U.S. GOVERNMENT PRINTING OFFICE

57–559 WASHINGTON : 1999

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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

JOHN T. DOOLITTLE, California

HELEN CHENOWETH, Idaho

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

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

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DAVID M. MCINTOSH, Indiana

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

HELEN CHENOWETH, Idaho

ROD R. BLAGOJEVICH, Illinois

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

JOHN F. TIERNEY, Massachusetts

THOMAS H. ALLEN, Maine

EDOLPHUS TOWNS, New York

BERNARD SANDERS, Vermont

(Independent)

JANICE D. SCHAKOWSKY, Illinois

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

(III)

C O N T E N T S

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

(1)

THE ANTHRAX IMMUNIZATION PROGRAM

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 experVerDate 11-MAY-2000 08:53 Mar 13, 2001 Jkt 010199 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 E:\HEARINGS\57559 pfrm02 PsN: 57559
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imental 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 inforVerDate 11-MAY-2000 08:53 Mar 13, 2001 Jkt 010199 PO 00000 Frm 00009 Fmt 6633 Sfmt 6602 E:\HEARINGS\57559 pfrm02 PsN: 57559
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mation 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

15

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.

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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.

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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

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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.

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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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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.

23

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?

24

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

25

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 preconditions. 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.

26

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?

27

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

28

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

29

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 pregVerDate 11-MAY-2000 08:53 Mar 13, 2001 Jkt 010199 PO 00000 Frm 00033 Fmt 6633 Sfmt 6602 E:\HEARINGS\57559 pfrm02 PsN: 57559
30

nancies 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,

31

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

32

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——

33

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

34

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.

35

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.

36

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

37

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.

38

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.

39

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

40

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 vacVerDate 11-MAY-2000 08:53 Mar 13, 2001 Jkt 010199 PO 00000 Frm 00044 Fmt 6633 Sfmt 6602 E:\HEARINGS\57559 pfrm02 PsN: 57559
41

cination 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.

42

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?

43

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.

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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

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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

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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

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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

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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 addiVerDate 11-MAY-2000 08:53 Mar 13, 2001 Jkt 010199 PO 00000 Frm 00094 Fmt 6633 Sfmt 6602 E:\HEARINGS\57559 pfrm02 PsN: 57559
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tional 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

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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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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

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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

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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

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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 lifethreatening 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

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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 servVerDate 11-MAY-2000 08:53 Mar 13, 2001 Jkt 010199 PO 00000 Frm 00110 Fmt 6633 Sfmt 6602 E:\HEARINGS\57559 pfrm02 PsN: 57559
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ice 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.

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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.

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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.

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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 caVerDate 11-MAY-2000 08:53 Mar 13, 2001 Jkt 010199 PO 00000 Frm 00114 Fmt 6633 Sfmt 6602 E:\HEARINGS\57559 pfrm02 PsN: 57559
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reers 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 getVerDate 11-MAY-2000 08:53 Mar 13, 2001 Jkt 010199 PO 00000 Frm 00115 Fmt 6633 Sfmt 6602 E:\HEARINGS\57559 pfrm02 PsN: 57559
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ting 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——

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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

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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.

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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.]

[Additional information submitted for the hearing record follows:]

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