Now with what degree of punishment, that is up to the line
commander, but I believe--then they should be where they can
make choices and that is as civilians.
Mr. Blagojevich. One final question. What do you think are
the biggest challenges the Department of Defense faces in
implementing this vaccination program?
Dr. Bailey. I think always there is a concern about
perception and as you have heard here today this is a safe
vaccine that provides us the very best way of protecting our
troops when they are in harm's way. I would be very concerned
if the perception and these low numbers of refusals that you
hear in an overwhelmingly successful program that is being
tracked at the highest possible level to the most minute detail
that in some way this program would be adversely affected
because it provides us such safety as we attempt to provide the
absolute best force health protection available.
Mr. Blagojevich. Thank you.
Mr. Shays. Before we go to our next panel, I would like to
get a few answers on the record and have a dialog about a few
areas that we have already discussed.
As a doctor, Dr. Bailey, what concerns do you have about
the health effects of multiple vaccines administered at the
same time?
Dr. Bailey. We have administered multiple vaccines, I have
taken multiple vaccines. It is part of my job to institute
policy and provide on-going health protection that often
includes providing multiple vaccines and at this time I have no
concerns about the vaccines that have been provided or that we
are planning to provide for those who deploy.
Mr. Shays. So you do not give much credibility to the
studies that talk about the cocktail effect of various
vaccines?
Dr. Bailey. I have seen nothing at this time. Now if you
are asking am I concerned, every one as well, I think, at this
table was involved as you have heard, when we went through the
issues that dealt with the medications, pretreatments and
protective medicine that was done during the Gulf war.
We are very concerned that we understand exactly what
happens to our troops in theater, so that we can assure
ourselves that, in fact, there are no long term health risk
effects for any of the treatments that we provide to protect
our troops.
So am I not concerned at all? I am certainly concerned
about those who may be sick who have deployed with the U.S.
military, and would want to follow that and have a better
ability to track. I am confident that this program you are
hearing about today provides us again, with the new standard
for allowing us to track that in the future so that we can be
absolutely certain from a scientific point of view that we do
not have a cocktail effect which could adversely affect
someone's long term health.
Mr. Shays. How many biological and chemical agents are out
there that we have concern about?
Dr. Bailey. The actual list is a classified list, but
clearly----
Mr. Shays. What has been printed in the newspaper?
Dr. Bailey. I will share with you a list that includes some
of the things that you have heard about. So again, I think
setting the standard here with anthrax is probably one of the
most essential aspects of the program you are hearing about
today. Clearly----
Mr. Shays. Ma'am, I just want an answer----
Dr. Bailey. Anthrax, plague, small pox, bot tox, ricin.
Mr. Shays. And their variations, right? I mean there are
different kinds of anthrax? Are there variations to them?
Dr. Bailey. Well, there are variations to some. Clearly,
small pox, there are a variety of what we call orthopoxes.
Plague, you can have bubonic plague or pneumonic plague.
Mr. Shays. Doesn't the Defense Department list a whole host
of biological toxin warfare agents? Isn't there a lot more than
what you have mentioned?
Dr. Bailey. Yes, but I am being very careful to mention
those that are specifically not on a list that I may be aware
of that are classified, but certainly, there are long lists of
biologic agents on the piece of paper that you have in front of
you, and by the way, in the world today, which concern me
greatly, which are biologic agents that could be weaponized.
Mr. Shays. I just want to know the truth. you are
expressing your concerns, but I also want there to be some
candor between us. When I do not see that candor I begin to
suspect. I mean this is a list with a whole number of threats
to our soldiers and this is not classified and it is a list
that includes probably 50.
Dr. Bailey. Sir, I do not know exactly what you have on
your list, but I would say, of course, there are concerns. But
what we are focused on are the assessment of threat risks in a
specific area where we may have deployed troops. Those are the
assessments we make on a regular basis so we can determine what
kind of protection we need to provide against those particular
illnesses or disease processes.
Mr. Shays. The trouble I am having communicating right now
is that we are both aware of a classified list. The classified
list includes more than what you have. And we are also aware
of--and as soon as we make a xerox copy, we will go through
some of that. But it is more than just a few.
Dr. Bailey. I agree.
Mr. Shays. And you talk about anthrax as killing you in 3
days. Some of what is on that list would kill you in less than
a day. And it makes me wonder--I do not need to be convinced
that anthrax will kill, but I also know there is a whole host
of others that will kill.
Dr. Bailey. Yes sir, but I will take a look at this list,
but let me just say that we know Saddam Hussein had vats and
production capability and planned for implementation of anthrax
as a weapon.
Mr. Shays. And we also know he had others.
Dr. Bailey. Yes.
Mr. Shays. Yes, right.
Dr. Bailey. That is correct.
Mr. Shays. But we are not protecting and that a vaccine
will not protect.
Dr. Bailey. And we know----
Mr. Shays. And so I am just making the point to you that
once we have made the point that anthrax can kill, I can see
that, it will kill. And I also can see the fact that if I was
ordered to take it, I would probably take it, if I was a
soldier.
I do not concede the fact that you have to--and I need to
be convinced of the fact, I would like to be convinced of the
fact that this has to be in order and that you cannot have 200
people who might decide not to take it and that I wonder what
harm is done in that instance and so that is another area to
talk about.
But first, just this issue. You are protecting against one
deadly substance, one biological agent. There are others.
Dr. Bailey. Yes sir.
Mr. Shays. And when we had pyridostigmine bromide [PB],
easier for me to talk about and we ordered every one of our
troops to take what was, in effect, for the use it was used--
experimental, and we had a requirement from the FDA in order
for you to use it in this experimental way that the records be
kept, and they were. There is credibility here. And I am happy
to know that you are taking recordkeeping. But there is concern
among scientists who have respect in their professions that
there was a cocktail effect. And you are telling me that you
have taken this agent and therefore you are comfortable. That
is somewhat interesting, but it does not answer the question.
There are people who are concerned about the cocktail effect.
It causes me concern that you are not concerned.
Dr. Bailey. Mr. Chairman, I do not mean to leave the
impression that I am not concerned. I clearly would be
concerned about any effect which is why I am so pleased we are
beginning to track immunizations which as you understand we did
not--we were not afforded the ability to do so during the Gulf
war. So yes, in fact, I am very concerned that there could be
any effect from any of the medical pre-treatments or
interventions that we provide and that it could, in fact,
affect adversely someone's long term health.
General Blanck. Mr. Chairman, if I could add briefly. I am
aware of at least four studies, most recent of which was
published in the Annals of Internal Medicine that has looked at
several thousand travelers who have received multiple
vaccinations, cocktails, if you will and has not found any
long-term health effects, plus we follow our workers, as I
described, not only for anthrax, but for exactly that effect
because many of our laboratory workers receive not only the FDA
approved vaccines, as our soldiers do, but also the
experimental vaccines that we are in the process of working on
so that we can have some protection for some of these other
agents. And we have found in those workers again, no long term
health effects. And they are fairly substantial numbers.
Certainly not on the hundreds of thousands, but more than 5 or
10. So we are concerned.
Last, I think your point about other agents is exactly
right now. Anthrax is probably the easiest to use and as you go
down the list, you find them more difficult to use, more
limited in their use. It is not to say they would not be used.
So it is incumbent on us to develop other additional vaccines,
other protective measures, detectors and so forth.
Mr. Shays. Thank you. Let me just conclude this part and
then I will go to the next line of questioning.
Are we concerned that some of our adversaries have been
able to alter anthrax and that the vaccine that we are
requiring our troops to take would not be protective?
Dr. Bailey. We have no evidence at this time of there
having been any genetic alteration that would affect the
efficaciousness of the anthrax vaccine.
Clearly, that would have to be a concern that could occur
as we move ahead in a complex world where there is much going
on in terms of DNA and altercations of DNA.
I am pleased to report, however, that there is also no
evidence that antibiotic resistant strains are not responsive
to our vaccine as well, so again, we feel comfortable the
vaccine we are providing will assure safety.
Mr. Shays. It has been--I am sorry, Doctor.
General Blanck. Well, the Russians have reported that they
were able to alter anthrax by genetically engineering it in a
way that actually made their vaccine different than ours
ineffective.
Mr. Shays. And is it not true that some of the soldiers
were affected by this themselves? Did they not have some
casualties themselves?
General Blanck. Well, that was from the natural anthrax
strain that they were working on that was released, that
General Roadman alluded to and there were 100, I do not know,
plus or minus----
Mr. Shays. Do we know that was a natural strain or not?
General Blanck. We do. That was a natural strain. It was
not a genetically engineered strain.
Now the genetically engineered strain not only was
engineered, but it changed its fundamental characteristics and
made it unstable. They were never--we are told, we believe, got
it out of the test tube. They were not able to do the things
with it that you would need to, to weaponize it.
Now we have been trying and trying to get some of what they
claim they have, but it is only reports, to see if our vaccine
is effective. I would simply say that our vaccine is effective
against drug resistance, against all natural strains. Whether
it would be against such an altered organism, I cannot say.
Mr. Shays. I would just conclude and express the concern
that this committee will look at this list.
We are basically having a force protection on one--anthrax,
when there are so many others. And it would strike me that our
adversaries will just choose another substance. And then we
have now--instead of going the direction the French have gone,
which is basically dealing their force protection with
protective gear which I believe is superior to ours, and
learning how to use it and perfect it, so that they can be
protected against a whole variety of agents and it is just a
concern I have.
I am pleased that we are keeping better records, however.
General Roadman. Mr. Chairman, can I? I have reviewed this
list and clearly it is a compendium of bacteria and virus. It
is a textbook of microbiology. In fact, we do protect against a
number of these and as you look at this, you look at Salmonella
typhoid, we give immunizations to that. Vibrio cholerae, we
give immunizations to that. But much of this has to do with the
public health issues and the sanitation of our force and it is
important to be able to put these into context and many of
these are not stable as anthrax. Now anthrax is a particularly
interesting micro organism because it develops spores when it
is not in an environment that is conducive to life. And those
spores can live for 40 years in the soil. I think, as you know,
there is an island north of the UK that was contaminated prior
to World War II.
The whole point of that is that anthrax is particularly
different from any of these in that it can be laid down by
aircraft. It can be put into an aerosolizer, like a fogger and
will remain suspended and therefore be aerosolized and not be
unstable.
So I think you are correct, there is a whole list of these
and there are public health responses. There are also
immunizations that we do give, but you cannot look at anthrax
and say well, that is the same as Clostridlum perfringens or
Vibrio cholerae because they are different organisms.
We believe that anthrax is, in fact, the primary threat
that we have. We know that it was weaponized. We were
fortunately not exposed to it. It is weaponizable. It is
lethal. We have an immunization for it.
Mr. Shays. Thank you, General, that is helpful.
Do any of my other colleagues have questions?
Ms. Biggert.
Mrs. Biggert. Thank you. There are people in the services
who have refused the vaccine. What about in the case of
religious reason or that they do not take any drugs at all
because of their religion. Is there a discipline for that?
General Roadman. No. It is not a disciplinary issue for
religious reasons.
Dr. Bailey. There are several reasons why you are permitted
to be excluded like if you are running a high fever, if you are
pregnant, if there are religious reasons. But outside of that,
it is a lawful order.
Mrs. Biggert. Would that be a reason for a transfer from
some areas that might be--they might be at risk?
Dr. Bailey. Absolutely.
Mrs. Biggert. And then my other question is as far as
multiple vaccines, do we keep records on having this vaccine at
the same time that other vaccines are given? Maybe that has
been asked. I do not know.
Dr. Bailey. I happen to have around my neck as I believe--
have you got yours as well? The personal information carrier.
We have been doing military medicine in many ways in terms of
our tracking, the same or through a lot of different wars and
deployments. We need to change things. We need to develop this
personal information carrier which is smaller than a dog tag
and which would let us know what the health concerns were
before deployment, during deployment, what occurred during
deployment and then post deployment and long term. And that is
the information technology that we are seeking and actively
involved in and hope to have very soon.
Mrs. Biggert. Thank you very much.
General Blanck. This, by the way, has my immunizations on
it. We will begin testing this at Fort Bragg and presumably
Bosnia later this year. It also has an ultra sound of a fetus
in utero which I assure is not mine, but the point is that it
carries an enormous amount of information. It is a 20 megabyte
chip.
Mrs. Biggert. Thank you very much. Thank you, Mr. Chairman.
Mr. Shays. Thank you very much. Is it the intention of DOD
to integrate this with the VA because right now----
General Blanck. Absolutely. Absolutely.
Mr. Shays. Thank you very much. I found this panel very
helpful and informative. Thank you very much.
I should have asked one thing. Is there anything that any
of you would like to say before leaving? I always like to give
that option.
Is there any comment that any of you----
Dr. Bailey. We appreciate the meaningful exchange and I
would also share with you, we absolutely appreciate the
concerns that you share with us, that we share as well. All of
us look for the same end, providing for the defense of this
Nation, but also defending those who do so. Thank you.
Mr. Shays. Thank you. May I just make a request that
someone on your staff stay for the next panel and be able to
respond to that, in writing, if there is a need to. Not that
you all need to, but just to have someone stay. Thank you very
much.
We have testimony from six witnesses our second and last
panel and we welcome them. Captain Thomas L. Rempfer,
Connecticut National Guard; Major Russell E. Dingle,
Connecticut Air National Guard; Private First Class Stephen M.
Lundbom, U.S. Marine Corps; Mr. Mark S. Zaid, attorney at law;
Colonel Redmond Handy, member, Reserve Officer Association; and
Ms. Lorene K. Greenleaf, Denver, CO.
We invite our witnesses. We need 12 chairs. If I could, I
would ask you to all stand and we will administer the oath.
Thank you.
[Witnesses sworn.]
Mr. Shays. We are going to go in that order. I am going to
put on the clock and it is going to be 5 minutes. I will let
you run over a little bit, but if we can stay close to that it
will be appreciated. But frankly your testimony is probably
more helpful than the questions we would ask, so we are happy
to hear your testimony and we are delighted to have you here.
Thank you.
Mr. Rempfer, we are going to start with you.
STATEMENTS OF CAPTAIN THOMAS L. REMPFER, CONNECTICUT NATIONAL
GUARD; MAJOR RUSSELL E. DINGLE, CONNECTICUT AIR NATIONAL GUARD;
PFC. STEPHEN M. LUNDBOM, U.S. MARINE CORPS; MARK S. ZAID,
ATTORNEY AT LAW; COLONEL REDMOND HANDY, RESERVE OFFICER
ASSOCIATION; AND LORENE K. GREENLEAF, DENVER, CO
Captain Rempfer. Thank you, sir. Good morning. I want to
begin by thanking Congress for all you do to insure America has
the best trained, equipped and protected military in the world
and I thank the members of this committee for your willingness
to thoroughly review the anthrax vaccine immunization program.
Given the rapid rate at which the costly program is
progressing, I believe timely action by Congress is absolutely
critical to insuring that the vaccination policy is truly in
the best interests of force protection.
There is an important common bond behind why we are all
present today. And that is because we all care about our armed
forces. We simply disagree on what form of force protection is
best for our troops. Do we achieve it through mandatory
vaccines or through other means?
I believe the answer to this question is important because
service members are making serious choices about their military
careers as a result. Out of respect for the military and my
chain of command I am not here today in uniform. My
professional dissent on this policy brings me to Congress only
after attempting to resolve this issue and my concerns through
my chain of command. I believe it is my duty to speak out
against a dangerous doctrinal precedence and the questionable
effectiveness presented by the anthrax policy.
We are not speaking out against a vaccine for public health
issues. We take a lot of shots. We have always taken them. We
are speaking out against vaccines against biological weapons.
As an officer in the Air Force I have obeyed orders for
nearly 16 years while serving as a fighter pilot in Korea,
Central America, Bosnia and the Middle East. That is what makes
my duty today particularly difficult, yet from my earliest
training at the Air Force Academy I have also been trained to
question orders if they are objectionable. I learned this from
officers who lived through the challenges and learned from the
lessons of the Vietnam War.
Today, it is not the legitimacy of this order that I
question or the officers that are enforcing this Department of
Defense directive. Instead, I am questioning the assumptions on
which the policy is based and feel that by implying our troops
are protected against anthrax we may actually place them in
more danger.
The Defense Department acknowledges they did not anticipate
a resistance to this program. The resistance is partly based on
our self-education process and what we have discovered as a
cursory nature of the review that occurred prior to the
implementation of the program. Therefore, I hope this
recognition warrants a congressionally directed comprehensive
review that also answers the following questions.
No. 1, what suddenly mandates the use of this outdated
vaccine? Both the capability to weaponize anthrax and the FDA
approval for the vaccine have existed for decades. The troops
are asking, as you have asked today, why now? No. 2, why force
us to take a vaccine that was not intended to combat the
inhalation exposure to anthrax and it will be defeated by using
different or mutated strains or simply a different pathogen
altogether. The body armor that our Department of Defense panel
refers to is perceived by many service members as ``tin foil
armor.''
No. 3, why abandon the time tested deterrence doctrine of
massive retaliation that was successful in the Gulf war by
mandating a force protection measure that may create a facade
of force protection, possibly endangering our soldiers?
No. 4, finally, could it be dangerous to erroneously imply
to our top military and civilian leaders that our soldiers can
withstand a biological attack through defensive posturing? Why
have we prudently avoided this path for the proceeding decades?
Perhaps it is because we cannot defend against the dynamic
nature of this warfare.
After answering these questions I believe you will conclude
we can do better than an outdated, marginally effective vaccine
that targets only one of many potential biological threats.
Instead, I hope Congress will mandate a program that offers
real comprehensive force protection based on the logical
foundations of intelligence, detection, external protection and
medical treatment.
These foundations of force protection rely on a credible
willingness to use force. This resolve won the cold war and it
won the Gulf war. Abandoning this time tested doctrine and
emphasizing the inevitability of biological attack to advocate
a defensive anthrax vaccination policy may inadvertently result
in legitimizing biological warfare.
A monument in Washington, DC, honors America's soldiers by
saying ``first in war, first in peace, first in the hearts of
our country men.'' Just as that quote impressed me, I am
equally encouraged by this committee's decision to keep your
service members' interests first by reviewing this program.
The dialog you have initiated today will perform a vital
service to this Nation by halting the potentially dangerous
doctrinal shift. You can help insure our armed forces readiness
by stopping personnel losses. You can also help insure that the
armed forces remain an attractive service option for young
Americans.
It is my ardent hope that this policy will be reviewed and
that mandatory inoculations will be discontinued. This review
may find that the cost of the anthrax vaccination policy far
outweigh its limited force protection benefits.
Thank you for the opportunity to speak today.
Mr. Shays. Thank you, Mr. Rempfer.
Mr. Dingle.
Major Dingle. Thank you for the opportunity for speaking
and while the other gentlemen----
Mr. Shays. Excuse me, Mr. Dingle. I am sorry, you need to
use that mic. And let me just say something to you. We are
doing 5 minutes, but do not feel you have to rush. You can take
your time and if you go over 5 minutes, we can deal with that.
Major Dingle. Thank you for that, sir. It is interesting to
listen to the first panel talk and during that short time I
wrote four pages of one line notes that I would love to address
with corrections and follow on questions, but I will read my
opening statement first.
Thank you once again for allowing us and myself to appear
today.
Mr. Shays. Mr. Dingle, let me just say that you will have
an opportunity to go through that. So you can have some peace
of mind.
Major Dingle. Thank you.
Mr. Shays. And let me just say to all the witnesses: It is
not easy to come and testify before Congress and I think it is
particularly difficult when you serve in the government and are
testifying. And I know that your superiors recognize that you
are doing this in the proper way and that we all respect that.
So we know it is discomforting to you, but I would like you to
feel at ease because you are welcome here. The committee
invited you. We want you here. And the military understands
that you are here by our request.
Major Dingle. Thank you for those words of encouragement.
We are, in fact, while I can speak for myself, very
apprehensive this morning, but after listening to the first
panel we are encouraged that we have been given the opportunity
to speak.
I am a Guardsman, a citizen-soldier, a Major and a former
Flight Commander in the Connecticut Air National Guard. I have
just completed my 10th year of flying A-10's for Connecticut
and 17 total years in the service. I will not see an 11th year
in Connecticut flying the A-10. I have declined the opportunity
to receive the anthrax vaccine and am resigning.
Last September, my unit announced an anthrax vaccination
policy that many officers objected to. In response, the wing
commander delayed the shot schedule, and formed a team to
research the vaccine. I was a key member of that team and in
little more than a week the information I gathered presented a
compelling argument against the DOD claims of safety and
effectiveness. The team presented 15 questions to the commander
on October 14th. He forwarded these questions to his superiors.
By the end of October and with no answers forthcoming, we were
told the anthrax conversation was over and that the shots would
commence as scheduled.
Connecticut began the anthrax vaccination program on
November 7th. Out lot was using lot FAV030, a lot specifically
identified by the FDA as being contaminated in their 1998
inspection report of the Michigan production facility. It
became apparent that our use of the chain of command to effect
a difference was not working. We felt that public involvement
was our last opportunity to get this program reviewed and
perhaps halted.
I have been a reluctant participant in this on-going
tragedy, but as a Guardsman, I am in a unique position. I have
the option to resign when I do not agree with an order. While
it would be easy to just walk away and leave this mess for
others to deal with, I cannot in good conscience allow this
program to go unchallenged.
I am here today to try to highlight the fallacies of the
DOD claims of safety and efficacy and to highlight the
uncertainty that traditional Guardsmen and Reservists face. The
questions we have raised have been distributed to our
commander, the news media, all of you and others.
Have our military leaders sought to answer these questions?
Have they prepared canned answers just in case you ask them?
While I cannot begin to argue the complex medical issues
with these medical experts, the literature available contains
clear, unambiguous statements that do not agree with the DOD
position. For instance, if the vaccine has been FDA approved
and licensed since 1970, why did a former Fort Detrick
commander define the vaccine as experimental in a 1990 article?
If the vaccine is absolutely safe and effective, why did
another Fort Detrick commander conclude that the vaccine was
unsatisfactory in a 1994 edition of the medical textbook of
Vaccines? If the vaccine is so widely used, why isn't it in the
latest Physicians' Desk Reference. The DOD relies on a 1994
American Academy of Pediatrics report that the vaccine is
effective against inhaled anthrax, yet the 1997 report by this
academy dropped that statement.
While it appears that the DOD is devoting vast amounts of
time, money and manpower educating its members about how safe
this program is, it is falling short in some key areas. Why
isn't the DOD telling members of the military what side effects
to be aware of or report? Why are they discounting those who do
report side effects and not report those side effects to higher
headquarters? Why isn't the VAERS Form available or made known
to members?
Mr. Shays. What was the last point, why what?
Major Dingle. I am sorry, I said why is not the VAERS Form
available or made known to members?
As citizen soldiers, we all face the uncertainty of medical
care should our health be affected while on some sort of
military status. We may be soldiers on the weekend, but when
Monday rolls around, we are civilians. What happens when a
Guardsman reacts to this vaccine on Tuesday or next week or 2
years after she retires? Will the State be forced to pay the
medical care of affected unit members? Will their civilian
insurance companies pick up the tab or will the Federal
Government pay? Will the member face a revolving door of
denials and blame games between the VA, the State and the
insurance companies? A threat to our personal health, perceived
or real, is a critical factor in whether or not we choose to
volunteer our bodies in service to our country.
How will this threat affect my civilian job? Should I risk
both my military career and my civilian career? These are real
and serious questions that many volunteers are asking
themselves, the threat and uncertainty of care needs to be
addressed.
Finally, the number games that DOD plays need to be
challenged. There does not seem to be one set of numbers that
DOD is using for public relations. One spokesman says they do
not know how many shots were given in Desert Storm. The next
has an exact number including an exact number of adverse
reactions. Another DOD spokesman reports one number of pilots
resigning and having first hand knowledge, I know that number
is incorrect. The lack of consistent data is troublesome.
The research and literature is out there. It was performed
and written by experts in the field. There can be little doubt
that it was accurate when accomplished. If the DOD refutes or
interprets these data differently to defend their position,
perhaps it is time then to allocate funds to the DOD, perform a
proper study of this vaccine in the interest of providing the
best protection to our forces.
This controversy is not about the Connecticut Guard, the
people seated with me or myself. It is about what is right, not
who is right and this is wrong.
I urge the committee to ask the tough questions, to demand
forthright answers based on documented evidence, to hold the
military accountable for its actions and decisions that affect
the health of all of its members including its citizen
soldiers.
Thank you so much.
[The prepared statement of Major Dingle and Captain Rempfer
follows:]
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Mr. Shays. Thank you very much, Mr. Dingle.
Mr. Lundbom.
Pfc. Lundbom. Thank you, Mr. Chairman, distinguished
members of the subcommittee, good morning. My name is Stephen
Lundbom. I am originally from Livermore, CA. I am currently
serving as a Private First Class, U.S. Marine Corps at 29
Palms, CA. I am here to tell you of my own personal experiences
after I decided that I would not accept the mandatory anthrax
vaccine. I believe that other Marines--refusers have also
shared some or all of my experiences. The views that I express
here are my own and not meant to reflect those of the U.S.
Marine Corps.
Since this is the first time I have been to Washington, my
Dad and I spent Sunday afternoon touring the historical sites
such as the Lincoln Memorial, Washington Monument and the
Vietnam Veterans War Memorial. At each I saw the words justice,
democracy, liberty and independence. These are concepts that
this great capital represents to me. They are the things that
America is based on and they are the things that our military
is sworn to protect and uphold.
I enlisted in the U.S. Marine Corps in June 1997 because I
believed in its stated values of pride, honor and dedication.
However, when I and other Marines began to ask our commanders
questions about the safety and effectiveness of the anthrax
vaccine, they responded in ways that in my opinion lacked
respect for fundamental legal and democratic rights as citizen
soldiers.
Like many Americans of my generation, when I felt a need to
learn more about the vaccine, I went first to the Internet.
There I quickly learned that there were a number of unanswered
questions about this vaccine, particularly as it was being used
to protect us from inhalated anthrax spores. I was especially
concerned that there was more debate about whether the vaccine
would keep us safe if bio weapons were to be used on the
battlefield.
The fact that there had been no research on whether the
vaccine could cause sterility, birth defects or cancer also
worried me, not to mention when we had the opportunity to get
educated by our command, questions that were to be answered by
the medical officers at the interviews were ceased and
questions were stopped. We were no longer allowed to ask any
more questions.
When we were called to take the shot, the first in Okinawa,
it was not the normal shot procedure. The normal shot procedure
that I am familiar with in the Marine Corps is going into a
medical facility, a medical personnel having a shot record, a
medical personnel having a computer and one medical personnel
giving the shot. They were being recorded on computer and on
medical record. In this case, the shot was given in a long line
with one piece of paper such like this with a list of names and
they were highlighted through once they received the shot. No
medical records were present at the time of the shot.
Twenty-seven of us announced that they would refuse the
shot. After much pressure and many threats, all but five of the
initial resisters in my battalion gave in and accepted the
vaccination. Like the other four, I was given nonjudicial
punishment, Article 15, my sentence was 30 days restriction, 30
days extra duty and a forfeiture of $539 pay which is one half
month's pay for 2 months. Some of the refusers were forced to
walk approximately 16 miles each day during the weekends and
holidays and many miles other days since the battalion office
was a half a mile from the barracks and we had to sign the duty
at the location almost every hour from 7 a.m. to 9:45 p.m. When
2 weeks of punishment period had passed, another anthrax
vaccine was scheduled and once again I was called in and
ordered to take the shot. I was again charged and put up for
another nonjudicial punishment. During this Article 15
proceeding Lt. Colonel Stuart Navarre, my Battalion Commander,
ordered me to provide him with the phone numbers of my mother's
employer, a doctor in general practice back in California. This
frightened me because I did not want my refusal to affect my
mother's job in any way as she is a nurse. Despite my fear I
told Colonel Navarre that I did not believe I had to answer the
question like that. He then punished me a second time. This
time I received 45 days restriction, 45 days extra duty
including signing in the log book every hour and another half
month's pay lost for each of 2 months. And this time I received
a reduction of rank from Lance Corporal to Private First Class.
To be honest, this constant harassment and punishment wore
heavy on my spirit and morale, yet I was able to stick to my
resolve not to be vaccinated because of the strong support I
received from my wife, who is also a Marine and my family. My
fellow refusers were a source of support also.
Finished with our 6 month deployment to Okinawa, my unit
returned to 29 Palms, CA where I naively perhaps hoped that my
situation might change for the better. Once I completed all my
punishment for both nonjudicial punishments, I submitted a
request for leave. I was not even allowed to fill out a leave
request. My command made it clear that any leave request would
be denied. I was told that I could not leave the base because I
had refused the anthrax shot and therefore did not deserve to
go on leave.
At this point my family and I agreed that I needed outside
legal help to help me cope with the unending harassment. My
brother had attended an anthrax town meeting which had been
sponsored by the G.I.'s Rights group, Citizen Soldier of New
York. The event was held in San Diego. My father contacted the
Director, Tod Ensign, and he put me in touch with Louis Font, a
Boston lawyer who specializes in military defense work. I
learned on April 10, 1998 that the Deputy Assistant Judge
Advocate General had sent an internal memorandum to all Navy
and Marine Corps Judge Advocates. This memo concludes that
after punishment for a first refusal, refusal to obey
additional orders to be vaccinated for anthrax cannot form the
basis for additional convictions of nonjudicial punishment or
court martial.
The Marines have violated this attorney's memorandum in my
case. I have been doubly punished and now I face a court
martial. I believe it is immoral, unethical, illegal and wrong
that I have been punished twice at NJP and now face a court
martial when the Marine Corps lawyers have been before them and
the internal memo that states that this is unlawful.
My father called my Battalion Commander Lt. Colonel Navarre
and he said that his hands were tied and he was only following
Marine Corps Commandant policies. He said the policy is an NJP
for the first refusal, NJP for the second refusal and a special
court martial for the third.
After my attorney explained to me the legal issue, I gladly
signed a petition of extraordinary writ which we filed on
Monday, March 22, 1999 before the Navy/Marine Corps Court of
Criminal Appeals at Washington Naval Yard. It asks that the
second NJP be set aside and that no court martial be allowed
for this refusal. I ask that Congress investigate whether the
Commandant or the Marine Corps has an illegal policy and
whether subordinate commanders such as my Battalion Commander
are subjecting enlisted men such as myself to multiple
punishments as a result of this policy.
It seems to me that the reason for the policy and the
reason the Marines are disregarding their own legal memorandum
is to keep the number of refusers so low that Congress will be
misled in thinking that the compliance is virtually total.
I had never before disobeyed an order and my unblemished
record reflects my desire to be a dedicated Marine. I love the
Marine Corps and everything it stands for. But when it came
time for me to accept this vaccine, I felt in my heart, mind,
body and soul that I was doing the right thing by refusing.
I appreciate hearing the testimony of the highest ranking
military health authorities who have testified today and it
made me respect even more the committee's willingness and
desire to hear the point of an enlisted person at the lowest
echelon.
Thank you very much for having me testify today. I welcome
any questions you may have.
Thank you.
[The prepared statement of Pfc. Lundbom follows:]
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Mr. Shays. Thank you, Mr. Lundbom.
I will go to Mr. Zaid.
Mr. Zaid. Mr. Chairman, distinguished members of the
subcommittee, thank you for the opportunity to appear before
you and offer my comments on the Pentagon's anthrax vaccination
program. My remarks are my own opinion, and not that of my
organization, the James Madison Project.
I have been involved in this controversy since April 1998
when I was requested to represent one dozen sailors who were
refusing the vaccine aboard the U.S.S. Independence. In June
1998, I filed a lawsuit under the Freedom of Information Act
for information on the anthrax vaccine and most recently I
served as the lead civilian defense counsel for Airman Jeffrey
Bettendorf who was the first serviceman to face a court martial
for refusing to take the vaccine.
My oral testimony will focus on the circumstances arising
when a member of the military refuses the vaccine and the
exposure of several significant problems with the Pentagon's
policy.
After being retained by the Independence sailors, I
investigated the prospect of a class action lawsuit in order to
halt the program. The planned strategy was to challenge the
safety, effectiveness and necessity of the vaccine. Legal
research, however, quickly revealed that the likelihood of
success was virtually nonexistent. The focus then turned to
obtaining information.
The FOIA lawsuit against the Departments of Army, Navy and
Air Force and FDA was quite comprehensive. It sought all data
that related to the anthrax vaccine. The overwhelming majority
of the released documents have never been publicly discussed
before today.
Let me first address the legal issues which are actually
very straight forward. There is no set policy as to how a
refusal will be dealt with, except as any other military
discipline problem. Because of the sensitivity surrounding the
program, many officers first emphasized counseling and
education before imposing punishment. Some, however, resorted
to threats of force, although official departmental policies
were that no force will be used.
Until recently, the military had been fairly consistent in
imposing penalties. Typically, the following would happen. A
soldier refuses the vaccine. He is taken to an Article 15,
nonjudicial proceeding. He is found guilty, reduced in grade,
fined, restricted to ship or base and assigned extra duty.
Eventually, he would be administratively discharged. If he had
a clean disciplinary record, a general discharge under
honorable conditions would likely be approved. In at least two
cases that I know of, even where an individual went AWOL, a
general discharge was still granted. It was only a matter of
time, however, before someone would proceed to a court martial.
Airman Jeffrey Bettendorf who was stationed at Travers Air
Force Base in California followed the typical pattern at first.
Clean record, wife, child, church going, basic Boy Scout.
Unlike prior cases, somewhere in his chain of command someone
wanted to set an example and Airman Bettendorf found himself
facing a court martial.
The key issue in an anthrax refusal case becomes whether
the order to take the vaccine was lawful. The biggest battle is
that the vaccine is FDA approved, therefore the order is
presumed valid. From my work on Gulf war syndrome issues, I was
aware of theories that the vaccine had been modified in order
to hasten or increase its potency. Therefore, our primary
defense strategy was that the order was unlawful because the
vaccine being used may not have been FDA approved and was
therefore experimental. As a matter of law, consent was
required.
It was also our position that legal precedent gave us the
right to challenge the safety, effectiveness and necessity of
the vaccine.
Through discovery we pushed for samples of the vaccine for
independent testing. But before we went to trial, the Air Force
agreed to accept Airman Bettendorf's earlier request for a
discharge and he was processed out of the service under other
than honorable conditions.
Airman Bettendorf's case has unfortunately now changed the
game plan. Rather than a discharge, refusers will now face much
greater prospects for a court martial and once a conviction is
obtained, in even one case, a precedent will be set that will
be nearly impossible to overcome absent extraordinary
circumstances.
Let me now address some very important concerns about the
program and I will do so through the Pentagon's own model of
myth versus fact.
Myth. The vaccine has been routinely used in the United
States since 1970.
Fact. No industry routinely uses this vaccine. Some use can
be found among veterinarians and livestock workers, but no
evidence of widespread usage exists. And if you ask someone
from one of these two fields about use of the vaccine, the
typical response is ``what vaccine?'' In fact, only about
30,000 individuals have received the vaccine since 1970 and
relatively few people outside of the military receive a shot
per year. The private sector uses between 400 and 500 doses per
year. This amounts to perhaps 100 to 300 people per year using
the vaccine. The inoculation of 150,000 servicemen during the
Gulf war was the first major use of the vaccine in any
significant quantity. Six times the number of people were
inoculated than had been in 30 years prior.
Myth. There has been no long term side effects from this
vaccine or no long term consequences have been demonstrated.
Fact. These statements are totally insupportable. The
Defense Department has never researched whether use of the
vaccine may result in long term health consequences. In fact,
no studies, either in the public or private sector have
examined potential long term consequences. The manufacturer's
label itself reveals that no cancer or fertility studies have
ever been performed. When confronted with these statements of
fact, the Pentagon's PR machinery responds ``the vaccine has
been used for 30 years. It is unethical to conduct tests on
humans.''
No one is calling for the initiation of tests on humans.
Accepting the Pentagon's assertions, however, that the vaccine
has been widely used, how difficult would it be to locate a few
hundred or maybe a thousand of people who once took the vaccine
and after taking into account all the appropriate variables,
examine their health. Do they suffer from cancer, leukemia,
Alzheimer, any medical malady? Can it be traced to the vaccine?
When 2.4 million lives are at stake there is a moral, if not
legal responsibility of the Pentagon to undertake such efforts
rather than offer excuses.
Myth. A safe and effective vaccine is available that will
protect our forces.
Fact. We have discussed there are some issues of other
spores and mutations, so I will not comment more about that.
But withheld from the public's knowledge, until our FOIA
lawsuit, was that the Pentagon discovered years ago, it was
briefly mentioned earlier, that the current vaccination series
of six shots is outdated and unnecessary. In September 1996,
the vaccine manufacturer with the approval of the Army filed an
initial investigational new drug application with the FDA to
reduce the vaccination schedule. The new proposal would be two
initial doses with annual boosters as compared to a series of
six doses over 18 months.
Despite ample proof of the redundancy of the six shot
series, the Pentagon still implemented the current program. By
not waiting for FDA approval, the Pentagon cost taxpayers at
least an additional $32 million in vaccination costs.
My final comments pertain to the adverse reaction rate. The
manufacturing label for anthrax states that systemic reactions
occur in fewer than 0.2 percent of recipients and that is
characterized by malaise and lassitude. Chills and fever were
reported in only a few cases. The real truth, however, has been
that systemic reactions among those in the military have been
nearly 7 times greater. Internal documentation we obtained
revealed that up to 1.33 percent of recipients suffered a
systemic reaction. And it is vitally important to understand
what is meant by systemic reaction. It is potentially extremely
harmful and possibly fatal and while a percentage rate of 1.33
percent may not seem high, when applied to the fact that 2.4
million servicemen will be receiving the vaccine, this means
that as many as 32,000 servicemen may suffer serious or fatal
reactions.
Reports of systemic reactions such as fever and prolonged
muscular weakness have been occurring since the program began.
Even more shocking we have heard stories that medical officers
have been reluctant or even refused to file adverse reaction
reports and that they routinely try to convince the servicemen
that what they are suffering has something to do with something
else, not the vaccine.
The Pentagon's response has been to distribute, and I do
not say this lightly, disinformation by manipulating the
statistics and the words. Documents that are now publicly
disseminated assert that systemic reactions of 0.2 percent or
more are very rare which is contrary to its own reports and
more importantly that fever and chill symptoms have been now
recategorized as severe local reactions, rather than the
systemic that they are. This gives the false impressions that
such reactions are common when the fact is such a reaction
could be deadly.
Mr. Chairman, it is a sad fact that we regulate industries
such as machinery and automobiles far better than we do those
that affect what may be placed in our bodies.
The anthrax vaccine currently in use for the military would
probably not withstand FDA scrutiny today were it to apply for
a license, yet no one seems concerned that we do not know
whether this vaccine is actually a safe product over the long
term. No one seems alarmed that the adverse reaction rates
exceed the figures supplied by the vaccine manufacturer itself
or that the Defense Department has sought to masquerade these
ill effects through questionable wording changes.
To be sure, as you said earlier, anthrax is an intensely
dangerous biological weapon. It is imperative that we seek out
ways to adequately detect the spores before contact and protect
ourselves afterward, but the Pentagon's anthrax program
represents nothing more than an easy out from the hard task of
devoting time and money to developing adequate detection
equipment and if possible, efficient vaccines that are truly
safe and effective.
The Pentagon has knowingly misled the American people
concerning this vaccine. Whether in 20 years from now advanced
medical technology will demonstrate the vaccine was either
dangerous or safe is anyone's guess, but until we know the full
facts, 2.4 million are potentially being placed in harm's way
and until the proper studies have been undertaken, the United
States should follow the lead of the United Kingdom and
implement its anthrax vaccination program as voluntary.
Sorry for going over time, I appreciate the opportunity.
[The prepared statement of Mr. Zaid follows:]
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Mr. Shays. Mr. Zaid, I am not a great fan of class action
suits, but your questions were very provocative. Before I go to
Mr. Handy, I just want to be clear, it is your testimony that
only between 100 and 300 people in the United States in the
private sector take this vaccine, a year?
Mr. Zaid. Based on documentation and reports and I believe
I think that dosage came from an article in the San Diego Union
Tribune, it indicated and I believe it refers to the private
sector, that between 400 and 500 doses per year are used which
given the FDA approved six shot series, I would presume that is
only of 100 to 200 or 300 people.
Mr. Shays. Even if you were off by 1,000----
Mr. Zaid. We are talking about a very, very small number.
Mr. Shays. Mr. Handy, I am going to get right to you, I
just will say that this is the first of many hearings and I
found myself wanting to ask a question based on what you said
of our previous panel, but we are going to have FDA in front of
us and we are going to nail some of this down. And we will try
to do it fairly quickly.
Mr. Handy.
Colonel Handy. Thank you, Mr. Chairman. I sincerely
appreciate the committee's inviting me to discuss my concerns
about the policy. I am grateful this important issue is
receiving serious review. Before proceeding, I would ask the
committee to enter my written testimony in the record, along
with supporting documents which I will provide in full shortly
after the hearing.
I am here today only as a private citizen. I am not
speaking on behalf or in any official capacity on behalf of the
Department of Defense, the Air Force or the Reserve Officers
Association which selected me as its most outstanding
individual Air Force Reservist in the Nation in 1996.
I am a Colonel in the Air Force Reserves, promoted just
last summer. Last fall, the Air Force selected me for a 4-year
full-time military position in the Pentagon. I elected not to
pursue that job. Right now I am seriously considering early
retirement which will mean a voluntary reduction in rank and
pay to Lt. Colonel. Why would I forego the remainder of my
career in protest over a shot I will not even face for several
years? I care deeply about the integrity of my DOD employer and
my service, but I am thoroughly dismayed by a tidal wave of
information and abuse which is causing widespread damage to the
dignity and the devotion of our Nation's defenders.
Mr. Chairman, my hope is that the deception stops here. Let
me be specific about just some of the disturbing information
which is causing reactions in the ranks. First, key experts
consider vaccines a useless defense against biological warfare.
Second, major medical journals give no credence to the
claims that anthrax vaccine will work against inhaled vaccine
in particular.
Third, and this is important, Fort Detrick studies show the
anthrax vaccine has an 82 to 100 percent failure rate. The DOD
is ignoring their own data.
Fourth, as already mentioned, the Joints Staff may be
developing as many as 50 or more other vaccines which could
provide additional sources of misery for our dedicated
soldiers, sailors and airmen.
Fifth, nearly 50 documented types of side effects already
occur with this vaccine.
Sixth, few think of challenging the statement that the
vaccine is FDA approved, but as Mark Zaid just pointed out, we
wonder and have heard that it would not be approved using
today's standards.
Last, and perhaps most ominous, the DOD intends to increase
its role in State biological disasters according to several
reports. In other words, if this prospect materializes, the DOD
may also abandon informed consent principles and proper
procedures in the civilian community.
I feel this policy must be addressed early before any more
damage is done to morale, recruiting, retention and combat
effectiveness. We are potentially witnessing the slow, but
systematic dismantling of a yet formidable total force with
balanced contributions from the Guard and Reserve. An Air Force
Reserve pilot recently remarked, ``For the past 2 months, I do
not know if I am coming or going. Being in the Reserves these
days is like being on active duty full time. Our guys have been
making a lot of sacrifices to do this job. We have reached the
breaking point and the anthrax issue is basically the last
straw.''
Mr. Chairman, I would like to humbly suggest several useful
congressional actions regarding this specific vaccine and DOD
practices in general. First, I believe it would be most
beneficial for the Congress to require DOD to cease its
baseless marketing claims of the vaccine as safe and effective.
Also, perhaps a funding moratorium could be imposed on the
vaccine program and money could be used to study its
ramifications so that both military and civilian doctors
understand how to treat all 50 side effects.
Although a catastrophic reaction has not occurred yet,
people have been hospitalized and the close friends and
relatives of our soldiers, sailors and airmen already consider
this situation totally unacceptable.
Finally, I would ask the committee to require DOD to
develop regulations and policies that would treat individual
service members with respect on medical matters. I would
suggest those policies include full medical workups prior to
inoculations, allergic reaction assessments, the right of
informed consent on questionable vaccines, FDA approved or not,
full disclosure of risks and side effects by a non-DOD paid
expert, and the right to exercise personal, religious beliefs
to decline questionable vaccines regardless of church
affiliation or stated written doctrine.
I believe the era of the mandatory use of questionable
vaccines must be terminated for the health of the force. Our
allies who do not do this to their soldiers also do not have
Gulf war syndrome or they have addressed their mistakes and
offered voluntary vaccines.
Mr. Chairman, I am sure that every member of the Armed
Forces will be grateful for your support and care in this
matter. I thank you very much for the opportunity to testify.
[The prepared statement of Mr. Handy follows:]
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Mr. Shays. Thank you, Mr. Handy. Ms. Greenleaf. I am sorry,
we need to give you that mic and then we can move the yellow
papers and you can put it in front of you a bit. Thank you.
Ms. Greenleaf. Thank you, Mr. Chairman, and members of the
committee. I am privileged to appear before you to present a
personal viewpoint on the anthrax vaccination policy adopted by
the Department of Defense. The position I present today is not
only my own, but it is shared by concerned parents, spouses,
family members and friends of military personnel who are
unfortunate and often unwilling participants in a policy which
is believed to be misleading to military personnel and the
American public.
Our views are neither radical nor unfounded, nor are our
sons and daughters and spouses troublemakers as implied by
government officials who are in charge of either implementing
the policy or presenting an acceptable public relations
position to the general public and the media.
Needless to say that people who have refused the vaccine
are volunteers and in some cases come from families who have a
history of military service. These men and women are often
well-trained, intelligent and articulate. They are truly, in
many cases, the best and brightest of their generation, trained
in nuclear technology, air combat and flight, and constitute a
cross section of the fields of training and study offered by
the military. Yet faced with an order to take the vaccine
without reasonable answers to reasonable questions, these men
and women have been borne to pressure and coercion of the
military authorities. They have suffered reduction in rank,
reduction in pay, restriction of liberty and dismissal from the
service, all because they refuse to accept the assurances of
the authorities that the vaccine is safe and effective.
The DOD points to the numbers and says look at how many
people support our policy. What they do not tell you is that
many personnel cannot afford to say no, cannot afford to take a
reduction in grade and pay and as a result are pressured into
subjecting themselves to the needle.
There is more resistance out there to this policy than the
numbers support. Unfortunately, the military sidesteps the
issues of the safety and efficacy of the vaccine with its
dictate, it is an order. We do not stand against this policy
without medical support. Drs. Meryl Nass and Victor Sidel, two
prominent physicians in the United States, have expressed
similar doubts in articles written for various scientific and
medical journals. The policy has had a negative effect on U.S.
military preparedness and expertise. The recent resignations of
Connecticut Air National Guard pilots cost the U.S. Government
the skill and training of fighter pilots who had a history of
service and were willing to continue to put their lives on the
line in Iraq or other unfriendly combat zones. Two U.S. Navy
nuclear trained personnel aboard a nuclear aircraft carrier
were recently disciplined and dismissed from the service for
failure to take the vaccine. More trained and qualified
personnel are on the horizon asking for answers. The answers
are not forthcoming.
And the response of the military is to take these well-
trained men and women, refuse them answers and discharge them
for insubordination. All this in a context of concern among the
military's own recruiting commands that the military cannot
attract or keep qualified people.
Look at what is happening to these young people and ask
yourselves why is there reluctance of younger people to join
our armed forces? I am the mother of a young sailor who has
completed his service. My son took the vaccines and I am upset
that the military has indifferently cast aside questions of its
safety. I am upset that the quality control questions on the
production of the vaccine have remained unanswered. I am
further upset that my son, as well as all military personnel
have possibly been inoculated with a vaccine the safety of
which is a big concern and which may not even work.
To subject our men and women of the armed forces to a
vaccine which is possibly unsafe, unreliable and ineffective is
to subject all such personnel to a misguided impression that
the vaccine will protect them from all strains of anthrax
regardless the manner of exposure. It is an Alice-in-Wonderland
approach to a problem. It is one shared by me and thousands of
men and women all over this country.
On behalf of myself, my family and on behalf of the men and
women who have had the courage to stand up to this misguided
policy, I thank you for the opportunity in allowing me to speak
today.
[The prepared statement of Ms. Greenleaf follows:]
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[GRAPHIC] [TIFF OMITTED] T7559.057
[GRAPHIC] [TIFF OMITTED] T7559.058
Mr. Shays. You all have made a very valuable contribution
and have given us areas to focus in on as a committee that we
will not fully get into today, but we will get into. When I
come to my questioning, Mr. Dingle, I am going to allow you to
go through that list and just give me reactions. But I am going
to, at this time, recognize my colleague from Illinois, Ms.
Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman. I just as a group
want to say about your testimony that I do not think anyone who
is listening to the testimony could doubt one, its sincerity or
two, the real commitment that you have to our armed services
and that you are--your strong belief in your commitment and as
good Americans. So I just wanted to say that that came through
to me strong and clear. And that there is clearly a difference
of opinion here.
I wanted to ask you if we really know, is it Colonel Handy?
You said that there has been no catastrophic occurrence. And
given the large numbers of people that have currently had the
anthrax vaccine, do you not think that there is something
reassuring about that?
Colonel Handy. Reassuring that the catastrophic event, some
kind of catastrophic event has not occurred?
Ms. Schakowsky. Yes.
Colonel Handy. When you look at the number of people who
will be vaccinated and the risk that is involved with the
numbers, eventually 2.5 million people, I find it unusual that
we are jumping from in the Gulf war, 150,000 to 2.5 million
based on shaky grounds. That is a 17 fold increase in the
number of vaccinations that will be given compared to the
largest number given previously. I think the risk would be
extremely large, in that case, that there certainly is a
greater chance, a much greater chance that that could happen.
I also think that given the situation where we have had
people in the hospital already, and if you look through the 50
reactions so far, you find some that are kind of disturbing,
blackouts, for one. There is one that Lorene mentions on a case
that is being reviewed now where there was a behavioral, a
severe behavioral problem that occurred with a person who has
not had any behavioral problems apparently in his life.
Ms. Schakowsky. So essentially, you are not comforted. You
say that there are--in your view, there is enough evidence that
multiplied many times that there could--I am wondering if any
of you would say that there is an acceptable level of adverse
reaction or if we have to seek out a vaccine where there is
none at all.
Mr. Zaid. Congresswoman, obviously, we are at somewhat of a
disadvantage of answering what is predominantly a medical
question, but obviously you have reactions to vaccines, almost
every type of vaccine invariably produces some sort of
reaction. That is not the issue.
The issue in this case is the extent of the adverse
reactions and the level of it, particularly being that the
adverse reactions being seen amongst our troops are up to seven
times greater than what the manufacturer and the FDA have
essentially approved. And that should be alarming yet I have
only seen it downplayed in all public comments. I would love to
hear a public comment from the Pentagon in reaction to that. I
have seen much of their internal documentation. Their internal
documentation, I can tell you, and I have provided it to the
subcommittee, differs from what they have said publicly and as
to how they have categorized adverse reactions and the rate of
adverse reaction. And if I might, with respect to what you
asked for Colonel Handy, there is another story down below the
surface that really has not come out to the public. Now those
of us that have worked on the issue have been aware of it
because we speak very often to family members and service
members. The level of opposition has been much greater than has
been publicly acknowledged by the Pentagon. It just has not
reached the level of punishment.
There were times where I would receive a call and be told
that units had 200 people initially trying to refuse the
vaccine. Ultimately, it only dwindled down to a few, typically
because some were persuaded often they read the information.
They felt that they were content enough to take the vaccine.
Most cannot refuse because of their level of seniority. They
cannot give up the salary. They cannot deal with the
possibility of losing a career in the military for this. Some
have been threatened. We have had many reports of threats. It
is not a widespread policy, but I can tell you it has occurred.
We had situations like in Ms. Greenleaf's son's case where
opposition to the initial shot occurred, punishment occurred,
but then the soldier consented to the vaccine. Those numbers
are not being counted.
The real impact upon the military will not be coming from
those on active duty. It will come from the Reserve and the
National Guard units. We have had almost two, at least two
units, for example, Connecticut and at Travis Air Force Base,
where the Guard units just up and quit as we have heard, and
almost become nondeployable. Now they did not, but we have not
just mechanics--my client at Travis Air Force Base repaired
equipment--we are talking pilots quitting over this. That is
where the impact will be and we have not really seen the true
extent as to how the Guard units will react.
Ms. Schakowsky. I am a little disturbed by that route of
argument as well, saying that because members of the armed
services have objected to an order then therefore it is by
definition our obligation to rethink that order. I mean one
certainly would not want to argue that in a combat situation if
there was some resistance to going into combat.
So what is it about this that makes it unique that because
there have been refusals, more perhaps than you say there are,
then we have to rethink our policy?
Mr. Zaid. That is true. There is a grave danger to refusing
a lawful order. Under military law, there is an ability to
challenge even the lawfulness of an order. Many times I would
presume it probably fails. In this circumstance, I think a lot
of the reaction certainly comes from a lack of credibility in
the Pentagon from past problems. The chairman mentioned some of
them earlier. That is not necessarily a reason why to create
serious doubts, but that has certainly fueled fear amongst
service members.
The true impact comes from when you consider some of the
policy implications and again, some of the issues the chairman
raised, why anthrax? In fact, internal documentation we
obtained in the lawsuit demonstrated that during the Gulf war
when another FOIA requester had asked for similar information
on vaccinations, the Pentagon said we cannot release this
information. It is harmful to our interests because we would be
telling our enemies how many people we vaccinate, what we are
vaccinating them against, and what is our stockpile of
vaccines. That was back in 1991. The reasoning was if a
biological or chemical weapon is going to be used against you,
you do not want to tell your enemy that you are vaccinated
against that because hopefully they will use something that you
are vaccinated against, rather than being hit by something
else.
So now from a policy standpoint, I am not a military
strategist, but this is fueling a lot of growing fear
particularly among the family members. Why publicize this?
Would not, as the chairman suggests, our enemies just shift
over to another weapon. That is one of the issues. It is a very
in-depth process, obviously.
Ms. Schakowsky. And a number of those questions, I think,
are medical questions and the FDA may be able to shed some
light on that. I am glad that the chairman said we will have an
opportunity there.
I wanted to get into some of the pressure tactics that were
used and not at length. I am just concerned, you said that
there were five others or five of you total who ultimately
refused. Were these kinds of pressure tactics kind of standard
operating procedure where you were? Have you heard of others?
So when we get these numbers of refusals, are they skewed based
on those kinds of tactics--those pressure tactics?
Pfc. Lundbom. Ma'am, in my situation, we were pretty
isolated. We were on the island of Okinawa, Japan, so we did
not really know about any what the other--how other units were
handling the situations, but with us, before the shots even
came up to be taken, the command took initiative and asked who
has doubts about this? Who is confused about this? When they
saw the alarming number of people stand up and say well, I
really do not want to take this vaccine, including many number
of people who were soon to be getting out of the military who
would not be allowed to finish the cycle of 18 months. They had
classes after classes, counseling and then when we started
getting rumors cycled through what the punishments might be:
time in prison, up to 2 years, we were told; dishonorable
discharges; threatened that you will ruin your military career,
you are going to ruin any chance of a successful civilian
career. This scared a lot of people because we have people in
the unit that have wives, children and other family members
that they need to take care of. So this scared a lot of people
and when the shots finally came around to it, they pretty much
had no choice, but to take the vaccination. And when we were in
the theater, when we were told we were going to have the
opportunity to ask questions, at first they told us their
information that they had and then once they came around to us
asking questions, the people answering the questions may have
been just a little underskilled in the field, they might not
just have had the knowledge, but they could not answer the
questions. And with that, the congregation of military
personnel became heated and they were quite distraught and the
command halted questions. They stopped questioning and that was
it. No more questions. You are taking the shot.
Ms. Schakowsky. Thank you. Did anyone else want to respond
to that?
Ms. Greenleaf. I would like to make a comment. Dr. Sue
Bailey, I believe it was, Dr. Bailey said that there had only
been eight adverse reactions reported to the FDA on the
vaccine. I have the current VAERS report. You will find that in
my written testimony. There have been 84 reported with 6
hospitalization and 2 life-threatening situations. The military
medical facilities are doing a horrible job of reporting these
adverse reactions. These people are being told they have got
the flu, go lie down, you will be OK in a few days. After
receiving the inoculations these symptoms start within hours.
My son is now suffering adverse reactions from the vaccine and
we had to complete the VAERS form ourselves, the military did
not do this.
Ms. Schakowsky. Thank you.
Captain Rempfer. I did have one thing to add if you don't
mind. I think myself and Major Dingle, as fighter pilots, seek
out root causes for problems. Personally, I have witnessed a
very unfortunate event in my unit, one that I think is going to
occur in many units across the country in our reserve
components and that is the implementation of this policy. As
fighter pilots, we tend to look for root causes. I do not think
our units are to blame. I think the policy is to blame. I think
that many believe and all the questions that are arising show
that the policy to be hard to defend. There are many
inconsistencies.
I would like to point out just a couple more of the
inconsistencies that were disturbing to us and caused us to
make these major decisions in our careers. The long-term
studies that the Department of Defense maintains by this
committee's opening statements concurs are in question, as
well, the widespread use. Of late, there was an article in the
National Guard Association Magazine that talked about the
National Bovine Ranchers Association. They had no knowledge of
this vaccine.
Even a comment by Ms. Bailey earlier today, she mentioned
that there were 634,000 troops that had taken the vaccine. That
number is widely inflated. I think what she meant to say was
doses, but I guess my question as a service member is why are
we creating a number concerning doses in order to try to create
the impression of a greater sample size that is being
inoculated? It comes down to trust. These are issues of trust.
We are not in a combat situation, but when we are in a combat
situation that is a vital element of our ability to perform.
Another example, we had a disagreement earlier about
whether or not the FDA had forced the close down of the plant.
The Department of Defense continues to maintain, there has been
letters to the editor that maintain that the FDA did not cause
that. But Dr. Burroughs in his letter, he was sanctioned by the
Department of Defense to do a study, agrees and it is in our
written testimony that the shut down was due to the FDA
As far as numbers go, most of us feel like the first
initial step would be an optional policy so we can continue to
sort through the program and the potential problems that there
are. It is creating problems out in the field. We are allowing
pregnant individuals not to take the shot. We are allowing
religious refusers not to take the shot and if the refusers of
the vaccine on other grounds are so few, that perhaps they can
be included as well, while we continue to study the issue.
Thank you for your time, ma'am.
Ms. Schakowsky. Thank you.
Mr. Shays. Let me start with you, Mr. Dingle, and ask how
you reacted to the first panel. You wanted to make some
comments and I would welcome that and I would welcome any other
of you making any comments to what you heard in our first
panel.
Major Dingle. Thank you for this opportunity and it may be
a little disjointed as I bounce around a little bit and I am
not going to go through all of them.
The DOD, panel 1, along with other staff presented a very
nice full color presentation for you. One of those large
posters was the 42 adverse reactions. General Blanck indicated
that he had a nodule and therefore an adverse reaction. I would
like to know if he was 1 of those 42, as was General Fisher. He
said the side effects of his shots were less than those of
other shots that he has received. Are his adverse reactions
part of that 42?
Mr. Shays. We will find that out. That is a good question.
Major Dingle. That is a fair question. That needs to be
asked.
Mr. Shays. You are making me regret you were not on the
panel asking questions.
Major Dingle. Dr. Bailey said that the anthrax was
identified, right at the beginning of her opening statement was
that it was a critical issue. I was curious to know when that
was identified. Was it identified in 1996? 1986? 1976? Also,
that number of 42--let me go back to that again. I know of six
in Connecticut alone. I have no idea if they have been reported
or not up the chain of command. So that is some of the number
stuff that I think needs to be--and once again, Mr. Zaid
commented on that at length, the numbers game.
If you will give me a couple of seconds to review my notes.
Mr. Shays. Sure. In fact, I would be happy to have you
review your notes and if you want me to call on somebody else,
you can come back.
Major Dingle. Thank you.
Mr. Shays. Does anybody else want to react to the first
panel? Mr. Handy.
Colonel Handy. There was another figure mentioned that the
reaction rate was 0.047 percent. That is quite an increase if
you just do the math. According to what was accorded earlier in
publications throughout the Department of Defense, for
instance, the Capital Flyer, Admiral Cowan was noted as saying
it was 0.0402 percent. That means the decimal place goes over 2
more points which really gets to be beyond the scope of
believability because if you take the 0.0402 percent times the
2.5 million in service that will get the shot, you are saying
that only five members in the service will have systemic
reactions. So the 0.047 percent, now is 175 if you do the math.
Again, 0.047 percent means you move the decimal place over
again 2 points. And as we have heard in testimony, the vaccine
insert says it is 0.2 percent. That translates to 5,000 service
members who will get systemic level reactions. Fort Detrick
studies as Mark Zaid pointed out, at 1.3 percent, again moving
the decimal place over 2 digits, gives as many as 32,000. So
the figures are all over the map and it causes a great deal of
credibility problems in our opinion.
Mr. Shays. Any other observations?
Pfc. Lundbom. Actually, I would like to kind of put a few
questions out there, if I may, Mr. Chairman. On page 1 of Dr.
Sue Bailey's testimony, she--paragraph 2 in about the middle of
it, she says, ``Extensive immunization tracking, strong
commander leadership with medical support'', I want to question
the command leadership and with the medical support on the
lower levels in such like battalions and platoons and squads
where people are actually getting vaccinated. We do not all
just go to a big hospital at the Pentagon and get overseen.
With my experience of watching all the members in my unit
stand in a big long line and get vaccinated without their
medical records on hand, and then having our name just simply
highlighted through a paper and it is supposed to be put into
records later, well, we had members that were on a rifle detail
who were going to miss their third shot. It goes first shot,
spend 2 weeks, second shot, another 2 weeks, and then third
shot. Well, they were on a rifle detail and they could not make
their third shot. So they were going to go documentate that
they were going to take their shot later than what FDA had
approved it for. When they went down to do that, they had found
that the first two shots had not been documented inside their
medical records. So I just wanted to throw that question out.
Mr. Shays. Had not been documented?
Pfc. Lundbom. Had not been documented, sir. And also
another question thing on the testimony because on page, at
about the middle of the page where it says Secretary Cohen
approved to implement on May 18, 1998 and again toward the
right hand side of the top paragraph below that it says over a
7 to 8 year period, well, that was true when they put it at
2006 to complete the program, but since they bumped it up to
2003 to my understanding. And I just wanted to throw that
question out there also. Thank you.
Mr. Shays. Any other observations, Mr. Dingle?
Major Dingle. If you have the moment and please indulge me,
maybe about 10 points and I do not necessarily want to generate
all the discussion over it. I would just like to enter them in
the record as possibly a question for follow up for other
investigations.
I will do it chronologically from the beginning of the
first panel's testimony. General Blanck stated that guinea pigs
were not a good model for studying the effects of the anthrax,
especially the aerosolized. If so, why is the most recent study
presented, which was presented in September 1998 conducted by
Dr. Ivins from Fort Detrick. Their animal was the guinea pig.
Why are they spending money on studies using animals that are
not conducive. I am not sure--I think there is some problems
with using monkeys and stuff, but apparently you do not have
those ethic problems with whether it is rabbits or guinea pigs.
So their most recent publicly presented study involves the use
of the animals they say is not a good model.
General Fisher said, talked about the criteria for filling
out a VAERS form was 24 hours off of duty or hospitalization. I
have talked with the folks at CDC/FDA that run the VAERS
program and that is absolutely different from the folks there
and what they would like to see reported. Any reaction
whatsoever should be reported and its use basically is that of
a post-marketing surveillance program to build the data base
for any and all drugs and vaccines, not just the anthrax
vaccine, obviously. So I am curious to know why the military
definition for a VAERS report, generating a VAERS report is so
different than the rest of the society?
General Blanck also stated that he was impressed by a
former, I believe general officer, what he said a few years ago
that soldiers give up rights when you wear the uniform. I would
like to know specifically which rights we give up when we took
the oath to serve our country. I do not remember reading or
accepting any abrogation of my rights.
Dr. Bailey spoke later on of the threat risks.
Mr. Shays. Could I just ask--I do think you give up some.
Maybe it is a definition of rights.
Major Dingle. I am not sure how the term was used, but I
would just be interested----
Mr. Shays. The military can tell you when to go to bed and
when to wake up, when to get up and a lot of things they can
tell you to do they cannot tell me to do.
Major Dingle. Point well taken. I just thought it was a
very strong statement. I was not sure that that statement--it
stuck in my mind. I thought it can be discounted or whatever
you want.
Additionally, later on Dr. Bailey talked about when we were
discussing the 50 or so biological agents on the piece of paper
there and why we were not, the DOD was not working to protect
its members against those threats. She talked about the need
for threat risks are made for specific areas in the world and
with Iraq being a sensitive one at the moment. Connecticut has
lost a quarter of its pilots due to this measure and they will
be deploying later next week for a tour in Kuwait.
Mr. Shays. How many pilots are we talking about total?
Major Dingle. Nine pilots have declined to take the
vaccine. Eight will eventually be leaving the unit to my
knowledge. One is----
Mr. Shays. Out of how many?
Major Dingle. At the time that our take it or leave policy
was enacted it was 35 pilots to my knowledge on the base.
So while we have left, being forced out of the military and
a career of service because of this policy, either right now or
very shortly another Guard unit will be deploying to Northern
Watch flying over the same enemy or flying over the same
country, Iraq, as we are going to and they do not even know how
to spell anthrax at their base. It has not been brought up. It
has been mentioned. Those people will be deploying to that area
and they have not even addressed this issue yet.
Mr. Shays. Mr. Dingle, let me just ask a question that
would gnaw me if I did not ask. Your unit is being deployed.
Major Dingle. Yes sir.
Mr. Shays. Is there some logic--can I make an assumption.
And how would you counter this assumption that some would find
this a convenient way to be deployed? In other words, they can
blame it on anthrax and therefore not have to take this
assignment.
Major Dingle. He wants to respond, but I am not really sure
what you are asking.
Mr. Shays. Sure. What I am asking is this. Your unit is
being deployed at an active duty, correct? Is that correct?
Captain Rempfer. We are not being activated. We will be put
on active duty orders. We are not being activated, but we are
supplementing the forces that are over in the area of
responsibility. I for one was on the deployment list, along
with many of the other pilots.
Mr. Shays. Let me just ask you for the record and we will
just take the best answer you have. Could some use this as a
means for not being deployed? Blame it on anthrax and therefore
be reassigned or be able to resign?
Let me ask you this first question. Do you have the ability
to resign from this duty for any other reason?
Major Dingle. Yes sir. We could walk away from our citizen
soldier responsibilities, but we do not choose to do that. This
is the issue that came in the way of our service.
Mr. Shays. Let me put it this way. Let me take my time
here. Your unit is being deployed where?
Major Dingle. Kuwait, sir.
Mr. Shays. It is going to Kuwait in a theater that is
pretty hot. In your case, Mr. Dingle, and I believe the
sincerity of all of you. I am not questioning your sincerity,
but I want to put on the record by your refusal to take
anthrax, you are not going to be going to Kuwait, correct. Is
that true for both of you?
Major Dingle. That is correct, sir.
Captain Rempfer. Yes sir.
Mr. Shays. If you did not want to go to Kuwait, would you
be able to not go for another reason, just simply say I am
getting out or would you not have to go to Kuwait because you
have signed up for a certain period of time?
Major Dingle. Sir, this is a--the way the Guard and Reserve
works, to the best of my knowledge and----
Mr. Shays. Sure.
Major Dingle. I am just a fighter pilot, but I do not want
to slight my military knowledge in all other areas, but it is
voluntary. You can volunteer to go on the deployment or not.
Most people sign up to go on these deployments. So there are
people that have just declined to not participate in this. It
is not--depending on the seriousness of the deployment or the
area of the world, people's personal civilian careers, what is
going on in their civilian jobs, people either volunteer for
deployments or not. It is not a case of everybody goes. In
order to make a whole unit go, and make it mandatory and an
order to go, I believe that Congress has to activate the unit.
Mr. Shays. OK. That is your knowledge and it may be the
accurate one.
Captain Rempfer. Sir, and for the record, if I may.
Mr. Shays. Sure.
Captain Rempfer. I was on the deployment roster. I was
ready and willing to go and so were most of the other gentlemen
that have left the unit as a result of this policy. I
personally spent 122 days in Kuwait last winter on two back to
back deployments and I was more than willing to go again.
Mr. Shays. I hear you.
Captain Rempfer. I personally have been in touch with many
Guardsmen and Reservists around the country. Many agree after
self-educating themselves on this policy and looking into the
issues revolving around it, that this could stand in the way of
their continuing to serve. It has just begun in the Guard
Reserve and we are already seeing the losses.
Mr. Shays. One of my fears is that the seven--or is it
eight--who are basically refusing to take anthrax and therefore
will not be deployed. And if they leave the service it will be
recorded as they are not necessarily liking the pay or you are
not liking some other thing and that we need to--it would be
interesting to see how the eight of you will be recorded by the
military.
Captain Rempfer. And sir, I think that is very important
that we record it properly. That we attribute the losses
appropriately. Unfortunately, both the unit and the Department
of Defense mistakenly reported only two pilots actually being
lost from the unit due to anthrax. In fact, it was all eight
pilots that are transferring out of the unit that have been
lost to anthrax. We put a letter together to that effect. We
included it in our written testimony and we feel it is most
important that we attribute it appropriately.
Mr. Shays. Now will both of you give up flying or will you
be flying somewhere else? The nodding does not get recorded.
Major Dingle. Sorry about that. That makes the cameras, but
not the tape. If this program turned around tomorrow, we have
been told that we are no longer welcome in our unit. I do not
anticipate any unit asking us to fly for them now or in the
future no matter what the outcome of this policy is, so I have
resigned to the fact that I am going to hang up my G-suit and
never fly for the U.S. military again.
Mr. Shays. Do you fly commercially? Do you fly
professionally?
Major Dingle. Yes sir.
Mr. Shays. What do you fly?
Major Dingle. I fly Boeing airplanes.
Mr. Shays. You, sir?
Captain Rempfer. McDonnell Douglas airplanes, sir.
Mr. Shays. But it is a different kind of activity, is it
not?
Major Dingle. Absolutely. It is a totally different type of
flying.
Mr. Shays. So you are giving up a real love, are you not?
Major Dingle. Yes sir. It is in fact, the military flying
is how I got into it and the commercial flying is a secondary
endeavor that occurred later.
Mr. Shays. Thank you. Yes sir.
Captain Rempfer. And if I may, sir, I think it is a very
important distinction to turn around that citizen soldiers are
leaving the service of their country in order to concentrate on
their families or civilian professions. I would like to turn
that right back around and say the reason we are serving is
because we want to serve our country and if our families are
important to us and our civilian careers are so important to
us, we have been for a long time making a sacrifice to serve
and we wanted to continue to do so.
Mr. Shays. Thank you. I know I have just been focusing on
the two of you because I wanted to clarify termination here,
but I want you to react to Mr. Lundbom's story and tell me how
it is different from yours because it is different.
Major Dingle. It is absolutely different, sir. He is active
duty and is under the U.S. Code Title 10, I believe, I am not
sure the Marines, but the active duty, UCMJ. We are,
technically, we are militiamen. And unless we have been
federalized by the President, we work for the State, for the
Governor. We come under a completely different set of UCMJs and
we basically wear a couple of different hats and today I am a
civilian. When I go and I am on some sort of military pay
status, that is when I put on my hat.
Mr. Shays. Tell me how you react to his story. It is
different in terms of how he interacted with his superior
officers?
Major Dingle. To me, it is really disheartening to hear
that type of story. As an officer, I think all officers, and we
do agree, I will even agree with the Surgeon General that
taking care of our folks is a top priority in all of the
decisions and things that we do. So it is disheartening to hear
stories of this kind of treatment.
Captain Rempfer. And if I may, I would like to implore
everyone to go back to the root cause of what might be causing
the challenges to the UCMJ and what might be putting this great
burden on the field commanders out there in the country. It is
the anthrax policy and the controversies that revolve around
it.
Mr. Shays. Let me conclude this part and then I am going to
recognize the ranking member of the committee. We have 27 boxes
that basically we have gotten from the Joint Program Office. We
have gone through about 5 of the 27 boxes. And one of the
documents I have before me is titled ``Procurement of Anthrax
Vaccine Single Source Versus Additional Site'' and it just kind
of speaks in one way to a point you made, Mr. Zaid. It has
facts A, B, C and then 1, 2, 3 under C and then it has 4 under
C and then D and then E says, ``the original license for AVA,
anthrax, was supported by efficacy data obtained in a very
small study of humans working in the wool sorting industry
during the 1950's and 1960's. More stringent FDA regulatory
requirements for a vaccine produced by another manufacturer
would likely require the development of a surrogate efficacy
model. This is high risk because no model currently exists.''
The implication is that the FDA standards today are quite
different than they are 30 years ago.
Mr. Zaid. That is right.
Mr. Shays. And that we are not quite sure how the FDA would
view this vaccine today.
Mr. Zaid. I believe I recall that document, as a matter of
fact. The 1970 approved version was based on a 1962 clinical
data study that was submitted, just one. It was not until 1972
that the FDA changed their requirements for biological
vaccinations to make more stringent standards for efficiency
studies and effectiveness studies. When Desert Shield started,
and I provided some of this documentation to you and I can give
you even more, there was a task force put together called
Project Badger that looked into getting enough vaccinations for
everyone in time for Desert Storm. And at this early date, even
10 years ago, the Pentagon knew that the current series that
the FDA had approved was unnecessary. In fact, the history of
it was that in the 1950's a worker arbitrarily decided six
doses was appropriate. And I will tell you, everything I saw is
from Defense Department documentation. This is all from
internal government documentation provided to us in the FOIA
lawsuit.
They tried to rush through to get the vaccinations. They
approached countless laboratories. The problem was the FDA and,
in fact in one document they indicate that if they are going to
have a problem with the FDA, they are going to have to put some
pressure on them and that is where the waiver came from.
Mr. Shays. Let me just conclude my statement and then
recognize Mr. Blagojevich. I made an assumption that I brought
to the table even before we had testimony from the first panel
that this vaccine was in widespread use in the private sector.
Your number of 300 to 400, even if it was 3,000 to 4,000,
compared to what I thought it was, is a big surprise to me. So
it will be interesting to nail down that number.
Mr. Zaid. The reason why there is only one major
manufacturing plant is that it is not a cost-effective,
profitable vaccine because nobody is using it besides the
military. And it is very tough to manufacture in the sense that
for spore-like vaccinations, you are not able to manufacture
other types of vaccines in the same vicinity. So it is very
expensive, not cost per dose, but if you are going to make it
your livelihood, you better have a good customer, like the
Defense Department, who all of a sudden wants to vaccinate 2.4
million people.
Mr. Shays. Thank you. Mr. Blagojevich.
Mr. Blagojevich. Thank you, Mr. Chairman. Private Lundbom,
I am going to be looking at you here on this question, but
anybody is free to answer the question and if feel you can go
lower than Private First Class, Private Lundbom, do not answer
this question. We were given a briefing by the Department of
Defense prior to this hearing. At that briefing, they provided
us with a status report on the number of adverse reactions to
the VAERS reporting system. We have that right here. This
printout was from February of this year and it shows that the
Army reported 22 adverse reactions. The Navy reported 5. The
Air Force reported 11 adverse reactions. But the Marines list
no adverse reports.
The question to you, Private, or anyone else, is do you
believe this is a result of pressure by commanders, especially
in the Marines not to report adverse effects?
Pfc. Lundbom. First of all, I have extreme respect for the
U.S. Marine Corps and for my command. Looking into the
situation and the punishment that I received, and to respond to
the comments you made about losing rank again, I have received
new information just now from Congresswoman Ellen Tauscher that
my court martial has been dropped now and by my merit they are
granting me an Admin. Separation under General with Honorable
Conditions. But to answer your question----
Mr. Blagojevich. Maybe you should not answer the question
in view of that, Private, why do not we just ask someone else.
We do not want to get you in trouble.
Mr. Shays. Let me just say this to you. With respect to the
military, they have cooperated with us and they respect your
testimony and I know that you are saying that in good faith.
But I just want it clearly understood. I do not think anything
of ill will will come your way by being honest with us and
being respectful of the service that you love.
Pfc. Lundbom. I can answer the question that is not in any
disrespect. With the Marine Corps, as far as I am concerned,
and this is a personal opinion, the Marine Corps is the best
fighting unit in the U.S. military, but I am a little biased
because I am part of that branch. But sitting where I sit, we
have so much pride in ourselves and what we do and I think when
say we complain about something, complain about an effect, a
Marine to himself, unless you are in a lot of pain, does not
even worry about complaining about it because it is no big
deal. That is the way I think most Marines feel. That is not
the way they are told to feel. That is just the way they feel.
And I think that is why the reports are so low, just because it
is in our heads, it is in our hearts.
Mr. Blagojevich. You are tough Marines.
Pfc. Lundbom. We are tough and we stick it out. And if it
was something serious, I am sure they would have reported it,
if they felt like their health was in danger like long term
sickness or something like that, but with just nodules on the
arms and sore arms. People have told me, my arm is sore. My arm
has been sore for a week, but they do not feel like it takes
precedence to report it just because they do not feel it is
necessary.
Mr. Blagojevich. OK, so based on what you have seen,
Private, or what you have not seen, in other words, you have
not seen any indication that any commanders in the Marine Corps
are putting pressure on any of you guys not to come forward.
Pfc. Lundbom. No. No pressure.
Mr. Blagojevich. OK, thank you very much, Private. Good
luck to you.
Ms. Greenleaf. I really feel like the medical facilities
are not instructed on what to do and when to report these
adverse reactions. I am aware of several cases where the
service member went into the medical facility with a rash,
vomiting, bloody diarrhea and they were just told they have the
flu. I am not sure that they are aware that this needs to be
done.
Colonel Handy. Congressman, I might also mention that I
looked at the swine flu vaccine debacle in the 1970's and the
Journal of the American Medical Association had an article on
that where they reported that the rate of adverse reaction
reports from the military were seven times fewer than that in
the civilian population and I do not know what the causes were,
but it was an interesting phenomenon. So there is perhaps
precedence there, perhaps due to the culture.
Mr. Blagojevich. Right, more cultural than any kind of
purposeful cover-up. Does anybody else want to address that?
Mr. Zaid. I think that is right from a command level. I
certainly am not aware of either any of my clients or any of
the service men or their families that have contacted me that
anyone is being threatened to not report adverse reactions.
There is a mentality among the military that unless, as the
private said, you are truly suffering, do not say anything. I
certainly have received reports that medical personnel have
down-played, as Ms. Greenleaf has said, the significance of
what our reactions to something, whether or not it is related
to the vaccine, I certainly do not know, but within a point in
time sufficiently close in proximity to the vaccination that
one would think the military medical personnel might want to
explore a little further. But they are telling people that they
are not going to file an adverse reaction report. That is
occurring. I am not saying it is widespread, but there have
been at least isolated reports of that.
Mr. Blagojevich. Thank you.
Mr. Shays. We are going to conclude, but I welcome any of
you having a closing statement, any observation you want to
make. Is there anyone?
Mr. Zaid. Yes sir. Can I just say just a couple of things
in response to some comments made on the first panel real quick
and I can meet with your staffers at a later date about this.
A couple of things that had been said. Coming from the
standpoint in at least the spring of 1998 when I was very much
involved on a more global scale when more in the Persian Gulf
were being vaccinated, many of those from the Independence that
were contacting me and the John Stennis, were not having
notations placed into their personal medical records. Now that
might have changed. I hope and I am sure it is better now. What
is significant about that--though let us go back to the four
conditions that were supposed to have been met before the
program was implemented and that was a key facet of it--was
that there had to be adequate medical recordkeeping. There was
not, at least in the initial few months. And I would encourage
the committee. I think I attached it as exhibit 2. The
independent evaluation of the vaccine. I dare say it is a
document that you or I could write very easily by doing public
research of available literature. There was no independent
testing or independent evaluation of this vaccine. And I will
leave it to you just to read the document and you can come to
your own conclusion on that.
Much of the data that has been the basis for the Pentagon's
decision is unpublished, and let me just say finally in
response to one thing Dr. Bailey had said about the cocktail
mix which you know from your Gulf war syndrome interest has
been a significant factor. There was a memorandum, and I have
given it to your committee, authored for Dr. Edward Martin in
1995, who was the principal Deputy to the Assistant Secretary
of Defense--I do not know if that was Dr. Bailey at the time--
from Brigadier General Ross Zautchuk at the U.S. Army Medical
Research and Material Command. And it said that a limited study
was conducted at Fort Bragg and Fort Detrick and revealed that
the combination of anthrax and botulinum vaccine did produce
mild and moderate reactions as well as a few serious side
effects. So the government has data that is inconsistent with
what is being publicly reported to our servicemen, the public
and I dare say to the Congress.
Mr. Shays. Thank you.
Colonel Handy. Mr. Chairman, just a couple of quick items.
It gets to a question that Ms. Schakowsky asked about what is
different about this particular program or vaccine and I think
two areas are worth exploring and I know you are going to have
a hearing on the doctrinal area and I think that is critical
because we keep hearing the idea that this threat, the
biological warfare threat, and in particular, the anthrax
threat, it is not a matter of if, but when. This is the kind of
mentality that occurred also in the swine flu vaccine problem.
The fact is the literature review and even during that
situation showed that the risk was extremely small. The
literature review now says the same thing. It is also
incalculable. The problem with the phrase, ``it is not a matter
of if, but when'' suggests that there is a 100 percent
probability that there will be an anthrax attack and that all
service members will be affected. Therefore, we must vaccinate
all service members. I think there is a patent fallacy in
attempting to create that kind of logic and I will appreciate
the results of that investigation.
The other thing that really gets to her question about the
differences as to why this program is different. For most of I
would think, the members of the service, having 25 shots for
one particular vaccine over a 20 year career is an amazing
difference. That is what we are really talking about. With the
standard vaccines that our members have to have when they come
in the service or even that they get for deployment and
especially the pilots get a lot of those, this is still a
significant increase and in most people's minds that is an
imposing threat that is probably suspected to be more probable
than an actual anthrax attack. And I think that is a big
difference.
Mr. Shays. Very interesting. Would anyone else like to make
a comment?
Major Dingle. I would just like to thank you once again for
the opportunity to speak before the panel.
Mr. Shays. Let me just say, you all have been very
interesting and very helpful and very sincere. You have served
your country in various ways that are quite significant and you
have taken a stand in something you believe in and I really
respect that from all of you and I thank you for coming. Stay
in touch.
[Whereupon, at 1:05 p.m., the subcommittee was adjourned.]
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