U.S. GOVERNMENT PRINTING OFFICE

65–604 CC WASHINGTON : 2000

DEFENSE VACCINES: FORCE PROTECTION OR

FALSE SECURITY?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

OCTOBER 12, 1999

Serial No. 106–130

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

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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

HELEN CHENOWETH-HAGE, Idaho

DAVID VITTER, Louisiana

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

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C O N T E N T S

Page

Hearing held on October 12, 1999 .......................................................................... 1

Statement of:

Bailey, Sue, M.D., Assistant Secretary for Health Affairs, Department

of Defense; Major General Randall L. West, Special Assistant to the

Secretary of Defense for Biological Warfare and Anthrax, Department

of Defense; Lt. Col. Randy Randolph, Director, Anthrax Vaccine Immunization Program Agency, Department of Defense; Cedric E. Dumont,

M.D., Medical Director, Office of Medical Services, Department of

State; Kathryn C. Zoon, Ph.D., Director, Center for Biologics, Evaluation and Research, Food and Drug Administration; and Kwai-Cheung

Chan, Director, Special Studies and Evaluation, U.S. General Accounting Office, accompanied by Dr. Charla ........................................................ 26

Crowe, Admiral William J., Jr. (USN Ret.); Jack Melling, biologics development center, the Salk Institute; Milton Leitenberg, senior scholar,

Center for International and Security Studies at Maryland; John B.

Classen, M.D., MBA; Major Sonnie Bates, Pilot, USAF; Major Thomas

L. Rempfer, Pilot, USAF Reserves; and Neal A. Halsey, M.D., director,

Institute for Vaccine Safety, Johns Hopkins University ........................... 129

Letters, statements, et cetera, submitted for the record by:

Bailey, Sue, M.D., Assistant Secretary for Health Affairs, Department

of Defense; Major General Randall L. West, Special Assistant to the

Secretary of Defense for Biological Warfare and Anthrax, Department

of Defense; Lt. Col. Randy Randolph, Director, Anthrax Vaccine Immunization Program Agency, Department of Defense, prepared statement

of ..................................................................................................................... 31

Bates, Major Sonnie, Pilot, USAF, prepared statement of ........................... 176

Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of .......................................................................... 6

Chan, Kwai-Cheung, Director, Special Studies and Evaluation, U.S. General Accounting Office, prepared statement of ........................................... 87

Classen, John B., M.D., MBA, prepared statement of ................................... 165

Crowe, Admiral William J., Jr. (USN Ret.), prepared statement of ............ 132

Dumont, Cedric E., M.D., Medical Director, Office of Medical Services,

Department of State, prepared statement of .............................................. 50

Halsey, Neal A., M.D., director, Institute for Vaccine Safety, Johns Hopkins University, prepared statement of ...................................................... 198

Leitenberg, Milton, senior scholar, Center for International and Security

Studies at Maryland, prepared statement of .............................................. 153

Melling, Jack, biologics development center, the Salk Institute, prepared

statement of ................................................................................................... 145

Rempfer, Major Thomas L., Pilot, USAF Reserves, prepared statement

of ..................................................................................................................... 189

Shays, Hon. Christopher, a Representative in Congress from the State

of Connecticut:

Letter dated September 23, 1999 ............................................................. 219

Prepared statement of ............................................................................... 24

Zoon, Kathryn C., Ph.D., Director, Center for Biologics, Evaluation and

Research, Food and Drug Administration:

Chart concerning stages of review and regulation ................................. 57

Prepared statement of ............................................................................... 60

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DEFENSE VACCINES: FORCE PROTECTION OR

FALSE SECURITY?

TUESDAY, OCTOBER 12, 1999

HOUSE OF REPRESENTATIVES, COMMITTEE ON GOVERNMENT REFORM, Washington, DC.

The committee met, pursuant to notice, at 1:15 p.m., in room 2154, Rayburn House Office Building, Hon. Dan Burton (chairman

of the committee) presiding. Present: Representatives Burton, Morella, Shays, Horn, Terry, Waxman, Cummings, Kucinich, and Schakowsky. Also present: Mr. Jones of North Carolina.

Staff present: Daniel R. Moll, deputy staff director; Mark Corallo, director of communications; David Kass, deputy counsel and parliamentarian; Renee Becker, deputy press secretary; Corinne

Zaccagnini, chief information officer; Carla J. Martin, chief clerk;

Lisa Smith-Arafune, deputy chief clerk; S. Elizabeth Clay, professional staff member; Robert Briggs, staff assistant; Robin Butler,

office manager; Heather Bailey, legislative assistant; Nicole

Petrosino, legislative aide; Phil Schiliro, minority staff director;

Phil Barnett, minority chief counsel; Sarah Despres and David

Rapallo, minority counsels; Ellen Rayner, minority chief clerk, and

Jean Gosa, minority staff assistant.

Mr. BURTON. The Committee on Government Reform will be

called to order.

Would you raise your right hands, please?

[Witnesses sworn.]

Mr. BURTON. We will have more Members coming. On Tuesdays

we usually have Members getting in later, so I apologize for all of

our members not being here, but they’ll be coming and going.

Good afternoon. A quorum being present, the Committee on Government Reform is called to order; and I ask unanimous consent

that all Members’ and witnesses’ written opening statements be included in the record. Without objection, so ordered.

We’re here this afternoon to discuss the development of the U.S.

defense vaccine policy. The Subcommittee on National Security,

Veterans Affairs, and International Relations chaired by Mr. Shays

has conducted a series of hearings looking at the Defense Department’s current anthrax vaccine program. The full committee today

will examine the overall picture of vaccines for defense.

As part of our ongoing investigation into vaccines we’re examining their safety, efficacy, the importance of informed consent, the

concerns about vaccine ingredients, purity, and the long-term safety concerns. We’re looking into the role of vaccines as a defense

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mechanism for biological warfare. Is it viable and appropriate to

use vaccines as a defense mechanism? Will it be possible and practical to develop vaccines to protect against all known and potential

biological threats?

Much has been said by numerous government officials about the

biological warfare threat. We’ve been told in previous hearings and

in testimony prepared for today that, ‘‘At least 10 nation states and

two terrorist groups are known to possess or have in development

a biological warfare capability.’’ Are all these nation states our enemies? How many are confirmed to actually have weapon dispensable anthrax poised and ready to launch?

Intelligence and military officials have testified that it is relatively easy to develop and produce chemical and biological weapons. However, they’ve also testified that it’s much more difficult to

successfully deploy chemical weapons. For instance, the Deputy

Commander of the Army’s Medical Research and Materiel Command testified in 1998 that, ‘‘An effective mask casualty producing

attack on our citizens would require either a fairly large, very technically competent, well-funded terrorist or state sponsorship.’’

In March 1999, another expert stated, ‘‘The preparation and effective use of biological weapons by potentially hostile states and

by non-state actors, including terrorists, is harder than some popular literature seems to suggest.’’

We’ve also been told that anthrax is the most likely candidate for

a biological warfare threat. What is the basis for that determination? With the aggressive information offensive the Department

has launched into its military members and the American public,

it’s made to sound like the equivalent of the Cuban missile crisis.

If that’s so, then those who are in harm’s way and the American

public deserve to know the whole story. A State Department fact

sheet on chemical and biological warfare states, ‘‘The Department

of State has no information to indicate that there’s a likelihood of

use of chemical or biological agent release in the immediate future.

The Department believes the risk of the use of chemical biological

warfare is remote, although it cannot be excluded.’’

There are several issues that need clarification regarding the

current anthrax vaccine program, including answering why the

United States is the only member of NATO that mandates this vaccine. We have on the screen all of the nations of NATO and their

attitude toward mandating the anthrax vaccine, and you’ll see the

United States is the only one that does that.

The Defense Department would have us believe that the concerns

raised about the anthrax vaccine are minor and by a small and

vocal group. In fact, on their website, Major Guy Strawder states,

Much of the hand wringing and bizarre allegations about the vaccine is coming

from a vocal minority of people who think the field is where a farmer works and

gortex is one of the Power Rangers. Most of these folks have never spent a single

moment in harm’s way and have no appreciation of what that sacrifice means.

How does that measure up to the following statements that have

been sent to us by people in the service?

A Sergeant from Oklahoma says,

I have served my country with honor and total dedication since 1970. To have this

unsafe and unproven vaccine put an abrupt end to my service is a travesty of jusVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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tice. I have constantly received excellent appraisals for the past 3 decades and had

nothing in mind but to continue receiving these favored appraisals.

We in the military have been told too many false statements about this vaccine.

We have been misled about the safety, the long-term effects associated with this

vaccine, the proper number of adverse reactions, and the attrition and refusals in

our total force. Many will leave the military because of this vaccine and its problems. Many of these folks will give up a career dedicated to service to their country.

Or we have a pilot from Maine who said,

I will be forced out of the Air National Guard and lose my retirement. I have put

in 15 good years as a pilot and have enjoyed every one of them. I will not, however,

put my health and my future ability to take care of my family on the line for a DOD

that refuses to examine their own programs for the safety and cohesion of our military.

Or the F–16 fighter pilot who stated,

I personally have over 22 years of faithful service in the Air Guard. My record

is exemplary. I was not planning to retire for at least 2 to 3 years, but the anthrax

vaccine program has expedited my retirement plans. The commander of my unit will

not allow me to stay in until March 7, 2000, when I will have 3 years time in grade

to keep my lieutenant colonel rank into retirement. After almost 23 years of faithful

service to my country, I will not be allowed to stay in for the 67 additional days

needed to carry lieutenant colonel into retirement, 67 days.

Either the Defense Department is being less than forthcoming

about the objections being raised or they have their heads buried

in the sand.

A lot of the concerns have been raised about the actual number

of adverse events from the anthrax vaccine. The numbers vary

greatly—everything from 0.0002 percent reported in the media in

February to two-tenths of 1 percent on the package insert to 20

percent, 20 percent, in the one active surveillance currently under

way.

We have a slide on this as well. That’s the Tripler Med Center

study which shows 20 percent.

If the Department is not doing active followup in tracking of

health care concerns servicewide, then how will we ever garner an

accurate representation of adverse events?

Vice Admiral Richard A. Nelson, Medical Corps Surgeon General,

U.S. Navy, stated,

I am aware of the controversy associated with the anthrax vaccine immunization

program and the concern our troops have regarding potential side effects. The vaccine is safe. Of over 82,000 marines and sailors inoculated, only eight reactions have

been reported via the vaccine adverse reporting system. All have returned to full

duty.

In cross-examination, one medic from 29 Palms had no knowledge of the existence of a Vaccine Adverse Event Reporting System

form, as adverse event reports are difficult to file when the medical

personnel are not even aware that they exist. The Defense Department states that it requires their medical personnel to report all

adverse events that cause the loss of duty of greater than 24 hours

of hospitalization or hospitalization. Are these the only types of

events that are truly adverse? 24 hours? How is it that the Defense

Department has been allowed to determine what constitutes a reportable adverse event?

The former FDA commissioner stated that adverse events are

dramatically underreported. Only 1 in 10, 1 out of 10, are typically

reported. We also know from previous statements made by the DeVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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fense Department that military reporting is one-seventh—one-seventh of the civilian rate, and we have an attachment up there.

Given these figures, less than 2 of every 100 systemic adverse

events are being reported. And for those who have an adverse

event, is adequate care being provided? Why is it that many individuals who have been suffering for a very long time with adverse

events are still waiting for appointments with appropriate specialists? Or the statement from one Sergeant from Georgia who suffered with memory loss, swelling, dizziness, a rash, muscle twitching, and a month of diarrhea. He said, ‘‘The doctors repeatedly ignored my statement that I became sick after taking the anthrax

vaccinations.’’ The Master Sergeant from Michigan was told his

symptoms showed that he had the flu for an entire year. This diagnosis came from a military doctor who chose only to talk to him

and did absolutely no blood work or examination.

And what about plans for more vaccines? Just how many vaccines can one human being safely receive in their lifetime? The

Federal Government currently recommends the total of 26 doses of

vaccines for children; 26 doses and there you have them. I would

like to go into some of the problems my family personally has had

with those vaccines. One of my grandchildren is autistic we think

maybe as a result of that.

Twenty-six vaccines for children. The typical 20-year career military member can expect an additional 37 doses of vaccinations plus

the anthrax and other deployment vaccinations. That would total

at least 40 doses over 20 years. There you see the doses we’re talking about. There are currently another 18 vaccines in development

under the Joint Vaccine Acquisition Program. These are the ones

that are planned. And if all the potential biological warfare threats

are developed into vaccines, these numbers will skyrocket. Are we

going to vaccinate our military to death?

Maybe we need to look at other approaches to dealing with the

biological threat. For instance, with good detection equipment and

protective gear, the use of products like the orphan drug we just

found out about today. We got a call from a company that makes

this or has this under review right now and research. The use of

products like the orphan pharmacy drug that we have just learned

is currently in development that causes the anthrax spores to explode rather than synthesize and can also be used to decontaminate equipment and clothing. Before we start vaccinating everybody, maybe this is an alternative that ought to be looked at and

analyzed.

I hope we can find solutions to these issues, get the full story on

issues raised and, by doing so, take action to begin to restore trust

in the ranks and restore and preserve the careers that have been

destroyed.

I just want to say one thing, General West. One of your good

friends from Florida, the chairman of the Appropriations Committee, brought to my attention your heroic service to our country. I

want you to know that if we get into a heated debate today, that

does not take away my respect for you or any of your colleagues

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up here at the table. We know of your service to the country and

some of the heroic activities you are engaged in, and I want you

to know that nothing we say diminishes that.

General WEST. Thank you, sir, but I knew that.

[The prepared statement of Hon. Dan Burton follows:]

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Mr. BURTON. I now recognize Mr. Waxman, the ranking minority

member.

Mr. WAXMAN. Thank you, Mr. Chairman.

Today we’ll hear testimony about the anthrax vaccine and its use

by the Department of Defense. This is a complicated issue with

compelling concerns on both sides. Some members of our Armed

Services are worried about the safety of the vaccine. This is an understandable and important concern. We need to be constantly vigilant in ensuring that vaccines are as safe as they can be. We must

ensure that people are educated about the potential risks of vaccines. We must also carefully monitor the production of vaccines,

and we must track all adverse events, treat individuals that suffer

side effects, and invest additional research funding to make vaccines even safer and more effective than they are now.

Today I look forward to hearing about how we can improve our

performance in some of these areas, but the potential risk of a vaccine is not the only factor to consider. We must also consider the

risk of not vaccinating. In the case of childhood vaccines, the risk

of not vaccinating is a reemergence of infectious diseases such as

polio, measles, or Rubella, diseases we now rarely see in this country.

The chairman had a chart of 20 different diseases—it looked like

20 different diseases—for which immunizations are given. I looked

at that list and I thought to myself, thank God we have vaccinations that can prevent those diseases. There were times in our own

history and there are places around the world where suffering from

those diseases had been a death sentence.

In the case of vaccines against biological weapons, the threat is

also severe. The threat of our service members may come in battle

or as a result of a terrorist attack. It may come without any warning, without the capability to detect it, and without an opportunity

to shield our troops. We are not talking about merely unpleasant

but relatively low-risk diseases. If you are infected with anthrax,

you die. There is no treatment. All of these risks must be balanced

against potential adverse reactions to the vaccine.

On August 3, the committee heard testimony from Antonio

Spathe who was diagnosed with an autoimmune deficiency, thyroid

disease, anemia, hypoglycemia, depression, hormone imbalance and

anxiety disorder after receiving the anthrax and other vaccines.

Mr. Spathe’s condition is a serious one. Not one person in this room

would want someone in their family to be that one in a million individual who suffers serious adverse reactions.

Unfortunately, I think we all know, as Dr. Satcher of the Centers

for Disease Control testified at the August 3 hearing, there is no

such thing as a perfect vaccine. The decisions facing the Department of Defense are not easy. The risks of anthrax vaccine must

be carefully balanced against the risks of not using the vaccine. I

believe we should measure these risks using the best scientific and

medical evidence available, not inflammatory accusations of unsubstantiated rumors and personal anecdotes. We should base our decisions on a grave, thorough, and extremely critical analysis of all

the risks involved.

Before concluding, I would like to note for the record the way in

which this hearing was put together and the lack of cooperation the

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minority has received from the majority. It is often difficult to learn

in advance who the witnesses are going to be and prepare for any

hearing. In this case, we did not learn the identity of one witness,

Major Rempfer, until this morning.

I recognize that last-minute issues can come up, but I do feel

there should be a greater effort to ensure that the minority is informed in advance about these hearings. As a matter of fact, I

think the testimony of witnesses has to be submitted 48 hours in

advance of their testimony. We should be getting this information

in advance so that the minority can prepare for the hearings adequately. We should be approaching these issues of health and safety on a bipartisan basis.

I thank all the witnesses for coming today. I look forward to

hearing their testimony, and I yield back the balance of my time.

Mr. BURTON. The gentleman yields back his time.

Do any of the other Members wish to be heard?

Mr. SHAYS. Thank you.

Mr. Chairman, I don’t usually have a statement in a full committee hearing, but I would like to place this statement in the record

and actually address the chamber here. The recent outbreak of the

West Nile encephalitis virus in the Northeast should stand as a

warning. Nature’s abundant and diverse biological arsenal dwarfs

our health surveillance and response capabilities. We’re not ready

to deter, detect, or treat emerging diseases deployed against us by

Mother Nature or by belligerent acts of man.

Responding to a similar warning sounded during the Gulf war,

the Department of Defense [DOD] adopted a policy in 1993 setting

a new priority on development and acquisition of vaccines to defend

against validated biological warfare threats. Today we examine the

implications of that policy for the individual war fighter and for the

future of the volunteer armed forces.

The forcewide mandatory anthrax vaccine immunization program

begun just last year has already raised profound questions about

the wisdom, practicality, and necessity of elevating vaccines to the

forefront of biological warfare defense. Individual soldiers, sailors,

aviators and marines are asking, will these vaccines alone or in

combination with the many others planned affect my long-term

health? How do I know these vaccines will work against

weaponized attack? Will the development of agent-specific vaccines

be funded at the expense of collective protective systems, remote

detectors, and the physical protective equipment, suits and masks,

effective against all biological threats?

Military strategists and scholars are asking, are we responsibly

confronting the inevitability of biological attack or surrendering to

it out of panic? Does reliance on vaccines betray a lack of confidence in long-standing tenets of force protection, international

sanction enforced by treaty, and deterrence backed by the prospect

of massive retaliation?

Modern military doctrine dismisses the effectiveness of fixed fortifications against a mobile enemy. Yet in choosing to deploy vaccines against specific biological arguments, we are, in effect, constructing a medical Maginot line. Given the number of possible biological warfare agents, it does not seem practical to build biological

barricades in every soldier’s body one threat at a time.

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Finally, in this important discussion, great care should be taken

to maintain the distinction between the military threat and the terrorist threat posed by biological weapons. They are not the same.

Next week the National Security, Veterans Affairs, and International Relations Subcommittee will hold a hearing on the scientific dimensions of the terrorist threat and the thresholds of

scale, expense, and technical expertise that differentiates statesponsored and military biowarfare programs from those posing a

greater risk to civilian populations. Mr. Chairman, these hearings

can make important contributions to our understanding of critical

national security issues.

I appreciate your convening these distinguished panels of witnesses today, and I look forward to their testimony.

[The prepared statement of Hon. Christopher Shays follows:]

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Mr. BURTON. Thank you, Mr. Shays. I want to commend you for

the work you’ve been doing on your subcommittee. It’s been extraordinary.

Mr. Horn.

Mr. HORN. I’ll save my fire for questions.

Mr. BURTON. Save your fire for questions. OK.

Our first panel today, they’ve already been sworn in because I

didn’t want them standing too long. Being in the military like I

was, I got awfully tired when I used to stand out there for hours

and hours, but then I was just an enlisted man.

Dr. Sue Bailey, thank you very much for being with us today.

General West, who is a very good friend of Chairman Young, we’re

very happy to have you here, sir. Colonel Randolph, very nice having you. Dr. Dumont, Dr. Zoon, and Mr. Chan. We really appreciate

you being here.

And who do you have with you?

Mr. CHAN. Dr. Charla.

Mr. BURTON. Thank you very much for being here. I would like

to let the record reflect the witnesses responded in the affirmative

to the oath.

We’ll start with Dr. Bailey with an opening statement. We’d like

to try to if possible stay within the 5-minute rule because we have

a number of people testifying today.

Dr. Bailey.

STATEMENTS OF SUE BAILEY, M.D., ASSISTANT SECRETARY

FOR HEALTH AFFAIRS, DEPARTMENT OF DEFENSE; MAJOR

GENERAL RANDALL L. WEST, SPECIAL ASSISTANT TO THE

SECRETARY OF DEFENSE FOR BIOLOGICAL WARFARE AND

ANTHRAX, DEPARTMENT OF DEFENSE; LT. COL. RANDY RANDOLPH, DIRECTOR, ANTHRAX VACCINE IMMUNIZATION PROGRAM AGENCY, DEPARTMENT OF DEFENSE; CEDRIC E. DUMONT, M.D., MEDICAL DIRECTOR, OFFICE OF MEDICAL

SERVICES, DEPARTMENT OF STATE; KATHRYN C. ZOON,

PH.D., DIRECTOR, CENTER FOR BIOLOGICS, EVALUATION

AND RESEARCH, FOOD AND DRUG ADMINISTRATION; AND

KWAI-CHEUNG CHAN, DIRECTOR, SPECIAL STUDIES AND

EVALUATION, U.S. GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY DR. CHARLA

Dr. BAILEY. Chairman Burton, Congressman Waxman, members

of the committee, my name is Dr. Sue Bailey. I’m the Assistant

Secretary of Defense for Health Affairs for the Department of Defense. I’m very pleased to be here today with General West and

Colonel Randolph to speak about our vaccination program for anthrax, and I’d like to submit my written statement and have a very

brief oral statement.

Mr. BURTON. Without objection.

Dr. BAILEY. Anthrax is a very deadly organism. It causes cutaneous or inhalation anthrax. It is very stable and can remain viable

for years. The incubation period is 1 to 6 days after which, if you

have not received the vaccine, you do die. Anthrax is readily

weaponized, it is highly lethal, and poses a clear threat in regions

where our service personnel are very likely to be deployed.

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Under our vaccine immunization program, the number of vaccinations has risen dramatically. We have now given over 1 million

of the vaccines. Although local reactions at the injection area itself

are not uncommon, they are usually mild and very short-lived.

There have been very, very few serious adverse effects, and those

are defined as resulting, as you stated, in hospitalization or loss of

duty for greater than 24 hours. These cases have all been medically

resolved.

The DOD is utilizing a civilian-based FDA system, which is the

VAERS reporting system, to document these more serious side effects. Reported reactions are in line with the other commonly prescribed immunizations, including those that you’ve seen that are

for school children here in America. The vaccine, which was licensed by the FDA in 1970, is effective and has an incredibly safe

record.

The evidence of vaccine effectiveness against aerosol exposure to

anthrax is very persuasive. Although obviously it would be unethical to test human subjects, we are at this point able to say that

our animal models using non-human primates have shown that the

vaccine is very effective in preventing the disease. Where nearly all

of the unvaccinated animals did succumb to an aerosol challenge,

we have a vaccine that can protect our troops from this deadly

weapon. It would be irresponsible for us to deploy our servicemen

and women without using the safe and efficacious vaccine.

I appreciate the opportunity to speak here today and look forward to any questions.

Mr. BURTON. Thank you, Dr. Bailey.

We’ll now go to General West.

General WEST. Mr. Chairman, Congressman Waxman, members

of the committee, I’m major General West, and I’m honored to appear before you today and hope we can answer your questions

about the Department of Defense Anthrax Vaccine Immunization

Program.

About 90 gays ago, I was reassigned from the Second Expeditionary Force where I was the Deputy Commander to work in the Office of Secretary of Defense as a Special Advisor for Anthrax and

Biological Defense Matters. I was already familiar with the threat

and with the vaccine program, but, after taking this assignment,

I’ve spent every working moment reading everything that I could,

reviewing all the studies that have been done, looking at the analysis, looking at the test groups and going to the field to talk to our

servicemen and women who are taking or expected to take the vaccine.

I also started that effort by going and having a meeting with

what might be referred to as the ‘‘know group’’ because I wanted

to know where they were coming from and what their argument

was from the very beginning.

I have to tell you, sir, that I’m more convinced today than I ever

have been that what the Department is doing in terms of giving

the anthrax vaccine to our servicemen and women is the right and

responsible thing to do. I could tell you many stories that I’ve run

into as I traveled about the field and talked with different people

about servicemen and women that have taken the vaccine and how

well it’s worked. I’ll limit that in the interest of time to just two.

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One is a Staff Sergeant, one of my fellow marines. He’s 43 years

old. He’s in good health. He has no debilitating disease. He has five

healthy children. He told me that he would give the anthrax vaccine to his own children if he could. He had his first shot when he

was 9 years old living on his father’s farm, who is a veterinarian.

He feels he made the right choice then and would make the same

one again today.

The second account I would share with you is from my own unit

at Camp Lejeune. We have a unit there called the Chemical Biological Incident Response Force. Their job is to do consequence

management if there should be either a military or a terrorist attack in the United States or somewhere abroad. They are literally

a 911 force. They’re ready to slide down that pole and go whereever

an event might happen. And, God knows, we hope one never does,

but if it does, they’re ready to go with whatever protective equipment and detection equipment and other things that technology

can provide us is available and do the best job they can to contain

the devastation that can be caused by an anthrax or another biological or chemical attack.

When they were briefed a three-part brief on the threat, the safety, and the efficacy of this vaccine, all 400-plus members of that

unit went down and took their shot. Not one person refused it. Not

one person had an adverse reaction that caused him to miss any

duty time. Not one of them asked not to take it or complained

about taking it afterwards. They understood the threat and they

knew that if they went in harm’s way and took one deep breath

of air contaminated with anthrax spores and wasn’t vaccinated that

they were going to die. That was motivation for them to take the

shot, and that was 1 year before DOD made the shot program mandatory.

Some have argued that if we protect our forces against anthrax

that the enemy would simply use another bioweapon. The point I

would make here is if the anthrax vaccine serves as a deterrent it

will have already accomplished its mission as being the prevention

of the use of a catastrophic weapon.

One of the CINCs that asked that all servicemen and women deployed to his theater take the vaccine before they arrive is a commander in chief in the Korean theater. We have service members’

families there, and there are many South Koreans that live on that

peninsula. If one North Korean airplane with 55 gallon drums of

anthrax aerosolized spray flew north of the DMZ about sunset one

evening and sprayed that spray from one side of the DMZ to the

other with a wind that was blowing at about 30 miles per hour to

the south, by the time everyone woke up the next morning, potentially the entire peninsula could risk breathing in air that had been

infected with anthrax spores. The deterrent, if it worked, would not

only protect our servicemen and women but it would protect the

lives of our family members and our allies that might not have

been vaccinated even when our servicemen and women are.

Let me take just a moment to talk to the threat.

I believe that there are at least 10 potential adversaries out

there who either have weaponized anthrax or are pursuing it. In

December 1990, I was in the Persian Gulf. We later learned that

Saddam Hussein had anthrax weaponized. He had it deployed on

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the battlefield. He had it pointed at our troops, and his commanders had the authority to use it. Deterrents or something worked

there, and they never pulled the trigger, and I’m tremendously glad

of that, but if he had, we would not have been ready. All of our

servicemen and women would not have been vaccinated. I’m afraid

many of them would have died.

At least two of our major theaters where our servicemen and

women go to work every day go to work under the threat of an anthrax umbrella, meaning that the enemy or a potential adversary

has the capability to deliver it and would only have to pull the trigger to do so. We have a vaccine that’s FDA approved. It has a proven safety record and we believe a proven efficacy as well. I feel that

I would be derelict in my duties if I didn’t insist that the servicemen and women that I send to those theaters and other places

where it might be used were not vaccinated against the anthrax

threat.

The servicemen and women entrusted to me by the mothers and

fathers of America are the greatest asset that our Nation has. I

would not want to send them there without vaccination.

I wish we had a deterrent that we would know would always

work. I wish we had intelligence that would give us advanced

warning every time. I wish we had biodetectors that had better

sensitivity and we had more of them deployed on the battlefield. I

wish we had clothing and equipment that our servicemen and

women could wear to protect themselves against a bio or chemical

threat and still be able to fight.

But the fact is that we don’t. We don’t have those things, and

they’re not in the foreseeable future. The one thing that we do have

today that works and we know it works is the anthrax vaccine. The

threat is real, and it’s now, and I believe we must take the responsible action in protecting our men and women before they deploy

in harm’s way by giving them the anthrax vaccine.

I can’t claim to be an enlisted man now, sir, but I did do 2 years

there before I became an officer, so I can understand what you

were saying. Thank you.

Mr. BURTON. My respect for you went up just a little bit more,

having been an enlisted man myself.

Let me just add one little caveat here, and I think one of the reason’s Saddam Hussein didn’t use other things was because there

was the threat of the possible use of low-yield enhanced radiation

tactical nuclear weapons, and I was glad President Bush indicated

that was not out of the question and General Schwarzkopf did as

well.

Colonel Randolph.

Colonel RANDOLPH. Chairman Burton and distinguished committee members, I’m honored to appear before your committee today

and address your questions about the Department of Defense Anthrax Vaccine Immunization Program. We call it AVIP for short.

I’m Lieutenant Colonel Randy Randolph, and I’m the Director of

the AVIP agency, which is an organization and office under the Office of the Army Surgeon General.

The AVIP agency is the central source for educational and informational materials on the Anthrax Vaccine Immunization Program. As such, I travel around the Nation, in fact, worldwide,

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speaking to service members, family members, as well as spouses

and mothers and fathers almost daily.

We manage the AVIP Internet website, which is one of the initiatives to improve our education and our communication with our

service members and their family members. Our office manages a

toll-free information line, the 1–877–GETVACC line. We also handle numerous daily informational requests from service members,

family members, Congress, and the media. We’re the focal point for

policy coordination for this program and for vaccine distribution

and allocation. We not only monitor the services execution through

reports from the services but in fact facilitate their execution.

I look forward to answering your questions about this program.

Mr. BURTON. Thank you, Colonel.

I’ve been out of the service so long I called you major earlier. I

didn’t see those silver leaves up there. I apologize for that.

[The prepared statement of Dr. Bailey, General West, and Colonel Randolph follows:]

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Mr. BURTON. We’ll now go to Dr. Dumont.

Dr. DUMONT. Mr. Chairman and members of the committee,

thank you very much for the opportunity to testify before your committee regarding the Department of State’s Anthrax Immunization

Program. My name is Cedric Dumont. I’m the Medical Director for

the Department of State, and the Office of Medical Services is responsible for promoting the health of all the Foreign Service and

all our community members overseas.

Mr. Chairman, in the spring of 1998, when it became clear that

Iraq had developed a biological weapon capability, the Department

of State prepositioned as a precautionary measure anthrax vaccine

and antibiotics at our missions located within SCUD range of Iraq.

These supplies were stockpiled at these posts with the intent to administer post-exposure vaccination and antibiotics following an attack.

On August 7, 1998, the bombings of our embassies in Nairobi

and Dar Es Salaam confirmed that we face a global and multidimensional threat against United States personnel and United

States interests overseas and that we can no longer assume that

missions outside of SCUD range are at low risk. With the assistance of the emergency security supplemental, we are improving the

security of our facilities, employees, and our family members. In

addition to physical security upgrades we have implemented a

worldwide chemical and biological countermeasures program which

includes the Department’s voluntary Anthrax Immunization Program.

The program we have initiated, Mr. Chairman, is a voluntary

Anthrax Immunization Program that makes the vaccine available

to all eligible individuals at our missions overseas, including eligible family members. It is administered on a voluntary basis following strict FDA guidelines.

Mr. Chairman, anthrax as a weapon can be delivered in an aerosolized form by a variety of devices ranging from SCUD missiles to

portable dispensers. There is presently no adequate device to detect

anthrax in its aerosolized form. It is colorless and odorless. The detection of an anthrax attack will most probably occur days after the

event with the appearance of severely, critically ill patients, most

of whom we believe would die in the first 72 hours.

The clinical presentation of inhalational anthrax is insidious. Patients may have non-specific, flu-like symptoms; and for the first

several days the definitive diagnosis will most probably elude providers and caregivers. Most of these initial cases would succumb to

the overwhelming infection.

Animal studies demonstrate that the anthrax vaccine combined

with antibiotics can be life-saving if administered within 48 hours

of exposure. In the overseas environment, it is very unlikely that

exposure can be detected within that timeframe. This is due to the

lack of local medical infrastructure at many of our missions. In

most cases, local medical providers, technologists, microbiologists

and public health officials have neither the training nor the equipment to rapidly detect and identify the anthrax organism.

Like all vaccines, the anthrax vaccine is most effective when

used prior to exposure. There has been extensive experience with

the administration of this vaccine in veterinarians, animal hanVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00052 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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dlers and laboratory staff, and it is approved by the FDA. Lab

studies tell us that in animals the preexposure administration of

vaccine is effective against lethal doses of aerosolized anthrax. The

vaccine is administered in a six-shot series, and studies suggest

that it is protective after the third immunization.

Mr. Chairman, Foreign Service employees and their families

serving abroad receive many immunizations throughout their careers in the Foreign Service. When serving overseas, our communities are often exposed to exotic diseases; and when an FDA-approved vaccine is available to protect them against these diseases,

such as hepatitis and yellow fever, we offer it to them and to their

families.

All our vaccines are administered on a voluntary basis. From our

point of view, we consider anthrax as one additional health risk for

which there is a protective vaccine. This is a health risk which we

believe is worldwide and which is focused on our workplace. One

could argue that families are less at risk if the anthrax weapon is

targeted against the workplace. We believe that family members

are still at risk of exposure, especially at missions where embassy

housing is clustered near U.S. Government facilities and where

services commonly used by family members are located within the

chancery, within the mission.

One of our most difficult challenges is how to protect those individuals who are presently ineligible for the vaccine, those less than

18 or over 65 or pregnant. Recognizing that these individuals are

also at risk, the Department of State is engaged in a dialog with

the Food and Drug Administration and the manufacturer of the

vaccine, BioPort, in exploring the feasibility of providing the vaccine on a voluntary basis to presently ineligible individuals through

a Food and Drug Administration approved clinical study. The purpose of the study is to determine the safety and immunogenicity,

the effectiveness of this vaccine in those individuals otherwise ineligible.

This concludes my statement, Mr. Chairman. Thank you for the

opportunity to testify before the committee.

Mr. BURTON. Thank you, Dr. Dumont.

[The prepared statement of Dr. Dumont follows:]

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Mr. BURTON. Dr. Zoon.

Dr. ZOON. Mr. Chairman and members of the committee, I am

Dr. Kathryn Zoon, Director, Center for Biologics Evaluation and

Research at the Food and Drug Administration. I appreciate the

opportunity to discuss the safety and efficacy of the anthrax vaccine currently manufactured by BioPort Corp.

FDA shares everyone’s concern that our military personnel receive safe and effective medical products. Mr. Chairman, we are

aware that some people question the safety and efficacy of the anthrax vaccine. Let me be clear. We believe the anthrax vaccine is

a safe and effective vaccine in high-risk populations for the prevention of anthrax disease, an often fatal disease, when given as according to the package insert.

Our confidence in this vaccine, like all vaccines, is based upon

four components: first, the clinical trials and the subsequent clinical experience with the vaccine—in this case, the Brachman trial

and the CDC trial, which I will discuss; second, ongoing inspections

of the manufacturing facility based on our GMP requirements;

third, our lot release requirements, which is another layer of protection; and, fourth, our ongoing collection of adverse event reports

that serve as an early warning system.

We will continue our efforts in all four of these areas with the

anthrax vaccine and all vaccines to assure that only safe products

are on the market.

Anthrax is a highly infectious disease caused by spores of a bacterium known as Bacillus anthracis. The only known effective prevention against anthrax is the anthrax vaccine. Use of the anthrax

vaccine to immunize people at risk along with vaccination of animals against anthrax has likely contributed to a favorable decline

in anthrax infections. The Centers for Disease Control and Prevention data on reported cases of anthrax in the United States indicate

a drop from 130 cases per year to zero cases per year in recent

years.

If I could, for the record, I’d like to enter this chart.

Mr. BURTON. Without objection.

Dr. ZOON. Thank you.

[The information referred to follows:]

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Dr. ZOON. Let me briefly explain the manner in which a vaccine

is licensed, and then I will discuss the studies that lead to licensure of the anthrax vaccine. This chart refers to the process, as you

can see.

Before a new vaccine can be studied in people, a sponsor must

submit an IND, or an Investigational New Drug application, to the

FDA. Often we have meetings before the submission of an IND to

discuss with the sponsors trial design issues and preclinical information which they should submit.

In addition, in the application, once it’s submitted, the sponsor

must provide specific information to the FDA. In this process, the

IND process which was described, there are three phases in general prior to product approval. However, the distinction between

these phases is not absolute.

Phase one trials are focused on basic safety and for vaccines also

usually evaluate the immune response solicited by the vaccine.

These trials are usually small, generally between 20 and 100 subjects, and they frequently are done in healthy, normal volunteers

and may last just several months.

Phase two trials often include several hundred subjects, are often

randomized and last anywhere from several months to several

years. These usually include individuals who are at high risk for

the infectious disease of interest.

Unless severe reactions or a lack of effectiveness surface during

the first two phases, the sponsor may decide to perform one or

more phase three studies that can include up to several thousand

people. These phase three trials are intended to provide the definitive measure of effectiveness as well as continue the evaluation of

product safety. The size of the efficacy trial will be affected by the

expected incidence of the disease that the vaccine is intended to

prevent.

If at the end of phase three trials the sponsor believes that there

are adequate data to show the vaccine is safe and effective for its

intended use, the sponsor submits a license application to the agency. After licensure, sponsors generally submit samples of each licensed vaccine and results of their own test for purity, potency,

safety, and sterility to the agency before the release of each of the

licensed vaccine products. In addition, licensed establishments are

inspected regularly by the FDA, and there are feedback loops in

this process all along the way.

In the interest of time, I would just like to skip and tell you a

little bit about the VAERS system. FDA uses the Vaccine Adverse

Event Reporting System [VAERS], to track adverse events possibly

associated with licensed vaccines. Any person, including a patient,

can file a report. Reporting is voluntary for individual health care

providers. The vaccine manufacturer, however, must report to the

FDA all reports of adverse events of which they are aware.

A VAERS report is not documentation that a vaccine caused an

adverse event, but only that an event occurred soon after the vaccine was administered. From the time VAERS started participating

in 1990 until October 1, 1999, there have been 425 submitted reports of adverse events associated with the anthrax vaccine. Of

those, 29 were considered serious events.

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Data gathered from the VAERS system can serve as a useful tool

in detecting potential problems with a vaccine, but VAERS reports

on anthrax vaccine thus far do not signal concerns about the safety

of the vaccine. As more people receive the vaccine, the number of

adverse events reported will increase.

Mr. Chairman, again let me state clearly that we are confident

that the anthrax vaccine is safe and effective for high-risk adult

populations for the prevention of anthrax infection when administered according to the package insert. FDA will remain vigilant in

its review of anthrax vaccine adverse events and its oversight of

the vaccine manufacturer.

I appreciate the committee’s interest in this very important topic,

and I will be happy to answer any questions. Thank you.

Mr. BURTON. Thank you, Dr. Zoon.

[The prepared statement of Dr. Zoon follows:]

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Mr. BURTON. Mr. Chan.

Mr. CHAN. Mr. Chairman, members of the committee, I’m

pleased to discuss the results of our ongoing examination of the

safety and efficacy of the anthrax vaccine.

My testimony is based on previous studies we have conducted to

determine the need for a six-shot regimen and annual booster

shots; the long- and short-term safety of the vaccine; the efficacy

of the vaccine; and the extent to which problems the FDA found in

the vaccine production facility in Michigan could compromise the

safety, efficacy, and quality of the vaccine. Finally, I will report on

studies conducted to determine the effects of the anthrax vaccine

on children and pregnant women.

Allow me first to discuss the background of the vaccine. The

original vaccine was developed in the 1950’s and was first produced

on a large scale by the Merck Pharmaceutical Co. In 1962, a study

was published on the safety and efficacy of the Merck vaccine

against cutaneous anthrax.

In 1970, the Michigan Department of Public Health was granted

a license for a similar vaccine that differed from the Merck vaccine

in three ways. First, the manufacturing process changed when

MDPH took over. Second, the strain of anthrax that Merck used to

grow the original vaccine was changed to another strain. Finally,

the ingredients used to make the vaccine were changed from the

original vaccine.

Now let me turn to the results of our study. With regard to the

need for a six-shot regimen and annual booster shot, we did not

find any study to determine the optimum number of doses for the

current vaccine. For the original vaccine, a three-dose regimen was

used initially based on a regimen developed using animals in the

1950’s. However, the number of doses was arbitrarily increased to

six when three people who received three doses of the vaccine became infected after exposure to anthrax. And the licensed vaccine

adopted this schedule. Likewise, although annual boosters are required, the need for annual booster shots has not been evaluated.

With regard to the long-term safety of the vaccine, we found the

long-term safety of the licensed vaccine has not been studied. DOD

is planning a study to examine this issue.

With regard to short-term safety, one study used only the Merck

vaccine and the other used both the Merck and the licensed vaccine. Safety data from the licensed vaccine is difficult to interpret

since part of the population used both the Merck and the licensed

vaccine. Let me repeat this. The safety data from the licensed vaccine is difficult to interpret since part of the population used both

the Merck which is the original vaccine and the licensed vaccine.

According to FDA, it is not possible to determine which individuals

received which vaccine.

Post-licensure data are limited since FDA did not have the Vaccine Adverse Event Reporting System until 1990, and only a limited number of doses were distributed each year between 1970 and

1998 with the exception of the Gulf war. Approximately 150,000 of

United States troops received the anthrax vaccine during the Gulf

war, but little information is available since many records were

lost. Data collected by Fort Detrick as part of the Special ImmuniVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00088 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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zation Program suggest that women significantly experienced more

serious adverse reactions attributable to anthrax vaccine.

Since the mandatory program began, DOD has used an adverse

reaction rate based on the number of adverse events it reported to

FDA. The FDA system is a passive surveillance system known as

VAERS. DOD uses two additional criteria for reporting an event:

The individual receiving the vaccine is hospitalized or is on sick

leave for more than 48 hours. This fact, combined with data from

studies conducted on VAERS, has shown that such systems do not

accurately reflect the true incidence of adverse events due to

underreporting.

However, DOD has conducted two other studies which used active monitoring where DOD personnel contacted the vaccine recipients directly to find out if they had any adverse reactions. Data

from these studies show that not only were there a much higher

rate of adverse events, but, additionally, a higher proportion of

women reported both local and systemic reactions to the vaccine

than their male counterparts. In addition, more than twice the proportion of women reported that they missed one or more duty shifts

after their vaccinations than did males.

With regard to efficacy, a 1962 study on the efficacy of the original vaccine concluded that it provided protection to humans

against anthrax penetrating the skin and not through inhalation.

However, it is important to note that even this protection was not

100 percent.

In 1985, the Federal Register stated that,

Immunization with this vaccine is indicated only for certain occupational groups.

It is recommended for individuals in industrial setting who come in contact with imported animal hides, furs, wool, hair, bristles, and bone meal, as well as laboratory

workers involved in ongoing studies on the organism. In general, safety of this product is not a major concern, especially considering its very limited distribution and

the benefit-to-risk aspects of occupational exposure in those individuals for whom

it is indicated.

In the 1980’s, DOD began testing the efficacy of the licensed vaccine in animals, focusing on its protection against inhalation anthrax. The studies showed that the vaccine protected some animals

against some strains but not all strains. Furthermore, the level of

protection varied for different species, and the results cannot be extrapolated to humans. DOD recognizes that correlating the results

of animal studies to humans is necessary and told us that it is

planning research in this area. DOD also plans to develop a second

generation anthrax vaccine and, as part of this effort, will need to

address whether strains of deliberately engineered or naturally occurring anthrax can overcome the protective immunity of such a

vaccine.

FDA’s inspections of the vaccine production facility in 1996 and

1998 found a number of deficiencies with the Michigan plant. The

deficiencies that the FDA identified in its February 1998 inspection

fall broadly into two categories: those that might affect only one or

a limited number of batches that were produced and those that

could compromise the safety and efficacy of any or all batches. The

facility was shut down in early 1998 for renovation. A new company, BioPort, which purchased the facility in mid-1998, is addressing these issues.

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Finally, you expressed concerns about the effects of the anthrax

vaccine on children and pregnant women. The anthrax vaccine is

not intended to be administered to children and pregnant women.

No studies have been conducted on the vaccine’s effects on these

groups.

This ends my statement. Thank you.

Mr. BURTON. Thank you, Mr. Chan.

[The prepared statement of Mr. Chan follows:]

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Mr. BURTON. Let me start the questioning. How many strains of

anthrax are there, do you know?

Mr. CHAN. As I understand it, the natural strains, there are at

least 33 of them at Fort Detrick.

Mr. BURTON. Did your research show how many strains of the

anthrax virus or bacteria were going to be dealt with with the inoculations that they’re giving to our military?

Mr. CHAN. The vaccine has been tested against guinea pigs, and

the results have been varied. I think we found that guinea pigs

were protected against 18 strains, but not all strains.

We also tested the vaccine in monkeys against the ames strain,

and the results were very promising, but that’s the only strain that

I know of that DOD tested in monkeys.

Mr. BURTON. It says here, overall results, vaccine fails against

nine of the tested strains. There are 33 anthrax strains. Is that accurate?

Mr. CHAN. Yes, that’s correct.

Mr. BURTON. Thrirty-three percent of the strains that it was tested against, it failed against 9 of the tested strains.

Dr. BAILEY. I would just like to add, to our knowledge, that the

vaccine we are using protects against all known natural strains of

anthrax. In fact, the testing—I understand that there were 33

strains tested against guinea pigs and 7 strains with rabbits.

Mr. BURTON. How many were tested on human beings?

Dr. BAILEY. Well, again——

Mr. BURTON. The reason I ask that question—let me just ask. It’s

been stated by Mr. Chan that you can’t—there definitely is a question about the correlation between the animals they tested it upon

and human beings. You’re talking about guinea pigs and rabbits.

There are 33 strains, and we just stated here, according to the

overall result from the NATO guinea pig test, it failed against 82

percent of the tested strains. Now, how do you know that it’s going

to be effective for human beings if it has not been tested on human

beings?

Dr. BAILEY. Mr. Chairman, I would like to share with you research that was done years ago with people who were working with

wool who had been vaccinated. Among the group that were vaccinated with anthrax vaccine for cutaneous anthrax they were exposed to that frequently, and it showed a high ability to protect.

However, there was a natural outbreak of inhalation anthrax; five

people died. No one who was vaccinated died. As well, it is unethical for us to test human beings. Therefore, we look to the

nonhuman primates who are so similar——

Mr. BURTON. OK. Let me just interrupt here. The inhalation of

the anthrax virus has never really been adequately tested, has it?

Dr. BAILEY. That’s why I share with you this case in which we

demonstrate——

Mr. BURTON. That was——

Dr. BAILEY [continuing]. In the naturally occurring——

Mr. BURTON. That was in the 1950’s, and that was regarding

people who handled animals—animal skins, hair and so forth, and

the vaccine was administered to protect them from having it conveyed through their skin. And you said that some of them died but

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none of them died because of the—none died because of the aerosol;

is that correct?

Dr. BAILEY. None of them that inhaled the spores died who had

been vaccinated. The five who had not been——

Mr. BURTON. How do you know that?

Dr. BAILEY. This is scientific data that we have.

Mr. BURTON. How do you know how many inhaled it? Was it in

the air? Did you know that?

Dr. BAILEY. I can get you specifics on that and attach it to the

record.

Mr. BURTON. Do you know it was in the air?

Dr. BAILEY. That is what is reported.

I would also like——

Mr. BURTON. No, let me finish. Do you know that it was inhaled?

Dr. BAILEY. That is what is reported. That is in the scientific literature.

Mr. BURTON. Mr. Chan.

Mr. CHAN. I do not agree with that statement. Because when we

talked to Dr. Brachman, who wrote the article, he basically said

that there was no attempt to measure the level of anthrax spore

in the air, and it was done—then he told us something different.

Certainly the occurrence of inhalation anthrax did not, first of all,

only occur during the crisis where lots of people also were infected

with cutaneous anthrax.

Let me state something for you. I hate to use this—the way it’s

stated appears that there’s protection of cutaneous anthrax fully.

The study basically said that even under this kind of circumstance,

they expect that number of people who are protected it’s 92.5 percent with a low confidence of 65 percent. That means that 95 percent of the time, 65 percent to 92.5 percent of the people would be

protected against cutaneous anthrax.

And it also stated in the study that there were insufficient number of incidents in the inhalation anthrax to draw the conclusion

about the protection, OK? That’s what the report says here.

Mr. BURTON. I see my time has expired. I will come back for a

second round.

Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman.

It seems to me that there are—this whole question of the hearing

boils down to two issues: One, is there a need for the vaccine? And,

two, if there is a need, is the vaccine safe and effective?

Let me address the first one first. Let me see whether there’s a

need for the vaccine.

There are witnesses in panel II that are raising questions about

the reality of a threat from anthrax and the need for an anthrax

immunization program. General West, what are your views on the

threat of an anthrax attack on DOD personnel?

General WEST. Well, Congressman, I certainly hope that there’s

never an attack. I hope the fact that our forces have been vaccinated and the other things that we can apply against that possibility will be effective. But what we know is that at least 10 of our

potential adversaries, and again I hope we never have an adversary, but people we’ve had disputes with, people that we’ve been

in conflict before, at least 10 of them either have anthrax

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weaponized in weapons ready to shoot or they’re actively pursuing

it.

We also know of at least two terrorist groups that either have

it and have tried to use it or are pursuing that capability. As I said

in my opening statement, in two of the major theaters, in Korea

and in the Persian Gulf, we have servicemen and women that go

to work every day in areas where the enemy at any time could deliver an anthrax weapon.

Mr. WAXMAN. Thank you.

I would like to ask this panel then to address the concerns that

have been raised about the safety of the vaccine. Dr. Zoon, putting

aside concerns about the manufacturer of the vaccine, put aside

problems with the implementation of the vaccine program by DOD,

would you consider the anthrax vaccine safe if it were properly

made and administered?

Dr. ZOON. Yes, sir, I do. Based on the studies originally done on

the anthrax vaccine, including the Brackman studies as well as the

studies done by the CDC, the adverse event profile in the package

insert very much mimics what we are seeing today in terms of the

types of adverse events and depending on the population, if the

population is a high-risk population, then the risk benefit profile

would warrant using the vaccine.

Mr. WAXMAN. Do any of the other members of the panel have additional views they would like to share on the safety question? I

understand that Mr.——

Dr. BAILEY. I would just share one additional thing. In looking

at the adverse reaction reporting we have, we have 314 that we’ve

reported through VAERS; 17 have had to be hospitalized, but only

5 of those were shown to directly relate to, as best you can determine, to the vaccine, and those were allergic responses.

I would just share with you that the rate that we’re seeing as

has been indicated is pretty much what we expected. It clearly is

in line with other vaccines that are given, diptheria, typhoid, tetanus, the kind of local reactions we see. So we’re seeing safety.

Also, we have not had a death. Often, as you know, there are

more serious reactions at times to vaccines. We have not had an

anaphylactic reaction. We are pleased to report that we feel this is

a very safe and efficacious vaccine.

Mr. WAXMAN. Thank you very much, Dr. Bailey.

I understand Mr. Shays’ subcommittee held five hearings that focused not on an abstract issue but on the specific details of the

manufacturing of the vaccine and on DOD’s implementation of its

program. Dr. Zoon, can you tell us what the most serious problems

are with the manufacturing of the vaccine and whether the manufacturer is taking steps to remedy those problems?

Dr. ZOON. Yes, sir. As stated, the manufacturer had received a

Notice of an Intent to Revoke. There were GMP deficiencies, and

the manufacturer is currently engaged in remedying those deficiencies.

Mr. WAXMAN. And, Dr. Bailey, could you comment on the most

serious problems with DOD’s implementation of this program and

what steps the agency has taken to remedy these problems?

Dr. BAILEY. These problems in what aspect of the program?

Mr. WAXMAN. In the DOD implementation of the program.

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Dr. BAILEY. I assume that’s not an acquisition question in terms

of BioPort but more a question about the program, actually the

clinical aspects of the program.

Mr. WAXMAN. I will tell you what. Let me withdraw that question, because we will probably want to bring it up later for the

record.

I couldn’t understand this argument, Dr. Chan. You say 82 percent of the strains didn’t seem to be affected, and I don’t know if

that’s an accurate statement or not. But what difference would it

make? It’s almost like saying if you find out a soldier wears a helmet to protect their heads but then they can get shot in the chest,

then you would want to make them wear a bulletproof vest. You

wouldn’t tell them not to wear a helmet any longer, would you?

If it protects against some of the strains of anthrax, isn’t that

worthwhile? Then we ought to make sure to continue working so

that it protects against other strains as well.

Mr. CHAN. I think it makes a lot of sense, unless you want to

take it to a limit. For example, if we know what strains Iraqi have

and, in fact, DOD had tested the vaccine against that particular

anthrax, that is weaponized, I would agree with you, Congressman.

But first I think you need to ask them whether they have done that

already or not. Let them answer that.

And the second question——

Mr. WAXMAN. You wouldn’t want to test it on people?

Mr. CHAN. No, use whatever animal model you want. I don’t

have any problem with that. But my point is that if they are in existence, 31, 33 different strains that are naturally there, not engineered, then at the very least, we need to test the vaccine against

those strains. DOD said, well, we will go to the monkeys model.

Try them out and see what happens.

Dr. BAILEY. In fact, I would share with you one of the tests that

I think is essential here. We did an aerosol challenge against the

Rhesus monkey, and with the Rhesus monkey, when they had received more than two doses, they all survived. Those who had received the vaccine, they survived the aerosol challenge. Again, it’s

not a human model study. It would be unethical for us to do that.

I would also just add in general with vaccines that you’re looking

for protective antigen response, and really the strain itself is not

so essential as the mechanism.

Mr. BURTON. Before I go to Mrs. Morella, let me just say, as I

understand it, that was not tested against all 33 strains in the

monkey; is that correct?

Dr. BAILEY. That’s correct.

Mr. BURTON. Thank you.

Mrs. Morella.

Mrs. MORELLA. Thank you, Mr. Chairman.

I thank the panelists for their presentations, too.

It’s interesting, as somebody who was very much involved with

having an Office of Research on Women’s Health established at the

National Institutes of Health, which has been working quite well

in including women in protocols and clinical trials, I’m fascinated

by our GAO report here which indicates a tremendous disparity in

some of the data with regard to gender differences, which says

something—I mean, there are big disparities here, and I’m just cuVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00111 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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rious about what this is saying. Do we need to look at that separately? Would anyone like to extricate from that data something

that adds to our base of knowledge of this?

Dr. BAILEY. Mrs. Morella, first of all, I would like to share with

you that I’ve had five of my shots already. I was certainly glad to

have done that as I was in the Persian Gulf last year within SCUD

range. But I’m confident, in general.

And, again, if a member of my family were in harm’s way or in

a theatre where I knew that to be a risk, I would certainly want

them to have that immunization.

I saw no ill effects. That’s beyond the point. The real point is

that you’re right. We’ve looked at the data, and we know that there

seems to be a higher reaction rate, a local reaction, especially

among women, but also in general we’re getting a greater response.

One of the theories is that women have a stronger immune response, and that may be part of what we’re seeing, and I think it

would be worth looking at.

But there’s a plus to that as well, which means that if, in fact,

you have a stronger response, it may be that you have stronger

protection as well.

Mrs. MORELLA. I would like to hear from our GAO people, too.

Mr. SHARMA. Let me say a couple of things on this. This is a very

significant finding on this vaccine. This vaccine has not been used

in large numbers. Although Brachman had some women in his

studies—he did not analyze his data on adverse reactions by gender. So we don’t know really how this vaccine was going to work

on women. However, DOD collected data on its own employees that

received the vaccine from 1974 to 1998 found that women had statistically significant higher reaction rate. They had, also, higher

lost duty time.

It is correct what Dr. Sue Bailey stated, that it means that

women have a better immune system. However, what I would also

like to state is that it also calls into question two things.

First of all, we have to ask this question: whether women need

the same level of dosing if they have a better, more sophisticated

immune system. And I’ve indicated that for the licensing vaccine,

no studies were done to determine the number of doses, the need

for the frequency of the booster by gender, so we have no information. This is very significant and alarming. And in our military

today, we’re going to have more and more women. Right now, there

is no protocol to determine what the antibodies levels are.

I think it is important because a point that I wanted to mention

earlier in the animal data, one of the things that we found is that

antibodies levels which are supposed to be correlated to protection

turned out not to be related to protection. In other words, animals

that had higher levels of antibodies died than animals that had

lower levels. This calls into question, if antibodies levels are not a

good measure, then how do we determine what do you need for protection?

So we need to do two types of studies: Are women at higher risk?

Is this vaccine or other vaccines in some way impacting the immune system of women? And, second, what is the optimum number

of doses for men and women?

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Mrs. MORELLA. Would you agree, Dr. Bailey? Did you want to

make any statement from FDA’s point of view?

Dr. ZOON. Yes, just one comment based on our data from the

VAERS system regarding adverse events that have been reported.

Although we don’t have a denominator for the total number of

minor and nonserious and serious reactions totally, other than

what’s reported to VAERS, our data does suggest that, in terms of

the serious reactions, the percentage of the total reports, the percent of serious over the total number of reports to VAERS is the

same for men and women, about 7 percent.

Dr. BAILEY. I would certainly agree we need additional research.

We have $8 million planned over the next—up until 2005, and I

think clearly we need to determine if there indeed is any gender

difference.

Mrs. MORELLA. Thank you. I think that’s an important point to

make. Thank you.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Mrs. Morella.

Ms. Schakowsky.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman.

Whoever can answer this—how many biological weapons are

there that are actually weaponized and that we might be able to

expect could be used aside from anthrax or near weaponized or

could easily be weaponized?

General WEST. We would get into a classified area pretty quickly

there. I can tell you that several are being pursued. The one that

seems to be the force of choice—or the weapon of choice is anthrax.

There seem to be more countries pursuing and using that than any

other. There are some others that may be possible, but I cannot tell

you of any actually that are in the weapons and ready to be shot

at this time.

Ms. SCHAKOWSKY. But, General, if it were widely known, as I’m

assuming it is, since everything we do is out in the open, that

American forces were immunized against anthrax, why would an

enemy directing its offense use anthrax if we have this program if

there were another weapon of choice?

General WEST. I think there are two parts to that answer,

ma’am.

First of all, I mean, anthrax is the weapon of choice for good reason. It’s easier to obtain. You can buy the ingredients to grow the

culture under the guise of other lawful activities. Once you make

it, it’s very stable. It lasts for a long time. It’s resistant to the elements. It’s very tenacious. It’s extremely lethal. Some of the other

and potential biological weapons are not as stable. They’re easily

deteriorated by sunlight, by wind, by rain, things like that. They

are also easily contaminated. They are also much more dangerous

to build.

So particularly on the terrorist side or the smaller nation state

side, they may not have the advanced laboratories, they’re very

dangerous to manufacture and the perpetrator may, in fact, bring

harm upon himself.

Ms. SCHAKOWSKY. Does DOD envision at some point in the future that we will attempt to have a vaccination program for every

biological weapon?

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General WEST. No, ma’am, but what we do is we try to determine

as best we can what’s being worked on in the world by potential

adversaries, what capabilities are there, and we try to do whatever

we can to deter that threat. And in some cases that may be vaccine, and in some cases it may be something different. And some

of those areas we’re already pursuing a vaccine in case they are

able to weaponize and in case we think that it’s prudent to give

such a vaccine. But that takes a while, and we can’t get ahead of

the FDA there, we can only use one after it was approved for use.

But there’s work going on in case that came to pass.

Ms. SCHAKOWSKY. Are you concerned, because we are all, of

course, interested in deterrence and our ability to maintain our

readiness, that we’re losing a number of pilots because of their fear

of the anthrax vaccine? I mean, if we’re talking cost benefit, where

does it kick in that we’re losing too many of our armed servicemen

and people?

General WEST. I’m concerned. I’m concerned about the loss of one

single serviceman or woman of a reason for not taking an anthrax

shot. I would be remiss as a leader if I wasn’t. I wish the problem

wasn’t out there. I wish that we would have been ahead in the

communication effort so that we would have gotten to some of

these bases where there have been problems before the people that

I assume for their own proper motivations think that it’s bad.

But I know that there’s a threat out there. And I know that on

any given day I may have to send our men and women to operate

under the umbrella of that threat. And I couldn’t responsibly send

them there without using a vaccine that we’re convinced is both

safe and effective.

Ms. SCHAKOWSKY. Following up on Congresswoman Morella’s

line of questioning, we had testimony from a woman who was—I

know the protocol is that if you are pregnant or suspect that you

may be pregnant that you’re not required to—that you shouldn’t

take the vaccine.

However, she was not only not asked if she suspected she was

pregnant but there were statements made that implied that women

in the Armed Services would just simply say that they suspect that

they might and, therefore, unless you were proving that you were

pregnant, you were going to take that vaccine. I know that was

later denied, and that there was a ‘‘he said, she said.’’ But I have

no reason to doubt that testimony. I mean, she had no particular

motivation, I don’t think, to come here and say that.

So I’m concerned that even the protocols that do exist for women

in the military are not being followed and that we may be putting

some woman at risk, particularly given the little data that we have

on the difference and adverse effects on women.

General WEST. I wasn’t present for that testimony. But I would

agree with you, if that happened, it should not have happened. It

would be contradictory to our policy. Every female is supposed to

be asked before they take the shot. If they are pregnant, they’re excused from taking them. There are no repercussions. They’re not

required to take the shot if they’re pregnant. We don’t even want

them to.

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If that happened, I would like to know about it. We would like

to investigate it. If you hear of any other incidents like that, we

would like to know about it, because we have——

Ms. SCHAKOWSKY. A lot of incidents of testimony here that is

contrary to what is stated DOD policy is on the record for you to

observe from people who have come to hearing after hearing after

hearing and told us things that we’ve been then told are not DOD

policy that make many of us very concerned about the way this is

being implemented.

Thank you.

General WEST. I could add, ma’am, that every one of those is

being looked at by the various services’ Inspector Generals. We will

get to the bottom of every one of those, and we will provide the answers for the record to what we find out.

Mr. BURTON. Thank you, Ms. Schakowsky.

Mr. Shays.

Mr. SHAYS. Thank you.

General West, I know that you sincerely believe that this is a

program that we need to pursue. So I don’t question your sincerity.

But we have an all-volunteer service, and you have a mandatory

vaccination program, and you have started a new course. You have

decided that, where in the past we would protect and provide vaccinations for what nature may throw at us, the new Army, the new

Navy, the new Marines, the new Air Force is that we’re going to

vaccinate you on the potential threats of terrorists and any military

force that may use a biological agent. That’s the new voluntary

military.

Do you think that will have an impact on our ability to have enlistees and on retention?

General WEST. I don’t think it will, if we get our message out

that the vaccine is safe and effective. If we convince our young

women and men that there is a threat and what we’re going to do

wouldn’t hurt them, there won’t be a problem with it. We haven’t

done that as well as we should. We’re trying to get better, and

we’re going to catch up.

Mr. SHAYS. The problem is that is almost like me saying, trust

me, I’m a politician.

General WEST. I would never say that, sir.

Mr. SHAYS. There’s enough history of politicians in the military

in the past, not you, but the military in the past that would not

make people feel very comfortable with your sincerity and my sincerity.

Dr. Bailey, do you believe there is a direct correlation between

antibody response to the vaccine and protection from infection?

Dr. BAILEY. The very specific scientific question, and you already

heard it addressed here today, it’s one of the questions as to whether or not a higher——

Mr. SHAYS. I just want the answer.

Dr. BAILEY. Everything in my scientific background tells me that

an antibody response to an antigen does impart immunity and protection.

Mr. SHAYS. Then why isn’t DOD tracking antibody titers of vaccinated servicemen and women to see just how much biological

body armor they will actually take into battle?

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Dr. BAILEY. All of the research at this point indicates that this

is efficacious. There clearly are studies which can—we can provide

for you and show——

Mr. SHAYS. The military isn’t doing this. You are starting a new

policy: We are vaccinating for what a terrorist or a military might

do. And I’m asking why we aren’t starting to gather this information.

Dr. BAILEY. Actually, I think maybe, Colonel Randolph, do you

want to respond to that antibody research that has been done? We

certainly do look at the body of knowledge that is out there. We do

not recreate everything.

Mr. SHAYS. Are you tracking this or are you doing studies? The

answer is no. And so the question is, why not?

Dr. BAILEY. Well, you know, one of the concerns is the amount

of medical intervention or therapeutics that are done at all that

would involve a program, I assume you would suggest that be voluntary to draw blood and to track that.

Again, Colonel Randolph, do you want to add to that in terms of

the research or the body of knowledge?

Colonel RANDOLPH. Congressman——

Mr. SHAYS. I need to know why you’re not doing it, is the bottom

line.

Colonel RANDOLPH. Sir, we don’t do titers on military personnel

simply because no one does titers on any personnel subsequent to

a dose of vaccine. We have to follow the FDA dosing protocol of six

doses over 18 months whether we found an antibody titer after two

doses or three doses or four doses.

Mr. SHAYS. Yes, Mr. Chan.

Mr. CHAN. I think the chairman noticed my sense of frustration

here.

I think, as Mr. Shays said, if we are implementing a policy which

is for almost 2.4 million people and potentially even 5 percent have

adverse reactions it means 120,000 soldiers are affected and that’s

significant, if that’s the case. It seems to me that we need to be

proactively looking for ways to explain the problem to the soldiers

so they understand that we care about them.

Now, I just don’t understand why we are sticking with six dose

schedule. If this is the protocol, and if women are reacting much

more adversely than men, and we certainly do not have the original set of data from the Brackman study, explaining the safety of

that vaccine, which is in fact not the same vaccine that is being licensed, so there are a lot of unclear unknowns. And I think it

needs to be looked into in such a way that we don’t stand behind

this question of is it safe, is it efficacious because FDA licensed it.

Mr. SHARMA. I would like to add too, there is an additional reason why we should be looking for the antibodies level and that is—

we have protocols from other vaccines whereby when people have

adverse reactions we check for the antibodies level to determine if

they have sufficient levels of antibody that is required and, if they

do them you will waive subsequent shots.

Second, when you find that somebody is adversely reacting to a

vaccine, we can either increase the time between doses or we can

reduce the dose or we also can apply pretreatment. And this body

of knowledge about protocol is not new. DOD applies similar protoVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00116 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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cols to other vaccines. Why it’s not being applied to the current vaccine, I do not know.

Mr. SHAYS. Thank you, Mr. Chairman. Mr. Chairman, will we

have a chance to ask a second round of questions before we go on

to the next panel?

Mr. BURTON. Yes, we will go back for a second round of questions.

Mr. Horn.

Mr. HORN. Thank you, Mr. Chairman.

I wonder if the gentleman on the end, I came in 5 minutes late,

would identify himself. Now would you give me the spelling on the

name, the gentleman to your left?

Mr. SHARMA. My name is Sushil S-U-S-H-I-L. Last name is

Sharma, S-H-A-R-M-A.

Mr. HORN. And you’re part of Mr. Chan’s staff?

Mr. SHARMA. Yes, I work with him.

Mr. CHAN. He is my colleague.

Mr. HORN. Very good.

Let me just ask this. I was curious when Dr. Dumont said, well,

we don’t give them to those under 18 or over 65. Now we’ve had

some discussion on the children. Will that policy be changed so that

children and seniors over 65 who are abroad—because a lot of

these missions aren’t State Department missions, they’re other

agencies. There are military. There’s a whole series of people that

is in every country we have, and if we should be protecting those

individuals, we need to look at people who are over 65. Since I’m

over 65, I would have a few concerns if I was in your embassy and

you weren’t doing it.

Now, if a person asks to do it over 65 or says I want my children

done who are in high school, elementary school, under 18, do they

get the anthrax vaccine or don’t they?

Dr. DUMONT. Congressman, at this point in time, we are just in

the beginning of looking at a feasibility——

Mr. HORN. Move that microphone, please, a little closer to yourself.

Dr. DUMONT. Excuse me, again. Congressman, at this point in

time, we’re concerned with trying to protect in the overseas environment all of those who are not eligible for the vaccine at this

point. And so what we’re trying to do is we’re in the preliminary

stage of exploring the feasibility of doing a study for those that are

not eligible and that means over 65 but also less than 18.

And so what we could do is do a study that would be FDA approved, but it would involve doing dosing and it also would involve

doing blood drawing and assessing titers in that community.

Mr. HORN. What’s the evidence in science that says don’t give

that vaccine to someone over 65?

Dr. DUMONT. To my understanding, and I really would defer to

the scientific experts on the FDA side that there is no data, but it’s

just never been tested and offered to those communities, and that’s

why there’s no information.

Mr. HORN. Well, then we’ve got an arbitrary standard here. In

other words, we’ve got age discrimination, and there are laws

against that, and I don’t understand why we have that. Suppose

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you’re 641⁄2, suppose you’re 64 and 11 months, are you not going

to give that person the vaccine?

Dr. DUMONT. Again, what we would like to do—and I think

we’re—we want to protect as many people as we can. We are forced

to follow FDA strict guidelines in the administration of this vaccine. If we can make this vaccine available through a study this

would be——

Mr. HORN. You’re telling me ageism at a point in time is an FDA

policy? I think that’s silly. Now, unless there’s some evidence that

people drop over when they get the anthrax shot because they hit

65, I find this unusual and weird. So let’s hear it FDA.

Dr. ZOON. Yes, sir. The age in the package insert is based on the

studies that were done to support licensure of the vaccine. So the

population that was used to show the safety and effectiveness of

the vaccine was in that age group, between 18 and 65. To promote

vaccines in areas outside that range would be an off-label use of

the vaccine.

Now, under some new rules, such as the pediatric rule and some

new guidances, looking at special populations now is an important

part of them extending medicines to the young and the elderly. The

development of the application of existing licensed medicines, can

be studied, but they need to be studied under an IND where you

have special monitoring of the individuals. To a large degree, many

times the very young and the elderly will elicit a different immune

response.

So one needs to study the particular agent, in this case the vaccine, to get information and data to assure that the safety and efficacy of that vaccine will be appropriate in those populations.

Mr. HORN. Well, they’ve picked an arbitrary cohort there, and it

seems to me—where’s the evidence one way or the other?

Let’s deal with women below 18 or women over who might become pregnant some day. It might be 1 month, it might be 1 year,

it might be 10 years. I mean, is there any evidence at this point

that when you give the anthrax vaccine that 2 years later a woman

became pregnant and something deformed the child? Where is the

evidence?

Dr. ZOON. At this point in time, no studies have been done to assess that. This particular product is labeled pregnancy category C,

which means animal reproductive studies have not been done nor

has it been tested in pregnant women, and according to the labeling, this should only be used in pregnant women in extremely highrisk situations where that exposure would be really an imminent

hazard.

So the answer to your question is, one can study this in animal

models, but it has to be under a properly controlled study with appropriate safeguards, informed consent, et cetera, in order to examine the particular safety and efficacy of any product, including vaccines.

Mr. HORN. OK. And that’s because you’re following an FDA cohort-type of analysis, is that it?

Dr. ZOON. This would be an IND study, and that population

would be studied for the safety and efficacy very closely under an

IND with informed consent.

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Mr. HORN. Mr. Chairman, I just think sometime maybe the committee would like to get into the FDA regulations on this that

they’re following, because it sounds to me like it’s simple ageism,

and I thought we got rid of that 15 years ago in this city. I don’t

know what happened.

Mr. BURTON. I think the FDA is aware that we will be having

a number of hearings involving them.

Before we go to Mr. Terry, let me just say that the immune response that I heard Mr. Chan talking about a while ago varied

greatly between individuals of the same age, same gender, everything else. I mean, the amount of immune response varied greatly

with the same number of inoculations. And the second thing is you

mentioned this stuff was tested—it’s not the same shot you’re giving today that was tested by Merck, is it? It’s a different one, isn’t

it? I mean, the tests you’re talking about were the Merck Laboratories. Has this new shot been tested like the Merck tests were?

Dr. ZOON. Sir, are you addressing me?

Mr. BURTON. Any one of you. You keep referring to this stuff

being tested. This is not the same vaccine that Merck tested back

in the 1950’s. It’s a different one. Has this been tested thoroughly?

Dr. ZOON. Let me describe what the situation is. The particular

type of anthrax that is used to make the vaccine comes from the

vollum strain. That is the parent strain. The Merck vaccine and

the current vaccine are both derived from the vollum strain. The

original Brachman study used a strain which was slightly different

but still derived from the parental strain of vollum.

Now, when the additional studies were done by the CDC, they

used some of the Merck vaccine and they also used some of the

Michigan vaccine, and over 3,000 individuals got almost completely

the Michigan vaccine, and those patients were studied for their

safety and comparable immunogenicity levels were observed, and it

came from the vollum strain.

Mr. BURTON. Let me interrupt you. You have not tested this vaccine thoroughly? This is not the same vaccine that was tested initially? You’ve already said there are variations, right?

Dr. ZOON. Yes, I said that the Merck vaccine has some differences, but they’re both a variant and avirulent.

Mr. BURTON. I understand. You don’t need to—the fact is, it’s not

the same vaccine and there could be different reactions because of

the changes, could there not be?

Dr. ZOON. Well, under the studies that were done, under the IND

that supported licensure of the vaccine, that strain was studied for

its safety and its immunogenicity.

Mr. BURTON. But it was manufactured differently, was it not?

Dr. ZOON. That other strain was also used in the clinical studies

done by the CDC, and it was compared to the original Merck vaccine. Under the FDA Modernization Act that was recently passed,

this would not be unusual for it today——

Mr. BURTON. I don’t want to belabor this. I want to go to my colleague today. But do either one of you have a response to that?

Mr. SHARMA. I think one of the difficulties in interpreting that

data is that we do not know which individual received which vaccine, and the adverse reaction data has not been analyzed by gender and by type of vaccine. We do not know what proportion of the

116

adverse reaction are specifically attributable to the Merck versus

the licensed vaccine from the IND data.

Mr. BURTON. Mr. Terry.

Mr. TERRY. Thank you, Mr. Chairman. Your question and the answers exemplify what I was going to bring up, and that is I’m sitting here and, you know, I only have 7 years of college and about

9 months here, and I haven’t learned the languages that I’m hearing here today.

Some of the testimony is confusing with the bureaucratic and scientific-ese that is being exposed. So let me—my questions are not

that probing. I just need some clarifications on some of the testimony.

Dr. Bailey, maybe you can help me out here. I’m not accusing

you of being the leader of bureaucratic-ese here. You seem to be

taking a lead on answering a lot of these types of questions. And

again following up on what the chairman brought up in his first

questions, there are 33 strains of anthrax, and through this one

study that has been discussed almost throughout the hearing today

it shows that the current vaccine is only good against, what, 18

percent of the nonstrains? First of all, do you agree with that? It

seemed to me in some of your comments that you disagree with

that conclusion. Am I correct that you don’t agree with that?

Dr. BAILEY. With—I don’t know.

Mr. TERRY. The fact that the current vaccine does not inoculate

against, what, 82 percent of the known strains?

Dr. BAILEY. It’s my understanding that the vaccine we have protects against all known strains. Some of that is because of the

data—you were out of the room when I presented some of the data

of the studies that were done, animal studies, on the majority or

many of those strains. But, more importantly, the antigen antibody

response is vaccine theory and scientific theory that we are depending on here and is good science.

Mr. TERRY. So the answer is that the vaccine covers all known

strains?

Dr. BAILEY. It does.

Mr. TERRY. General West, do you agree with that?

General WEST. I do, sir. And I certainly don’t have the scientific

background that Dr. Chan has, but from the limited look that I’ve

taken at it, if you only look at the guinea pig studies, you can go

look at guinea pig studies for any of those vaccines that you had

on those charts over there, and the data is not nearly as impressive

as it is in mice or rabbits or Rhesus monkeys. The tests that we

did with all of the strains that have been tested against in the Rhesus monkey model, if they had at least 2 shots, they lived; if they

didn’t, they died.

Mr. TERRY. Mr. Chan, help me through this now. Have you not

incorporated the Rhesus monkey research into your conclusions?

Mr. CHAN. We tried to present them separately. We didn’t combine them. What we did look at is the evidence for guinea pigs

first, and as we stated 18 out of 33 strains that were tested were

found to be efficacious.

Mr. TERRY. What does that mean?

Mr. CHAN. That means it worked.

Mr. TERRY. Thank you.

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Mr. CHAN. But with the monkey model, as I stated before, as far

as we know, it’s only tested against one strain. So my answer is

I don’t know the efficacy of this vaccine in monkeys against other

strains.

Mr. TERRY. Is the one strain, parent strain that is representative

of all 33 strains?

Dr. ZOON. The strain that is used to make the vaccine is not virulent, meaning it doesn’t cause disease and that’s why it’s used for

the vaccine. It is a particular strain of the organism that has certain characteristics, so it doesn’t give the disease you’re trying to

protect against.

Mr. TERRY. Mr. Chan, are these characteristics inherent to all 33

strains?

Mr. CHAN. I think——

Mr. TERRY. If you can reasonably inoculate focusing on those

similarities.

Mr. CHAN. Let me state it differently. If, in fact, that theory is

correct, then it should be OK—either it works for all guinea pigs

or it doesn’t work for all guinea pigs. You know, if it doesn’t, then

you say, well, whatever the catergorization you’re talking about of

the Protective Antigen and so on, how come it didn’t?

So, as Dr. Sharma just said, when we looked at the animal models, we found that the level of the antibody in those animals does

not correlate well with protection. That means it does not imply the

higher antibody levels are associated with greater amount of protection. OK.

So it suggests that maybe something else is going on, that’s all.

I don’t know the answer to that.

Mr. TERRY. I only have one more minute, Dr. Bailey, so I want

to ask General West one question here. Do we know what strain

of anthrax North Korea and Iraq use?

General WEST. We believe that we do. We believe that we’ve tested for it, and we believe our vaccine will be effective against it. I

can’t guarantee you that we know everything about them that we

would like to know. But based on what we’ve been able to gather,

our vaccine is effective against what they have. And I can’t give

you all the data on what’s been tested, and we tested animals.

Mr. TERRY. Are we testing the vaccine in the general sense that

it is your statement that the vaccine works against all 33 strains,

or have we done testing with the specific strains that through our

intelligence we have found North Korea possesses and Iraq possesses?

General WEST. We could give you for the record how many

strains have been tested in each of the animal models. I recollect

from the readings that I’ve done that we tested in the Rhesus monkey model at least four strains. And it was those against all four.

Mr. TERRY. Including what your intelligence has found is used by

North Korea and Iraq?

General WEST. Yes, and in our interrogation.

Mr. TERRY. Would you please supply that for the record? That

would be helpful.

General WEST. I will, sir.

Dr. BAILEY. Let me just add that the strain—again, I believe you

were out of the room—is immaterial in that we’re looking at the

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antigen antibody response. But I would like to say that USAMRI,

the Army Medical Research Institute, in the guinea pig, 33 strains

have been tested; in the rabbits 7 strains have been tested; in

nonhuman primates, 4 strains have been tested. We believe this

vaccine works.

Mr. TERRY. Thank you, Mr. Chairman.

Mr. BURTON. We now have our guest, Mr. Jones, who has sponsored legislation of which many of us have cosponsored dealing

with allowing members of the military to have a voice in the decision on whether or not to take the vaccine.

Mr. Jones.

Mr. JONES. Mr. Chairman, thank you, and thank you for allowing me to join your committee today on what I think is a most,

most important hearing regarding military and, quite frankly, the

readiness of our military.

I would like to, if I may, Dr. Chan, just ask you a yes or no question. Would you agree with General West—I have great respect

for—his comment that we know that—10 adversaries that we

should be concerned about as it relates to anthrax? Would you say

yes or no?

Mr. CHAN. Yes.

Mr. JONES. OK. Let me ask you, Dr. Dumont, would you think

a Member of Congress that writes the Secretary of State to ask

how she arrived at a policy of whether this should be voluntary or

not should get answered back?

Dr. DUMONT. I think you would get an answer back, yes.

Mr. JONES. So you think if the letter was written on August

23rd, sometime before the end of this year, that the Member should

receive an answer?

Dr. DUMONT. I can’t tell you more than I would think that if the

letter was written, that you had sent her the letter, that she would

respond.

Mr. JONES. You would be glad if the Member asked you to look

into it if—when maybe he should look for an answer.

Dr. DUMONT. Most certainly.

Mr. JONES. I’m asking if you would, please. My name is J-O-NE-S, and if you would find out when I might get a response to that

letter to her.

Let me also—and I’m basing this question on the fact of your response to this committee, and I believe I wrote this down correctly.

You argued that the anthrax threat is such that they are compelled—meaning the State Department—to offer the vaccine. Is

that somewhat correct to what you might have said?

Dr. DUMONT. That is correct.

Mr. JONES. OK. Let me tell you what I found on the website

today, and I’m going to read this for the committee: The Department of State has no information to indicate that there’s a likelihood of use of chemical or biological agent released in the immediate future. The Department believes that the risks of the use of

chemical, biological warfare is remote, although it cannot be excluded.

Did you know that’s on the website?

Dr. DUMONT. Yes, I do, sir.

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Mr. JONES. OK. So, therefore, if you don’t feel like the likelihood

of an attack is imminent so therefore there’s some justification for

the fact that the State Department says this should be voluntary?

Dr. DUMONT. Congressman, I guess the key piece is that we cannot eliminate the risks completely. And again, as I mentioned in

our testimony, is that we believe that, and again I’m coming from

the medical background, the information with regard to threat and

our missions being at high risk, really comes in from other expertise versus diplomatic security or from the intelligence field.

But the information that I’m given is that our missions overseas

are at some risk. And again our point is that if there is a vaccine

out there that works and that we can protect our communities, why

not offer it to them? Why not make it available to them?

Mr. JONES. Right. And so your decision, because you want to

offer this to the employees of the State Department, is that it

should be voluntary, not mandated?

Dr. DUMONT. All of our vaccines, sir, under our program are voluntary. We do not have any mandatory vaccines.

Mr. JONES. OK. That’s what I needed to know. Even though I

have great respect for the men and women in uniform, and particularly from all levels up, that it just amazes me, Mr. Chairman, that

this handout—that we have NATO allies that mandate anthrax

vaccine and there’s only one, and that’s America.

Dr. BAILEY. Mr. Jones, may I respond?

Mr. JONES. Yes, ma’am.

Dr. BAILEY. I met with the Minister of Defense from the UK last

week, Mr. Spellers, and he told me that, in fact, they would like

to have access, but it is a production problem in the UK that prevents them from implementing as aggressive an anthrax vaccine

program as we have.

Mr. JONES. Dr. Bailey, as of yet, as far as the government, they

have not made a decision to mandate it. It might be what they

would like to do or they might be debating whether they should or

should not, is that correct, at this time?

Dr. BAILEY. Yes, sir, it’s a moot point at this time.

Mr. JONES. OK. Thank you.

Dr. Chan, would you pick up mainly for me, because I’m not on

this committee, I am somewhat amazed by Dr. Zoon’s answer and

that is how the FDA—is this a normal practice that you take the

research done by a separate company, even though it relates to the

issue, and this issue being anthrax, and they take the data from

another company to make a decision to implement a vaccine that

was produced by someone other than that company? Is that normal?

Mr. CHAN. I don’t think we have found another case like that.

Mr. JONES. Dr. Zoon, would you pick up on that, if that doesn’t

seem to be a normal course of decisions?

Dr. ZOON. Yes, sir. This is not a unique case. And, in fact, there

were data in the license file that used the particular vaccine produced by Michigan at that time in the studies conducted by the

CDC. So there were data in the file regarding the material that

was manufactured at the Michigan facility in the license application.

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Now, in terms of are there other situations where a certain vaccine has modifications during its clinical development and changes

are made, the answer is, yes, that does happen.

Mr. JONES. Mr. Chairman, thank you.

Mr. BURTON. Thank you. We really do need to get to the next

panel, but I’m going to yield to Mr. Shays. He has a few more questions, and I have a couple more. Then we will go to the next panel.

Mr. Shays.

Mr. SHAYS. Thank you.

Dr. Zoon, what supports the DOD’s statement that the anthrax

vaccine is effective after three shots?

Dr. ZOON. I think DOD needs to answer that question.

Mr. SHAYS. No, I’m asking you.

Dr. ZOON. I’m not aware of any data that supports its use.

Mr. SHAYS. But you were in this room and you heard the DODs

make that statement, correct? I heard it today. And I heard it at

other hearings, and it’s in their documents. What protocol allows

them to make that statement?

Dr. ZOON. The only thing I could say, sir, that the information

in the package insert requires the full administration of the vaccine, and that’s what it’s approved for.

Mr. SHAYS. It’s approved for six shots. Is there any data that you

have allowed—any protocol that allows this shot to be three shots?

Dr. ZOON. Not to my knowledge.

Mr. SHAYS. OK. Do you have any concern that DOD has said consistently that this is effective after three shots? If we’re supposed

to trust the DOD and trust me as a politician, what right do they

have to make that claim?

No, I’m asking you.

Dr. ZOON. Sir, my——

Mr. SHAYS. You’re supposed to oversee what DOD does, and FDA

did not do that when we had TB. We didn’t keep any records. And

we’re not going back a few decades. We’re in this decade. They

didn’t do what you required them to do, which is to keep records.

You all said you would do a better job at watching what the DOD

does now. So I’m asking you that question.

Dr. ZOON. I wrote a letter to the DOD reminding them of what

the package insert said regarding the administration of anthrax

vaccine. I reminded them, as well as Dr. Henney sent a letter saying that this vaccine should be used according to the schedule on

the package insert, which is the six injections plus annual boosters.

Mr. SHAY. They are not allowed to change the protocol?

Dr. ZOON. They can do studies to study whether the three dose

regimen has comparable properties using an IND if that is what

they choose to do.

Mr. SHAYS. They can do studies?

Dr. ZOON. Yes, they can.

Mr. SHAYS. They have to come back to you, don’t they? They

have to come back to the FDA in order to gain validity for their

claim?

Dr. ZOON. The FDA is responsible for oversight of the manufacture—the DOD, if they were to file an IND to explore that option,

FDA would be actively engaged in studies surrounding those studies that would be submitted to the FDA for review.

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Dr. BAILEY. Mr. Shays, may I offer some information that I think

could be helpful? We have a preliminary report to the FDA for a

comparative study to determine the best dose schedule. In fact, by

the way, it does look at the antibody response that we discussed

earlier.

Mr. SHAYS. That’s a request to the FDA?

Dr. BAILEY. Right.

Mr. SHAYS. Have they approved it?

Dr. BAILEY. That has not been approved yet. We asked for further studies.

Mr. SHAYS. Why would you tell your military personnel that

they’re going to be protected after three doses?

Dr. BAILEY. Sir, the policy is that we follow the regimen dictated

by the FDA, and that is the one that we are adhering to.

Mr. SHAYS. You’re just playing a game with me. The fact that

you made a request to the FDA is meaningless. You have already

gone out in the field and told people that they are safe after three,

that this is proved to be effective.

Dr. BAILEY. Sir, the human antibody response data shows that

the peak antibody level following the first three shots occur at 6

weeks after starting the anthrax vaccine series. That does not

mean we move off the protocol, however. There are people, however, they’re in harm’s way in the Persian Gulf today, and we are

doing everything we can to protect them.

Mr. SHAYS. I know you’re doing everything you can to protect

them, but you have a protocol. You’re supposed to keep records,

and you’re supposed to give six shots, and you have gone out into

the field and said because you have determined, not yet approved

by FDA, that they are safe after three, that they have——

Dr. BAILEY. No, sir, that’s not the case.

Mr. SHAYS. That is the case. Is it not true that in your literature

you say that it’s been proven to be safe after three? It’s been proven?

Dr. BAILEY. No, I’m sorry, we have not proven that. In fact——

Mr. SHAYS. Do you have any documentation that says it’s safe

after three?

Did you not say it today?

Dr. BAILEY. Yes, sir, I did say it, but that was a study, and we

are doing ongoing—we follow the protocol at this point.

Mr. SHAYS. But the problem is, you’re following the protocol, but

you are telling your military that they are safe after three.

Dr. BAILEY. We’re providing them all the protection we possibly

can.

Mr. SHAYS. That’s a different issue. That’s a different issue.

That’s your judgment. It hasn’t been approved by the FDA.

Dr. BAILEY. Yes, sir, because I have sons and daughters out in

those areas where we know the risk to be high. I cannot move up

the schedule and provide any better protection.

Mr. SHAYS. It’s irrelevant whether you have daughters, sons or

whatever. You have a legal obligation to follow what the FDA has

said, and you have decided to introduce information not yet approved, not yet proven.

Dr. BAILEY. Information I presented today is research information about the rhesus monkey and the challenge that was given

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after two, three, four doses and that they survived after that challenge.

I would like for those who are in harm’s way to survive as well.

I am doing all I can.

Mr. SHAYS. Isn’t it true that you have not kept up with the protocol, you have not kept with the schedule? Isn’t it true that you

have a responsibility to follow a certain period of program for the

first shot, the second shot, the third shot, and so on? Isn’t it true

that you have not kept on schedule with the fourth, fifth, and

sixth?

Dr. BAILEY. Sir, it is the policy to follow that schedule and we

are tracking that, yes, sir.

Mr. SHAYS. I didn’t ask the policy. I asked whether, in fact—the

policy means nothing if it’s not followed. Isn’t it true that you have

a deadline, and you have not kept up with the deadline?

Dr. BAILEY. We are at compliance, over 90 percent compliance

with that. If someone is 2 days late for a shot, if you feel that that

means we’re out of compliance, yes, we’re out of compliance.

Mr. SHAYS. Dr. Bailey, I don’t know ultimately how I am going

to come down on this program or how our committee is, but I just

want a straight answer. In order to have faith that we can trust

you, I just want honest answers. And the honest answer is that you

haven’t kept up to the schedule, and a simple and honest answer

would have been, yes, we have not kept up with the schedule.

You have not abided by what the FDA has said you should abide

by; is that not true?

Dr. BAILEY. If being late for an immunization, whether it’s your

second DPT shot or your third anthrax shot, means you feel we

have not kept up with the schedule, of course, with over a million

vaccinations, we have not always kept with the schedule, but that

is our intent. It is the policy and that is what we are attempting

to do.

Mr. SHAYS. Dr. Bailey, intent doesn’t cut it. You have to abide

by the protocol, and if you don’t abide by the protocol, the FDA has

a moral obligation, a legal obligation to withdraw your right to use

that vaccine.

Your job is to keep up to the schedule or not to do it; isn’t that

true?

Dr. BAILEY. Well, again, I would go to other vaccines in this

country that are also on a schedule. You do not withdraw polio vaccine or DPT because a child is late getting a shot.

Mr. SHAYS. So you’ve decided on your own that you don’t have

to abide by the FDA requirements?

Dr. BAILEY. No, sir. I am making every attempt to abide, but

with over 340,000——

Mr. SHAYS. Why do you say, no, sir? You just told me that you

aren’t keeping up with it, and then you used as an excuse that

you’re not doing it with other vaccines, and you have decided that

you were going to do it anyway.

Dr. BAILEY. It is all we have to protect against this deadly

threat.

Mr. SHAYS. So the bottom line is that because you believe that

this is so important, you are not going to abide by the FDA requirement.

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Now, I’d like to ask you, Dr. Zoon, given that fact, what is your

requirement?

Dr. ZOON. DOD is not the licensee; DOD is a user. FDA has regulatory control over the licensee, which in this case is BioPort.

Mr. SHAYS. Are you going to withdraw their ability to do this

vaccine now that you find that the people who are using it aren’t

abiding by the protocol?

Dr. ZOON. We have control over the manufacturer, which is

BioPort. We don’t have control over the users.

Mr. SHAYS. Have you not given DOD the right to use this vaccine?

Dr. ZOON. This is a licensed vaccine. If a physician uses it, or

DOD uses it, that does not really fall under our jurisdiction.

Mr. SHAYS. So it’s your statement before us now that if DOD

doesn’t abide by the protocol, you have no responsibility, that you

have set out a requirement—who is responsible then? Who is going

to make sure that DOD abides by the protocol, if you don’t do it?

Dr. ZOON. We don’t have the authority.

General WEST. Sir?

Mr. SHAYS. I just want to say, Dr. Zoon, I cannot believe that you

have just said under oath that you do not have responsibility to

deal with this issue or the authority. You said you don’t have the

authority.

Dr. ZOON. Yes, that’s correct.

Mr. SHAYS. That is your testimony?

Dr. ZOON. We don’t have the authority.

Mr. SHAYS. Well, who is going to protect our men and women if

you aren’t going to do it? Who? Who has the authority?

Mr. BURTON. I don’t think you’re going to get an answer, Mr.

Shays.

General WEST. Could I add to that answer, Mr. Chairman?

Mr. BURTON. General West.

General WEST. Sir, we want to abide by the six-shot protocol. We

want to give every one of them on time. There will be cases when

a person is due for their second or their third or fourth or fifth or

sixth shot, that they will be ill, that they will be pregnant, that

they won’t show up for drill day, that for some reason they will get

an exemption; and we will have to, to follow the FDA protocol, deviate from the exact day on which the shot is due, but we don’t

want to.

We don’t want to stop after three shots. We want to give six

shots, and we’re going to try to stick to that as best we can. Nobody

in DOD has decided that three shots is enough and we’re going to

stop there. We’re not going to do that, sir.

Mr. SHAYS. I honestly don’t believe that. I believe that because

we have a problem in productivity and production of this, and because there has been such a resistance to take it, that you all have

decided to turn away when you get to four and five and just make

sure you get up to one, two, and three.

You have decided as a military to do it because you sincerely,

sincerely believe that will protect them, you’ve already told us that,

but you don’t have the legal right to do that.

General WEST. No, sir, and we know that, and I certainly hope

you’re wrong. I don’t believe that. I believe that we’re trying to

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stick to it as religiously as we can. In some cases, we fail. Some

cases are really good reasons for it.

Mr. SHAYS. I have had six hearings on this and I haven’t lost my

cool or temper. I’ve been able to kind of, you know, just look away

and just ignore these statements, but it’s finally getting to me because, Dr. Bailey, you told us that there has been less of a response

than what the label said would be accounted and yet we have Mr.

Claypoole saying he expected it would be more, and it’s like you

say whatever you need to say in order to satisfy the event of the

day.

And, Dr. Zoon, for you to say that you have no authority is the

most amazing thing I have ever heard at a hearing because the

FDA has the obligation, whenever it licenses a drug, to make sure

it’s used the way the protocol requires, and you don’t allow the

military or anyone else to deviate from that. That is your requirement.

Mr. BURTON. Let me move on here just a little bit.

We’ve had hearings on other drugs and we know of doctors and

pharmaceutical companies who have had the wrath of the FDA

come down upon them because things weren’t being used in conjunction with what the FDA specifies as the way it should be done;

and that’s why I concur with Mr. Shays, because I have heard it

before that you do come down on them, you close down companies.

You pound them on the head with a meat cleaver, for crying out

loud, and yet you say you have no authority over the military.

Let me go on to a couple of questions, because I don’t want to

debate this endlessly. A lot of the concerns—and this was in my

opening statement; a lot of the concerns have been raised about the

actual number of adverse events from the anthrax vaccine. The

numbers vary greatly. Everything from two ten-thousandths of a

percent reported in the media in February, to two-tenths of 1 percent on the package insert, to 20 percent—20 percent in the one

active surveillance that’s currently under way, the Tripler Medical

Center study.

Now, what I don’t understand, if the Department is not doing active followup and tracking of health concerns, service wide, then

how we will ever garner an accurate representation of the adverse

events? I mean, this Tripler Med Center study shows 20 percent

side effects, adverse events. Why the disparity in what’s in the

package and what was in the newspaper?

Dr. BAILEY. May I explain the Tripler study?

Mr. BURTON. Sure.

Dr. BAILEY. That is a study that is under way at this time looking for any kind of adverse reaction. It’s with health care workers.

They are, in fact, instructed to bring forth any symptom whether

they feel it’s related to the vaccine or not. Findings were generally

encouraging. We’re being more proactive and encouraging reporting

what may or may not relate to the vaccine.

At the same time, I would also say that the original reports were

from the vaccine program when we had at that point not provided

the vaccine to that many of our personnel. As we continue the program now and have over a million vaccinations, we are seeing a report which puts it about in line with other vaccines.

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Mr. BURTON. Well, Vice Admiral, let us see here, Vice Admiral

Richard A. Nelson, Medical Corps Surgeon General, said, ‘‘I am

aware of the controversy associated with the anthrax vaccine immunization program and the concern our troops have regarding the

potential side effects. The vaccine is safe.’’ He said, ‘‘Of over 82,000

Marines and sailors inoculated, only eight reactions have been recorded via the vaccine adverse reporting system. All have returned

to full duty.’’ But in cross-examination, one medic from 29 Palms

had no knowledge of the existence of a vaccine adverse events reporting system form.

Now, how can you know what the percentage of adverse reactions is if the people that are supposed to be on the front lines reporting the adverse reactions don’t even know you have a system

to do it? I mean, this guy was a medic; he said he had no forms,

nothing. He said he had no knowledge of the existence of a vaccine

adverse events reporting form, and yet this admiral was saying

there were only 7 cases out of 82,000.

Now, if you don’t have a reporting system or the forms to report

it, how in the heck do you know? Explain that to me. I mean, this

guy was a medic up front that was supposed to be giving the inoculations. He was supposed to have a form there that said, here’s an

adverse reaction, here isn’t and so forth. He didn’t even have a

form, didn’t even know about it, and yet you guys can make a categorical statement, there are very minimal, adverse reactions. How

could you do that?

Colonel RANDOLPH. Sir, I’d like to make a comment, and I’d like

to make a comment based on the fact that I am not a physician,

I’m just a soldier, and I think the disparity here can be explained

in the way that the FDA and physicians define an adverse reaction

versus an adverse event.

A serious adverse reaction is defined by the FDA as death, lifethreatening illness, hospitalization or chronic long-term illness. As

soldiers and sailors and airmen and Marines, people who are not

physicians, what we look at perhaps as a reaction, whether it’s serious under this definition or not, is a broader spectrum.

And so the lumps, the bumps that we commonly see and the

common side effect profile of this, and other vaccines for that matter, means that what the common soldier like me sees are 30 percent of the minor reactions at the injectionsite—the redness, the

swelling, the occasional nodule, and in women, actually about twice

that.

Mr. BURTON. Well, Colonel, I appreciate your answer, but that

does not address what I am talking about. You have people who

are medics who are the front line people giving the shots in many

cases. There have been categorical statements made by the military, by this Admiral Nelson and others, saying there are very

minimal reactions, and yet the people giving the shots don’t know

of any adverse reporting system, don’t have any adverse reporting

forms, don’t have anything.

So if there are severe adverse reactions, how do you find out

about them if they don’t have any way of reporting them?

Colonel RANDOLPH. Sir, we have advertised in our health care

providers briefing that every health care provider is supposed to

get and then obviously in this one case someone didn’t. We have

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advertised in all our commanders briefings about the VAERS report. It is on our DOD website exactly how you report an adverse

event. In all of our forums, we explain to our people how you file

a VAERS 1, and in fact we encourage patients to file, other than

a health care provider.

Mr. BURTON. Well, there are an awful lot of military people, I

had a young man come into my office this past week. He’s a pilot.

He’s got a family. He said he’d like to be an airline pilot when he

leaves. If he doesn’t take the shots, he says he won’t be able to get

a job as an airline pilot because of the kind of discharge he’s likely

to get, No. 1, and if he does take it and it adversely affects his

health, he says he won’t be able to get an airline pilot job because

it might cause dizziness, not focusing properly with his eyes and

all. And he says he’s a mess, he doesn’t know what to do; and his

wife wants him to get out of the military, and he doesn’t know

what to do.

And that is not an isolated case. Every Member of Congress has

had somebody contact them with these same kinds of problems—

not just one or two, but many—and these things need to be answered, and the answers have not come forth.

Today, I don’t think Mr. Shays feels it and I don’t feel it. I don’t

think Mr. Jones feels it. We simply don’t have the answers yet, and

so we’re probably going to have to look into this further. But the

military who defends this Nation needs to know that they’re not

being unduly jeopardized when they take these shots, and they

need to know that the protocol’s being followed and everything’s

being explained thoroughly, and they know what’s going to happen.

And I don’t think anybody in Congress knows, and I don’t think

anybody in the military really knows, other than maybe those of

you who are so-called experts.

Let me just say this, I’d like to, since we’re running out of time

and want to get to the next panel, we’d like to submit to all of you

for the record a number of questions, and we’d like for you to respond to those since we haven’t had a chance to get to it.

Dr. Zoon, really quickly.

Dr. ZOON. Yes, I want to have one clarifying point made, Mr.

Chairman.

When you said that FDA gives oversight to the pharmaceutical

industry, that is absolutely true because they are the individual

corporations or sponsors that are regulated by the FDA; and that

is true—similar to BioPort for the anthrax vaccine. Certainly, we

are concerned about the use of the vaccine, which is why we sent

DOD a letter when we found out, actually from members of this

committee, about some information.

So we are very much interested in this, but in terms of our authority, our authority is over the people we license or over people

manufacturing the vaccine.

Mr. BURTON. So what you’re telling Mr. Shays and me and others is that there’s a gap there. Once the pharmaceutical company

makes the product, and it is given to a doctor or the military or

whatever, it’s up to them to administer them; and if they don’t,

there’s no way to enforce it.

Dr. ZOON. We can write letters, but that’s correct, we don’t have

the authority.

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Mr. BURTON. OK.

Mr. Shays, do you have any final questions?

Mr. SHAYS. Yes, thank you. Who owns BioPort? Does the military

have any financial interest in BioPort?

General WEST. No, sir.

Mr. SHAYS. No financial interest at all? They’ve received no

loans, you’ve built no plant?

General WEST. No, sir.

Mr. SHAYS. The military has not paid for any expenditure at the

plant?

General WEST. I am sure that there are things that we have invested in at the plant to make it possible to produce the drug and

produce it correctly.

Mr. SHAYS. Well, the answer is, yes, you have invested money in

the plant. You are not stockholders in the plant. You are the

plant’s basic—only customer, practically.

Mr. BURTON. Would the gentleman yield real briefly?

There was an $18.7 million advance that was given to BioPort

by the military for what you’re talking about.

Mr. SHAYS. Have you put liens on the facility? Is there any obligation there?

Dr. BAILEY. Let me just say that as BioPort is the only manufacturer of the FDA-licensed vaccine, DOD has funded a total of 11

million since 1991 to ensure that continuous supply. We also are

providing significant administrative, scientific, technical, and consultative assistance to assure that production is safe.

Mr. SHAYS. Basically, this is a military operation.

Mr. JONES. Would the gentleman yield for just a moment?

Mr. SHAYS. Yes.

Mr. JONES. May I ask Dr. Bailey if it’s true, in addition to the

$18.7 million that has been advanced, that they have increased the

cost of the vaccine from $4-and-something to $10 a shot; is that correct?

You’ve approved that type of increase; is that correct?

Dr. BAILEY. Well, again, we are out of my area, but let me just

say that we have a contractual relationship with this organization,

and I think that General West should answer that, particularly

about pricing.

General WEST. Sir, I think your numbers are correct or very near

correct. When we first started buying the vaccine, we were buying

it from a facility owned by a State and a university. Part of the

overhead for that plant was covered by the State and by the university.

During the process of buying the vaccine from the only supplier

that there is in the country, the State of Michigan decided to sell

that facility to a private owner. That corporation, once they had to

take care of paying the light bill and mowing the grass and a lot

of other things, had to increase their cost. We’re disappointed that

it went up from $4 to $10, but I can tell you that if we compare

that to the cost of a lot of other vaccines, it is less than half as

much—more than we’d like to pay, but it could be worse.

Mr. BURTON. I ask the gentleman to yield real quickly.

$18.7 million advance, according to what we have here in front

of us. So I want to make sure I understand this. They received an

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$18.7 million advance and then you also increased, or they increased, the cost per share from $4-and-something to $10. So you

not only gave them an advance, but they also received over double,

two and a half times the amount of money they were getting per

shot to help them cover their expenses?

General WEST. They will, yes, sir, whenever they sell the vaccine.

That’s been reviewed by the contracts and the legal people, and

they did not pay the price that the company asked for. We are paying significantly less than they asked for, but we’re paying what

the contractual and legal people believe to be a fair and justifiable

price.

Mr. BURTON. Two and a half times what they were getting when

it was the State of Michigan producing it?

General WEST. That’s correct, sir.

Mr. BURTON. Did you have one more question? Because I want

to get to the next panel.

Mr. SHAYS. I know that, Mr. Chairman.

Dr. Zoon, you have allowed BioPort to sell this vaccine to the

military for a use it wasn’t directly tested for. This is being used

to combat a weaponized aerosol challenge, and so whereas you

have acknowledged that the standard procedure is 65 and older,

you weren’t technically tested for, but this wasn’t technically tested

for aerosol. So you have given a lot of leeway to the military

BioPort to use this. BioPort is basically funded by the military, and

in the quarterly readiness report, at the bottom of this quarterly

readiness report, it says, ‘‘Note, soldiers with three or more vaccinations are protected.’’ Could you approve that statement by the

manufacturer if the manufacturer made that claim?

Dr. ZOON. If the manufacturer wanted to claim three doses were

protective and safe, we would have to evaluate the data before adding that to their package insert.

Mr. SHAYS. So you would not allow the manufacturer to make

this claim, soldiers with three or more vaccinations are protected,

but we’re allowing the military—and I’ll just conclude, General

West, to you.

Bottom line, Dr. Zoon has said she doesn’t have the authority.

Basically, you’re allowed to run this program as you see fit. Then,

basically, you don’t have to follow the protocol evidently, which is

news to me. Today it’s news. Why should I feel comfortable that

I can trust the military?

You are making a statement that the FDA would not allow a private manufacturer to make. So why should I feel comfortable with

the military?

General WEST. It may very well be that we put a statement on

the brochure that we shouldn’t have put, because it’s being interpreted as meaning something different than we implied. The only

thing that we mean when we say that is that the research analysis

indicates that if you’ve had at least three shots you have protection

against the anthrax virus. We never, ever, sir, planned to stop

there. We intend to follow the protocol unless it’s changed.

Mr. SHAYS. I know that’s your intention, but you’re doing something we wouldn’t allow the manufacturer to do.

General WEST. We’ll take that statement up, sir.

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Mr. BURTON. I want to thank the panel. You’ve been under some

pretty heavy grilling today, and we appreciate your patience, and

we may be talking to some of you later. And we will be submitting

a number of questions to you for the record. Thank you very much.

Our next panel is former chairman of the Joint Chiefs of Staff,

Admiral Crowe; Major Bates; Major Rempfer; Dr. Melling; Dr.

Leitenberg; Dr. Classen; and Dr. Halsey. Would you all come forward, please. Thank you, gentlemen. Once you all come forward,

we want to put everybody under oath as we always do.

I want to thank you for your patience as well. We went much

longer on that first panel than we anticipated.

Would you raise your right hands, please.

[Witnesses sworn.]

Mr. BURTON. Have a seat. OK. I think we’ll start with the former

Chairman of the Joint Chiefs of Staff, Admiral Crowe. We are looking forward to hearing from you, Admiral, and we appreciate you

all being here today.

STATEMENTS OF ADMIRAL WILLIAM J. CROWE, JR. (USN RET.);

JACK MELLING, BIOLOGICS DEVELOPMENT CENTER, THE

SALK INSTITUTE; MILTON LEITENBERG, SENIOR SCHOLAR,

CENTER FOR INTERNATIONAL AND SECURITY STUDIES AT

MARYLAND; JOHN B. CLASSEN, M.D., MBA; MAJOR SONNIE

BATES, PILOT, USAF; MAJOR THOMAS L. REMPFER, PILOT,

USAF RESERVES; AND NEAL A. HALSEY, M.D., DIRECTOR, INSTITUTE FOR VACCINE SAFETY, JOHNS HOPKINS UNIVERSITY

Admiral CROWE. Thank you, Mr. Chairman. I answer to both

Crowe or Crowe, but I do pronounce it Crowe, and I found one very

disturbing thing in the previous testimony. They made an age line

of 65. I’ve taken it at 74. Maybe I should retreat. I’m not sure.

Mr. BURTON. You look much younger.

Admiral CROWE. Mr. Chairman, I’ve submitted a statement, and

with your permission, I will summarize it. This will be highly compressed.

Mr. BURTON. Thank you.

Admiral CROWE. As your invitation requested, my statement reviews in more detail the development of policy during my term as

Chairman of the JCS, 1985 to 1989. In the way of background, the

President announced in 1969 that we would dismantle our inventory of biological weapons. In 1975, the United States ratified the

Biological Weapons Convention.

Clearly, by 1985, we no longer had the option of deterring biological weapons with their own agents. It was the view of the JCS

that our conventional and nuclear capabilities offered a high degree

of deterrence against hostile governments. Still, we were painfully

aware that the Biological Weapons Convention offered no guarantees.

We had evidence that several governments continued to experiment with and to produce biological agents. While our appraisal

did not anticipate frequent employment of such weapons, it concluded that, if used, they could reap appalling casualties. We initiated a multifaceted effort to improve our passive defenses. I can deVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00133 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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scribe this effort in more detail, if you think it necessary, but it is

covered in that statement.

During that period, the subject of biological agents had not

reached the urgency it enjoys today. We did launch an exploration

of the potential role vaccines might play in an antiterrorist effort,

but we were primarily seized with the problem of deterring or

countering biological attacks on U.S. forces by the military units of

hostile governments. It was a deliberate process that received normal funding and did not carry an especially high priority. By the

time I retired, we had not fully grappled with the possibility of covert terrorists mounting serious biological challenges.

When I served as Ambassador to Great Britain, the State Department had also not begun to address the problem seriously. In

1998 and early 1999, I headed two accountability review boards to

examine the August 1998 embassy bombings in Nairobi and Dar es

Salaam. We concluded that although these weapons were not used

in these two cases, we concluded that the United States would

sooner, rather than later, see terrorist groups turn to biological or

chemical agents trying to harm Americans overseas.

Desert Storm, of course, demonstrated that American strength is

vastly superior to any conventional forces the Third World might

employ. The lesson that came out of that conflict, I believe, was for

nongovernment organizations and governments hostile to the

United States; it was clear that if they wished to harm our interests, they were going to have to resort to some covert method, more

than likely terrorism.

Such groups are extremely difficult to isolate or retaliate against.

Ease of concealment and delivery, when coupled with difficulties in

detection of agents, severely complicates the retaliation problem.

Unquestionably, the threat level is increased because of these developments. My statement examines this subject in some detail.

The anthrax spore, which you’ve heard a great deal about in the

first tranche, is an ideal terrorist biological weapon. I won’t go into

it because it was examined at some length previously. In fact, the

Department of Defense rates anthrax as the No. 1 biological threat

today.

As you know, I am a director of BioPort Corp. I’m well aware

that the issue of safety has provoked some dispute. BioPort has a

deep interest in providing a safe and pure product, and that’s exactly what its current owners are bending every effort to produce.

The popular press often confuses the issue by mixing up questions

of safety and effectiveness, but actually anthrax vaccine has a rather impressive safety record, putting aside the question of effectiveness, starting in the 1960’s.

Again, there a number of studies, and I talk about the things

that were persuasive to me in my statement. I don’t think I should

spend time on that since you have explored it at some length already. I will say, though, that I am convinced that the opposition,

or rather, that there were some statements about service people

that are being rather exaggerated.

In the current program—and I have checked this week with Defense. In the current program, over 340,000 military men and

women have taken shots, including myself, and of that, approximately 200 have refused. I also checked with all the personnel orVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00134 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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ganizations of every service as to whether they were actually seeing vast numbers leave the service or that they were concerned

about this problem, and they have no evidence, hard evidence, to

support that.

Frankly, there is no question in my mind that we should bend

every effort to protect our forces against anthrax attacks. I should

note, which came out in the previous hearing, that not one dose of

the vaccine has been released without FDA approval and will not

be released without FDA approval.

Before closing, I would like to comment on one peripheral issue.

It has, on occasion, been rumored that the decision to inoculate all

personnel was made to benefit BioPort and, indirectly, to benefit

me. If the charge were not so ridiculous, it would be offensive. It

outrageously exaggerates my influence. I didn’t have that much influence when I was the chairman, much less now.

Let me be completely clear: I never, never solicited any official

of the administration to install or promote a mandatory inoculation

program. Even the timetable of events firmly refutes the charge. I

would of course be happy to elaborate on this. The attempt to link

me with the Secretary’s decision is pure fantasy.

And that concludes my summary, Mr. Chairman.

Mr. BURTON. Thank you, Admiral Crowe.

[The prepared statement of Admiral Crowe follows:]

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Mr. BURTON. Dr. Melling.

Mr. MELLING. Thank you, Mr. Chairman and members of the

committee, for your invitation to present testimony to this committee. My name is Jack Melling, and I am the former director of the

Salk Institute Biologicals Facility in Pennsylvania and also the

former director and chief executive of the UK’s Center for Applied

Microbiology Research, which was also involved in defense vaccine

work.

Vaccines for defense against biological agents differ from normal

public health vaccines in several important ways. First, the effectiveness of defense vaccines cannot be determined by normal

human epidemiological trials, due to the rarity of the diseases involved. Animal models are therefore critical to assess efficacy. Such

models are limited in their ability to predict what will happen in

humans, and in most cases, can at best indicate some possibility

of efficacy, but do not allow us to determine if a vaccine will protect

40 percent, 60 percent, 80 percent or whatever in the case of humans.

Nor, in fact, can we predict the human vaccine effectiveness

against different levels of biological challenges. I have heard this

afternoon also comments about being able to measure antibodies in

humans and use that as a predictor. In some cases that is indeed

true, but in many cases of infection, the immune response is much

more complicated than that which can be measured by a simple

antibody response. I believe that a number of the agents that are

of concern to us fall in the category of having that complicated an

antibody response.

Now, the uncertainty about the level of effectiveness has a number of implications, I believe. First, if vaccines are used, then they

should only be one of several protective measures incorporated in

a prudent strategy. It also means that if we don’t note the level of

the effectiveness, then an unknown proportion of vaccine recipients

can remain vulnerable. For example, if the vaccine is 60 percent effective, then 4 out of 10 persons remain at risk. Even with 80 percent efficacy, it’s one in five. I think this counts as one key argument against a voluntary policy, that is, that it’s unacceptable to

have a mixture protected and unprotected troops, since even a

mandatory policy will leave some people who are vulnerable. It’s

just that we won’t know ahead of time who they are.

And the final implication of the efficacy issue is, certainly for me,

that antibiotic administration still remains an ethical essential in

the event you know or believe people to have been exposed.

The second way in which these agents differ from normal public

health vaccines is in terms of—and I won’t dwell on this, as it was

discussed earlier—the number, the range and the potential variability of the threats; and taken together, that means that developing, producing, and gaining regulatory approval for a large number

of vaccines becomes extremely difficult. I think it also becomes

questionable whether in fact the pace of vaccine development,

which has to move in accord with regulatory approval, can in fact

match the weaponization ability of an aggressor.

The third point is that, unlike diseases which are prevalent in

the community where assessing the risk——

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Mr. BURTON. Excuse me for interrupting. I just want you to cover

that last sentence again, because it seems so relevant. You indicated that keeping pace with the ability of an enemy to produce

other biological agents would be difficult. I want to make sure I got

that straight.

Mr. MELLING. That is what I said, sir.

You know, our record in developing, producing and monitoring

defense vaccines is that in the course of some 30 years we have licensed, I think it is correct to say, in the United States, two vaccines in the defense field. We have licensed two in the UK out of

that range of agents; and therefore, if that time scale is indeed appropriate, I think it does mean that vaccines alone as a counter to

aggression raise major problems simply because, unfortunately, the

balance will tend to be with the aggressor because they can

weaponize potentially faster than we can develop approved vaccines.

If I may continue, unlike diseases which are prevalent in the

community where assessing the risk of a person acquiring a disease

is based on epidemiological data, determining the risks from BW

agents depends basically on intelligence assessments, and the basis

of these reports is not open to the same kind of debate and scrutiny

that we see in the public health field.

In respect of safety, I see no inherent technical reason why defense vaccines should be any less safe than vaccines in general. I

would, however, say that because of their specialist nature, because

we don’t have several firms producing the same vaccine and competing, I think there is a risk that defense vaccines could be stuck

in a time warp, and if we are not careful, we could end up with

a vaccine equivalent to a bunch of Model T Fords, which were great

in their day, but not many people would actually use them today.

And last, I think acceptability is a key issue. Government agencies are heavily involved in research, development, regulatory approval, assessment of disease risks, vaccine procurement, and decisions on use; and therefore, to maintain confidence, it’s going to be

essential to avoid conflicts of interest, even perceived conflicts of interest, and to clearly demonstrate that especially the regulatory

agents treat these vaccines in the same evenhanded way that they

do other medicines.

Last, Mr. Chairman, it’s my belief that these issues raise serious

questions about the feasibility of relying on defense vaccines to protect large numbers of people against numerous disease agents. It

is vital that these problems are addressed based on objective and

sustainable factual information if we are to properly protect those

people on whom we rely for our security.

Mr. Chairman, members of the committee, thank you for your attention, and I’ll be happy to answer questions.

Mr. BURTON. Thank you, Dr. Melling.

[The prepared statement of Mr. Melling follows:]

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Mr. BURTON. Dr. Leitenberg. Did I pronounce your name correctly?

Mr. LEITENBERG. As in ‘‘light.’’

Mr. BURTON. Leitenberg. Dr. Leitenberg, I’m sorry. Thank you.

Mr. LEITENBERG. Mister, actually mister.

Mr. BURTON. Mr. Leitenberg.

Mr. LEITENBERG. My role is a bit different. Thank you for permission to present testimony. I am an arms control specialist, not

a vaccine specialist, though I was a trained in biochemistry. I

began working on chemical and biological warfare problems some

33 years ago, and over that period have gone back to the subject

many times, and since 1992 nearly full time. I will discuss three

things: first, a review of biological weapon proliferation since the

Biological and Toxin Weapons Convention treaty was signed in

1972 and ratified in 1975; then a discussion of the potential for terrorist use in the United States; and last, as a subset on that, because I have done some research on the Aum Shinrikyo, the Japanese group, to tell you what that group was able to do and not to

do because, in fact, it’s significance is exactly the opposite as it’s

been portrayed for the last 4 years. It’s been both misunderstood

and purposefully misrepresented.

First, about the proliferation of biological weapons. The kind of

things you would want to know are: Which Nations have sought to

have biological weapons? How advanced were their programs? Do

we know why they were started? And is there any likelihood of getting any of them to stop?

There are official U.S. Government statements, many of them,

stating that in 1972 there were four nations that had these weapons, and in 1989 we said 10, and beginning in 1989 repeated congressional testimony from senior administration officials identified

these nations, and you have that summarized in table 1 in my prepared statement. You see that I have grouped them: in the Middle

East, Iraq, Libya, Syria, Iran, Egypt. In Southeast Asia, China,

North Korea, Taiwan, India with a question mark, and South

Korea.

The first two columns are the official U.S. Government sources.

There is no official UK government source naming individual countries, but they have said 10. I put in the only official Russian Government source, their foreign intelligence report in 1993, because

in fact it said something about North Korea beyond what our own

official statements contained.

There were some countries which didn’t appear in these statements, though in 1995 both the United Kingdom and the United

States said that South Africa had had a biological weapons program. We also believe that Israel has a program, though we don’t

talk about that because Israel is not ‘‘noncompliant.’’ It is not a signatory of the Biological Weapons convention and, therefore, the

United States Government does not include Israel in the noncompliance statements. There are also obvious political reasons; we

don’t discuss it, but that’s the formal reason.

All of these countries have offensive biological programs. That

does not mean they have deployed usable biological weapons. Anything beyond offensive research is a violation of the treaty and,

therefore, not compliance; but you can have offensive research, you

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can have experimental production. That’s what we call development. You can then have testing of the agent you develop. Then

you can weaponize. Then you can produce your stockpiles.

I tried to distinguish those aspects—the U.S. Government has

never chosen to do this—which you find in table 2. I tried to extract this information from both the official United States and the

official Russian statements, to attempt to distinguish these separate categories. And that’s terribly important. We have a habit in

official statements, not only of confusing things by lumping those

nations that have biological and chemical weapons programs together in one statement—there are administration statements that

even include nuclear weapons programs and supply a single number for all together—but we also use the same phrase for all of

those different stages in proliferant biological weapons programs.

There’s only one statement in the public record, dating 1989 and

not dealing with biological weapons, but dealing with chemical

weapons, in which official United States statements said that there

were 20 countries that had offensive chemical programs, and in

that single statement, it said, aside from the United States and Soviet Union, only five or six others had chemical weapons. So that

indicated a difference, between 8 and 20, and that’s significant.

We don’t have anything on the public record which indicates the

same thing for biological weapons. So one cannot provide in the

public domain, out of the 10 countries that the United States previously identified, and two others which we added in November

1997, raising that number from 10 to 12, but United States officials

didn’t identify them. I cannot therefore tell you from the public

record which or how many of them have biological weapons.

There’s an attempt to do that in table 2, but beyond that, I can’t

go further because no one can. If General West can in classified

testimony, that’s another matter. In the public domain you cannot.

Table 3 was an attempt—and time does not remain to go into

that—it was simply to show you that those nations who have made

biological weapons don’t just make biological weapons. They have

either made all three weapons of mass destruction, nuclear, chemical and biological, or at least two, and for biological, and I think

in every case after already having made chemical weapons.

Four specific little remarks, and I then have to leave the subject

of biological weapons proliferation.

BW isn’t new. BW has been around for a while, and all those programs that I named and the U.S. Government has named have

been there for about 15 years. These are not new developments.

Second, one country, South Africa, supposedly ended and dismantled its BW program, in the same way as it ended its nuclear weapons program, and that’s accepted in the international community.

Now, two things which are important and overlap with the BW

terrorist in question. There’s no available evidence that the former

Soviet laboratories since 1992 have leaked material or personnel to

countries of proliferation concern, in other words, those countries

listed in table 1. As for the total number of people that left the

former Soviet BW laboratories, at least to my knowledge, the U.S.

Government thought it knew that number at the end of 1997. It

was a small number, and 90 percent of them went to the United

States, Western Europe, and Israel. That left a very small portion

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for all other places, and some of the other places were not countries

of proliferation concern, which left a still smaller fraction.

I want to say something about the Japanese Aum Shinrikyo

group, because that’s really the event that started everything that’s

going on now. In March 1995, that group used Sarin, a chemical

agent which they had produced, in the Tokyo subway. It killed a

dozen people—those are not mass casualties—and it injured a few

hundred, not the 5,500 that went to hospitals. It injured a few hundred. The year before, in another Japanese city, the same group

killed 7 people and also injured 200 using the same chemical agent.

It was then discovered that the same group had been trying to

produce and use biological weapons agents, and that they had tried

to disperse such agents nine times in Tokyo and in surrounding

areas. That event produced the hearings in the U.S. Senate, by the

Committee on Government Operations, at which I also testified in

October 1995, and that hearing and its consequences produced all

the government decisions since. So that’s been the seminal event.

Now the Aum supposedly had been working on two agents, and

they’re usually said to be the simplest—botulinum toxin which you

extract from clostridium botulism, which is food poisoning, which

we know of in poor caning, or when people get that in jars, and anthrax. It turns out they were not able to produce either agent, so,

of course, their dispersion attempts failed. They were in effect dispersing nothing—water and culture medium. They may, in fact,

have grown anthrax, but they had a vaccine strain of anthrax.

Therefore, it couldn’t make anyone ill. It’s probable that the person

who was in charge of the program understood that, because that’s

what he had been able to purchase from a Japanese academic.

They did not have Q fever, so they were not working on Q fever,

which has been claimed in the literature and in the Senate report.

They did not have Ebola virus. They did not do any genetic engineering. That’s a brief summary of what they did and didn’t do.

What’s important about that? The Aum group had 4 years in

which to work. They had the appropriate facilities, two rooms

about the size of this hearing chamber. They bought all the right

equipment. They had virtually unlimited funds; the estimates go

into the hundreds of millions of dollars. They didn’t spend that

much for BW, but they did spend tens of millions of dollars for it.

They had about a dozen academically trained people, not all in

the right discipline, but when you have postgraduate degrees, you

in theory know how to learn what you need to know. Nevertheless,

they failed in all their BW efforts. That’s significant.

The other significant thing is that after I did this research, it

was circulated in the U.S. Government and I was told that the U.S.

Government knew all this and that everything I had found was the

same as the best information that the government had. Nevertheless, no one in the U.S. Government has bothered in 4 years to

make public a proper assessment of what the Aum did and was not

able to do.

Mr. BURTON. Mr. Leitenberg, we have a number of panelists.

Could we go on with the rest of them? I’ll come back to you.

Mr. LEITENBERG. Well, the last section was on BW terrorism. Let

me just say one more thing.

Mr. BURTON. OK, sure. Go ahead.

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Mr. LEITENBERG. The third portion of my presentation was simply to discuss the way the BW terrorist potential is currently understood in the United States. I will leave that aside if you don’t

have time.

I want to say one thing, however, since my presentation is as an

arms controll specialist. My testimony should not be understood as

being either pro or con the basic question you’re addressing, the

military anthrax vaccine initiative, but no arms controller would

oppose passive defenses. If our troops are faced with chemical

weapons, any arms controller wants to have that antidote inoculation available after U.S. troops would be exposed to chemical weapons. If the forces are exposed, it saves lives; if the forces are not

exposed, it’s a deterrent. So as a general issue, any arms controller

is very much in favor of passive defenses, of which vaccines are

one.

So my testimony, whatever it is, should not be understood to

bear against that question.

Mr. BURTON. Thank you very much, Mr. Leitenberg.

[The prepared statement of Mr. Leitenberg follows:]

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Mr. BURTON. Dr. Classen.

Dr. CLASSEN. My name is Bart Classen. I am a physician and an

immunologist. Thank you very much, Mr. Chairman and committee

members, for inviting me to speak.

I oppose mandatory anthrax vaccination. This vaccine has not

undergone proper testing and will increase the recipient’s risk of

autoimmune diseases, including diabetes. My research involves

studying the long-term effects of vaccines on autoimmune disease,

including diabetes.

I started working with this anthrax vaccine 8 years ago. The vaccine was approved for marketing in 1970 without a single controlled clinical trial. I know of no controlled clinical trial performed

since approval. This is documented in the FDA letters enclosed in

my written testimony. My animal studies indicate that even low

doses of the anthrax vaccine caused significant immune stimulation, and the effect is additive with other vaccines such as

diptheria, tetanus and pertussis. The results indicate immunization

starting in the first month of life can prevent autoimmune diseases. However, immunization starting after 2 months increases

the risk in both humans and animals.

My work with the anthrax vaccine involves starting immunization in the first month of life. However, based on similarity with

other vaccines I have worked with, I would expect that it would increase the risk of autoimmunity, including diabetes in recipients,

including humans.

Published data supports an association between military vaccines

and an increased risk of diabetes. A very high rate of insulin-dependent diabetes exists in the Navy. Those entering the Navy have

a similar rate to the general population. However, after being in

the military for several years, their rate of diabetes exceeds the

rate reported for the general population. In Sweden, where all men

are drafted, but women traditionally aren’t drafted into the military, the rate of diabetes prior to the draft is about the same in

men and women. After the draft, however, when the men receive

the vaccines, their rate is about twice that of women between the

ages of 20 and 34. By contrast, in the U.S. Navy where men and

women receive the same vaccines, their rate of diabetes is about

the same.

This suggests that military vaccines may be doubling the risk of

diabetes in the recipients. Based on my work with vaccines and diabetes, I estimate the anthrax vaccine may cause diabetes in 1 out

of every 1,000 recipients and some form of chronic adverse event

in 1 in every 200 recipients. These effects may not occur until 4

years or more after immunization.

I can give numerous examples where employees of the U.S. Public Health Service lacked commitment to medical science and instead appeared to be furthering their careers by acting as propaganda officers to support political agendas pertaining to vaccines.

In one case, I can demonstrate that employees of a foreign government who are funded and working closely with the U.S. Public

Health Service submitted false data to a major medical journal.

The true data indicated that the vaccine was dangerous. However, the false data indicated that there was no risk. An employee

of the NIH, who manages large vaccine grants, jointly published a

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misleading letter about the subject with one of these foreign civil

servants.

In May, the U.S. Public Health Service assured Congressman

Mica’s subcommittee that the hepatitis B vaccine was safe. Weeks

later, the U.S. Public Health Service, however, changed its hepatitis B vaccination policy because there was too much mercury in

the vaccine. It’s hard to imagine that they didn’t know a problem

existed when they tried to convince Congressman Mica that the

vaccine was safe.

I have several recommendations that are discussed in my testimony. However, I think the most important is that there’s a need

to hire a special prosecutor to determine if public health officials

are following the laws enacted to ensure safety of vaccines, and if

public health officials, along with manufacturers, are misleading

the public about the safety of these vaccines.

France investigated the actions of its own public health officials

and found that they had not followed the law in ensuring the safety of biological products. After imprisonment of several public

health officials in France, France now has a leadership position in

ensuring vaccine safety as demonstrated by their discontinuation of

the routine hepatitis B immunization program for school-age children in France.

Simple improvements with vaccine technology may lead to over

a 50 percent reduction in insulin-dependent diabetes and other

autoimmune diseases.

I want to thank you very much for the opportunity to speak. This

ends my testimony.

Mr. BURTON. Some of the things you brought up there are very

interesting. I’d maybe like to talk to you a little bit more about this

later, Dr. Classen.

[The prepared statement of Dr. Classen follows:]

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Mr. BURTON. Major Bates.

Major BATES. Mr. Chairman, members of the committee, I thank

you for the opportunity today to speak here on this critical issue.

I’m a C–5 pilot, newly assigned to Dover Air Force Base. Two

months ago I arrived at Dover in high spirits, excited about the

new challenges that lie ahead. However, within the first few weeks

I became aware of some very disturbing facts. I learned that people

were suffering, and I have an attachment here to run down this list

of suffering.

A captain on active duty, pilot, has been grounded for several

months. She was healthy before receiving the vaccine—suffers from

autoimmune disorder, has sustained thyroid damage and has testified before Congress.

Another captain, active duty C–5 pilot, has been grounded for

several months after taking the fourth shot. He was healthy before

receiving the vaccine, and he developed cysts on numerous places

on the inside and outside of his body, to include his heart. He has

undergone surgery to remove the cysts and was hooked up to an

IV for 6 weeks. He says the medical group is working on a waiver

to get him back on flying status, even though he still has a cyst

around his heart. He is afraid for his future. He is afraid he will

never fly again in the military or civilian community. He said the

flight doctor did eventually hand him a VAERS report and told him

she was going against her instructions to do so, but she thought

he should fill one out anyway.

Another major, pilot, C–5 pilot, is being treated for an autoimmune disorder.

Another major, active duty C–5 pilot, has been grounded for several months. He was healthy before receiving the vaccine. He has

been suffering crippling bone joint pain and ringing of the ears.

The pain is so bad he can’t climb into the airplane. He has been

battling the various infections continuously during the past several

months and has developed new allergies in the past month. He’s

been in physical therapy for the last 3 months with no progress.

Staff sergeant, active duty C–5 flight engineer, after the fourth

vaccine began to experience diverse symptoms which included

chronic bone joint pain, chronic fatigue and a loss of ability to concentrate. He’s been cross-trained into another, less demanding career field.

Tech sergeant, active duty flight engineer, has been grounded for

8 months after receiving the vaccine. He’s experienced eight seizures. Other symptoms include crippling bone joint pain, memory

lapses, ringing of the ears, dizziness, and inability to concentrate.

Tech sergeant, active duty flight engineer, grounded for 4 months

after the vaccine, being treated at Walter Reed.

Master sergeant, retired, C–5 flight engineer. During his retirement ceremony just a couple of weeks ago, the squadron commander described him as becoming very ill in the last several

months of his service and not being able to fly, and I found out that

he had diabetes.

Staff sergeant, active duty C–5 loadmaster. He was healthy, 33

years old, until receiving the vaccine September 1998. Since then

he’s suffered from pneumonia, chronic pneumonia, more than once,

memory loss, severe bone joint pain, dizziness, and hearing probVerDate 11-MAY-2000 06:57 Aug 21, 2000 Jkt 000000 PO 00000 Frm 00177 Fmt 6633 Sfmt 6633 C:\DOCS\65604.TXT HGOVREF1 PsN: HGOVREF1
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lems. The recent bone scan revealed lesions on his ribs, spine, and

pelvis. They’re treating him for skeletal tuberculosis, although the

doctors are still puzzled. He’s been grounded since February.

Staff sergeant, active duty loadmaster on C–5. He experienced

chronic bone joint pain after receiving the vaccine. Said his arms

frequently go numb. He filed a VAERS report. He’s been grounded

for so long the medical group asked him about a medical discharge,

but he’s not interested. He’s been on active duty for 17 years and

he wants to try to keep his pension.

Tech sergeant, active duty loadmaster, healthy prior to receiving

the vaccine, first shot September 1998, 33 years old. Started having

severe sinus problems, bone joint pain in October, started having

memory lapses in December, and he described these memory lapses

as, why am I standing in this room. He didn’t know how he got

there. And there’s more than one testimony like that.

He was on convalescent leave during February following a surgery and told by the squadron supervision to get up to the base

now and get your third anthrax vaccine. He had a friend drive him

up there because he couldn’t drive. He was uncomfortable to get

the shot since he was on antibiotics and he had just come off a

steroid IV 2 days prior. He described the condition to the med tech.

The med tech gave him the shot anyway, to receive the fourth shot

on March 10th, and then 2 days after that has thyroid damage. He

says he will be on thyroid medicine the rest of his life. He’s been

grounded since February. The VAERS report the base completed

for him had incorrect data on it he found out. His home phone was

incorrect, and they said he was not on medication when he received

the vaccines so he filled out one on his own.

Airman, first class, active duty mission control specialist. She

was healthy prior to the vaccine. After the second shot she started

experiencing episodes of vertigo, ringing in the ears, and memory

lapses. She has had five vertigo episodes. She describes them as

being so severe she can’t walk. The vertigo has ceased since the

vaccine stopped and she is on a waiver not to receive anymore anthrax vaccine until her health improves. She said the anthrax issue

is one reason why she plans on not reenlisting.

And by the way, we have more than one of those anthrax waivers

after people have had a couple of shots until their health improves

or for a period of a year depending on how the letter is written.

And I’d like to talk about one other person I wasn’t planning on

talking about because they’re not in my squadron. It was the

anaphylactic shock incident we had earlier this year. We have had

one. The first panel said there hasn’t been one. The chief of the immunization clinic at Dover had an anaphylactic shock experience.

They are now putting her on antiallergy medicines, so she can

maybe get the shot in the future I was told by the chief flight surgeon.

All these people have three things in common. They’ve all received the anthrax vaccine; they’re all healthy prior to the vaccine;

and they’re all, except for the antephialtic shock, in my squadron.

I’ve never seen anything like this before. I’ve been to five bases, to

include Dover. If the Ninth Squadron health figures were the norm,

then 101,000 troops would be suffering from this.

Excuse me. I’m getting a little shaken up here.

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Our leadership seems to be desensitized, and that is not an attack on my chain of command. I believe there are people so close

to this issue, they are so deep in the woods, they can’t see the forest.

I’m a new guy. I’ve got a fresh set of eyes, and I can see the forest. It is as if it were snowing in the summer, and nobody wants

to acknowledge it.

I’ll close by saying I don’t have any physical evidence. I don’t

have the resources for that. I don’t have any physical evidence to

link the anthrax vaccine to the illness, but I would like to close

with a quote by who was then Senator William S. Cohen about

drawing conclusions during the 1974 debate relating to the impeachment of President Nixon. ‘‘If you went to sleep on the ground

outside here and woke up with fresh snow on the ground, certainly

you would reasonably conclude that snow had fallen during the

night even if you did not see it.’’ I couldn’t agree more. I would like

to close by thanking you and the committee for allowing me to testify today.

Mr. BURTON. Thank you, Major Bates. I know that you and

Major Rempfer had to take some risk to come here today. We appreciate that, and we’ll do our dead-level best to make sure you’re

treated fairly. We appreciate your bravery in coming forth.

[The prepared statement of Major Bates follows:]

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Mr. BURTON. Major Rempfer.

Major REMPFER. Thank you, Chairman Burton, members of the

committee.

I open my testimony with the core values of the United States

Air Force: ‘‘Integrity first, service before self, and excellence in all

we do.’’

I’ve served our Nation faithfully and honorably for 12 years as

an officer, 4 prior to that as an Air Force Academy cadet. I’ve flown

F–16’s and F–117’s and most recently A–10’s for our Nation’s Air

Force, and I intend on serving for many years to come.

I’m not here to speak about the safety of the vaccine or the efficacy. Instead, I’m here to discuss another reason for the growing

retention problem generated by the Anthrax vaccination policy. Its

integrity and its relationship to this policy and how it extends to

doctrine. After exhausting all avenues within my chain of command

and communicating with hundreds of service members for the past

year, I’ve concluded that the root cause of the negative reaction to

the anthrax vaccination policy is a sense that the professional

standards demanded of military personnel have been consistently

violated by those implementing this program. It is not, as DOD officials assert, simply a failure to educate the troops. Instead, it is

a failure to communicate the truth, the whole truth, and nothing

but the truth, and I’ll offer up a few examples.

First, when the Anthrax vaccination policy was announced on

December 15, 1997, a senior officer who refused to be named told

reporters, ‘‘It’s been licensed since 1970 and has a proven safety

record. It’s been documented.’’

The whole truth is that in April 1998, Dr. Catherine Zoon of the

FDA stated in a letter that, ‘‘clinical studies conducted on the longterm health effects of taking the anthrax vaccine have not been

submitted to the FDA.’’ The Government Accounting Office reiterated this fact on April 30, 1999, and just recently the Army has announced that they will now conduct a study.

Next, the Assistant Secretary of Defense for Health Affairs, who

is a physician, also told Congress on March 24 that, ‘‘The safety of

our AVIP was also confirmed by an independent review of the program.’’ She was referring to a report by a Yale University medical

professor who was selected by DOD to review the health and medical aspects of the anthrax vaccination policy before its implementation. This is one of the four mandates by the Secretary of Defense.

The whole truth is that the doctor our DOD repeatedly cited for

over a year as their independent expert is really an obstetrician

and gynecologist. He wrote Congress, upon being requested to testify last April, that he had informed the DOD at the time of the

review that he had no expertise in anthrax. DOD has never acknowledged this admission by their ‘‘expert’’ or explained why they

asked an OB/GYN to review a biological warfare immunization program. As a result, by service members the DOD’s independent review is considered to be a sham.

Finally, the Assistant Secretary of Defense for Public Affairs has

also asserted for months that the number of refusals is only about

200 service members, inferring no significant impact to readiness.

Yet on September 30th a DOD spokesman finally acknowledged

that the DOD has made no effort to track refusals.

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The whole truth is that the DOD has carefully crafted a ‘‘no bad

news’’ tracking system that only tracks the administration of the

shots but does not track adverse reactions or refusals. The Deputy

Secretary of Defense admitted to Congress on September 30 he was

reluctant to count refusals through a central tracking system because it would undermine command authority. He did not elaborate

why telling the truth would undermine the chain of command.

I have seven additional examples of contradictory statements by

DOD and senior officials that elaborate on this concern of service

members. One is from the Assistant Secretary of Defense for Public

Affairs, two from the Assistant Secretary of Defense for Reserve Affairs, one from the Deputy Secretary of Defense, one from the Secretary of the Army, one from the Director of the Air National

Guard, and one from the Secretary of Defense. I can hold those off

until later, and they are included in my written testimony unless

you would like me to elaborate at this time.

Mr. BURTON. Major Rempfer, I think we’ll get to those after a bit.

I really appreciate the research that you’ve done on this, and we

will have those for the record. We will look at those.

Major REMPFER. And so, to conclude, I would just like to say that

these three lapses and the others that I’ve included are merely the

beginning of the unraveling of the truth. They have placed the military commanders at all levels in an untenable position, either implement a questionable policy or sacrifice their careers. Consequently, the anthrax vaccination policy has turned into a biological loyalty test.

The anthrax vaccine is no longer perceived by the troops as a

health policy. Instead it’s become an issue of good order and discipline. Loyal service officers must now show their loyalty to the

chain of command by submitting to the vaccine. For those who

don’t, there is arbitrary discipline, incarceration and court marshal

for some, dismissal and disgrace for others. And some are merely

asked to leave and keep quiet.

Each of these examples demonstrates a breakdown of intellectual

honesty, which is the linchpin of integrity and doctrine between

commanders and their troops. Without honesty, doctrine is merely

dogma, as Congressman Shays referred to with the ‘‘medical Maginot Line’’ concept today. Doctrine would require the tacit cooperation of our adversaries to use the only biological agent against

which we have invasively defended ourselves. It requires our adversaries to not use chemical agents at all. It requires our adversaries

to attack only the 1 percent of Americans who are vaccinated.

Recognizing the long-term logical implications of this facade of

force protection, Dr. Ken Alibek, the former deputy director of the

Soviet biological weapons program, told the Joint Economic Committee of Congress that, ‘‘In the case of most military and all terrorist attacks with biological weapons, that seems to be of little

use.’’

Further, he recently stated, ‘‘We need to stop deceiving people

that vaccines are the most effective protection and start developing

new therapeutic and preventive approaches and means based on

broad-spectrum protection.’’

I think that’s what your service members are asking for as well.

Service members have discovered an acute dichotomy between

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what defense officials are telling Congress and the information

readily available in government documents, congressional testimony, medical research, and news reports. This contrast creates an

ethical dilemma for service members whose core values require the

questioning of immoral orders.

Consequently, out of respect for the constitutional imperative of

civilian control of the military, we have reluctantly and repeatedly

asked for Congress to intercede and stop the corrosive impact the

anthrax vaccination policy is having on our Nation’s military. If

Congress is not proactive in response to the DOD’s absence in this

case, the unfortunate reality is that those members of the voluntary military who are tying to embody these core values simply

leave.

I’ll close with an excerpt from the Soldier and the State by noted

Harvard military scholar Samuel Huntington. He rhetorically

asked, ‘‘What does the military officer do when he is ordered by a

statesman to take a measure which is militarily absurd when

judged by professional standards?’’ Huntington answered, ‘‘The existence of professional standards justifies military disobedience.’’

Our professional standards have been made very clear to us: Integrity first, service before self, and excellence in all we do. I believe I would be derelict in my duty if I did not take this opportunity to express this professional dissent. As well, it would be unconscionable for me not to seek redress for all the service members

that have been affected by it, that are dedicated to the profession

of arms and who have inextricably been drawn into this professional military dilemma.

Mr. Chairman, thank you for listening to us today and looking

out for the interest of service members.

Mr. BURTON. Thank you, Major.

[The prepared statement of Major Rempfer follows:]

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Mr. BURTON. Dr. Halsey.

Dr. HALSEY. My name is Dr. Neal Halsey. I’m a pediatrician specializing in the study of infectious diseases and vaccines at the

Johns Hopkins University School of Public Health. I thank you,

Mr. Chairman, for the opportunity to provide this committee with

my perspective on the important issue of vaccine safety.

I’ve had the opportunity to care for children who have suffered

from each of the infections that can be prevented through vaccination. I’ve also cared for children who have developed serious adverse reactions to vaccines. My objective, and I believe the objective

of most people in this room, is to ensure that both children and

adults receive the safest vaccines possible to protect them from serious infectious diseases.

I’ve had the opportunity to review the written testimonies of Drs.

Harold Margolis, Samuel Katz, and David Satcher in their appearances before this committee and Congressman Mica’s subcommittee. These witnesses have detailed the enormous benefits from immunizations, and I agree with their statements. Therefore, I will

not reiterate the benefits of vaccines in my testimony today, but I

will be happy to answer any questions regarding this issue.

I was asked to comment on three issues: one, the number of vaccines that children receive; second, combination vaccines; and,

third, diabetes. I am not concerned about the number of vaccines

that children receive, and I look forward to the availability of several other vaccines that will help us prevent serious infections and

cancer.

The human immune system is remarkable in its capacity to respond to millions of different antigens. Children are exposed to

many thousands of bacteria, fungi, and viruses beginning at the

moment of birth. Exposure to a single bacteria stimulates an immune response to 17 to 50 different proteins.

Some new vaccines, such as the Haemophilus influenzae, or Hib

vaccine as it’s called, contain only one or two bacterial antigens.

Therefore, children immunized with this vaccine are exposed to

fewer antigens than naturally infected children, and immunized

children are protected against meningitis and sepsis.

Recently, concerns have been raised about the amount of thimerosal, a mercury containing preservative, and other products in

some vaccines. Manufacturers, the Food and Drug Administration,

the CDC, and the American Academy of Pediatrics have responded

rapidly to these concerns to make new products available and reduce infants’ exposures to these components. I anticipate that further steps will be taken in the near future to eliminate these concerns. The use of combination products reduces the total exposure

to these components and theoretical concerns about these issues.

Children benefit from combined vaccines because they’re protected against several different diseases with a single injection,

thereby reducing pain and discomfort. If vaccines that are currently given in combination were administered at separate visits,

children would be left unprotected against some diseases for varying periods of time. As we learned a decade ago with the resurgence of measles in this country, leaving children unprotected even

for a few weeks or months can lead to epidemics and unnecessary

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suffering and deaths. We do not need to learn those same lessons

over again.

I know that you, Mr. Chairman, are concerned about combining

measles, mumps, and Rubella vaccines in the same syringe. The

studies and theories that were raised by Dr. Andrew Wakefield

have not held up to careful review by investigators in this country,

in Japan, and at his own institution in the United Kingdom.

We know that encephalitis predisposes children to autism. All

three of the diseases prevented by the MMR vaccine, measles,

mumps, and Rubella, can cause encephalitis. We would not want

to leave children unprotected against these diseases for even a

short period of time. I support the continued use of the combined

measles, mumps, and Rubella vaccines as the safest and most effective means to protect children against these diseases.

With regard to diabetes, there have been two workshops that

have been conducted to investigate the possible link between childhood diabetes and vaccines. One was held at the Institute for Vaccine Safety at Johns Hopkins and the other at the National Institutes of Health. The conclusions from both inquiries have revealed

no scientific evidence to support the hypothesis that any vaccine

causes diabetes. I will append to my testimony the conclusions of

one of those workshops and provide a summary of the other one.

The history of medicine is filled with stories of physicians and

others who have been quick to claim that they have answers to

complex medical problems based on inadequate studies. Just as

people should not be misled by promises of cures from fake medications, we should not mislead people with false villains to blame

when unexpected illnesses occur.

The parents of children with diabetes, autism, and other disorders that we do not fully understand deserve answers as to why

their child developed these diseases. These answers should be

based on sound scientific inquiries. Congress should support increased funding for research to identify the basic causes of these

disorders.

Identifying the safest vaccines is a process, and there are no absolutes. Promoting unproven hypotheses and hearsay about vaccine

safety could have a negative effect on the willingness of vaccine

manufacturers to invest the large amount of resources necessary to

develop new vaccines that will protect our children against cancer

and other serious diseases.

Congress should be concerned about vaccine safety and provide

sufficient resources to assure that the best possible science is conducted to assist with the development of vaccine policy. We need

highly qualified scientists who are on the cutting edge of their

fields to be conducting reviews of new and existing vaccines. Therefore, it is disconcerting to learn that the research budget for the

agency responsible for approving vaccines, the Center for Biologics

and Evaluation Research of the FDA, has been cut to one-third the

level that it was just 5 years ago. If this committee is truly concerned with assuring that the safest possible vaccines are used for

children and adults, I urge you to investigate the issue and restore

funding for vaccine safety research. You should also query the

other agencies to determine the funding needed to address other

aspects of vaccine safety.

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Thank you for the opportunity to share my views on these subjects. I’ve provided a much more detailed statement, including references, for the record. I would be happy to answer any questions.

Mr. BURTON. Thank you very much, Doctor.

[The prepared statement of Dr. Halsey follows:]

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Mr. BURTON. I share your concern about the cut in funding for

that research regarding the safety of vaccines. I think that’s extremely important.

I hope nobody that’s followed our hearings believes that I and

members of this committee don’t believe that vaccines are absolutely necessary. I think they’re the reason that we have the highest quality of life and health of any nation in the history of mankind.

However, in my family, my granddaughter received a hepatitis B

shot, and 6 hours later she was not breathing. Now, that does

cause a little bit of concern.

My grandson received the shots that you referred to, a perfectly

healthy young man who is going to be 6 foot 10, according to his

doctor, his pediatrician, when he grows up. I want him to be in the

NBA so he can support me. He’s autistic, and there was no manifestation of anything like that prior to him getting these shots. So

I think more research needs to be done.

I would like to ask you one question, however. Do you receive

any funding or any kind of research grants or anything of that type

from any pharmaceutical companies?

Dr. HALSEY. Yes, I have received in the past year funding for research on Lyme disease vaccine, the safety of Lyme disease vaccine

in children.

Mr. BURTON. From what company?

Dr. HALSEY. That is from SmithKline Beecham, the only manufacturer of Lyme disease vaccine.

Mr. BURTON. I just wanted to know if you had any funds being

received from the pharmaceutical companies.

Dr. HALSEY. Could I address the point you made, just briefly?

I think it’s the No. 1 issue that people have trouble understanding, from the testimony that I heard from this panel, from what I

heard on the earlier panels, and from what I just heard from you.

The science of causality assessment is not understood by most people, and I think we need to do a better job of educating as to how

we do determine that something that occurs following a vaccine, a

drug, or a food is or is not caused by that problem. We must have

good science to say that either there’s a very specific test that can

be done, which is the case with some situations with adverse

events to vaccines, such as live virus vaccines, or you must demonstrate a difference in risk.

Mr. BURTON. I have to ask other questions, but that’s one of the

reasons why we’re having all of these hearings.

We had the DPT shot. There’s been substantial information coming to us from doctors and others that there were side effects that

could have resulted in autism; and the DPAT shot, which is a substitute, has been on the market for some time. It’s much safer. Everybody knows that, and yet they’re still using the DPT shot. We’re

trying to find out why that’s the case, among other things, but

we’re looking into the things you’re talking about.

Let me go to Major Bates here, real quickly. How many people

are in your squadron?

Major BATES. 270, sir.

Mr. BURTON. Of the 270, how many did you say have had these

kinds of problems?

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Major BATES. Twelve, sir.

Mr. BURTON. Twelve out of 270.

Major BATES. About 4.4 percent.

Mr. BURTON. Did you have any others that refused the shot?

Major BATES. Yes, sir. There was an airman a few months ago

that was discharged with less than honorable conditions. He’s the

only active duty member at our base that I’m aware of.

However, the new group of pilots—and not just pilots, the new

group of people that come in the summer, usually we do a lot of

moves in the summer, none of us have received the vaccine yet.

When we walk around the halls and talk to each other, everybody

looks both ways. They say, man, I don’t want this vaccine. I hope

the Congress stops it. That’s what the new people say. But, of

course, we have to wait to see when it comes time to roll up the

sleeve where they stand on that.

Mr. BURTON. I’ve had a couple of flight engineers and pilots come

in and talk to me about this. They’ve indicated the same consternation that you have.

Major Rempfer, how many people do you have in your squadron?

Major REMPFER. The squadron I was in prior to transferring over

to the U.S. Air Force Reserves, my situation was I didn’t want to

disobey the order, and we were—it was made very clear to us

that—leave the unit if you’re not planning on taking the shot. So

I’ve done that. There’s a pattern all across the country of that occurring in many bases.

In my squadron, we had approximately 32 A–10 fighter pilots,

and 8 of us ended up choosing to leave the unit in lieu of accepting

the vaccine. And there was an additional couple of individuals that

chose to take non-mobility positions within the unit.

Mr. BURTON. They were no longer in flight status.

Major REMPFER. That’s very true. They were in mobility slots,

but they chose to go ahead and allow themselves to be grounded

and not fly anymore. That was the ultimatum. We’re going to

ground you and process you out of the unit.

Mr. BURTON. Of those who had the shots, were there any adverse

side effects that you know of?

Major REMPFER. I don’t think there have been any VAERS forms

filed in the unit. I’m not aware of any at least. But our informal

communications with all our friends who still remain in the unit

are that many of them felt like they had adverse reactions. Nobody

reported, and they back us up 100 percent.

Mr. BURTON. Why did they not report it? Did they say whether

they were afraid of losing their flight status?

Major REMPFER. I think most folks are reluctant to do it because

most of them also hold FAA certifications as well.

Mr. BURTON. They’d like to be pilots in commercial aircraft after

they——

Major REMPFER. In my case, in this unit most of them are commercial airline pilots.

Mr. BURTON. I see. You’re in the reserves?

Major REMPFER. Yes, sir.

Mr. BURTON. Admiral Crowe, during your career was there ever

discussion for the need to use the anthrax vaccine to protect our

troops against a biological attack?

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Admiral CROWE. Mr. Chairman, I retired in 1989; and in my

statement I went through some of the measures that we took in the

JCS. But the question of toxin or anti-toxin and terrorism, et

cetera, really had not—the urgency had not developed to that

point. We were just beginning to explore the potential of this problem but not individual vaccines, et cetera.

Mr. BURTON. Let me just ask one more question, and I’ll go to

Mr. Shays. You state that you had no contact with the Defense Department in negotiations with regard to the BioPort contract. Have

you had any communications with anyone in the Department or

the Pentagon since your retirement?

Admiral CROWE. First of all, I didn’t say in regard to the contract. I said in regard to the decision to make inoculations—mandatory inoculations.

Mr. BURTON. Did you have contact with them or talk to anybody

at the Department of Defense about the BioPort company or

what——

Admiral CROWE. I did after it became a BioPort company but not

at the policy level. This was at the working level. And I wrote a

letter to Secretary Cohen after we became a company to point out

some of the problems we would be experiencing with foreign sales,

et cetera.

Mr. BURTON. Did you ever talk to them about anything like the

financial problems the company was having and the need for additional funding?

Admiral CROWE. I had one contact where I said that, if that is

true, we want the U.S. Government to be in on it, and all the

records would be accessible to them at BioPort. That was all that

was said. I really had very few conversations on this subject with

anybody in the Defense Department.

Mr. BURTON. There was $18.4 million that was advanced because

the company was in difficulty. I just wondered if you ever talked

about that.

Admiral CROWE. I’m aware of that. That, incidentally, is a contract that’s been signed, but it’s not been forwarded yet.

Mr. BURTON. But did you discuss that with anybody, sir?

Admiral CROWE. Not within the Department. No, I did not, sir.

Mr. BURTON. Thank you.

Mr. Shays.

Mr. SHAYS. Thank you.

Admiral, I wasn’t going to get into this because there are so

many issues that concern me more, but I’m surprised that you actually had retired a good number of years before you started working for BioPort.

Admiral CROWE. Yes. I was retired about 5 years, and then I was

Ambassador for 3 years, and I retired again.

Mr. SHAYS. I didn’t know that, because I hadn’t paid much attention to the issue. I thought you had left sooner. It’s clear, though,

you joined this facility, this operation, because you had value to

add to it.

Admiral CROWE. I think that’s correct, yes.

Mr. SHAYS. It’s also clear to me that you sincerely must believe

that this potentially is an important business to be in because you

believe it is a serious problem?

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Admiral CROWE. Well, I thought terrorism—I had a great deal of

experience with that in England, and also these two boards I was

on—I felt that, No. 1, terrorism was a coming threat. They need

more attention to it. And, No. 2, that it was a business that didn’t

engage in offensive weapons. It was not engaged in killing people.

It was engaged in a passive defense, and I thought it was necessary for the military to have that kind of thing.

Mr. SHAYS. Thank you.

Dr. Halsey, I may have sounded that my mind is made up more

than I think it is on this issue. I am leaning toward a voluntary

program until DOD and BioPort get their act together before it becomes mandatory. But I would really appreciate—and I’m not practicing the lawyer’s creed of knowing the answer to the question before I ask it, so I would be very interested in knowing what your

answer is. And that is what should be the role of the FDA as it

relates to the oversight? This is a very interesting——

Dr. HALSEY. I can speak from my experience as a practitioner

and with my experience serving with the Academy of Pediatrics in

an advisory committee capacity, and I believe that what Dr. Zoon

stated is correct and applies not just to the military but it applies

to the practice of medicine everywhere.

The military is a little different in that it is part of the Federal

Government, and that may change things certainly from your perspective, but there are many instances when people are obligated

to, because of the science that’s out there, to do some things with—

drugs is much more common, vaccines I don’t favor at all—to do

things that are slightly different than what the package labeling

says.

From the pediatrician’s perspective, our biggest frustration is

that many drugs and vaccines are not tested in children adequately. This has been addressed recently by Congress in a law

which I’ve forgotten the name of that requires more testing in pediatric patients so that we do know how we can use these effective

products in them. But the FDA cannot govern the day-to-day practice of medicine of physicians.

I am not prepared at all to speak about the military. My service

has been with the Public Health Service, a branch of the military,

but——

Mr. SHAYS. Would BioPort, though, be allowed to claim that the

vaccine is proved to be effective after three——

Dr. HALSEY. Again, that’s a regulatory issue, but my understanding is that any advertising——

Mr. SHAYS. I don’t understand your answer, that’s a regulatory

issue. This is something you get involved in all the time.

Dr. HALSEY. Yes, I am involved in it. But I’m not the FDA, and

I can’t speak for the FDA, but I’ll tell you what my understanding

is.

Mr. SHAYS. Let me ask you, do you have any—can you answer

honestly? There’s not—nobody has anything over you, do they?

Dr. HALSEY. No, nobody has anything over me at all at this time.

Mr. SHAYS. I just want to know your expertise. And we have certain rules that apply to one group. Should it apply to the DOD?

Dr. HALSEY. The question, as I understand it, should—does FDA

have regulatory authority over BioPort’s advertising——

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Mr. SHAYS. Let me ask you this.

Dr. HALSEY. Let me try to answer.

Mr. SHAYS. No, I can tell you exactly the question. Should a company that has been given a license be able to advertise that the

drug will do something that the license doesn’t give approval for?

Dr. HALSEY. No. And the FDA does have authority over advertising by companies.

Mr. SHAYS. And promotional material and so on.

Dr. HALSEY. Correct.

Mr. SHAYS. So if BioPort was doing this, you have a problem.

You would have a problem with them claiming that it is efficacious

after three when their license says and they only have the documentation to be licensed for six.

Dr. HALSEY. I believe that the answer is yes to your question.

I would have to say that my understanding of the response

from—and I’ve forgotten the General’s name who is responding—

is that it is their effort to try to get all six doses in, but they have

looked at the immune response after three doses, and there is evidence of an immune response which they believe will provide some

protection, may not be all the protection. But I don’t believe there

was a state—the response that I heard was that there wasn’t any

conscious effort to say that’s all you need, that they’re trying to do

that. But they recognize that, gee, maybe we get some protection

after three rather than six. That’s my understanding.

Mr. SHAYS. Why did you want to make that point? That wasn’t

my question, but why did you want to make that point?

Dr. HALSEY. Well, I believe there’s a difference between——

Mr. SHAYS. You sound like you’re an apologist for the military.

Dr. HALSEY. I’m no apologist for anybody—the military, the FDA

or vaccines in general.

Mr. SHAYS. That’s exactly what they said. But I want to know

who watches the military, who protects our soldiers, our sailors,

our pilots? Whose role——

Dr. HALSEY. I can’t answer that question. I think you have to—

you have better access to the people who can answer who watches

over the military. I think you do.

Mr. SHAYS. That’s true. And, because of that, I have a gigantic

problem with what I’m hearing. Because the FDA basically has

given the military the ability through the license of BioPort to use

a vaccine in a way that is new, an aerosol type of exposure, not

tested for. We’re letting them do that, and we’re saying, though,

you’ve got to follow the practice. They’ve said to the military that

you need to follow the protocol. But now I learn today they don’t

have the authority to back up that requirement.

So I’m asking you, as someone who is very close and is concerned

about vaccines, I want to know who should do it and then tell me

what I should do. You said it’s up to me, so what should I do about

it?

Dr. HALSEY. If you believe there was false advertising taking

place by someone in the Federal Government, then I think you

have a right or an obligation to try to determine if that is true or

not. Now, I can’t speak to whether it’s true, because I haven’t seen

any of this material.

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Mr. SHAYS. But this is what I’m trying to understand. What I’m

trying to understand is, you said, this is my responsibility, so I’m

going to exercise it. I need to know whether or not we should ignore the licensing procedures, the six shots, and go with new studies that haven’t yet been accepted by the FDA as valid for the licensing of the product.

Dr. HALSEY. Based on everything that I’ve heard here today and

my previous reading, I think everybody in the military would be

happy if there were additional studies that——

Mr. SHAYS. Could a private company get away with saying to

FDA we would like to follow it? We would be happy if we could,

but we can’t follow the protocol? That’s a good enough answer?

Dr. HALSEY. A company that manufactures the vaccine cannot

advertise such things without approval by the FDA, but a private

physician or a health maintenance organization or such can actually do some things with drugs or vaccines that are not exactly in

accord with what is in the package label.

Mr. SHAYS. And they’ve been given this right by the FDA. The

military has been given this right by the FDA, correct?

Dr. HALSEY. I don’t believe that that’s who grants that. I believe—I don’t know the law in this situation. I do know the practice

of medicine.

Admiral CROWE. I think he was talking about private doctors.

Mr. SHAYS. Pardon me, sir? I didn’t hear what you said.

Admiral CROWE. I said I think he was talking about private doctors.

Mr. SHAYS. Yes. It’s a wonderful circumstance that we have right

now. Basically, we’re supposed to trust the military—and I wonder

why, based on past experience, whether it was Agent Orange,

whether it was people my office has had to help that have been exposed to radiation—we’re supposed to trust the military to do the

right thing, and now we have a program where we had 300 people,

give or take, a year who got the vaccine, and they were tested

under one type, and now we have a circumstance where it’s to be

used as a prophylactic from exposure by a terrorist or a military

organization through aerosol spraying, and we now have 2 million

plus who are going to get this vaccine, and we’re supposed to trust

the military to govern itself.

And I made the assumption when I walked into this hearing that

the FDA was in fact going to make sure its protocol was maintained, and in fact the FDA wrote the military and said, you

haven’t kept up with your schedule. And if they didn’t have that

authority, I wonder why they even bothered to write the letter. I

mean, I just thought they had that authority.

Mr. BURTON. Can I come back to you in just a moment?

Mr. SHAYS. Just to make one point.

I’m not comfortable with generals practicing medicine, and I’m

not comfortable with doctors planning wars, and, frankly, I’m not

comfortable with doctors planning war doing medicine. I’m not

comfortable with doctors planning wars, I’m not comfortable with

politicians planning wars or doing medicine. This was an area—I

was eager to get into it, but I basically see we have no one watching the military, and they have no basis in which to say, trust us,

based on past experience.

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Mr. BURTON. I’ll come back to you in just a moment if you have

further questions, Congressman Shays. Let me just ask a couple of

questions, and that will do it for me.

Dr. Melling, I want to go back to something you said in your

opening statement. I think it’s extremely important that everybody

who may be paying attention to this hearing understand it. You

said in your opinion that if we start—and I may be paraphrasing

what you said—but if we start inoculating people against things

like anthrax, that the potential enemies who would use anthrax as

a weapon would see that, and there are a number of things that

they could use to counter that, other biological weapons which they

undoubtedly would do. I mean, why would they attack us with anthrax if they knew that nobody was going to get it? They would go

to somebody else. Is that what you were saying?

Mr. MELLING. It wasn’t precisely that, but I do agree with the

comment that you made. I think what I was really saying was that

the time it takes to develop vaccines and take them through the

approval process is long. This is true not just for defense vaccines,

it’s true for commercial products. Because an aggressor is not constrained by the need for regulatory approvals, ethical considerations and all the rest of it, I think the pace at which they could

move is likely to be faster than the pace at which we can defend

through vaccine development.

Mr. BURTON. While we’re going through the process of developing

and passing through FDA and the other agencies the anthrax vaccine, they knowing what we’re doing, would say, why should we

concentrate on perfecting this weapon when we can perfect another

one very quickly?

Mr. MELLING. Yes.

Admiral CROWE. May I make a comment?

First of all, if we succeed in doing it, that would be progress. In

other words, we convince terrorist organizations not to use anthrax

against us. That’s the purpose of this whole thing. What it would

do, you’re absolutely right, it would go to other weapons. We feel

that when you get into more sophisticated forms of biological warfare, that’s not as easy for the terrorist to wage, and it causes him

big problems.

Mr. BURTON. How many biological agents are there that could be

used?

Admiral CROWE. Probably three or four. In the next 10 years,

there will be even more maybe. But whether they’re practical for

terrorist use severely limits the number, and anthrax is one of the

easiest for them to make. We would like very much if they reached

the conclusion they couldn’t attack us with anthrax.

Mr. BURTON. The only concern that I have is that with the Internet and all the new technologies we’re seeing develop very, very

rapidly, it seems to me in the not-too-distant future they’ll be able

to move more quickly with these agents than they have in the past,

and to try to vaccinate against all of them is going to be very difficult. I think the point that Dr. Melling is making is that they can

move faster because they have no restrictions than we can in producing a vaccine.

Admiral CROWE. But their resources are limited to certain

things.

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Could I make a comment in this regard, Mr. Chairman? You

asked me to talk about development of policy. One of the things

you have got to be aware of is when the Secretary of Defense

makes the decision to do these sorts of things, there are lots of

pressures that act on him. They have the same kind of testimony

you’re having. They try and look at the pros and cons. They try to

look at the entire spectrum. But I don’t get any feeling in these

hearings that his problems are being considered.

One of his major problems is that he is in command of several

million men. He is given a lot of information that says anthrax vaccine will work in many, many cases. It’s not flawless. There will

be some reaction, et cetera. I would just like to imagine a hearing

where, if we didn’t use the anthrax vaccine and all of a sudden our

forces are hit with it and several thousand people in this country

are killed by anthrax, then we’d have a real hearing on why we

had a vaccine that wasn’t used and didn’t save those people. That

would be a real situation.

Mr. BURTON. There’s no question that we believe that the troops

ought to be protected, and I think everybody here agrees with that.

What we’re asking is has there been proper testing? Have we been

very straight with the military personnel about the side effects of

all this? And should there be informed consent?

I was in the military, too, and if I thought there was a real

chance that I might be incapacitated for life by taking a vaccine,

even though I might be more at risk if I went into combat and had

to face that, I think I might make a different kind of choice. I think

that’s what a lot of these people are talking about.

I want to ask you, Major Bates, quickly one thing. Were you

threatened at all if you refused to take the shot, that you’d be

court-martialed and incarcerated?

Major BATES. Yes, sir.

Mr. BURTON. Tell me exactly what they said to you.

Major BATES. I spoke with my squadron commander, told him I

was very uncomfortable with this. He reiterated the policy. If I

didn’t take the vaccine, I would be court-martialed. There were no

other options. I asked him about a religious waiver. He said, no

chance.

Mr. BURTON. They told you flat out you’d be court-martialed and

probably incarcerated for up to 2 years?

Major BATES. He sent me to the area defense counsel after he

told me I would be court-martialed. I went to the area defense

counsel; and they said, because of your rank, you have the chance

of spending up to 2 years in prison.

Mr. BURTON. That’s the same case for your colleagues in the military who might refuse to take this.

Major BATES. Yes, sir.

Mr. BURTON. There’s no way that we could really tell how many

people who don’t want to take it or feel they might be in jeopardy

because of the threat of prosecution or dishonorable discharge.

Major BATES. Yes, sir. And one female naval officer has been released from the military with an honorable discharge. I would like

to see this kind of lack of consistency across the country with the

military corrected.

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Mr. BURTON. What you would like to see, if military personnel

says, OK, we don’t want to take this shot because we think it’s a

risk to me and my future, rather than to having face a court-martial that they just be able to be discharged if they want to do that?

Major BATES. Yes, sir. And if you don’t mind, I don’t want a dishonorable discharge from the military.

Mr. BURTON. Under honorable——

Major BATES. I don’t want an honorable discharge from the military. I want an honorable military.

Mr. BURTON. You want an honorable military.

Major BATES. Yes, sir.

Mr. BURTON. OK. Very good.

What about in the reserves?

Major REMPFER. In the reserves and the guard, as a matter of

fact, the Assistant Secretary of Defense of Reserve Affairs testified

on September 29th, after he was reminded that he was under oath

by Congressman Shays, that, ‘‘If someone is going to resign over

anthrax, they are certainly not going to be subject to any penalties.

This is one of the points of the guard and reserve.’’ And,

unfortunately——

Mr. BURTON. That was before Congressman Shays’ subcommittee?

Major REMPFER. Yes, sir. Unfortunately, the whole truth is that,

5 days after that, the commander of the 184th Bomb Wing in Kansas for the Air National Guard issued a written warning and a letter of reprimand to a B–1 bomber pilot threatening a $500 fine and

6 months in jail because the pilot had asked to transfer out of the

unit in lieu of submitting to the vaccine. And we have similar contradictory occurrences compared to Mr. Cragin’s testimony.

In the U.S. Air Force reserves they’ve recently, again just after

that hearing, come down with a policy that says anybody who’s essentially refused the anthrax vaccine is not going to be allowed to

transfer.

Mr. BURTON. Let me ask just one more question, and I’ll yield

back to you, Mr. Shays.

Dr. Classen, you’re the only one who has really come out and

said categorically that this vaccine being administered would cause

and could cause side effects, including diabetes. On what do you

base that?

Dr. CLASSEN. Based on extensive animal studies and human

studies with vaccines. We find that when you stimulate the immune system you’re going to get an increased risk of autoimmune

diseases, including diabetes. There is a lot of substantial evidence,

including related literature and interferons as well.

Mr. BURTON. Was that just because of this one vaccine or any

vaccine?

Dr. CLASSEN. It’s any vaccine, practically. If you stimulate the

immune system, you stimulate macrophages cells. You release

interferons. You are going to increase the risk of——

Mr. BURTON. Is it greater with the anthrax vaccine or vaccines

of that type?

Dr. CLASSEN. I can’t say that for sure. Aluminum maginate probably is not a good thing to have. It stimulates certain cells. Six

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doses is probably not as good as having two or one dose. So there

are some problems with the anthrax vaccine.

Also, anthrax vaccine is made from a filtrate which is an

unpurified sort of material, as opposed to certain vaccines that may

just have a specific amino acid or specific protein. The anthrax is

less pure, and so that would tend to stimulate the immune system

as well.

Mr. BURTON. Thank you.

Mr. Shays.

Mr. SHAYS. Thank you.

Dr. Melling, you made—in point one of your statement you said

the effectiveness of defense vaccines cannot be determined by normal human epidemiological trials due to the rarity of diseases involved. Animal models, therefore, are critical to assess efficacies.

Such models are limited in their ability to predict what will happen

in humans and in most cases can best indicate some possibility of

efficacy but do not allow us to determine if a vaccine will protect

40, 60, or 80 percent or whatever of humans, nor can we predict

the human vaccine effectiveness against different levels of challenge. Is that, your view, generally accepted or if I ask Dr. Halsey

would he disagree with that?

Mr. MELLING. I believe that my view is one that is generally accepted; and, in fact, this has been traditionally, I think, one of the

reasons agencies both here and other countries have required

human epidemiological trials before they actually license vaccines

in order to demonstrate efficacy.

Unfortunately, our detailed knowledge of the human immune

system is still limited, and this has meant the number of vaccines

where we can make an accurate prediction of human efficacy solely

based on animal studies is also equally limited. This really is the

problem we’re wrestling with.

I think we’ve heard and certainly I’ve personally done work on

animal models relating to anthrax, the guinea pig model that was

referred to earlier, and what we see is different animals respond

in different ways. It doesn’t mean that the vaccine will not protect

humans.

In fact, I’ll answer the question you haven’t asked me, but I do

believe it has some protective effect in humans. What I can’t estimate is the level of that protective effect, and that’s why I personally would not wish to rely solely on the vaccine, that I would look

at one of several measures.

It’s interesting, the Institute of the U.K. that I used to direct, we

have people working on anthrax. They were all vaccinated, but we

took great care that, if they were working with the organism, they

were also protected by other containment measures, and there was

no way we’d be able to rely solely on the vaccine.

Mr. SHAYS. Thank you.

Dr. Halsey, what is your sense of that?

Dr. HALSEY. Well, I think all of us would prefer to have epidemiologic studies proving efficacy for any vaccine prior to it being

licensed, but I do understand the difficulty in this situation where

the disease is so rare that it virtually is impossible to do that

study. I mean—and the other way in which we sometimes can

learn an enormous amount is through human volunteer challenge

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studies, but I don’t think anybody wants to do that with this organism, just as we are not doing that with HIV vaccines. It’s too dangerous to do that.

Now, I can’t say that it might not be done under some circumstances, but then you must depend upon the animal data and

you look for a correlation with protection. And that correlation with

most vaccines is antibody, but that is not the only measure of an

immune response, and for many other vaccines there are other factors which we are not very good at measuring which are associated

with protection.

Mr. SHAYS. Dr. Leitenberg.

Mr. LEITENBERG. I just want to clarify one thing.

During World War II, the natural mode of infection by BW

agents in the natural world was not through aerosol inhalation.

The ‘‘breakthrough,’’—unfortunate breakthrough—in the World

War II United States-U.K.-Canadian BW program was to discover

aerosol dissemination of BW agents. You cannot expect to have aerosol BW agents being tested against a human population. That’s

impossible. That’s really at the crux of your conundrum, and what

you’ve been asking for. You can’t do that in the United States.

Mr. SHAYS. Let me ask you, Admiral Crowe, did we ever provide

anthrax to any of our Middle East allies or adversaries?

Admiral CROWE. I think we did. I know that some other countries in Desert Storm received it, but I think most of that was furnished by U.K.

Mr. SHAYS. I mean before that. For instance, did we ever give

Saddam Hussein anthrax?

Admiral CROWE. I’m not aware of that. I don’t think so.

Mr. SHAYS. Mr. Leitenberg.

Mr. LEITENBERG. I think what you’re asking about for that is

Iraq was able to obtain from the type culture collection in the

United States some of their anthrax cultures.

Admiral CROWE. But that was not a government——

Mr. LEITENBERG. That was certainly inadvertent, and that was

a universal practice. Such international supply has now been tightened up enormously, subsequent to the discovery that that’s where

some of Iraq’s cultures came from. Iraqi strains of anthrax were

also obtained from other sources, but some were obtained from the

United States type culture collection, yes.

Mr. SHAYS. Mr. Classen, any of the questions I asked, did you

want to respond to?

Dr. CLASSEN. The only issue I guess that really I want to address

is the previous panel where you kept saying you’re not getting a

straight answer. You know, that is what really gets my blood boiling, too, is that we just don’t—when you confront these people,

which are public health officials, they just aren’t upfront, I believe,

and they’re not doing their job. I think they’re looking after their

career. They are career government people who are going to say

what they say to improve their career.

And I think that the real problem here is that there’s no downside. You don’t have to obey the laws. You just do what you have

to do to promote your career, and then there’s no repercussions.

I think that is why we need a special prosecutor to come in and

to look in fact and see are these people in the public health service,

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are they obeying the laws and the legislation that Congress has enacted to ensure safety of biological products.

And I think if you look at France, France did that. I think they

sent four public health officials to jail. They clearly were looking

after their own careers and not abiding by the laws. In doing so,

they jeopardize the health of the public. And I think that clearly

that’s what’s going on here, and I think we really need some

changes in that regard.

Mr. SHAYS. Mr. Chairman, I just have a few more questions, not

long.

I would like to put in the record a letter received—excuse me, a

copy of a letter that Sue Bailey, the Assistant Secretary of Defense,

received; and it’s stamped September 29, 1999. It’s from Kathryn

Zoon, and it’s three paragraphs. I’ll read the last paragraph.

We reiterate our previous statement made to DOD on December 16, 1997, that

FDA approval of the anthrax vaccine is based on the six-dose regimen found in the

approved labeling. Because we are unaware of any data demonstrating that any deviation from the approved intervals of doses found in the approved labeling will provide protection from anthrax infection, we strongly recommend the anthrax vaccine

immunization program follow the FDA-approved schedule. We would like to hear

from you as soon as possible regarding this matter.

[The information referred to follows:]

219

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Mr. SHAYS. I read this letter and made an assumption, and I

started to smile as I read it. I didn’t realize when she said recommend, it wasn’t a joke. She was recommending it. And one of

the things that—instead of requiring it.

And one of the things that I just think is of interest to me is that

the bottom line from this hearing, I’ve learned something that I

clearly should have known before, but bottom line is the—this program run by the military does not have to follow the protocol and

that the FDA does not have to make them follow the protocol. And

so that the military says they’re trying to follow the program. They

don’t have to. And we have no one I guess who can make them do

it, I guess, unless Congress.

Clearly, one of the recommendations that I’m going to recommend to our subcommittee is that we not allow a government

agency to administer drugs without there being some outside

source or organization or institution that is there to protect from

the misuse of a potential drug.

I’ll yield back.

Mr. BURTON. The gentleman yields back his time.

Mr. Leitenberg.

Mr. LEITENBERG. Since I previously answered ‘‘yes’’ to your question, Congressman Shays—you had asked did the United States

ever provide anthrax to Iraq—and I really shouldn’t have answered

an unqualified ‘‘yes.’’ The U.S. Government didn’t give the Iraqi

Government anything. An institution in Iraq was able to obtain the

culture from the type culture collection. That’s really a better answer.

Mr. SHAYS. It is a better answer. There’s always speculation that

in this battle between Iran and Iraq that we were helping Iraq,

and I appreciate your answer.

Mr. BURTON. Mr. Waxman.

Mr. WAXMAN. Thank you very much, Mr. Chairman.

I think that the FDA position is that they don’t regulate the

practice of medicine. They approve a product that is presented to

them by the manufacturer to be safe and effective in order to get

their approval, and then I don’t think FDA has ever been the appropriate agency to go and police how medicine is practiced by government or nongovernmental agencies. So I think that point you

raise is an interesting one, but I’m trying to think it through.

Off the top of my head, I find it very difficult to expect the FDA

should have to deal with that burden. And then if you take the position that no government program can be run unless it follows the

protocols you’re making an assumption that the Department of Defense has not followed the protocols, and I’m not convinced of that,

although I am convinced that they didn’t do what they should have

done in monitoring. And it’s upsetting that they didn’t because they

have a captive audience, so to speak, where they should have been

monitoring any adverse reactions. But I don’t think they would

admit to the conclusion you’ve reached, that they weren’t going to

give all the shots required.

Mr. SHAYS. Would the gentleman yield?

Mr. WAXMAN. Sure.

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Mr. SHAYS. The challenge I have is I’m wondering if this is the

practice of medicine when in fact we have our soldiers who are basically ordered by the superior officers to take a particular drug.

Mr. WAXMAN. I think you raise a good point—if I could take back

my time, I think you raise a very good point.

I was responding to FDA’s responsibility, but we as a government have a responsibility, if our young men and women are going

to be required to take a vaccine, to make sure that it’s administered to them in a way that’s proper and will protect them and if

there are adverse effects that we know about them.

I think we need to know more about adverse effects. There are

all sorts of pharmaceutical products that we don’t know about because we rely on the self-reporting of a lot of the companies, sometimes voluntarily, particularly in the area of medical devices, and

we need to know more.

Let me just ask a few questions unless I get more time.

Dr. Halsey, Dr. Classen has described his theory that vaccines

cause various diseases such as childhood diabetes. I understand

NIH conducted a workshop in May 1998 to address Dr. Classen’s

claim; is that correct?

Dr. HALSEY. Yes, that is correct. And I had mentioned in my testimony that there were two workshops. We also conducted one at

the Institute for Vaccine Safety at Johns Hopkins. Both workshops

concluded that no vaccines have been shown to cause diabetes in

humans.

I would add part of where some of the confusion has occurred is

that there is work in at least four different laboratories with animals predisposed to get diabetes, and you can prevent diabetes in

those animals with some vaccines given very early in life. Dr.

Classen has done some of those studies, but it is inappropriate to

move from that to then say that you can cause diabetes with vaccines. There is no evidence to support that statement.

Mr. WAXMAN. I have a statement from the National Institutes of

Allergy and Infectious Diseases which reported on the meeting, and

this summary expressed the following findings: ‘‘the consensus was

that existing studies in humans do not indicate an increase in Type

1 diabetes attributable either to any vaccine or to the timing of vaccine administration.’’

So the summary says this was a consensus. Do you agree with

these findings and, if so, why?

Dr. HALSEY. I agree completely with those findings. We could go

through all of the data and the problems that occurred with the

methods and the logic that were presented by Dr. Classen, but I

think you would have to give me 15 minutes to say that. But basically, you cannot use what we call ecologic data, temporal trends

that are occurring, to draw a conclusion about causality assessment.

The most telling evidence is in a clinical trial that was done in

Finland, and those data were published. I will provide the committee with the final publication of that study, which clearly demonstrated in a randomized trial of Hemophilus influenza vaccine,

that there was no difference between the two groups, it was a random chance that there would be a slight difference in numbers, but

they’re basically identically the same in children that got multiple

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doses early in life versus a single dose later in life. And it’s very

convincing data.

Mr. WAXMAN. Thank you very much. I see the time is running

out, but Admiral Crowe, I wanted to thank you for being here on

such short notice and making yourself available to the committee.

I know you had to shuffle around your schedule. I want to thank

you for raising that issue of your relationship to BioPort, the anthrax vaccine manufacturer. There have been a lot of rumors floating around; you addressed it head on in your statement.

Some of these rumors are on the Internet. Several members of

the Armed Services Committee suggested last week that you may

have benefited improperly from inside information when you joined

BioPort. And you just said that’s absolutely not true; is that correct?

Admiral CROWE. Yes, sir. I sometimes think the Internet is more

dangerous than taking the vaccine.

Mr. WAXMAN. You stated that anyone could have bid on the purchase of the Michigan facility with the full knowledge of DOD’s

planned vaccination program; isn’t that correct?

Admiral CROWE. I’m sorry, would you say that again?

Mr. WAXMAN. Anybody could have bid on the purchase of the

Michigan facility and had the knowledge about DOD’s planned vaccination program?

Admiral CROWE. Oh, yes. That was public knowledge as early as

1996.

Mr. WAXMAN. And did other companies compete for that contract?

Admiral CROWE. They all knew about that. They all competed in

that environment. They were all aware of it. Secretary Cohen’s announcement, of course, in May, which was an official one, formal

one, intensified the competition, but it didn’t bring anything new

to the debate.

Mr. WAXMAN. I’m pleased that you set the record straight and

people should have known that.

Admiral CROWE. Thank you.

Dr. CLASSEN. Can I set the record straight on my own research,

if that’s possible?

Mr. WAXMAN. It’s OK with me, let me find out what the chairman wants to do, because my time is up.

Mr. BURTON. Let me followup on that very quickly.

Mr. SHAYS. Can I ask a question, Mr. Chairman? We don’t have

any time restraints do we? We just have three members here.

Mr. BURTON. No, we don’t. I would like to ask a question or two.

Henry is welcome to ask questions. I would never stop Henry.

Admiral Crowe, it’s my understanding that in September of—

what year was that, 1998—the BioPort company was formed, and

the papers were filed with the secretary of state, I guess, in Michigan who formed BioPort; and within 30 days of the filing of those

papers, BioPort had the government contract. And during that interim period, you became a member of the board; is that correct?

Admiral CROWE. I became a member of the board because

BioPort completed the transaction.

Mr. BURTON. But it was a 30-day period within about a month

or so?

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Admiral CROWE. The contracts were already set, and that was

part of the agreement with the State of Michigan they would go on

with the new owner.

Mr. BURTON. Before you became a part of BioPort, did you have

any contact over——

Admiral CROWE. We had nothing to do with the contracts.

Mr. BURTON. Did you have any contact at all with the Department of Defense about the company at all?

Admiral CROWE. I visited the GPO office with my CEO 1 day.

The State of Michigan, during the process of the negotiations,

wanted to ensure—and this applied to all of the bidders, not just

to BioPort—to ensure that if they won the bid, that the Defense

Department would express some sense that it could accept their

ownership of the firm. And all the bidders had to do that with the

Defense Department, and that’s what we did.

The negotiations——

Mr. BURTON. But you were the one that talked to them about

that?

Admiral CROWE. Well, I went with the meeting where we asked

them to answer this question. They didn’t answer it in the meeting,

they wrote a letter later, but——

Mr. BURTON. Did any of the other bidders, to your knowledge,

have people who had been formerly high officials in the Pentagon?

Admiral CROWE. Certainly members of the government and the

military.

Mr. BURTON. But high up in the Pentagon?

Admiral CROWE. Not that I know of, no, sir.

Mr. BURTON. OK.

Dr. Classen, you didn’t have a chance to respond to the comments that Dr. Halsey was making regarding Mr. Waxman’s questioning.

Dr. CLASSEN. Right, I would like to make the record straight.

There were two meetings to discuss vaccines and diabetes. The

first was Dr. Halsey’s meeting. That was a meeting that was funded by several vaccine manufacturers. My understanding is that

that they fund Dr. Halsey’s institute on safety, hundreds of thousands of dollars. I called the public health school and asked them

particularly what vaccine manufacturers were funding this meeting.

It was not an objective meeting. Before the data was even presented, Dr. Halsey attacked me for being on TV regarding this

issue, and that was clearly inappropriate since the data should

have been discussed before his conclusions were made, but his conclusions were made beforehand.

He asked the panel, from what I was told, to sign a consensus

statement essentially denouncing my findings. The panel absolutely refused to sign a consensus statement that denounced my

findings. Therefore, I don’t think there’s any way you can say

there’s consensus if people would refuse to sign a consensus statement.

However, in his publication that he did on this meeting, there

were numerous false information in this publication including the

statement that there was consensus.

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Mr. WAXMAN. Excuse me, Dr. Classen, you’re talking about Dr.

Halsey, but the National Institute of Allergy and Infectious Diseases had a meeting.

Dr. CLASSEN. Right, I’m going to discuss that.

Mr. WAXMAN. They had a consensus at their meeting from what

I understand from their summaries.

Dr. CLASSEN. They did not have a vote. I mean, how can you say

there’s a consensus without some type of formal vote? It would be

like saying, OK, this is——

Mr. WAXMAN. This isn’t a report from Dr. Halsey, this is a report

from the NIAID, and they say the consensus was that existing

studies in humans do not indicate an increase in Type 1 diabetes

attributable either to any vaccine or to the timing of vaccine administration.

Dr. CLASSEN. That’s exactly why I’m so upset, and I talked to

Mr. Shays about this. I mean, they’re not being honest. They didn’t

have a vote. The only vote they had, from my understanding, was

at Dr. Halsey’s meeting where they in fact refused to sign a consensus statement. Then they had somebody go up in front of them, in

front of this meeting saying, we have come to consensus, good day.

There was no vote. You can’t have a consensus unless you take

a poll and find out what’s going on.

And the same day that Dr. Halsey is talking about was, in fact,

his data from Finland where in fact the investigators submitted

false data. This data was in fact funded in part by the United

States Government; they submitted false data to the British Medical Journal. They did not include their sources of funding, that partially funded this study. In fact, the British Medical Journal then—

as a neutral party, the British Medical Journal reported—whereas

in the process of reporting these investigators to an ethics committee on ethics in publication in the UK—so it’s a complicated issue

and the people weren’t always telling the truth.

And in fact——

Mr. WAXMAN. Excuse me. If people disagree on a scientific issue,

is that not telling the truth if they disagree with the conclusions?

Dr. CLASSEN. It’s not a consensus.

Mr. WAXMAN. You’re saying one thing, somebody else says another thing. If they disagree with you, are they liars?

Dr. CLASSEN. No, but it’s not a consensus. If they say there is

a consensus, then there had better be a consensus.

Mr. WAXMAN. The National Institute of Allergy and Infectious

Diseases says there was a consensus. You say there wasn’t a consensus?

Dr. CLASSEN. Absolutely.

Mr. WAXMAN. Then we have a disagreement on that point.

Dr. CLASSEN. OK.

Mr. WAXMAN. Thank you, Mr. Chairman.

Mr. BURTON. I’m not sure this is going to be resolved today. I’m

sure that you and Dr. Halsey have strong differences which we

can’t resolve. But I would like to have information from both of you

that we can put into the record on your positions which we can’t

go into because of time constraints today.

Do you have some more?

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Mr. SHAYS. Mr. Chairman, I apologize for extending this. There

are different people here I would love to get their answers; and

some of the answers I don’t think I will like, but I want them on

the record.

My fear is, and maybe I don’t need to be afraid of this, but my

fear is that we are entering a whole new area of—and I address

this to you, Admiral Crowe, and, Dr. Halsey.

Admiral, my understanding is that you obviously believe there is

the threat of biological, chemical, and potentially nuclear threat. I

believe—I happen to believe that; I think we share that.

My sense is that you have gotten involved in this area because

you believe this is an area that you are doing good; as you said earlier.

Admiral CROWE. I originally thought that, yes.

Mr. SHAYS. The question I have is, though, do you see that this

is just the first of many vaccines that we will take as a prophylactic against the terrorists or attack by a military force?

Admiral CROWE. I don’t know that I’m competent to answer that

question. I don’t foresee it specifically.

Mr. SHAYS. You are competent because I’m asking from your

military background. Your military background said this was an

area you should get involved in.

Admiral CROWE. Yes.

Mr. SHAYS. But I did make the assumption that you weren’t just

getting in for anthrax.

Admiral CROWE. Military history would suggest that in this challenge and many others that there will be movement in the weapons

themselves and counterweapons.

Mr. SHAYS. And that the way to protect our military is through

a vaccine?

Admiral CROWE. We will look at that.

Incidentally——

Mr. SHAYS. Don’t run away too quickly here.

We’re opening the door; this is a whole new approach for the

military?

Admiral CROWE. Absolutely.

Mr. SHAYS. And I gathered from you that you believed this is a

very positive development.

Admiral CROWE. That you could get protection from a vaccine?

Mr. SHAYS. And that we would go down that road.

I don’t view it as positive.

Admiral CROWE. When you say ‘‘go down that road,’’ I would

agree with the comment made that it should be one of many steps.

Mr. SHAYS. OK. So this would be, the same logic that applies to

anthrax could apply to some of the other threats?

Admiral CROWE. Possibly.

Mr. SHAYS. Because when you say to us, because I think about

this, I mean if I have a role that makes this a voluntary process,

and then there isn’t some circumstance where anthrax is used, you

know, that would be a pretty horrible thing to live with.

But you could say that about almost any threat?

Admiral CROWE. Yes.

Mr. SHAYS. And so I can’t think that way. I have to kind of take

myself out of that, you know, that consequence.

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Dr. Halsey, do you see this as a positive development? I mean,

are you concerned that we could have a military—drawing the military and get not only so many vaccines for natural potential, you

know, Mother Nature, but also what your enemy may do, we’re

going—you’re going to get 10 or 15 vaccines in the course of your

service?

Dr. HALSEY. Well, I don’t think that I or probably anybody else

here wants to pretend that they can predict what will happen in

the field of bioterrorism over the next decade or two with regard

to what organisms might occur. Just from an infectious disease

standpoint and a history of infectious disease, the military have

had to be out front with routine immunization of troops against so

many other organisms which we don’t normally use for the general

public.

I personally am more comfortable knowing that should there be

a bioterrorism event that we at least have some troops who are not

going to be susceptible to the organism and who will be available

to help defend the country in any way they can.

So I see it as a positive development, because it does look to me

as though anthrax is a very real risk.

Mr. SHAYS. So this just may be the beginning. And I don’t say

that other than just to say this may be just the beginning, correct?

Dr. HALSEY. Certainly. But I don’t want to predict the future.

Mr. SHAYS. OK. Then do you not think it makes sense that if we

are going to go down that route that there be some ability to monitor and regulate how the military does this?

Dr. HALSEY. Certainly everybody needs oversight. And I would

agree with what I think you’re saying, in that there should be some

oversight of this process. Who that is, I don’t know, but you’re in

a much better position to determine who that might be.

There is the Armed Forces Epidemiologic Board which has in the

past provided a lot of this coordination, but I don’t know the oversight mechanisms.

Mr. SHAYS. The DOD acknowledges they’re not in technical compliance. They are trying to comply. But even their definition of

‘‘compliance’’ is, if they miss within 30 days, they’re still in compliance.

So we have got this double challenge; one is, first, to acknowledge that they’re not even within their 30 days past date, but even

their writing a rule that basically says they’re in compliance if

they’re 30 days late.

Doesn’t that tell you something about how the DOD is approaching their effort to live up to the protocol, and forgetting—I’m not

talking about the whole issue of getting involved in medicine. I’m

just talking about abiding by the protocol.

Dr. HALSEY. I probably am not qualified to speak, because I don’t

know the precise protocol that they’re following and what windows

of time that they provide opportunities for people to meet the requirements of the protocol. And I think you should address that to

the military.

Mr. SHAYS. If a protocol says you’re supposed to have a shot

and—six shots, and it gives the exact dates of time within a certain

period, I’m asking—this is your area of expertise.

Dr. HALSEY. I will be glad to respond.

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And I think it’s very evident to me as a pediatrician that has

been concerned about vaccination of children that we do have

guidelines that call for precise ages at which those vaccines are

given. But, unfortunately, there are many children in this country,

in spite of having very conscientious parents, who don’t get those

vaccines at exactly the time that we recommend them—2, 4, and

6 months. We don’t call them delinquent unless they go at least a

month beyond the time that is recommended and then we consider

them behind.

So the principle of setting up some guidelines like that is widespread in immunization.

Mr. SHAYS. OK, thank you.

Thank you, Mr. Chairman.

Mr. BURTON. These people look like they’re getting hungry.

Mr. SHAYS. Don’t give up here. Let’s pursue this.

Mr. BURTON. I can handle it, if you can, Henry. Go ahead.

Mr. WAXMAN. Thank you, Mr. Chairman.

Admiral Crowe, as a military proposition, if you’ve got a possible

enemy with a new weapon, you want to figure a way to counter

that new weapon.

Admiral CROWE. Yes.

Mr. WAXMAN. And what we’re talking about is a vaccine that

can, we would hope, be able to counter a terrorist activity.

Admiral CROWE. Hopefully.

Mr. WAXMAN. I’m sort of surprised that we wouldn’t be pleased

that we have such an opportunity.

Admiral CROWE. That was my original approach. I thought the

country would be—would welcome this.

Mr. WAXMAN. I have my doubts about the strategic defense initiative, because it’s very expensive and I don’t know whether it will

be effective. And I tend to think that one of the dangers would be

not a nuclear weapon sent by a missile but a nuclear weapon being

brought in by a terrorist. I suppose the answer to that would be,

well, you don’t leave your troops vulnerable to that attack.

Is that the way you would look at that, or how would you respond to that?

Admiral CROWE. There are many ways to deliver the weapon, it’s

a multifaceted problem, and it’s a very serious threat.

Mr. WAXMAN. So bioterrorism can be multifaceted as well?

Admiral CROWE. Yes, as well.

Mr. WAXMAN. You try to figure out, as best you can, how to do

that?

Admiral CROWE. Actually, we do a variety of things. We do a

great many things besides this to try to protect our men, our equipment from—to live in a biological environment. One of the things

that we should consider about this vaccine is, we discuss the military aspects today, but it also should be—if it’s successful, and we

can refine it so that it is, it should probably be administered to civilians at some point. If we ever have an anthrax scare on this

country, there is going to be a great demand for it on the civilian

market.

Mr. SHAYS. Would you like to advertise in the hearings?

Admiral CROWE. I find that sort of upsetting, not comfortable.

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Mr. WAXMAN. I’m not sure if I agree with that, because I know

that the larger the population that we immunize, the greater the

chance of risks.

Admiral CROWE. OK.

Mr. WAXMAN. And I think that, as Mr. Shays indicated, we have

a responsibility wherever our people are taking risks. Especially if

the government is telling them to take those risks, we have to be

very responsible and cautious to be sure that it’s a risk that is a

prudent one for us.

Admiral CROWE. I will say one thing. If I was exposed to anthrax, I sure would like to have this kind of protection and I do

have it.

Mr. WAXMAN. And I would agree with you there. Thank you very

much. I know you’ve been on for hours, and I had another committee hearing, so I’m coming in fresh. But I thank you, Mr. Chairman, for being so indulgent of me and the members of the panel.

Mr. BURTON. No problem, Mr. Waxman.

Did you have anything else, Mr. Shays?

Mr. SHAYS. No, thank you.

Mr. BURTON. I want to thank you very much. You’ve been patient. And you gentlemen in the military, if you have any undue

pressure, I hope you will contact my office and maybe we can help.

We will do our best to help you out.

Thank you very much. We stand adjourned.

[Whereupon, at 5:40 p.m., the committee was adjourned.]

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