U.S. GOVERNMENT PRINTING OFFICE

65–673 CC WASHINGTON : 2000

ANTHRAX VACCINE ADVERSE REACTIONS

HEARING

BEFORE THE

SUBCOMMITTEE ON NATIONAL SECURITY,

VETERANS AFFAIRS, AND INTERNATIONAL

RELATIONS

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

JULY 21, 1999

Serial No. 106–131

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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH, 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

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS, AND INTERNATIONAL

RELATIONS

CHRISTOPHER SHAYS, Connecticut, Chairman

MARK E. SOUDER, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DAVID M. MCINTOSH, Indiana

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

HELEN CHENOWETH, Idaho

ROD R. BLAGOJEVICH, Illinois

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

JOHN F. TIERNEY, Massachusetts

THOMAS H. ALLEN, Maine

EDOLPHUS TOWNS, New York

BERNARD SANDERS, Vermont

(Independent)

JANICE D. SCHAKOWSKY, Illinois

EX OFFICIO

DAN BURTON, Indiana HENRY A. WAXMAN, California

LAWRENCE J. HALLORAN, Staff Director and Counsel

ROBERT NEWMAN, Professional Staff Member

JASON CHUNG, Clerk

DAVID RAPALLO, Minority Counsel

(III)

C O N T E N T S

Page

Hearing held on July 21, 1999 ............................................................................... 1

Statement of:

Chan, Kwai-Cheung, Director, Special Studies and Evaluation Group,

Natonal Security and International Affairs Division, U.S. General Accounting Office, accompanied by Sushil K. Sharma, Assistant Director,

Special Studies and Evaluation Group, National Security and International Affairs Division, U.S. General Accounting Office; Major General Robert Claypool, Deputy Assistant Secretary for Health Operations

Policy, U.S. Department of Defense, accompanied by Rear Admiral

Michael Cowan, Deputy Director for Medical Readiness, Joint Staff,

U.S. Department of Defense; Colonel Frederick Gerber, Director,

Health Care Operations, Office of the Army Surgeon General, U.S.

Department of Defense; Colonel Renata Engler, chief, Allergy-Immunology Service, Walter Reed Army Medical Hospital; and Susan Ellenberg,

Director, Division of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, accompanied by Dr. Miles Braun ........................................................................... 74

Piel, Captain Michele L., U.S. Air Force, Stevensville, MD; Lieutenant

Richard Rovet, U.S. Air Force, Dover, DE; Sergeant Robert Soska,

U.S. Army, Fort Stewart, GA; Captain Jon Richter, U.S. Air Force,

Annapolis, MD; and Lieutenant Colonel John Jensen, Great Falls, MT . 6

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

Chan, Kwai-Cheung, Director, Special Studies and Evaluation Group,

Natonal Security and International Affairs Division, U.S. General Accounting Office, prepared statement of ....................................................... 77

Claypool, Major General Robert, Deputy Assistant Secretary for Health

Operations Policy, U.S. Department of Defense, prepared statement

of ..................................................................................................................... 97

Ellenberg, Susan, Director, Division of Biostatistics and Epidemiology,

Center for Biologics Evaluation and Research, Food and Drug Administration, prepared statement of ..................................................................... 121

Jensen, Lieutenant Colonel John, Great Falls, MT, prepared statement

of ..................................................................................................................... 41

Piel, Captain Michele L., U.S. Air Force, Stevensville, MD, prepared

statement of ................................................................................................... 10

Richter, Captain Jon, U.S. Air Force, Annapolis, MD, prepared statement

of ..................................................................................................................... 35

Rovet, Lieutenant Richard, U.S. Air Force, Dover, DE, prepared statement of ........................................................................................................... 19

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

of Connecticut, prepared statement of ........................................................ 3

Soska, Sergeant Robert, U.S. Army, Fort Stewart, GA, prepared statement of ........................................................................................................... 26

(1)

ANTHRAX VACCINE ADVERSE REACTIONS

WEDNESDAY, JULY 21, 1999

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS

AFFAIRS, AND INTERNATIONAL RELATIONS,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 10:05 a.m., in room

2154, Rayburn House Office Building, Hon. Christopher Shays

(chairman of the subcommittee) presiding.

Present: Representatives Shays, Souder, Terry, Schakowsky, and

Tierney.

Also present: Representative Gilman.

Staff present: Lawrence Halloran, staff director and counsel;

Robert Newman, professional staff member; Jason Chung, clerk;

Bill Ochs, intern; David Rapallo, minority counsel, and Earley

Green, minority staff assistant.

Mr. SHAYS. Good morning and welcome.

In April, we heard testimony from three members of the Michigan Air National Guard unit who suffered serious health effects

after receiving the anthrax vaccine. Their personal stories conveyed

the concerns of many men and women in our armed forces about

the long-term safety of a little-used vaccine.

Their testimony also raised important questions about the willingness and ability of the Department of Defense, DOD, anthrax

vaccine immunization program [AVIP], to acknowledge the side effects and adverse reactions caused by the vaccine. We address

those questions today.

All vaccines cause reactions. In fact, that is their purpose, to

stimulate a response from the immune system. But in doing so,

vaccines also cause in some people varying degrees of negative

health consequences ranging from a sore arm to potentially fatal

hyper-sensitive or allergic reactions.

Due to its composition and the number of inoculations required,

the anthrax vaccine causes local and systemic reactions at what

DOD once called problematic rates. Some reactions may become apparent as vaccine usage expands from a few hundred people each

year to 2.5 million members of the military.

To capture the true rate of health effects and to detect unexpected reaction trends, AVIP surveillance systems must be sensitive and receptive to adverse events reports.

Are they?

Military doctors must be advocates for their patients, not purveyors of program orthodoxy.

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Are they?

Those receiving the vaccine must be free to seek medical advice

and pursue suspected associations between the vaccine and their

illnesses without fear of retribution or ostracism.

Are they?

Many think not. Service members report massive vaccination

sessions during which little medical information is imparted, little

medical history elicited, and no questions or doubts are tolerated.

They describe a program that often fails to offer legitimate medical

exemptions from the inoculation, glosses over potential side effects,

and aggressively denies any attempt to link adverse events with

the vaccine.

Others, like the Michigan National Guard members who testified

in April and those who are here today, face intimidating official resistance when they ask whether the vaccine may be a cause of

their medical problems. As a result, the number of AVIP-related

cases in the Food and Drug Administration [FDA], Adverse Event

Reporting System, referred to as VAERS, seems purposefully and

implausibly low.

Despite the under-reporting inherent in a passive surveillance

system, VAERS is a tool DOD could use to gather important data

about the impact of the AVIP on troop health and readiness. Instead, illnesses subsequent to vaccination are attributed to coincidence or pre-existing conditions in the interest of protecting the anthrax program rather than the patient.

The practice of medicine, not public relations, should be driving

the adverse event reporting process. Whether the adverse reaction

rate is two-tenths of 1 percent or 21 percent, DOD has an obligation, a profound obligation, to protect those in the military force,

in the force made ill by this force protection program.

If women suffer adverse health effects at twice the rate of men,

DOD has an obligation to acknowledge and ameliorate those effects. If a pure vaccine or fewer than six inoculations would provide

protection while causing fewer reactions, DOD again an obligation

to pursue FDA approval of those options.

We are going to proceed from the premise all our witnesses share

one interest, the health and safety of those in service to the Nation.

That is going to be our premise.

Thank you all for your time and your testimony this morning.

And again, welcome.

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

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4

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Mr. SHAYS. At this time, I would ask if Mr. Tierney has any

opening statement he would like to make for the record.

Mr. TIERNEY. I do not. Thank you.

Mr. SHAYS. Thank you, Mr. Tierney.

So at this time, let me first get some business out of the way.

And that would be to ask unanimous consent that all members of

the subcommittee be permitted to place an opening statement in

the record, and the record remain open for 3 days for that purpose.

Without objection, so ordered.

And I ask further unanimous consent that all witnesses be permitted to include their written statements in the record. And without objection, so ordered.

And I am further going to ask unanimous consent to insert in the

hearing the record written statements from Randy Martin-Allaire,

Roberta Groll, and David Churchill, members of the Michigan Air

National Guard, who testified before the subcommittee in April.

And we asked them to update us on their health and their efforts

to determine whether the anthrax vaccine played a role in their illnesses.

I am happy to report their health has improved somewhat, but

they remain very frustrated and disappointed over the DOD response to their plight.

And without objection, we will put that in the record as well.

Now we will welcome our first panel. We have five witnesses who

will testify. Captain Michelle Piel, U.S. Air Force; Lieutenant Richard Rovet, U.S. Air Force.

Captain Piel is from Stevensville, MD, and Lieutenant Rovet is

from Dover, DE.

Now we also have Sergeant Robert Soska, U.S. Air Force—U.S.

Army, I’m sorry—Fort Stewart—excuse me, Sergeant—and Captain

John Richter, U.S. Air Force, Annapolis, MD, and Lieutenant Colonel John Jensen, Great Falls, MT, and he is with the Montana Air

National Guard.

We welcome all of you here today, and as is our practice, we

swear in our witnesses, this being an investigative committee. We

do it for Members of Congress as well when they testify before us.

And we would welcome you to stand and we will administer the

oath. If you would raise your right arms please.

[Witnesses sworn.]

Mr. SHAYS. Thank you. For the record, all five have responded

in the affirmative.

And I think we have you seated according to the way we are

going to proceed. We will start with you, Captain Piel.

And what we do is, we have the light on for, it will be on for 5

minutes. We will roll it over another 5 minutes, and certainly ask

you to finish before that second roll-over is done. And do know that

your record will be—your full statement will be in the record if you

care to leave out some parts.

Capt. PIEL. Yes, sir.

Mr. SHAYS. I am also going to say to all of you before you testify,

I have served in Congress 11 years, and I know for a fact that military personnel do not like to come before Congress. This is not

something you look forward to. It is not something you enjoy. And

6

you do it with some recognition that you put your careers in some

jeopardy, even when we say you don’t.

And we certainly keep track of our witnesses and do our best to

make sure they are treated fairly as they complete their career.

But we know you are here at our request, and we thank you for

being here.

Captain Piel.

STATEMENTS OF CAPTAIN MICHELE L. PIEL, U.S. AIR FORCE,

STEVENSVILLE, MD; LIEUTENANT RICHARD ROVET, U.S. AIR

FORCE, DOVER, DE; SERGEANT ROBERT SOSKA, U.S. ARMY,

FORT STEWART, GA; CAPTAIN JON RICHTER, U.S. AIR

FORCE, ANNAPOLIS, MD; AND LIEUTENANT COLONEL JOHN

JENSEN, GREAT FALLS, MT

Capt. PIEL. Good morning, Mr. Chairman and members of the

committee.

Mr. SHAYS. I am sorry, Captain, I am going ask you to move that

mic a little closer to you. If it kind of gets in the way, you could

lift it up a speck if you wanted. Is it all right? Can you——

Capt. PIEL. It is fine.

Mr. SHAYS. OK. That is better. We hear your voice better. Thank

you.

Capt. PIEL. First of all, I would like to thank you for interest in

the anthrax immunization program and also for requesting my testimony today. The views which I will express will be my own and

in no way reflect those of the Department of Defense, the Air

Force, or my superior officers.

I am a C–5 pilot at Dover Air Force Base, DE. I hold the position

of aircraft commander and I am also a flight commander within my

squadron. My whole life I have wanted to fly and serve my country.

And as a graduate of the Air Force Academy, I was able to achieve

both.

I have had a very rewarding 13-year career, and I am grateful

to everyone who has helped me along the way. Today I am going

to talk to you about my experiences.

In October, I was healthy and flying operational missions. I became ill the first of November and then again in December following my first and second anthrax immunizations. On October 1st—

excuse me, on October 21st I received my first immunization from

Lot 030. It wasn’t until weeks later, while I was flying a mission

in support of Hurricane Mitch relief efforts, that I became ill.

The right side of my head filled up with fluid while I was on a

return leg to Pope Air Force Base. After landing, the flight surgeon

grounded me. I had otitis media, which is an inflammation, or an

infection of the middle ear. And I also had a very bad head cold.

These symptoms persisted for 3 weeks. My doctor back at Dover

and I discussed whether or not I should receive an immunization

at this time, and we felt that it would be improper and that we

should wait until I had fully recovered.

On November 30, I went to the flight surgeon’s office to get put

back on flying status. He returned me to flying status and I went

straight to the immunization clinic to get my next vaccination. Following the second vaccination, I felt fine directly afterward. But

later that afternoon, I began to feel very tired.

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I went home, straight to bed, and I did not wake up until the

next morning. I awoke feeling very ill, and I returned to the doctor.

The doctor was very surprised at my condition, the change from the

day before to that day. And, of course, I went back on non-flying

status.

And he asked me, what did you do differently between yesterday

and today? And I told him, the only thing that I could think of was

that I had my anthrax immunization.

In December, I had dizziness to the point it affected everything

that I did. I could not drive; I could not read a page of paper; I

could not concentrate. At the lowest point, my vision blurred, which

is very critical to me because it affects my career as a pilot.

During this time, the diagnosis was viral labrynthitis, which is

an inflammation of the inner ear, and it can cause dizziness because it affects your balance system.

I do not know exactly what was happening to me, but the doctors

assured me that within 4 to 6 weeks I would recover from viral

labrynthitis. Well that did not happen.

I saw many doctors over the course of the next 6 months, and

nobody could, I don’t feel, adequately address my problem. It

wasn’t until I began going to Walter Reed at the decision of my

wing commander, Colonel Greider, that I began to get my problems

recorded in my medical records and receive blood tests, which

would help try to determine what was causing my symptoms. I

have had a very slow recovery, with periods of regression, but I

strived to maintain a positive mental attitude and recover my flying status and career.

I would like to talk to you know about deferral criteria. The only

information I was given at the time of the shot was the trifold

pamphlet, which we are all familiar with, what every service member should know.

Although I did not have deferral, I have not received any shots

since November, during the first few months of my illness, doctors

asked me if I would like to continue my anthrax immunizations.

They even suggested taking incremental doses to see what would

happen.

Because I was still ill, I felt that this was unwise, and no one

pushed the issue. At this point, I was in a gray area.

There was no diagnosis, and yet I was still ill. I valued my career, but I also couldn’t afford to jeopardize my health, because

without my health, I have no career.

No I will talk about the VAERS system, Vaccine Adverse Event

Reporting System, and how that was communicated to me.

The doctors did not file a VAERS report on me. It wasn’t until

May that I learned about the VAERS system. At that point, I felt

it would be wise for my doctor and I to file it together because I

wanted it to be accurate.

When I went to the chief flight surgeon at Dover Air Force Base,

my request met reluctance. I thought that any loss of duty over 24

hours should be reported in VAERS. But he did not agree that I

had had a reaction.

So then I asked him what he did think was reportable under

VAERS. And he listed things like difficulty breathing, rash, sweatVerDate 11-MAY-2000 12:43 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 C:\DOCS\65673.TXT HGOVREF1 PsN: HGOVREF1
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ing, fever, nodules, and anaphylactic shock. My case clearly did not

fall within those criteria.

I asked him, what about effects on the immune system and the

nervous system, because I felt that maybe that was happening to

me. But I had no answer to that question.

At this point, I was confused because I was too sick to fly and

I was too sick to get another shot. But I wasn’t sick enough or in

the right ways for it to be reportable.

There would be no data collection at Dover Air Force Base if it

wasn’t for the fact that Lieutenant Rovet pursued the issue. He followed up on all of our cases; he tried to help us out. And all of his

efforts were met with resistance and discouragement.

However, when we reported our symptoms to our commanders,

it went up the chain of command to Colonel Greider. And when our

wing commander, Colonel Felix Greider, found out what was happening at his Air Force base, he took the health of his wing very

seriously. That was when we had the series of briefings, and we got

a lot of attention at our base, to say the least.

The information that we got in the first briefings wasn’t adequate. And, dissatisfied, Colonel Greider decided to call a timeout

until our health issues could be addressed properly. This is important to the collection of data because before he called the timeout,

there was no VAERS data from Dover Air Force Base. There was

no collection or reporting.

No one knew what was happening outside of our base.

I would also like to say that as far as diagnosis and treatment

within the medical community at Dover, I did not get directed to

Walter Reed. I got directed to from Colonel Greider and put in

touch with the immunology clinic, where they began to actually

record my symptoms in my medical records and give me blood tests

to try to determine what may have, what may be wrong with me,

besides the fact that I had an ear infection.

What they did find was that I had a positive ANA marker, which

is an auto-immune disorder, an indication of that. It is not that I

have been diagnosed with a specific disease; however, my symptoms are consistent with having immune system problems.

The last few months I have felt some improvement; however, the

fatigue is affecting how I live, and it is also affecting whether or

not I am capable of flying. I also have periodic returns of the dizziness, which I also cannot fly in that condition. And I also have

headaches and other things which affect me to a lesser degree.

I missed several weeks of work in January; I missed all of work

in December; I missed 3 weeks of work in November. I missed a

lot of work. And none of this was reported.

However, now it is. An IG complaint was filed at Dover because

when the VAERS reports were finally filed, they were filed inaccurately. The most egregious error is that they marked that the reports were self-filed, indicating that I and the others that they filed

reports on had filed it ourselves, when, indeed, we had nothing—

I had nothing to do with my VAERS form. I saw it later, and I noticed that there were some inaccuracies on the form.

What’s happened since then is we have gone back and corrected

what is wrong with those forms. So at least adequate information

is making it to the FDA right now.

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VAERS is important because it is our only way of tracking this

illness or I should say adverse events that may be connected to the

vaccine. I realize that a diagnosis and treatment in cases of unexplained illnesses are complex. And I know that the doctors had a

very difficult time, and they did not, or were not, fully prepared to

take care of me at the time.

But right now I am receiving excellent medical care. I do not

know the cause or impact of the ANA antibodies in my blood, but

my focus is on flying and getting healthy. I want my whole life

back.

I have testified today at your invitation because I believe our

military’s health is critical to our Nation’s war-fighting readiness.

That concludes my statement. Do you have any questions?

[The prepared statement of Capt. Piel follows:]

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Mr. SHAYS. Thank you. Captain, we are going to have everyone

testify, and then we are going to be asking you questions. And your

testimony is very important. I didn’t want to interrupt it, but I

know that Mr. Gilman, the senior on this full committee, would be

chairman if he chose to, but he is chairman of the national—international committee.

If the other members don’t mind, I would welcome you to give

a statement.

Mr. GILMAN. Thank you, Mr. Chairman. Thank you for allowing

me to intervene. I have to go back to the floor to conduct our hearing on our major bill that’s before the house, and I was very much

interested in Captain Piel’s testimony, and I have been glancing

through the other testimony. And I hope to get back to the committee at the earliest possible opportunity.

I want to thank you, Chairman Shays, for convening this hearing

today as part of your series of ongoing hearings related to the Department of Defense anthrax vaccination program. I think it is an

important hearing.

I recall serving under subcommittee in the last Congress, where

we held a series of very productive hearings on the subject of the

Gulf War Syndrome. Those hearings led to much-need legislation,

providing valuable assistance to our Persian Gulf war veterans and

their families. And hopefully, these series of hearings on anthrax

will do the same.

While I no longer serve on your subcommittee, I have followed

your previous three hearings with great interest. And after reviewing the background material from these hearings, I find myself

with more questions when I finished than before we started.

It appears that this vaccination program was initiated in a hasty

manner, before a proper amount of research on the effectiveness

and safety of the vaccine was completed.

Even more distressing has been the reports of deliberate downplaying of adverse reactions among our military personnel who

have received the shots to date. These reports, of course, are all too

familiar for those of us who investigated the Gulf War Syndrome

issue.

Then as now, there was the all-too-frequent case of commanders

who are more interested with following the official public relations

message rather than being concerned with the welfare of the personnel under their command.

Mr. Chairman, these hearings are important, as they help keep

the Department of Defense focused on an uncomfortable issue and

remind both officials at the Pentagon and the members of the public of Congress’ determination to fully address this subject.

Mr. Chairman, I commend you for your efforts and look forward

to today’s testimony in our ongoing investigation.

Thank you, Mr. Chairman.

Mr. SHAYS. Thank you, Mr. Chairman. You need to get back to

that floor. I would just like to, before calling Mr.—Lieutenant

Rovet, just to acknowledge the presence of Janice Schakowsky. I

don’t know if you have a statement, but she has been a very active

member of the committee, and a very helpful one, besides Mr.

Tierney. And also, we have Lee Terry, who has been very active on

16

the committee as well as the vice chairman of the committee, Mark

Souder.

Do any of you have any statement you would like to make.

[All nod in negative.]

Mr. SHAYS. OK. Thank you, because that helps. We will get right

back to our witnesses.

Lieutenant.

Lt. ROVET. Good morning, Mr. Chairman——

Mr. SHAYS. Good morning.

Lt. ROVET. And members of the subcommittee. Thank you for inviting us here today. It is an honor to appear before you on this

important issue. But I must say at the onset that these are strictly

from my perspective at Dover Air Force Base and don’t reflect the

views of the Air Force of the Department of Defense.

I am a veteran of 14 years of service. I come from a wide variety

background in the Air Force. I was prior enlisted. I worked my way

up through the ranks, and it is an honor to be a commissioned officer and serve in the Air Force.

And my job at Dover entails what we call health-care integrator.

And in that capacity, what I do is clinical nursing, case management, and patient advocacy. All those are very important to me.

One that came to the forefront with this issue is patient advocacy

because you have to be a voice for someone when they don’t feel

like they are being heard.

And that is not a knock against the folks of the medical group

or the Air Force at large. They are good people.

Some of the things we have seen at Dover at the onset were a

reticence upon the medical community to touch this issue. It was

viewed as let’s say politically sensitive, professionally risky to veer

off the line on this issue.

I, myself, felt that in the beginning, but once I saw people coming forward, I had some questions. And I voiced those to my superiors. And I was not quite comfortable with the answer, although I

smartly saluted and about-faced and went back and did my job.

Next, I started hearing some rumblings, and more people came

forward. Then it became a matter of core values, it became a matter of, well, you are a patient advocate, you need to start looking

into this issue.

What I would like to do is just briefly outline for the committee

some of the adverse reactions at Dover, what we have seen. So far,

we have reported 30, but there will be 5 to 6 more within the next

week. And it is fair to say, out of these 30, there are unexplained

illnesses. That may not sit well with the public relations machine

or whatever have you, but if they are not diagnosed, we have no

answer to these peoples’ question, then logic states that they are

unexplained illnesses. These people are all being worked up for anthrax, possible anthrax reactions.

I also would like to say that the vast majority of people it seems

can tolerate the vaccine, and this may be a vital link to force protection, but I think we need to hash out these problems here that

weren’t put up forth in the beginning, at the onset of this program.

OK, for individuals, we have—some of these are multi-symptoms

that people may exhibit—6 report dizziness; 6 report ringing in

their ears; 10 report joint pains; 3 report muscle pain; 3 report

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memory impairment; 2 report constant fatigue; 3 report numbness

and tingling in various parts of their body; 1 reports

photosensitivity, which the lights in this room are probably bothering the individual right now; one reports having a miscarriage

post-vaccination, although the individual did not know she was

pregnant at the time.

One individual reports what they call having gray-outs. That is

like a pre-seizure, or it is something that we just don’t know. But

he calls it a gray-out. One complains of swollen and painful testicles; two report cardiac problems; one reports chills and fever

greater than 48 hours post-vaccination; three report rash, swelling,

and nodule at the injectionsite; two report non-localized persistent

rash; one reports hyperthyroidism.

Again, when we say report, these are bona fide medical workups. They do have hyperthyroidism.

OK, according to the anthrax vaccine insert, we have, right now,

according to the rhetoric that is out there, two mild reactions, three

moderate local reactions, and three systemic, characterized by

chills, fever, lassitude, and malaise.

Mr. SHAYS. Excuse me for interrupting you. Just so I understand

the testimony. You are saying what’s reported is the official documentation of the effect of the anthrax vaccine at Dover? Is that

what you are saying?

Lt. ROVET. It is not official yet, but according to the insert, if we

were to apply what’s in the package insert, and strictly this is my

testimony, it is not the Air Force’s, so it is not official yet. I am

just saying, if we were to apply the package insert to what we have

here right now, this most likely would be what we have. But it is

not a confirmed, they are not confirmed reactions.

There is significant confusion in relation to these categories, and

especially in regard to what constitutes systemic reaction. This I

hope will be looked into further to seeing that these are things that

were not originally thought through in the beginning as systemic

reactions.

I would like to speak briefly about the medical cultural climate

that we see. I speak about the reticence upon the medical community, and I am not painting wide brush across all of the medical

community, but providers, medical providers, view this issue as politically sensitive and like to avoid it.

One clinical supervisor stated on July 15, 1999, my providers

won’t touch this. They want nothing to do with it.

Initially, patients were thought of as malingerers, liars, and hypochondriacs, that this is some sort of mass hysteria akin to the

polio vaccine when it came out. I don’t, I cannot see these honorable men and women coming forward all over the country making

this up or having some massive psychosomatic illness.

Sir, this needs to be looked into for the health of our country, for

the morale and welfare of our troops. There are too many questions

that are left unanswered.

This vaccine was sold with a 28-year track record of safety and

efficacy. Now we notice that they say we don’t know the long-term

effects. Things seem to be fluctuating daily, recantations of statements. It was given to veterinarians on a widely used basis. We

found that is not true.

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This is such a sensitive issue post Gulf war era. We have veterans who are still sick and dying across this country, and some are

making the link to the vaccine. I am not doing that here, but I find

it interesting that we have unanswered questions with that. We

have similar complaints to Gulf war illness appearing all over this

country, and yet, we don’t have the foresight in some areas, and

I am not finger-pointing, to know that this was going to come up?

I work in an emergency downtown. I moonlight in the evening.

And I met an individual, a retired individual, who injured himself.

And we got to talking afterwards. And he knew I worked in flight

medicine.

He started to bring up the anthrax vaccine program. And I listened, and I told him that it is obviously a hot topic. He explained

to me his symptoms that occurred a little bit close to 9 years ago,

and he perfectly described another individual who is in this room

today. Instead of using the word gray-out, he used the word ‘‘episode.’’

His wife was in tears, and they were afraid to—and I said, well

you need to come forward and be evaluated. He goes, I am afraid

I will lose my benefits.

Speaking of fear, all through the squadrons on base, people are

afraid to come forward for they are going to lose their flying status

and lose their career if they come forward. For every one individual

that comes forward, there are three individuals that will not.

These are many unanswered questions, sir. I just hope that for

the good of the country and the good of the morale of our volunteer

force that we will find some answers soon and press on and get

back to business.

Thank you, sir.

[The prepared statement of Lt. Rovet follows:]

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Mr. SHAYS. Thank you. Lieutenant Rovet.

Sergeant Soska.

Sgt. SOSKA. Congressman Shays, members of the committee,

thank you for inviting me to testify today.

This last year has been difficult for my family and me because

of the adverse effects I experienced after receiving the DOD-mandated anthrax vaccinations. I receive the injections as ordered on

three occasions. The vaccine that I received came from lot FAV

020.

These ordered injections were administered during my deployment to Kuwait in support of Operation Southern Watch in 1998.

Upon returning from Kuwait on June 10, 1998, I developed problems with my right arm, and a sore spot in my right wrist led to

severe muscle spasm in my upper arm. These symptoms advanced

to burning sensation in my fingertips, radiated to my left arm, and

throughout the remainder of my body.

The pain in my ankle and joints at times is excruciating. On

many nights, I am unable to sleep through the night because of the

pain. I have trouble keeping food in my system. I have problems

such as joint-muscle pain, swelling on my hands and feet, dizziness, memory loss, sleep disorders, one blackout, night sweats,

chest pains, and shortness of breath.

Environmental changes cause the symptoms to increase with severity.

My condition continues to worsen. Problems and ailments have

developed throughout most of my body. As with most long-term illnesses, some days are better than others, but the pain is always

there as a constant reminder of the hardship and headache suffered by my family and me.

Although I continue to try to stay active and in shape, I am

afraid I could be fighting a losing battle. As mentioned in my letter

to Congressman Shays on April 29, 1999, many other soldiers are

having similar problems, flu-like symptoms, chronic pain, and so

forth.

The DOD reports that there are a low number of adverse reactions while they report a high rate of success for the AVIP. I have

included in my reports that I sent to the Vaccine Adverse Events

Reporting System [VAERS], as an attachment to my written statement. I hope those reports plus my testimony will cast doubt on the

DOD claim that the AVIP is a successful program.

Soldiers who are getting sick are reluctant to report their symptoms out of fear of reprisal. The uncooperative spirit of military

doctors makes bringing these symptoms to light seem like a lost

cause to soldiers. The feeling is that there is a reluctance and even

denial on behalf of the medical staff to inform their superiors so

that proper treatment can commence.

Many soldiers have approached me with concerns for my condition. Our conversations, more often more of them realize they have

many of the same symptoms. These symptoms are becoming prevalent in soldiers who did not even deploy to Kuwait but underwent

AVIP.

I addressed my concerns over the AVIP during the Persian Gulf

outreach meeting conducted by Mr. Rostker’s staff at my duty location. I was present for three meetings. All I heard them say was,

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we need you to come forward; we want to know what is happening

to you.

However, in my opinion, the only thing that was really accomplished was a reiteration that the vaccine is safe. I was not the

only person present that felt the meetings were an ineffective mode

of covering up the truth about the anthrax vaccinations.

Soldiers are not being informed of the adverse effects as stated

on the product inserts, nor were they being told about the various

forms. I am charged with accomplishing the mission of looking out

for the health and welfare of my soldiers. How can I accomplish my

mission when the people who treat my soldiers are turning a deaf

ear to their reports?

I have been told to come forward and let you know what is happening. I am here before you now, and like many, I am telling what

I know but I feel my testimony is falling on deaf ears within the

DOD.

My case is also unique. Since the onset of my symptoms, I have

been persistent to investigate both my physical ailments and the

program itself. I have written several Members of Congress. I have

had the backing of my chain of command and the help of some outstanding doctors. I am one of the lucky ones. I am now being sent

to the clinics to find out what is wrong with me.

But my question is, what will become of soldiers who have not

aggressively sought diagnosis and treatment but accepted their

plight? What will be done to ensure that they are getting the same

care?

Being an NCO is a rewarding career. I have invested 17 years

in the proud service of my country. I have no regrets. I did what

was asked of me, and now I am sick. I must stand up for what I

feel is moral and ethically right. I am here to testify that this program is wrong.

Procedures are not being followed as spelled out in the AVIP documents. Soldiers are getting sick at an alarming rate. Soldiers

should not be made to feel afraid to come forward with their medical complaints; soldiers need to come forward and inform responsible and caring physicians of their symptoms.

When they do come forward, they should not be told the symptoms are all in their heads or that there is nothing to worry about.

Soldiers deserve better.

This concludes my opening statement, Mr. Chairman.

[The prepared statement of Sgt. Soska follows:]

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Mr. SHAYS. Thank you, Sergeant Soska.

Captain Richter.

Capt. RICHTER. Good morning, Congressman Shays, committee

members. Thank you for the invitation to appear before you. Yes,

my name is Captain Richter, and at this point I am really happy

I suffered through Public Speaking 101 in college. [Laughter.]

I, too, am a C–5 pilot in the U.S. Air Force Reserve at Dover Air

Force Base in Delaware. Like my father and my grandfather before

me, who are both career Naval officers, the military has been an

integral part of my life. For over 12 years now, I have served as

an aviator in both the Navy and the Air Force.

I am not a malcontent nor do I have any personal vendetta

against the military. On the contrary, I have served proudly and

faithfully through Desert Storm in the Navy and through Operation Provide Comfort and Northern Watch in the Air Force.

I am not here representing the Air Force or the Department of

Defense. These are my view and opinions only. I am simply here

to tell you my story.

In June 1998, I left the active-duty Air Force as a special operations pilot at Hurlburt Field, Florida. I was accepted into the Air

Force Reserve and went to C–5 Galaxy pilot training, which I completed in January 1999. Upon the return of my unit in Dover, I was

told that all personnel needed to start the anthrax vaccine series

of shots if they had not already done so.

I had heard a few of my peers discussing the vaccinations and

possible unpleasant side effects in various cases and how they

would quit before being forced to take it. I dismissed the talk as

rumors and innuendo, thinking that the military wouldn’t vaccinate the troops with something unsafe or unproved.

I took my marching orders, saluted smartly, and went to the clinic for the first of my shots on February 3, 1999. I was injected with

lot number FAV 030. I had no noticeable negative reaction. No one

at the squadron asked me, nor did anyone at the clinic question me

if I had experienced any negative reactions before I went in for my

next injection.

On February 19, 1999, I submitted to the next shot in the series,

which were to be 2 weeks apart. I was again injected with lot number FAV 030. Approximately 5 days later, the problems began. My

right shoulder joint started to ache, much like when I had played

catch as a kid without properly warming up.

A few days later I noticed my left shoulder joint aching. I

thought it was odd. About a week later, I experienced pain in the

center of my spine, to the point that I had some difficulty getting

out of bed in the morning. These aches and pains lasted for several

weeks each before dissipating.

Again, there was no followup from any medical personnel to discuss any possible negative reactions to the vaccine.

In April, my ankles and feet began to hurt as well as my left

thumb and index finger joints. I noticed swelling in my hand. I was

not starting to register genuine concern. I could not get out of the

bed without limping with pain for the first few hours until my body

loosened up.

Today the pain has stabilized mostly in my feet and left hand,

with an occasional flare-up somewhere new in my body. Last week

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it was my hip joints; next week it may be something else. I awaken

and ease into my day with a couple of over-the-counter Motrin. I

cannot walk without a limp and severe discomfort for the first

hour.

Furthermore, if I am stationary for more than an hour during

the day, my joints and muscles stiffen, making movement extremely unpleasant.

I have lost flexion in my left thumb, and it is still swollen. I am

a 36-year-old man with no previous history of arthritic symptoms,

and I was perfectly healthy before my first anthrax shot.

In May, I learned that Colonel Felix Greider, 436th Airlift Wing

Commander, at Dover Air Force Base had boldly decided to suspend all further vaccinations until information was available on the

vaccine and the concerns of his people were addressed. I quietly applauded this gallant decision, as I decided that taking a third shot

in the series was not in my best interest.

Shortly thereafter, the Air Force surgeon general, Lieutenant

General Charles Roadman, came to Dover to discuss the anthrax

vaccination program and hopefully assuage the doubts of base personnel. I was not in attendance, but learned through a few people

who were that Lieutenant General Roadman assured everyone the

vaccine was completely safe and that only a minute percentage of

those military personnel inoculated had a negative reaction.

Meanwhile, I was encountering more of my squadron mates who

were vaccinated that said they too had experienced various reactions, including tinnitus, dizziness, muscle and joint pain, and, in

one case, gray-outs.

However, most were attempting to keep it low-profile and did not

readily discuss these matters for fear of reprisal.

In June, as I became more and more concerned that my condition

was not getting better, I took the initiative to discern what is going

on in my body. I learned from what is now a full-scale anthrax information network among my peers that 1st Lieutenant Rovet and

Tech Sergeant Domm were taking information on anthrax vaccine

reactions for entry into the VAERS data base.

After meeting with Tech Sergeant Domm and speaking to 1st

Lieutenant Rovet over the phone, they convinced me to come forward and go public, so to speak, about my condition and to encourage others who were vaccinated and are having problems to do so

as well. They also gave me the number of the Allergy-Immunology

Clinic at Walter Reed Army Medical Center.

On June 23, 1999, I called the immunology clinic at Walter Reed

and was seen that same day. After discussing my symptoms and

stating my concerns about continuing the anthrax vaccination program, the doctor ordered a series of blood tests.

In paraphrasing our conversation, he told me he could take blood

tests to determine that I do not have rheumatoid arthritis, but

there are no tests that could positively link my condition to the injection of the anthrax vaccine. The doctor then gave me a temporary waiver from taking the next anthrax injection until my

blood-test results were returned for review.

He later informed that the results of the blood test revealed that

I was not positive for rheumatoid arthritis factor.

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Therefore, he stated, that he would in all likelihood ultimately

have to recommend that I continue the anthrax vaccination shot

series.

I told him that put me in a very tenuous situation, and one that

left me with only one clear option. The doctor went on to say, and

I am again paraphrasing here, that the threat of being exposed to

anthrax while on a deployment outweighed the possible negative

reactions that some military personnel might have to the vaccination and that it was not a matter of if but when some of our troops

would come in contact with it.

I am unsure if this was his opinion or Department of Defense

policy. Apparently there is an unusually high level of acceptable

risk with this vaccine.

The squadron policy and I assume the 512 Airlift Wing policy

was clearly and unequivocally stated in June. We were told the

next time a drilling reservist comes into drill, he or she will commence the anthrax vaccination series or continue with the next injection if the series was already begun.

This policy was re-emphasized on or about July 7, 1999, when I

got a phone call at my home from my unit saying the next time

any reservist planned to drill he or she had to take an anthrax shot

or turn in an Air Force Form 1288, which is a resignation form,

or be subject to Uniform Code of Military Justice Article 15 procedures.

Currently, approximately 60 percent of my squadron’s pilots are

quitting the Reserve military because they have been forced to

make a decision to gamble with their health. I can only assume

that the people in the other specialties required to execute the mission of an airlift airplane such as the C–5 are leaving as well.

Word travels fast. Morale is at an all-time low. People are trigger-shy about coming forward with their symptoms. There is an air

of fear and distrust prevalent throughout.

By coming here today, I have most assuredly fallen on my sword.

I recently made the rank of major, but I never expect to be able

to wear it because I will resign before I take another anthrax injection. This is sad because I like my job. I love my country. The military has always been a part of my life, and I had planned on continuing to serve in it.

I am just a captain and a very small cog in the huge wheel of

the military, but I am the guy in the trenches of the DOD’s implementation of the anthrax vaccination program.

I am not a medical professional, but I am medically qualified to

discuss one thing, and that is the status of my own health.

I was healthy before, now I am not. I know what is good for me

and what is not. And right now, taking another shot is not part of

the John Richter health-care program.

Those in command seem to have shrugged their shoulders at the

numbers of people leaving military with the attitude that an order

was given and it should be carried out. We are growing tired of the

denials that everything is OK when, in fact, it isn’t.

Over 12 years ago, I raised my right hand and solemnly swore

to support and defend the Constitution against all enemies foreign

and domestic and to obey the orders of the officers appointed over

me. I took that oath freely and willfully. I knew that I could and

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would give my life for my country, and on several occasions during

the course of my military flying career, I almost made that sacrifice, as have many others.

But at no time did I ever agree to be slowly poisoned, however

well-intentioned, under the guise of being combat ready so that

every day is one filled with pain. That wasn’t part of the contract

as I know it.

I have defended my country and I have obeyed the orders of the

officers over me, but taking another anthrax shot is not an order

I can carry out.

Thank you.

[The prepared statement of Capt. Richter follows:]

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Mr. SHAYS. Thank you, Captain Richter. How many years have

you served in the military, sir?

Capt. RICHTER. Almost 13.

Mr. SHAYS. Thank you.

Lieutenant Colonel Jensen. You will conclude.

Col. JENSEN. Yes, sir. Mr. Chairman, distinguished members of

the subcommittee, I am Lieutenant Colonel John Jensen, wing

chief of safety for the 120th Fighter Wing, Great Falls, MT, Montana Air National Guard.

I am here today in response to your invitation seeking my views

and experience with regards to the AVIP program. The views expressed in my testimony are my personal views and not meant to

be taken as those of the DOD, Air Force, Air National Guard, or

my command.

As a military member since 1979, I was raised in a family of

military service, with my grandfather serving in World War I and

my father serving during the Korean conflict as a Marine fighter

pilot. I joined the Marine Corps in 1979, following in my father’s

footsteps and am continuing to serve my country today in the Air

National Guard.

In my opinion, one of the biggest challenges to the success of the

AVIP program is understanding all of the issues and perceptions

that exist out there, even those perceptions that do not follow the

party line. I feel that if commanders in senior leadership do not understand the intricacies of the issues that have arisen out of the

anthrax vaccine, they will be ill-equipped to meet the concerns

raised by the field.

Accurate, consistent, non-conflicting information is the key. In

my research to enhance my knowledge and understanding of these

issues, I have come across two areas that concern me greatly. First,

there appears to be a perception in the field that they are not being

given accurate, consistent information on the vaccine, to include its

safety and efficacy, and as a result, they are losing or, in some

cases, have lost their trust in the DOD. Second, it is perception or

lack of trust may be impacting our force readiness.

The following is provided in hopes that the committee can better

understand and fully appreciate these two significant challenges

that I feel we face today.

Before proceeding, I would like to offer my view of those who

serve in the military today, as I believe this is a key element in

meeting the challenges cited above. There is no doubt in my mind

that those volunteers who serve their country today are the most

educated and best trained in our country’s history. They are

trained and qualified to work, maintain, and employ some of the

world’s most sophisticated equipment in the most demanding of environments.

They are taught such things as risk-management, ethics, law of

armed conflict, and the importance of accountability. Since my

written testimony covers in great deal those items that bring to

light the concerns and challenges cited above, I will address only

a few in this testimony.

Acknowledged: The threat of a biological attack of anthrax has

existed since 1990. There is a vaccine available that either by itself

or in conjunction with chemical warfare gear and/or post antibiotic

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treatment should significantly increase one’s survival rate if subjected to an anthrax attack.

Concern: Anecdotal evidence indicates the reaction rate of AVA

exceeds the product insert and what the field is being told. Anecdotal evidence shows the AVA is at least temporally associated

with systemic reactions, hospitalization, cardiac events, and symptoms similar to those suffered in Gulf War Illness Syndrome.

The anthrax vaccine will not be completely safe based upon the

above concerns and/or due to the improper manufacturing procedures identified by the FDA and testified to by the GAO.

Examples that I feel are fueling the perception that the field is

not being given consistent, up-front, accurate information: The

VAERS reporting system used to substantiate the adverse reaction

rates cited by DOD is perceived as not being impartial. The FDA

requests and encourages VAERS reports on all reactions, even

those that only temporally associated with vaccines.

The AVIP program filters the VAERS system. It requires the reporting of events that only result in hospitalization or 24 hours loss

of duty. AVIP requires recording severe local reactions and systemic reactions in the medical records but directs that these will

not be reported unless contamination of the lot is suspected.

VAERS forms do not go directly to the FDA. They are reviewed

at least once more prior to reaching the FDA. This filtering has one

tremendous downside, it does not allow for the identification of less

severe reactions which may indicate a problem that may be occurring in large numbers across the population.

The public recently learned that the Secretary of Army granted

indemnification to the anthrax vaccine manufacturer in 1998. The

DOD states this is a normal procedure to reduce insurance costs

to the company.

A Pentagon spokesman is reported in the paper as saying that

the last time an indemnification was given for a vaccine was in

1976 for the swine flu.

Next, a letter of indemnification appears on the web, signed in

1991 by the Secretary of the Army, granting indemnification to PRI

for the production of anthrax vaccine to be shipped to MDPH,

where MDPH was to bottle, label, and test.

This indemnification states, quote:

The obligation assumed by PRI under this contract involves unusually hazardous

risks associated with potentially severe adverse reactions and the potential lack of

efficacy of the anthrax vaccine. These concerns stem from: a) the limited use of the

vaccine to date, i.e., tests prior to the approval of a vaccine by the Food and Drug

Administration are too small a scale to permit accurate assessments of the types

and severity of adverse reactions. Only widespread use can provide this assessment.

And b) insufficient experience in mass immunization programs to truly evaluate the

efficacy of the vaccine. Moreover, there is no way to predict whether the pathogen

against which the vaccine may be used will be sufficiently similar to the pathogen

used in tests to ensure vaccine efficacy.

Mr. SHAYS. Is that still a quote?

Col. JENSEN. Close quote. Yes, sir.

Mr. SHAYS. All of that is from the indemnification letter?

Col. JENSEN. Yes, sir. I have a copy, if the committee would like.

Mr. SHAYS. We do too. Thank you.

Col. JENSEN. How does a health-care worker or commander respond to this when presented it by a troop?

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Unfortunately, accurate vaccine records identifying the approximately 150,000 individual vaccinated during the Gulf war with

AVA do not exist. I have read that this vaccine’s systemic reactions

are no worse than those of hepatitis A or typhoid or other vaccines.

This may be true. But shouldn’t the issue be, are the actual reaction rates in line with the expected rates and types for which the

FDA licensed it, not how they compare to other vaccines?

Some people say the benefit outweighs the risk. My only question

of this, and hopefully the committee can provide an answer, is,

what exactly is the risk.

My first impression of the vaccine’s side effects were those stated

in the product insert and quoted by numerous officials. Are those

the risks? Or is the risk ending up like those individuals that have

previously testified before this committee and those testifying here

today, assuming the anthrax vaccine is the cause of their ailments.

Finally, will this yet undefined risk increase or decrease over

time as the number of those vaccinated increase, thereby increasing our data base.

Greatest fears: AVA, a potentially valuable force protection tool

may not be available: The program may be killed by Congress due

to poor communication, i.e., the field perceives they are not being

provided the whole story.

Force readiness is being compromised, the trust issue. The following are some of the effects that the AVA program appears to be

having on our retention. I would offer that those leaving over this

have made a benefit-outweighs-the-risk assessment, and their version is, the risk does outweigh the benefits.

Dover Air Force Base, supposedly 30 to 40 percent of the air

crew—pilots, flight engineers, loadmasters—have or intend to resign vice take the vaccine.

Connecticut Air National Guard, eight pilots forced to resign

after they refused to take AVA. Note, some of these pilots were

part of a information-gathering team directed by the commander.

They refused to take the vaccine after the issues raised in their research could not be answered.

Wisconsin Air National Guard, the story ran in the Madison

Newspapers, Inc., June 19, 1999: At least six pilots are expected to

refuse the vaccine. Note, one was in line to be the next squadron

commander.

Travis Air Force Base, 17 tanker air crew resigned from the

79th. Thirty-one pilots out of the 301st have submitted resignations. The number is expected to climb to over 60 percent by the

end of fiscal year 1999. That is 429 years of flying experience gone.

I am told an IG complaint is pending due to an individual’s 1288

reflecting job conflict as the reason for leaving, vice AVA.

From the above, it appears that before units are even moving to

enter the theater where anthrax may or may not be used, their

combat readiness is being compromised, in some cases, by as much

as 50 percent.

Important note: People are not leaving because they have read

some article on the dark side of the web. They are leaving because

they have seen people with whom they have served for years, and

in some cases combat, take the vaccine, become ill, and no reason

given to as why other than we know it is not the vaccine.

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To the end, those with whom I have talked, state that they are

leaving because of the vaccine and that they have lost their trust

in their leaders.

In closing, I would ask not only the committee but those commanders who read and hear this testimony to take an honest look

at the AVIP program, the issues raised above, and those being

raised in the field.

My purpose in testifying here today is not to kill the AVIP program. I welcome a vaccine that would protect not only myself but

those whom I am entrusted to lead into battle, provided it is truly

safe and effective.

It troubles me deeply to watch outstanding service members

leave in the fashion that they are.

Finally, it would be irresponsible of me as both an American citizen and military officer had I chosen the easy path and declined

your offer to testify here today.

Mr. Chairman, integrity begets loyalty, loyalty does not beget integrity.

Thank you.

[The prepared statement of Col. Jensen follows:]

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Mr. SHAYS. Well, we have heard some very powerful testimony

from five very patriotic members of our country and of our service.

We thank you all.

Mr. Terry.

Mr. TERRY. Thank you, Mr. Chairman. Indeed, powerful. Captain

Richter, I think all of us up here love our country, and that is why

we are here as you have spent 13 years in the military. As I have

sat here over the last hour listening to testimony, I think if it was

a condition to serve as a Member of Congress we had to take the

vaccination, I too would probably take the same path that you are

choosing.

Mr. Chairman, our hearings, at least, no pun intended, my exposure to this vaccine has been more on the academic side. We have

studied protocol, testing, side effects or what has been tested by the

manufacturing process, quality control, and today I think is the

first time that we have truly seen the human side, although it has

been certainly why you have undertaken this process.

The testimony we have heard here today is powerful, and there

are so many areas, so many questions that I want to ask all of you,

but I am going to narrow it down into two areas. And, Lieutenant

Rovet, I am going to start with you because you are the first one

that said it, the first one to ask really the true magnitude of which

our service personnel are experiencing symptoms. And you know

more than I do in the sense that medicine has become more of a

science than an art and that it has to fit into specific pigeonholes

and have certain labels placed upon it, and that probably more the

discussion, as the lieutenant colonel has said, needs to focus not on

hospitalization for 24 hours but just the symptoms that we have

heard here today of a variety of different symptoms.

But you said, and Sergeant Soska also said, that probably one of

every three have come forward or voiced concerns. And certainly I

think that is probably more anecdotal than scientific, the one in

three. But why don’t you explain and draw out how you were able

to base a conclusion that Captain Piel, there’s three others out

there that are in the same position that have refused to come forward.

The second part of my question is going to be, why have they refused to come forward? But let’s talk about, first, how do you base

that one in three?

Lt. ROVET. If I understand your question correctly, sir, it’s when

an individual comes forward and we start seeing what we believe

is a trend, we go back and look at some of the symptoms, the symptomatology of what they are presenting with.

My job as a case manager also, I was privy to data throughout

the air crew members that were sick for long-term. So I would start

looking and saying, well, we have a person here who has a longterm illness who has not been really diagnosed with something concrete. There is no concrete etiology. So we would start drawing conclusions in our mind, or just asking questions, not conclusions. It

was more of a hypothesis in the beginning.

And when they came in, we discussed, we listened, and it was

opened up to us from the air crew members that there were more

people out there experiencing the same side effects.

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Mr. TERRY. So these folks have reported some sort of illness,

gone to see a doctor, but reported symptoms that weren’t necessarily associated to the vaccine?

Lt. ROVET. Right. They were—I know Captain Piel, who was captain at the time, had come forward with problems with balance,

what they call labrynthitis or otitis media, and that was originally

diagnosed as just strictly a medical problem that we had a concrete

etiology on. But also it was the timing relation to the anthrax vaccine and the persistent dizziness that started raising some questions. And then we saw other people coming forward with this

timeframe event of the vaccine administration and illness and subsequent no concrete etiology for their illness.

Mr. TERRY. So there is, for these other three folks, there is some

medical record that will document an ailment or a symptom?

Lt. ROVET. Yes, sir, there is.

Mr. TERRY. All right. I was concerned when you said, or envisioned when you said that one in three is that three knew they

were symptomatic but refused to come forward for fear of some reprisals.

But what we are talking about is that one out of three is not

being associated with the vaccine.

Lt. ROVET. Right.

Mr. TERRY. I mean that only one of three is associated.

Lt. ROVET. No. There hasn’t been any conclusions drawn in that

area yet, but about the fear to come forward, there are some people

that have expressed it over the phone that they are afraid to come

forward.

Mr. TERRY. All right. So when you testified that there were 30

cases currently and about five or six in the pipeline——

Lt. ROVET. Yes, sir.

Mr. TERRY. First of all, how big of a field are we talking about?

Lt. ROVET. Well, I don’t have exact numbers.

Mr. TERRY. Is it 30 out of 300; 30 out of 60?

Lt. ROVET. Right now, out of 1,100 people, a little over 1,100 people at Dover who had been vaccinated, these are what we have

now, the number 30.

Mr. TERRY. All right. And then ballpark it based on your earlier

testimony there are probably about 90 folks that you think probably have symptoms associated with the vaccine.

Lt. ROVET. Yes, for me to make that leap right now, without scientific data, would probably be incorrect, but as a gut feeling——

Mr. TERRY. Anecdotal based on your experience though.

Lt. ROVET. Yes, sir.

Mr. TERRY. It is a fairly significant percentage.

Lt. ROVET. Yes it is, sir.

Mr. TERRY. Can I have just a couple more minutes?

Mr. SHAYS. Yes.

Mr. TERRY. Captain Piel, I want to start with you. We have

heard discussion about reprisal, and we have heard it really in two

different categories. One was, as Captain Richter and Lieutenant

Colonel Jensen pointed out, is that one reprisal for not taking the

vaccination is mandated resignation. But you hinted there may be

reprisals for simply even reporting or voicing concern that some of

your symptoms may be related to the vaccination.

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Can you tell me where you would feel that? How, if you could

kind of focus or pinpoint that for me.

Capt. PIEL. Yes, sir. First of all, I would like to say a lot of people

don’t come forward because they have seen what has happened to

the people that were ill and then it become know that it might be

possibly due to the vaccine. In other words, they have seen what

has become of me in the medical system and they realize——

Mr. TERRY. Called a malingerer, a liar, and those type of things.

Capt. PIEL. And it appears a dead end. So why risk your flying

status if you are just suffering some of the mild symptoms of joint

pain or you feel a little bit tired. Why should you go to the doctor

if you feel you can continue to operate airplanes? And that is why

people don’t come forward.

As for myself, this whole time period it really didn’t seem to matter what the doctor said because I thought it would just be a few

more weeks before I felt better. But it became apparent that these

comments were starting to erode my character. And I was not

being—sometimes I wasn’t being examined when I went into the

doctor’s office.

So that does not encourage one to go try to seek more help from

the same individuals that will not, that don’t seem to be helping

you in the first place. And they dealt with me as if they believed

in their office and then sometimes I would hear later that they

didn’t believe me.

But my commander and others believed me. And I think part of

the reason why it is easy for people to believe me in my squadron

because many people have felt mild symptoms.

Mr. TERRY. All right.

Sergeant, would you answer that same question: What type of reprisals from reporting, basis of your fears of reprisals, and also

from whom. And maybe your opinion of whether you think the reprisals are what I would classify as a malicious nature of trying

to—I don’t want to use the word cover-up because everybody likes

to use that conspiracy-minded terminology—but if you think it is

even related to minimizing the impact of side effects from this vaccination.

Sgt. SOSKA. Mr. Terry, I can only tell what I have been seeing

with my soldiers.

Mr. TERRY. All right. That is what we want to hear.

Sgt. SOSKA. A lot of the soldiers who are new to the military—

I am a career soldier; I have better benefits than they do—if soldiers that are getting married and coming in with family members

that have various obligations that they are just struggling to get

by to begin with—several of the people, many of the people that

went with me to Kuwait during Operation Southern Watch during

1996, we came back and we started cross-talking amongst each

other. I guess I was the worst of the group with my condition.

And others started taking notice to that. I have told many, you

need to go, you need to get it checked out, you need to do this, you

need to do that. Many have listened, many have not.

Many are afraid to come forward, and I kind of feel like the guy

being pushed out the door with the door slam shut behind me right

now. But, you know, this is me and that is them. I can only do

what I feel is right.

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Several of the soldiers have—I can tell you for a fact there has

been a survey on the web trying to characterize systemic reactions,

fibromyalgia and stuff like that they have filled out. And others flat

refuse because they are afraid that if they do say something or if

their name is used, that it is going to have an impact on their career.

Now, what goes on in their head, I have no idea. But they are

afraid to come forward, if that answers the question, sir.

Mr. TERRY. Well, it does. I think the fear is probably real, but

part of our job up here is to determine if that is a personal opinion

or whether that is a problem in the military. Unfortunately, that

may be as tough to decipher as it is scientifically to link these

symptoms back to the vaccination.

Appreciate the opportunity, Mr. Chairman.

Mr. SHAYS. Thank you. Mr. Tierney.

Mr. TIERNEY. Thank you, Mr. Chairman.

Mr. Chairman, I want to thank you for having these hearings.

They are obviously important, and hopefully we will be able to

come to some resolve that will address these issues.

Captain Piel, I wanted to ask you, were there any pre-existing

conditions that your doctor suspected you might have had or discussed with you before the vaccination was given?

Capt. PIEL. No, there weren’t any.

Mr. TIERNEY. And was there any talk amongst your medical people afterwards that they thought perhaps they had overlooked

some, or any conversation about that?

Capt. PIEL. No, there hasn’t been any conversation about that to

my knowledge.

Mr. TIERNEY. You indicated that you got good support from your

chain of command but you felt you didn’t get good support from the

medical people that you went to. And how does that work on your

base? Where do the medical people fall in that chain of command?

Capt. PIEL. Well, they fall outside of—they have their own chain

of command on the base. So they don’t report to my boss, and he

doesn’t have anything to do with the medical group either.

Mr. TIERNEY. And that is true all the way to the top of the nonmedical people at your base?

Capt. PIEL. Well, I am not sure. I think the medical group falls

underneath the wing commander, but other than that, there is

nothing—that’s where it meets, that’s where the operational side

meets the medical side.

Mr. TIERNEY. Now your wing commander has been supportive?

Capt. PIEL. Yes, sir, he has, and he has been trying to help me

get the right medical treatment.

Mr. TIERNEY. And Lieutenant, with respect to your wing commander and his involvement with the medical people on base, have

you witnessed any interaction between them, any action by the

wing commander to try and address this issue with the medical

people?

Lt. ROVET. He has shown significant interest, sir, in the health

and welfare of his wing, as should be. A man of amazing core values and personal fortitude and strength. Just wish you could clone

him. But he has—yes he has been very involved with my medical

group commander and my squadron commander, who both are very

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wonderful people also who I know have been putting in long nights,

sleepless nights, over this program.

And just like to make a statement concerning our medical program at Dover. Originally, we had some bugs to work out with the

adverse reaction reporting. There was—it just came so fast and furious, the reactions and what not. And we may have not handled

things appropriately in the beginning. And as humans, we learn

our lesson. But I do believe that under the leadership of Colonel

Greider and Colonel Buck and Colonel Luna and down through the

AMDS squadron where I work, including public health, we have a

pretty good system now. And we have identified some of the short

falls, and we will be aggressively, I can assure you, pursuing a cogent reporting that can be very valuable to not only our service

men but to our country at large.

Mr. TIERNEY. Would you be a little more specific about what has

changed with this vaccine program on your base. Originally there

was a high threshold. What I mean by high threshold, when patients were to come in, they would be—there was that reticence in

the beginning that I was talking about. The threshold, a doctor

would be viewed as a filter. The doctor would say, if they would

go ahead and check the box up in the right-hand corner—I forget

the box on the VAERS form—that would be a provider saying, my

gosh, you know, that is a bona fide reaction; I kind of believe this.

So that would lend validity to the report.

To date, no provider has ever signed a VAERS form or checked

the box off.

OK.

Mr. TIERNEY. That hasn’t changed? That continues to be the

case?

Lt. ROVET. That continues, but what we have now is lowering of

the threshold when more people come forward. And I think, and I

am not an epidemiologist, sir, but I think that will statistically

even out the more reports that we get coming forward if we can

start—the researchers at Brooks Air Force Base, at the FDA, at

Walter Reed—that’s a problem in itself, it is so spread out. Bureaucracies have a tendency to do that, I guess.

Mr. TIERNEY. So I hear.

Lt. ROVET. But what I think what we are going to do is see it

work its way out in the end. The more data we get, we’ll let the

numbers just work themselves out. So it is changing. It is a lower

threshold, and the medical group at Dover now is right on it.

Mr. TIERNEY. Well, Captain Piel, do you think somebody in your

circumstance would be treated better today than you were treated?

Capt. PIEL. I definitely hope so, sir. I would suspect that they

would be treated better after everything that has happened. Things

have changed.

Mr. TIERNEY. Do you think they have made some positive adjustments as a result of your situation and others.

Capt. PIEL. I think that they are working on it.

Mr. TIERNEY. With room to go?

Capt. PIEL. It is a very difficult problem, and it is not something

you can just solve or correct overnight.

Mr. TIERNEY. What might you suggest that could be done on your

base that would make it easier for somebody in your circumstance?

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Going back to the beginning of your circumstance, what would have

made your experience——

Capt. PIEL. Well, I think if my case had been forwarded to Walter Reed sooner, that definitely would have helped because Dover

doesn’t have a lot of doctors. We have a pretty small clinic. It is

not necessarily one of your large medical centers where they can

deal with all different types of problems. There aren’t specialists

that you can go see. You get farmed out to everyone else.

So if I had been forwarded to the immunology clinics at Walter

Reed sooner, that would have helped. You know, in the process, I

kept getting referrals to ear-nose-throat doctors, and they can take

care of my ear, but they can’t take a look at my whole body.

Mr. TIERNEY. OK. Thank you. Sergeant Soska, do you have a

feeling that there is a difference at your base also between the way

the medical professionals treated individuals and the way that the

chain of command did?

Mr. TIERNEY. Mr. Tierney, I can tell you from a personal standpoint that and what I have went through for the last year and the

acceptance by both the division surgeons, both the outgoing and the

incoming, have been, they have been there for me. In talking with

Lieutenant Colonel Carrigan, who is our new division surgeon, 3

hours on 2 separate days, took an active interest in my situation

after speaking out before the Anthrax-Persian Gulf Illness Outreach program meeting we had there.

They took an active role in it. I would like to comment on similar

problems she had where it took so long to get to the right areas.

It was here, go here, and there was always a long wait in between.

Yes, the doctors were trying. They didn’t have the answers. But

it is just the way the system is set up, sir.

I feel that in my situation and in talking with Lieutenant Colonel Carrigan, who apparently was a member of that hundred-doctor meeting in Fort Detrick, my indication I got after talking to

him was that I think they realized there is a situation here and

they are trying to make an effort to just see how big it is.

I can’t say anything negative on that aspect about them. I think

there is genuine concern within the ranks and the leaders themselves. They are seeing this happening more and more. And just

like myself—and I may add, the comments I make here are mine,

I am just saying what is happening to me and what I have witnessed. And that is the impression I have been given, sir.

Mr. TIERNEY. Thank you. Lieutenant Colonel Jensen, you have

some particular problems in your division, I assume, because of the

Guard, those units having a different access to medical attention

than others do. Do you want to talk a little bit about that?

Col. JENSEN. If I understand you correctly, sir, our access to medical care basically the shot in the Guard—my unit has not received

the shot yet. We are not due to receive it until May 2000; however,

due to operational commitments, I believe we have approximately

100 individuals who have received the shot, or the series.

In the Guard as in the Reserves, you are placed on active duty

for the shot. And that is for, my understand is I am told, a medical

requirement so if something happens to you, you can come back

and provide you. It also has the opportunity, obviously, if you are

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on an active duty status, then you can be given a direct order

should you choose to refuse the vaccine.

For instance, if somebody were to have a reaction the next day,

if they were a traditional Guardsman or civil service employee such

as myself, primarily I would have to go and seek medical care

through the civilian community and/or come back to the military

community and attempt to file what they call a line-of-duty statement in which—and that would only be filed if the, as I understand

it, if the medical community deemed that the vaccine was causal

to the condition.

The line-of-duty statement is filed if you have a loss of duty. For

instance, a hypothetical situation, or I will give you a real case situation, if I may.

We have an individual that was in that series shot and he was

on active duty, placed on orders, I believe, or on a Reserve active

duty status, RUTA as they call it, and the next day he took 24

hours of sick leave. He is a fireman and he is on a 24-hour schedule out of his own sick-leave time due to flu-like symptoms that he

placed on his sick leave form as caused by the anthrax vaccine.

He did not seek medical attention. OK? And as such, basically

he ended up taking 24 hours of sick leave. An important note here,

I believe, is that even if he followed the line of duty status on that,

the way I am told by my finance officer is he would not be reimbursed for the sick-leave time. He is only reimbursed if he physically or she physically has a loss of pay.

So if you have sick leave, you haven’t lost any pay.

Does that answer your question, sir?

Mr. TIERNEY. Yes. Captain Richter, does—secondarily to obviously the medical implications of all this, the individuals, it is disturbing to hear about the loss of trust that you talk about in the—

I’d like to hear your ideas of how that trust might be restored in

this instance.

Capt. RICHTER. Well, at this point I don’t know. That is a hard

question to answer. I don’t know if the trust can be restored. The

obvious thing would be at least, first of all, come out and say there

is a problem. Acknowledgement would be 99 percent of it. Continuous denial that these symptoms are from some other cause is not

helping matters. Like I mentioned, Colonel Greider, our wing commander, went and stopped all the vaccinations for a period of time

until he could address the situation, find out what was going on,

try to allay everybody’s fears, and get it rolling again.

I don’t know what the outcome of that—again, I am just a reservist. So I am there only part time, unlike my counterparts who

are there all the time—active duty. But I got a feeling he was

called down to Washington and called on the carpet because shortly

thereafter Lieutenant General Roadman came up and said: Hey,

take the vaccine. There is no problem with it. The percentages of

people having problems is minuscule. These are your marching orders.

So I think just an admission that well, maybe there are more

than just a few people having these problems would help. I mean,

that would start the ball rolling to be sure.

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Mr. TIERNEY. Thank you. I just want to echo the chairman’s

words that all of you show great courage coming forward here

today. And patriotism doesn’t always take place on the battlefield.

I want to thank you for your courage.

Mr. SHAYS. Congresswoman Schakowsky.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. And I too want to

thank you for your personal courage in coming forward and all the

things that led up to today, and also express my concern regardless

of what one thinks about the vaccine that it takes so much courage

just to speak out on these issues.

I have a number of questions. I wanted, Captain Piel, to note

that in testimony that I don’t believe that you read, that you were

told by some doctors things, comments such as, you’re depressed;

maybe you just want to have babies; called a malingerer; perhaps

you need counseling.

These clearly are very demeaning kinds of things and would contribute to your feeling of not being believed for sure, but you also

say that you still don’t have—even now, I still don’t have a waiver.

Can you tell me about waivers? How does one get one? What do

you mean by a waiver?

Capt. PIEL. Well, a waiver, what I mean is to get a waiver from

further anthrax immunizations.

Ms. SCHAKOWSKY. And how does that happen?

Capt. PIEL. I have no idea exactly the process for that.

Ms. SCHAKOWSKY. There is such a thing though? Can anyone answer that?

Capt. PIEL. Well, that is just under the guise that there are waivers for everything. [Laughter.]

Ms. SCHAKOWSKY. Oh, OK. Can any of you testify to that?

Capt. RICHTER. I can comment on that. I am on a medical waiver

right now. It is just a temporary one, but I am on a temporary

medical waiver, and I do not have to take the next injection until

they figure out the results of my first visit. I am now scheduled to

see a rheumatoid arthritic doctor at Bethesda next month. So I

have a waiver that will take me through August, until I go see him

and he discusses what my problem is.

Ms. SCHAKOWSKY. And while on waiver, are you allowed to carry

out your other duties. For example, would Captain Piel be able to

fly?

Lt. ROVET. Ma’am, I really think I could answer this one cause

it is in my department where we work.

Ms. SCHAKOWSKY. Take your time.

Lt. ROVET. Excuse me, Captain Richter, I didn’t mean——

Capt. RICHTER. Go for it.

Lt. ROVET. What a waiver actually is, is more than just a verbal

granting of like a person has a doctor’s note that says you can’t fly.

It has to be sent up headquarters and has to be evaluated and

blessed and filter back down.

What they are looking at right now, and this is again my perspective. It is not policy, but I think this is going to be a logistical

problem and a personnel problem that is going to crop up here

shortly. So we need to be pro-active on this issue.

If individuals are seen and evaluated, and again the key word is

evaluated—who is going to be the actual medical body that is going

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to evaluate and say this individual cannot receive the vaccine?

What they do is they put on the profile. At that point, it is an official profile. And then they get given a medical board.

What they are looking at doing is giving these people a C code,

waiver C code, which means they can continue out their duties and

fly, but they won’t be able to go into Southwest Asia or Korea,

areas where high threat of bio-attack or chemical attack. That is

going to present its own nightmares.

Just a scenario, if a pilot’s air crew member is in Mildenhall,

England, and that’s OK. He can fly there. Then they get a tasking

to say go down range to Southwest Asia—there is going to have to

be a centralized tracking system of which pilots are on C codes. So

they will have to bump that air crew member, put on somebody

that can fly down there, who has the anthrax vaccine, to complete

the mission.

This is going to present some problems.

Ms. SCHAKOWSKY. But I did want to establish that there is some

kind of individual waiver policy that could exempt certain people

currently.

Lt. ROVET. Not right now in the Air Force. And, again, that is

just my opinion. But we are still looking for answers on that,

ma’am.

Ms. SCHAKOWSKY. OK. We’ll try and establish that.

I wanted, Sergeant Soska, to ask you, you testified the procedures are not being followed as spelled out in AVIP documents.

What did you mean?

Sgt. SOSKA. Well, ma’am, in my written testimony, on January

27th I was given an MGC meningococcal, I believe is the name of

it. This was after—I was graciously overlooked; my chain of command knew I was having problems after the first three shots that

I received. When I went down there for that, I explained to the

NCOIC in charge that hey, I am under B–12 replacement shots.

For some reason my system will not retain B–12.

And she concluded that, yes, it would be a bad time to do it. But

I did have to get what I call the MGC or meningococcal shot.

Up to this point I was having problems all along in my testimony, but after I got that vaccination, on the 29th, went to PT, I

did my normal profile PT thing, went home from work, had two

cups of coffee, was coming back into work, and started feeling

rough. After formation, I managed to get to the troop medical clinic, which is right next door.

I remember being escorted back to the treatment room, and then

I don’t remember much after that cause I was out of it. I totally

locked up. I didn’t know what happened. I was out.

And, my understanding, I was reading some of the AVIP documents and what else, and I don’t fault the doctors. I think they are

outstanding doctors that have been taking care of me. I just think

there is a lot of areas that, you know, we’re not, we don’t do all

the time or we don’t practice all the time. And some of the stuff

is falling through the cracks.

But it is in my medical records, but how come it wasn’t reported.

It wasn’t until later that I spoke up in the Persian Gulf Illness

meetings that, you know, the attention—my attention got to the division surgeon, and they started really looking into it.

66

So, forgive me if I ramble, I have problems staying on track some

times.

That’s what I say, it’s really not being reported like it should.

Others that have been with me, have been to Southwest Asia and

that have came back, are having similar problems. And I reiterate,

they are afraid to say something.

But, you know, the problem, the problem is there.

Ms. SCHAKOWSKY. Captain Richter, you said in your testimony,

‘‘The threat of being exposed to—the doctor went on to say that the

threat of being exposed to anthrax while in deployment outweighed

the possible negative reactions that some military personnel might

have to the vaccination’’ and that it was not a matter of if but

when some of our troops would come in contact with it.

So I want to get to the issue of threat versus the risk of the vaccine and wonder what your feeling is that if the threat is so great

and if 99 percent of those who inhale anthrax spores would die,

which seems to be the science there, then at what level do you feel

the risk is acceptable? I mean, how serious—if the threat is so

great, at what point should the Department of Defense say, well,

this is what we have to do?

Capt. RICHTER. I don’t know if I am qualified to answer that

really. For me, I can only speak for myself, I go in, I drill once a

month, I maybe take a trip down to the Middle East. I have another job. I am an airline pilot out in the commercial sector as well.

My health is my life, and the odds that I am going to go down

range to the Middle East somewhere and get exposed to anthrax,

I think, is probably pretty minute. If I was called on active duty,

it would be a different story, but, having said that, my—at this

point I just can’t afford to gamble because I have to feed myself

with mostly my outside endeavors, my outside job.

I think what he was trying to really lay out was the policy of the

DOD. I don’t think that was really his opinion. When I was discussing this with him, we were kind of in a continuous tail chase.

I kept telling him, well, if I feel this bad and I pretty darn sure

it came from the anthrax, then what is the point in me taking another one if ultimately I am not going to be any good to the military if I am not functional.

And that is when he was saying, you know, that a few people

may have a negative reaction; however, overall, we need to protect

the troops en masse, and that risk is worth taking, to vaccinate everybody with the expense of a few.

Ms. SCHAKOWSKY. Well, maybe part of the answer then is in my

next question to Lieutenant Colonel, maybe you can answer it. You

said in your testimony, you would welcome a safe and effective vaccine. I don’t know if we are all in agreement here that that is an

important goal. I would think that we are, that there is a real

threat.

I had a wonderful briefing yesterday that convinced me that

there is enough reason to think that we need to find a vaccine.

Are you saying that we need to do more to develop a safe vaccine?

Col. JENSEN. Based upon what I have heard, what people have

told me, the anecdotal evidence, I think there is a tremendous concern out there that the safety of the vaccine may not entirely be

67

what it was made out to be. You talk about what is the risk. We

are in a timeframe of dwindling budgets, where we are constantly

told that we are going to have to do more with less.

If you take Dover, for example, if the numbers, if I remember

correctly in testimony here today, you have about 1,000 people that

were vaccinated there. And out of those folks, you have got six, is

my understanding, that are still permanently denef, some over 6

months after taking the vaccine. The cause is still unknown.

You have got 30 people that are potentially being worked up at

Walter Reed. You heard testimony that related to the potentially

three times those folks that are out there are having similar reactions but are not reporting them for a variety of reasons.

That creates a far greater concern too that whether it is caused

by the anthrax vaccine or not, I have individuals out there that are

not being provided proper medical treatment, and therefore we may

have a false sense of security as their ability to perform their job,

thinking that they are 100 percent capable when, in fact, they are

not.

You heard the numbers cited for those that are leaving the Reserve squadron, let alone. So you may have, you know, if you take

the threefold, you may have upwards of 100 people or 10 to 12 to

potentially 15 percent of your combat force which may not be ready

to enter or perform the mission that we are assuming they are capable of.

And you have not even entered a theater yet before you can be

exposed to the vaccine—excuse me, exposed to the threat of the

weapon.

Ms. SCHAKOWSKY. So on the question of readiness, we need to be

concerned about the effect of the vaccine itself?

Col. JENSEN. Yes, ma’am, I think it is the classic risk-management or risk-analysis that has been preached by the Army program

that was developed and the Air Force has adopted, is truly look at

what are the cause and effects across the board in that fashion.

Ms. SCHAKOWSKY. Thank you very much.

Mr. SHAYS. We have a system where, in the United States, as a

force protection we require, at least in phase one, for our military

personnel to take the anthrax vaccine for those who are in areas

that may require them to be protected. And then there is a question of whether we go to phase two, which would be the military

personnel who aren’t directly anticipated to go into areas where

they might even be exposed.

We have another country, Great Britain, that has decided to use

the vaccine and made it voluntary. And we have the French who

looked at the vaccine and decided that this would be a mistake, at

least so far.

And, I am struck by a lot of feelings as I listen to you all make

your testimony, and I heard the excellent questions and responses

to those questions, the questions asked by my colleagues.

And I am also reacting to the varied circumstances each of you

have. Captain Piel, you are in the active duty. You aren’t a reservist; you are not in the National Guard; you don’t work for a commercial airline. But you are a pilot.

Capt. PIEL. That is correct.

Mr. SHAYS. And my understanding is you fly C–5’s?

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Capt. PIEL. That is also correct.

Mr. SHAYS. Yes. And someday, when you are out of the military,

there is the potential that you might continue to fly. Is that also

a possibility?

Capt. PIEL. Sir, I was hoping to fly the rest of my life.

Mr. SHAYS. Yes. Sometimes, not often, but sometimes we have

had witnesses come before us, say with the Gulf war illnesses, and

you heard very important stories. But you kind of doubted—sometimes I am just saying to myself, I didn’t, I wasn’t fully convinced

of every witness that came before us when it dealt with the Gulf

war illness.

So I believed the vast majority of them. And that is why this

committee moved forward.

But there is not a scintilla of doubt in my mind about the testimony I have heard from you and others. You want to fly. So you

don’t want to be sick, and yet your illness was at a point where

you must have made a determination that you might endanger the

command of your plane. So you stepped forward.

There are others who might be on the margin, who, if they could

have the faith that they would be treated with respect, would step

forward. And if they doubted—even if that doubt isn’t, if it’s a

doubt that they believe, even if it is not justified, the doubt would

lead them not to do what action they should take.

You did the right thing. You weren’t well and you came forward.

And now you are paying for it big-time.

Others saw that, and they are going to say, I am going to do

whatever I can to avoid coming forward.

So first and foremost, I just want to say, I really accept the fact

that you are dealing with some heart-wrenching concerns.

Captain Richter, I will say to you, if I was a commercial pilot,

besides being a Reserve pilot, there is no doubt in my mind. I

wouldn’t take the chance. And that doesn’t pre-judge how ultimately this committee is going to decide.

We have had three hearings. This is the fourth now. And we

don’t know ultimately what we are going to recommend, but we are

going to be recommending some course action of the committee

itself.

But I have to tell you, I would do the same thing you are doing.

I would not jeopardize for a minute that source of income that provides you the opportunity to support your family.

And so it raises a lot of questions for this committee. Do we suggest that this program be totally discontinued? We have one source

provider. We have old technology. Another is, do we suggest to be

voluntary? Another is, do we suggest that if you are going to do

phase one, you do it for the people who are clearly going to be in

the theater, but others you are not going to phase two.

We are wondering why it is all right for the military to deploy

you in an area of concern, in a theater of concern, after beginning

the first shot—you can now be deployed. So the military is given

the option that they can send you into harm’s way, but you don’t

have the ability to say ‘‘no’’ to the shot.

You are not given that other option.

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It would be interesting to know, and we will ask our next panel,

are you given the option since the military says you need six shots

that you should not be deployed until you get six shots.

Another question that is raised is, what kind—how are they

treating people who, military personnel who have had the first shot

and have reacted negatively to it. Shouldn’t that give you additional rights to say ‘‘no.’’

So a lot of questions are being raised. And it is also a fact that

you have been very respectful of your command. All of you have.

And the problem we have is knowing how far we push you without

putting you in a different kind of harm’s way. Because no one could

listen to anything you have testified and say you haven’t—in a

sense, we are a command too. And we asked you to be here and

you accepted our request.

And, but you all have been very respectful.

It fascinates me, Mr. Rovet, that you have, you are not, you a

medical personnel. You are in that area. And so you are stepping

forward. Have you been asked to take this vaccine?

Lt. ROVET. No, sir.

Mr. SHAYS. So you are stepping forward because of what you

know, and if you didn’t step forward and things happened in the

future, you would have to live with that the rest of your life.

Lt. ROVET. Yes, sir.

Mr. SHAYS. So, we appreciate you stepping forward for that reason, among others.

So we have someone in active duty; we have someone who has

a medical background and has seen how it is operating and it’s not

a pretty story. Sergeant, we appreciate your testimony as well.

We have two pilots. What fascinates me is, in the area where I

have the most conviction that if I spent a good chunk of my life

learning to become a pilot, I would do nothing to jeopardize my not

continuing to fly. And yet we have in the National Guard and Reserves, we have a plethora of talented, capable people who are saying, I am not going to take this vaccine; I am leaving.

And I have to believe that leaving—that you enjoy, Captain Richter, and I will just—tell me the difference: You are serving your

country, that is clear, but do you meet all your flying—tell me the

difference of being in the Reserve and being a commercial pilot.

Capt. RICHTER. Well, first and foremost, it isn’t as much fun.

Mr. SHAYS. Which way?

Capt. RICHTER. Being in a military pilot is probably more fun

than being a commercial pilot. I guess the most gut-wrenching

thing I have had to face, that while I saw myself continuing to

serve in the next 8 years, I am being forced into a position where

I take this shot and perhaps my condition will get worse, perhaps

it won’t. I don’t know.

But it is that fear of the unknown that will not only affect my

military flying, but it will also affect my commercial flying. Everybody needs to be healthy to do their job. We, as pilots, need to be

100 percent healthy to do our jobs. And if there is any question or

any doubt about what something is going to do to you, at least——

Mr. SHAYS. What do you fly as a commercial pilot?

Capt. RICHTER. I am a prop pilot out of Dulles. I fly for Atlantic

Coast Airlines.

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Mr. SHAYS. And in the military you fly?

Capt. RICHTER. C–5 as well.

Mr. SHAYS. Lieutenant Colonel Jensen, what do you fly?

Col. JENSEN. I fly F–16’s, sir. I am an instructor-pilot with nearly

2,000 hours in the F–16.

Mr. SHAYS. OK. The bottom line to both of your testimonies is

we are losing a lot of good pilots. Is that not correct?

Col. JENSEN. That’s correct.

Capt. RICHTER. That’s affirmative. A lot of them.

Mr. SHAYS. Yes. OK.

Capt. RICHTER. They just can’t afford to take the gamble. And

most of them can afford to give this job up, as much as they don’t

want to. Because it is, like I as I said, it’s a good, fun thing to do

to be still serving your country.

Mr. SHAYS. I am going to have—the counsel is going to ask a

question that Mr. Souder wanted to ask, but beforehand I just, I

am going to do two things. One, I read again Mr. Jensen—Colonel

Jensen—what you read. This is a memorandum of decision, and it

deals with the authority under Public Act 85–804 to include an indemnification clause in the contract.

And I am just going to read it again, and I am just going to think

of what people think who are being asked to take this shot: The

obligation assumed by MBPI under this contract involves unusual

hazardous risks associated with the potential for adverse reactions

in some recipients and the possibility that the desired

immunological effect will not be obtained by all recipients.

Which, that in a sense means, the whole clause means it may

hurt you and harm you, and in the end, it may not even work. And

the company is being indemnified.

I understand why, but I can understand the concern when you

read that.

Now, I will end my part by just asking if any of you would like

to make a closing statement, because really you answered the questions. I was able to get more into a monolog because you really answered the questions of my colleagues.

Would any of you like to make a closing comment?

Captain Piel.

Capt. PIEL. Yes, sir. There is one thing I would like to say. I understand that we can make decisions based on acceptable risks;

however, I feel that we need to know exactly what those risks are.

And the VAERS system doesn’t seem to be adequately providing information.

And that is all I wanted to say.

Mr. SHAYS. Thank you. Lieutenant.

Lt. ROVET. Mr. Chairman, I would like to echo that. Informed

consent is based upon having information up front. I know there

may be some legalities that military may not need informed consent. I am not quite aware of that. But I think if this comes to light

that the reaction rates are much higher, and now the rhetoric is

changing to the risk outweighs—I mean the benefit outweighs the

risk, we are opening up a moral pandora’s box that is worse than

any dusting with anthrax vaccine.

Mr. SHAYS. OK. Sergeant Soska.

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Sgt. SOSKA. Congressman Shays, on a personal note. My son told

me about 4 or 5 months ago—excuse me if I get a little emotional

on this one—he says, dad, mom told us to pray about you. And I

asked him, why. He says, because she sees you getting sick and it

worries her. That hit home, sir.

It is not just about me. This is affecting a lot of people that are

having problems. And I encourage all soldiers in all branches, and

as a mentor, my command sergeant major said to me, sergeant,

don’t put yourself in a position where things can be misconstrued.

They are having problems, and they are not getting the help they

need, they need to bring it to the chain of command. The only thing

you can do is advise them what to do, nothing more, nothing less.

And I thank him for that.

That is all I have to say, sir.

Mr. SHAYS. Thank you, Sergeant. Captain Richter.

Capt. RICHTER. I think I have said enough, sir. I have nothing

else to add.

Mr. SHAYS. Thank you. You have been very helpful.

Colonel Jensen.

Col. JENSEN. Sir, if I may take a moment to address the question

that was posed about risk and benefit?

Mr. SHAYS. OK.

Col. JENSEN. I think one of the things when you get into that

risk versus benefit analysis is a true analysis of the efficacy of the

vaccine. And for that, I would offer this as an area to explore.

On the DOD anthrax web page, they talk about the vaccine efficacy, excuse me, has been tested against numerous anthrax strains

in animal models. They talk about the guinea pig and the mice are

poor animal models for anthrax vaccine testing. However, they consider the rabbit to be a more appropriate one, and the monkeys are

considered the best. Yet I see nothing in documentation that

equates that to the studies that say, this is why these are better

models.

For example, yet mice are labeled to be poor, numerous guinea

pigs and mices have been tested and their reaction rates or survival rates can range anywhere from 10 to 90 percent. The rabbits

I am unaware of what the rates are, but I am told they are extremely good survival rates.

The few monkeys that have been tested have a very high rate.

Is the reason that the monkey and the rabbit are being viewed as

the more appropriate models because they appear to survive the

vaccine better? Or is there an actual study to support that?

And on an interesting side note, the guinea pigs and the mice

that are considered poor animal models for this exposure against

inhalation anthrax, the mice have been used extensively by the Air

Force with regards to the Air Force Office of Scientific Research,

the folks that are doing the inhalation studies right now, and have

been for the last 4 to 5 years out of the University of Arizona under

Air Force contract.

They have been using mice extensively to examine the respiratory effects that inhalation of jet fuel, in particular JP–8, have.

And they use that as the model to compare to human studies. Mice

are also used extensively, I am told, in cancer research because of

the ability to—or their life expectancy is so short they can see that.

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Guinea pigs, they state again, are poor animal models, and yet

my understanding is the guinea pig is used pretty much exclusively

to test the potency or the efficacy of the vaccine before the lot is

released.

So, you know, I kind of sit here and beg the question. OK, in

some cases, why is it good here, why is it not good there? And just

looking for the published studies that indicate, because I have also

seen other folks or heard statements by folks out of the medical

field that question truly what is the, you know, have the models

been actually made.

Mr. SHAYS. I’m beginning to think I should hire you as one of our

staff members. [Laughter.]

Col. JENSEN. Do you have F–16’s that I can fly here, sir. [Laughter.]

Mr. SHAYS. OK. Well, I am just going to say one last point, and

that is that there is something we can do before our report, and

that is that we can encourage the military to make sure, in their

chain of command, they encourage proper reporting and don’t discourage people to step forward.

We can do that.

And I believe that would be something that we could have some

positive result on. And that would be something we can do now.

Thank you very much. Been wonderful witnesses. Appreciate you

being here.

We will get to the next panel.

Our next panel is comprised of Kwai Chan, Director of Special

Studies and Evaluation Group, National Security and International

Affairs Division, U.S. General Accounting Office, accompanied by

Dr. Sushil K. Sharma, Assistant Director from the same division.

Our second testimony will be from Major General Roger

Claypool, Deputy Assistant Secretary for Health Operation Policy,

U.S. Department of Defense, accompanied by Rear Admiral Michael Cowan, Deputy Director for Medical Readiness, Joint Staff,

U.S. Department of Defense; Colonel Frederick Gerber, Director of

Health Care Operations, Office of the Army Surgeon General, and

Colonel Renata Engler, chief, Allergy and Immunology Service,

Walter Reed Army Medical Center.

And our third testimony is from Susan Ellenberg, Director of the

Division of Biostatistics and Epidemiology, Center for Biologics

Evaluation and Research, Food and Drug Administration, commonly referred to as FDA.

I want to make sure we have enough seats there and that everyone is comfortable. There will be one or two others who——

[Pause.]

Mr. SHAYS. Everybody I called, are they represented up here. Is

there anyone who is not sitting at the front desk.

OK. Whoever isn’t at the front desk but will potentially be asked

to come forward, I will be asking them to step forward.

Do we have enough room there?

Yes. OK.

Are we OK, Jason?

OK. Is there anyone who is up who was not called but will be

potential witnesses so we have their name to give——

OK. Could you state your name please?

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Dr. BRAUN. Dr. Miles Braun.

Mr. SHAYS. Doctor, I am going to have you, just so the recorder

can get it—do you have a card? Did you give your card to the reporter?

Dr. BRAUN. Yes.

Mr. SHAYS. Just state your name again, sir.

Dr. BRAUN. Miles Braun.

Mr. SHAYS. Dr. Miles Braun, thank you very much.

If I could, I would invite you all to stand.

If you would raise your right arms, please.

[Witnesses sworn.]

Mr. SHAYS. Thank you.

I am going to state one bit of prejudice first and then invite the

testimony. And that is, I think the thing that causes me the greatest concern and can make you a bit annoyed is the thought that

our soldiers and other military personnel, our pilots, our airmen,

and so on, our Navy personnel, Marines, would feel in any way intimidated from stepping forward if they thought they had an adverse effect.

And I am just going to go under the assumption that that would

trouble you as much, any of those of you—and that from a military

standpoint that this will be something that you will make clear

would not be treated well if you thought that any in the chain of

command were a part of that, and that just as you might be, challenge someone who think they have an adverse effect and you

think they have not done it in a proper way, you would be just, if

not harder on those who would make someone feel intimidated to

step forward.

I do welcome this panel. It is an excellent panel. And we will

start with you, Mr. Chan, and we will then go to you, Major General Claypool, and we will then go to you, Susan Ellenberg.

Is it Doctor, am I? I am sorry.

Usually my staff corrects me. And I just have this feeling you

must be a doctor. So you can give me that check.

OK. Let’s start.

Thank you, Mr. Chan.

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STATEMENTS OF KWAI-CHEUNG CHAN, DIRECTOR, SPECIAL

STUDIES AND EVALUATION GROUP, NATONAL SECURITY

AND INTERNATIONAL AFFAIRS DIVISION, U.S. GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY SUSHIL K. SHARMA,

ASSISTANT DIRECTOR, SPECIAL STUDIES AND EVALUATION

GROUP, NATIONAL SECURITY AND INTERNATIONAL AFFAIRS DIVISION, U.S. GENERAL ACCOUNTING OFFICE;

MAJOR GENERAL ROBERT CLAYPOOL, DEPUTY ASSISTANT

SECRETARY FOR HEALTH OPERATIONS POLICY, U.S. DEPARTMENT OF DEFENSE, ACCOMPANIED BY REAR ADMIRAL

MICHAEL COWAN, DEPUTY DIRECTOR FOR MEDICAL READINESS, JOINT STAFF, U.S. DEPARTMENT OF DEFENSE; COLONEL FREDERICK GERBER, DIRECTOR, HEALTH CARE OPERATIONS, OFFICE OF THE ARMY SURGEON GENERAL, U.S. DEPARTMENT OF DEFENSE; COLONEL RENATA ENGLER,

CHIEF, ALLERGY-IMMUNOLOGY SERVICE, WALTER REED

ARMY MEDICAL HOSPITAL; AND SUSAN ELLENBERG, DIRECTOR, DIVISION OF BIOSTATISTICS AND EPIDEMIOLOGY,

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH,

FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY DR.

MILES BRAUN

Mr. CHAN. Thank you, Mr. Chairman.

Mr. Chairman and members of the subcommittee, it is indeed my

pleasure to be here today to share the results of our work on the

anthrax vaccine. And may I also introduce my colleague, Dr.

Sharma, and my staff in the back of me, Dr. Howard DeShong, who

helped me with this work.

As you know, many questions have been raised about the Department of Defense anthrax immunology program. We have previously

reported to you a number of concerns regarding the safety and efficacy of the vaccine. Today, I will present our findings on four

issues.

First, the extent to which data support the need for six initial

shots and annual booster for the anthrax vaccine. Second, the relationship of—the relative merits and weaknesses of passive surveillance system for monitoring adverse events. Third, available data

on differences on adverse reaction rates between men and women.

Finally, the disadvantages of the current vaccine and the status of

Federal efforts to develop an improved anthrax vaccine.

With regard to the first question, what is the support for the current regimen of six-dose schedule and an annual booster shot? We

found that the current six-dose schedule was arbitrarily determined. No studies have been done to determine the optimum number of shots required. And although annual boosters are required,

the need for this frequency and amount of the booster dose have

not been evaluated.

Second, with regards to what are the relative merits and weaknesses of passive surveillance systems? That is the VAERS system

that you have heard about, which DOD used to determine the rate

of adverse events. We found that this system has several advantages as well as disadvantages.

The advantages: It alerts FDA and CDC to previously unreported

or unexpected increases in reported adverse events. It is also a relVerDate 11-MAY-2000 12:43 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00078 Fmt 6633 Sfmt 6633 C:\DOCS\65673.TXT HGOVREF1 PsN: HGOVREF1
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atively affordable way to supplement the data collected on vaccines

before they are licensed.

However, there are several disadvantages. Studies show that adverse events are often under-reported in a passive surveillance system. A former FDA Commissioner acknowledged that under-reporting of adverse events in such systems and cited one study showing

that, ‘‘Only about 1 percent of serious events,’’ are attributable to

drug reaction reported to FDA. That means 99 percent are not reported.

Also, outcomes with delayed onset after vaccination are outcomes

not generally recognized to be associated with vaccination are often

under-reported.

There is no mechanism within VAERS for a 1-, 3-, or 10-year followup to evaluate vaccine reactions that have a long latency period.

The limitations of VAERS suggest it is not a valid source for assessing the rate of adverse events.

With regards to the third question, on gender differences, we

identify three DOD efforts which examine gender difference with

regards to adverse events. Data from these efforts show that

women reported twice the rate of adverse reaction than men for

both local, for example swelling, and systemic reactions, for example malaise and chills. And we observed some reactions—these reaction rates to increase with each successive shot.

In addition, a high proportion of women than men reported making an outpatient medical visit after a vaccination, and more than

twice the percentage of women reported that they missed one or

more duty shifts after their vaccinations than men.

Finally, with regards to your fourth question, we found that the

current vaccine has several disadvantages. It is an impure mixture

of bacterial products using outdated technology. The amount of protective antigen in the vaccine cannot be precisely measured, and it

varies from lot to lot as you produce them.

There is some evidence that the current anthrax vaccine may

have diminished efficacy against certain virile strains of anthrax.

Also, the requirement for a six-dose schedule and annual booster

shots complicates the logistics of inoculating all of DOD’s troops

and increases the cost of the vaccine program.

Knowledge of anthrax infection in studies of experimental anthrax vaccine indicate that a second-generation vaccine with a

more precise amount of protective antigen could be developed and

that fewer doses of the vaccine could be required.

In 1995, the U.S. Army Medical Research Institute of Infectious

Diseases developed a second-generation recombinant vaccine

against anthrax. The vaccine was tested on animals, but clinical

trials were not conducted in humans.

DOD currently considers such a vaccine an unfunded requirement. The Department of Health and Human Services has allocated funds to develop a second-generation recombinant vaccine because of a perceived bio-terrorism concern.

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In developing this second-generation recombinant anthrax vaccine, researchers believe they will need to address the additional

problem of whether deliberately engineered or natural strains of

anthrax can overcome the protective immunity of such a vaccine.

Mr. Chairman, this concludes my statement.

Thank you.

[The prepared statement of Mr. Chan follows:]

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Mr. SHAYS. Thank you very much.

Major General Claypool. Thank you.

Gen. CLAYPOOL. Chairman Shays, Representative Schakowsky,

Mr. Tierney, it really is a pleasure to appear before this committee,

and I would like at the beginning to acknowledge the first panel.

I truly do recognize that they are heroes and it took a great deal

of courage for them to come before this group to testify.

I really think this kind of openness that your hearing is provoking is indeed one of the things that help make America great. And

from the standpoint of the department in terms of its encouraging

individuals to come forward, in the department policy, of course, is

that individuals who have concerns about their health care and

health-care system should come forward with their own individual

complaints and we will do what we can to solve them and fix that.

Mr. SHAYS. Could I just interrupt you a second to thank you for

making that statement. And also to thank you for not objecting to

having the military personnel speak first and that you were here

for two-plus hours to listen to them.

That is not always usual. Sometimes people of your rank, out of

protocol, say, I would like to go first. So, on behalf of all three of

us, I appreciate, one, your being here, and second I appreciate your

statement.

Gen. CLAYPOOL. We found it very illuminating, actually. And it

has been a long time since my kids say that I was a real doctor.

So the opportunity to sit and listen to individuals with their medical problems was very illustrative to me, and I would like to offer

to any of them that any of us on the panel here, the DOD members, that can help them get access to the evaluation or care that

they need—it looks like they are already plugged into the right system. But we will do our best to do so.

Mr. SHAYS. Thank you.

Gen. CLAYPOOL. I would like to focus the testimony initially on

five points about our program that I would like to emphasize. No.

1 is that we know that anthrax exists this very day as a

weaponized agent in arsenals of countries hostile to the United

States. And as such, it presents a clear and present danger to the

U.S. forces around the world.

No. 2, the cornerstone of our defense against this biologic agent

is the anthrax vaccine, which has been licensed by the FDA for

nearly 30 years. The vaccine has an excellent safety record and is

highly effective.

Three, to date nearly 300,000 service men and women have received nearly 1 million anthrax immunizations. And while side effects do occur in some people, they tend, and I say, they tend to

be temporary, confined to an area around the injectionsite and mild

or moderate in most people.

In this age of no-notice worldwide deployments, immunizing the

total force is the only way to assure force protection against this

biological warfare agent, which, in the form it would be used

against us, is as deadly as the ebola virus.

And fifth, this is not a medical program. It is a commander’s program to prevent combat casualties and keep our forces ready for

battle. It is also a program for our soldiers, sailors, airmen, Marine,

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to fulfill our national obligation to do everything in our power to

keep them safe and free from the consequences of biologic war.

A number of studies listed in our written statement have shown

that the anthrax vaccine is a safe vaccine with an incidence of adverse events that is comparable to other commonly used vaccines.

On either side up here, there is a histogram that depicts several

vaccines, both new and old vaccines, and I think there are sort of

three points to take from this chart.

No. 1, systemic complaints such as headache, fever, joint pain,

fatigue, are common kinds of system complaints that we see with

the anthrax vaccine as well as the commonly used vaccines.

Second, the incidences of these side effects to the anthrax vaccine

is comparable of that to the Lyme vaccine, diphtheria, tetanus and

pertussis, which is a common child immunization agent, the typhoid vaccine, as well as hepatitis A.

The third interesting observation is, you can see—Colonel Gerber

made these slides, and I think he challenged my vocabulary for

knowledge of color—but one very tall vertical bar, which I guess I

will call turquoise, shows fever. With the exception of fever, I think

the other interesting feature is the fact that the Lyme placebo, the

placebo immunization used in the Lyme product, shows a significant incidence as well.

And so we expect to have system effects, not uncommonly, with

a number of vaccines. And the anthrax vaccine is comparable to

those.

It is important for everyone to understand that any vaccine carries with it a degree of risk. And the decision whether or not to use

this particular agent, as we have heard, must be based upon an

analysis of weighing the risks from the side effects against from

the risk from the disease the vaccine will prevent.

In the case of the anthrax vaccine, the scales of balance are

clearly tipped in favor of its use to protect our military forces.

Furthermore, in the case of protecting the entire force against

anthrax, the risk versus risk decision is not one that can be left

to the personal choice of each service man or woman. An analogy

is that the risk versus risk decision for childhood diseases results

in several mandatory vaccinations for schoolchildren. This is because the risk of not immunizing presents a public health threat

that extends beyond personal health concerns.

In the military, the risk of not immunizing affects the

capability——

Mr. SHAYS. Excuse me. Just hold off 1 second.

[A series of vote buzzers go off.]

Gen. CLAYPOOL. It’s not an anthrax attack, I assume. [Laughter.]

Mr. SHAYS. My astute counsel said that is six bells.

Gen. CLAYPOOL. Now, could I bargain for a little more time to

talk, or is that—[laughter.]

Mr. SHAYS. What we are going to do is have you finish your

statement, and we are going to have a few others so we may get

a little lunch break here. We will see. But let’s have you finish your

statement.

OK?

Gen. CLAYPOOL. Yes, sir.

Mr. SHAYS. Thank you.

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Gen. CLAYPOOL. The point I was trying to make is the risk of not

immunizing presents a public health threat that extends beyond

personal health concerns, and for the military, the risk of not immunizing affects the capability of the entire military unit and the

success of the military mission.

Secretary Cohen and General Shelton said it more succinctly

when they wrote, ‘‘Our commanders must know that all, not simply

some fraction of their forces, are protected from this biologic threat.

Soldier, sailors, airmen, and Marines fight in teams. And they need

to know that all team members are protected from the anthrax.’’

While we are aware of isolated, unexplained persisting systemic

conditions that have appeared in relation to the administration of

the vaccine, we are not aware of any pattern of long-term side effects from the anthrax vaccine.

As is typical for other vaccines licensed at the time the anthrax

vaccine was licensed, the FDA did not require long-term studies to

be conducted after licensure was awarded. The standards for recently released vaccines include provision for post-marketing evaluation.

As we have gained additional experience with this vaccine, we

have come up with questions of our own, the answers to which we

feel would allow us to improve an already excellent vaccine. And

so the Department is convening at the end of this month a team

of military and civilian experts to design a set of studies to better

evaluate the long-term safety of anthrax vaccine as well to answer

some of these questions which we have raised.

We are conducting these additional studies of the FDA-licensed

vaccine to conform with present-day, post-marketing practices. It is

important for all of us to establish every reasonable degree of confidence in the minds of Americans, who are all stakeholders in this

important force health-protection issue.

I would like to spend a minute talking about how we collect data,

that is about passive surveillance versus active. One kind of surveillance is active surveillance in which all of them, or more commonly, a cohort, are evaluated as to whether or not they have had

any side effects from the vaccine. This is a tool that is often used

in post-marketing situations.

It would be labor-intensive, cost-prohibitive, and would not conform to civilian expectations for us to use this in all 2.4 million

service personnel whom we will administer the vaccine to. It is one

method we have used in some of our studies and will use in cohort

manner in our ongoing studies.

Another type of active-surveillance method advocated by the

CDC in post-marketing evaluations is the large, linked data base.

DOD will utilize this approach in our research efforts through accessing our immunization tracking program’s data base, the

DEERS system, and through the large medical data base residing

at a tri-service defense medical surveillance system here in the National Capital region of the Walter Reed installation.

Passive surveillance is a common surveillance method employed

for the collection of adverse events. We know that it does not give

a picture of the total number of adverse events, but it does provide

a large pool of vaccine recipients from whom we can collect information regarding the emergence of spontaneous or infrequent reacVerDate 11-MAY-2000 12:43 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00099 Fmt 6633 Sfmt 6633 C:\DOCS\65673.TXT HGOVREF1 PsN: HGOVREF1
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tions whose low numbers would otherwise slip through a focused

active surveillance system.

DOD uses a passive surveillance system developed collaboratively by the FDA and CDC called the VAERS system. DOD requires its providers to report through the VAERS system all cases

of loss of duty of more than 24 hours, hospitalization for any reaction, or suspected contamination of the vaccine lot.

However, it encourages all health-care professionals to report all

adverse events that they consider important and clinically relevant,

even if they don’t meet the aforementioned criteria.

It is also important to mention that patients themselves are encouraged to and can input information into the VAERS system, and

many of them have already done so.

The department has set up a process to have all VAERS reports,

those reported by providers as well as by patients, to review by an

independent external review panel, called the Anthrax Vaccine Expert Committee [AVEC]. The AVEC consists of a special panel of

experts from the Health Resources and Services Administration, a

component of Department of Health and Human Services vaccine

injury compensation program.

The AVEC uses explicit criteria for attributing causality to adverse events coincidentally associated with the administration of

anthrax vaccine.

As of July 1, 215 VAERS reports have been received, of which

174 have been review by the AVEC. They have found no pattern

of causality stemming from the use of the anthrax vaccine.

In conclusion, the department is and will continue to be vigilant

in our surveillance for any unexpected reactions to anthrax immunization. We are committed to fully investigating all concerns or all

questions on the safety of anthrax vaccine, and will continue full

and complete disclosure of all risks based on objective evidence.

We know anthrax kills immunization protects. We know death

from anthrax is vaccine preventable, and that the Department of

Defense has a safe and effective vaccine to protect its service members.

Immunizing men and women we place in harm’s way to prevent

death or a serious injury is our moral and ethical duty, a leadership responsibility we perform with great confidence. It would be

unconscionable for us not to do so.

Thank you, sir.

[The prepared statement of General Claypool follows:]

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Mr. SHAYS. Dr. Ellenberg, I think that we have three votes. The

machine is going to close in about 10 minutes and takes about 8

minutes. I think what we will do is let people know that they can

have some lunch or something, and we will start sharp at 10 of,

barring they keep us on the floor. But I think we will be out before

then.

So we will start sharp at 10 of. Is that OK with you? That’s when

we will start.

So we will reconvene at 12:50. We will recess, if you need to get

some lunch or something. Let’s do that.

[Recess.]

Mr. SHAYS. Call this hearing to order. And I think we have one

remaining testimony from you, Dr. Ellenberg.

No, just slide that whole thing. Do you have enough room? It is

kind of difficult there. Are you OK?

Ms. ELLENBERG. Yes, I think it is OK.

Mr. SHAYS. OK. Let me say, the bigger mic is not the one that

amplifies. So—that’s it. Thank you.

Ms. ELLENBERG. Mr. Chairman and members of the committee,

I am Dr. Susan Ellenberg, director of the Division of Biostatistics

and Epidemiology in the Center for Biologics Evaluation and Research at the Food and Drug Administration. I am accompanied by

Dr. Miles Braun, a medical officer in our Epidemiology Branch. I

appreciate the opportunity to discuss with you today FDA’s Vaccine

Adverse Event Reporting System [VAERS], which is designed to receive and evaluate reports of adverse events following vaccinations,

and in particular, VAERS reports related to anthrax vaccine.

My written testimony is more detailed and I ask it be included

in its entirety in the record. I would also like to say that we very

much appreciate the testimony of those on the previous panel and

wish to assure them that we will continue to review and monitor

these reports and that we encourage anyone developing any medical problems following any vaccination to report those to VAERS.

Vaccines are among the most significant public health achievements of all time. They have been responsible for saving millions

of lives and improving health worldwide and are extremely safe.

Nevertheless, like all other medical treatments, vaccines are not

entirely risk free. While serious complications are extremely rare,

they can occur because vaccines are administered to healthy individuals and because of the virtual universal exposure of our population to different vaccines, it is important to identify even these

very rare adverse reactions.

VAERS is a joint program of FDA and CDC. It receives reports

from vaccine manufacturers, health professionals, State and local

health clinics, and vaccinees themselves. To encourage reporting of

any possibly vaccine-induced adverse event, the criteria for reporting to VAERS are deliberately non-restrictive. The system accepts

and includes any report submitted, no matter how unlikely the connection with vaccination might seem.

Such reporting system——

Mr. SHAYS. I am going to ask you to slow down just a little bit.

I think General Claypool was speaking a little more quickly because of the bell, but we have time.

Ms. ELLENBERG. We have more time. OK.

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Such reporting systems are essential to the discovery of potential

rare adverse consequences of medical products that may not become evident until many thousands or even millions of people have

been exposed to them. There are important limitations, however, to

the interpretations of the data collected by such systems, as I will

discuss later.

VAERS receives 11,000 to 12,000 reports per year. About 15 percent of these reports describe a serious event, defined as an event

that is fatal, life-threatening, requires or prolongs hospitalization,

results in permanent disability, or, in the judgment of the physician, could lead to such an outcome in the absence of medical intervention.

Most of the remaining 85 percent of the reports describe self-limited transient events such as injectionsite reactions, allergic reactions, and fever, and such events as irritability and prolonged crying in infants.

Currently, all reports of serious events are followed up in detail

by a health professional. Medical staff carefully monitor trends in

adverse event reporting for vaccines. It should emphasized that adverse-event reports can be submitted by a health-care professional

or a patient or anyone else. FDA protects the confidentiality of individuals reported to have experienced adverse events.

VAERS performs a critical function by generating signals of potential problems that may warrant further investigation. It is especially valuable in assessing the safety of newly marketed vaccines,

but it is important to recognize that VAERS data alone are usually

inadequate for drawing firm conclusions or providing a basis for

regulatory actions.

Probably its greatest limitation is its inability to establish causality for most reports of serious events. This is because most of

the types of serious problems reported to VAERS occur in

unvaccinated as well as vaccinated individuals. When large numbers of individuals are vaccinated, some of them by chance alone

will experience adverse medical events within a few days of vaccination.

For this reason, the fact that an event happens to occur shortly

after a vaccine has been administered cannot by itself lead to the

conclusion that the event was caused by the vaccine.

As of July 1, 1999, 215 reports of adverse events associated with

the use of anthrax vaccine have been reported to VAERS. Of these,

22 are considered serious events, as defined earlier. These reports

describe diverse conditions with no clear pattens emerging at this

time. Some of these events are described in detail in my written

testimony.

The remaining reports describe a variety of symptoms, including

injectionsite pain and swelling, rash, headache, and fever. With the

exception of injectionsite reactions, all of these reported adverse

events can occur in the absence of immunization.

I will skip any comment on the Anthrax Vaccine Expert Committee, as that has already been described by the previous panelist.

While the date gathered from the VAERS system can serve as a

useful tool in identifying potential problems, the reports on anthrax

vaccine received thus far do not raise any specific concerns about

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

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number of adverse events reported will increase. The agency will

continue to closely monitor and investigate these reports.

FDA continues to view the anthrax vaccine as safe and effective

for individuals at high risk of exposure to anthrax. Vaccine safety

is a high priority of the Food and Drug Administration.

I thank you for this opportunity to discuss VAERS and our efforts to monitor and ensure the safety of licensed vaccines.

[The prepared statement of Ms. Ellenberg follows:]

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Mr. SHAYS. Let me say to you, I have a number of questions that

we have written down. I am going to follow the script somewhat

cause these are very important questions for our study and I don’t

want to have my staff tell me later on that I should have asked

that question and that we need to get it later.

So I am going to ask you, Mr. Chan, how does the number of

shots affect adverse reaction rates?

Mr. CHAN. The six shots that are given over 18 months period—

what we found based on the—first of all, there are differences between active monitoring and also passive surveillance systems.

Mr. SHAYS. Bring the mic a little closer to you.

Mr. CHAN. I am sorry.

Mr. SHAYS. Yes. Yes.

Mr. CHAN. For the three efforts that we mention in our testimony, I think we found that certainly the number of not only the

number of adverse events increase as after the first one to the second one to the third one and so on, but also that there is a type

of adverse reactions very similar. They are consistent, but really

had not analyzed whether these things are significant or not. I

think it does suggest though that, you know, DOD is pursuing looking at a possibility of reducing a shot out of those six.

Mr. SHAYS. I am not quite sure what your answer is. I asked,

how does the number of shots affect adverse reaction rates. And

your are not giving me a very clear answer.

The followup question was after which shot in the series do more

people experience serious local or systemic reactions.

Mr. CHAN. Yes.

Mr. SHAYS. After which shot in the series do more people experience serious local or systemic reactions?

Mr. CHAN. Well, first of all, I guess, to answer this question, it’s

six shots, as we stated, was it was established in an arbitrary manner. OK, so from a scientific point of view, it went from a threeshot regimen through the animal study, whereupon they found that

in applying to humans, they found that they had three cases of anthrax contracted.

So, that number has been raised from three to six, particularly

in the early study, in 1962 of Dr. Brachman’s work.

Mr. SHAYS. What GAO has done is basically look at what’s on the

table, the documentation on the table. And it is your testimony before this committee that the six shots is arbitrary.

Mr. CHAN. Yes.

Mr. SHAYS. That there is, what, no scientific evidence that six is

better than three?

Mr. CHAN. What we were looking for was how was that determined in terms of is it based on the antibody to the antigen or protecting antigen, as we use, or is it based on a tradeoff between

what is the difference in reaction, you know, in terms of the antigen level from three shots, to four shots, to five shots, and six shots

and see which one came out with the right answer for you, looking

for the optimum number of shots. And we didn’t find that.

Mr. SHAYS. OK. Major General Claypool or any of the people

with you, are you able to respond to that?

Gen. CLAYPOOL. I will take a crack at it. I mean, I think this is

a vaccine, as we said, that is 30 years old. Back in the 1970’s, when

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it was submitted for licensing, we do think probably that—I think

‘‘arbitrary’’ may be a word that has boundaries to it. I mean, certainly we don’t think you need to have 40 shots; we don’t think one

shot is sufficient. But six shots is what the FDA has, indeed,

states, goes along with license assurification. And that is why we

follow the FDA guidelines in our program.

Now we do believe that there may be a case to be made for fewer

doses, and that is why we have developed a protocol, as I think you

know, to look at reducing the number of shots. And we are currently working with the FDA to see if we can bring that into reality.

Mr. SHAYS. I am going to make an assumption, General, that you

would welcome anyone else on your staff joining in.

Gen. CLAYPOOL. Yes, sir.

Mr. SHAYS. So I am not going to specifically ask. So, and I am

also going to make the assumption that if we have slight disagreements that there won’t be silence on it because, for instance, Admiral Cowan, if what General Claypool is saying, and you have some

medical disagreement with that, I am going to assume that if you

don’t disagree, you agree.

Adm. COWAN. Yes, sir. Certainly.

Mr. SHAYS. OK. OK.

Col. ENGLER. Sir?

Mr. SHAYS. Yes.

Col. ENGLER. I thought I might be able to help clarify the answer

to your question.

Mr. SHAYS. Thank you.

Col. ENGLER. All vaccines series, i.e., more than one dose, are

based on some immunologic science of priming the immune system

and then solidifying the immune response to create immunologic

memory that will protect you long-term. And so it is a standard

that many vaccines, you need more than one dose to optimize the

long-term protective response to the vaccine.

And as that immune response enhances with booster doses, you

will see more large local reactions. And some people who are genetically predisposed to be what we call hyper-responders, will

make very robust immune responses, which many manifest in some

systemic symptoms, like low-grade fever or chills that last only a

few days.

Mr. SHAYS. So if you have someone who, Colonel, who has reacted negatively on the first one, it is likely that they will find it

even more difficult with the second one, or the third, or the fourth?

Col. ENGLER. That is true in most vaccines, but in the old anthrax literature, it is described that the person who has a reaction—we are mainly talking about local reactions with dose one—

may not have it with dose two, or may have it with dose two and

not dose three. And in actual fact, the local and self-limited systemic reactions go down on the fourth dose, where there is a time

interval of several months. And the immune system basically lowers again, because it is not being challenged.

Mr. SHAYS. You use the word ‘‘old literature’’——

Col. ENGLER. I am talking about in the sixties.

Mr. SHAYS. Yes, that is old literature.

Col. ENGLER. For us, yes.

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Mr. SHAYS. Given the kind of advances we make in medicine and

with vaccines, that is old literature, but we have an old vaccine

that we are dealing with. And it is basically your testimony that

it doesn’t always follow but that the answer—let me re-ask the

question: Are you saying, in response to my question, that if you

have an adverse reaction with the first one, that is not an indication that you might not have it, that it is an indication you are

more likely to have it with followup?

Col. ENGLER. At the present time, we don’t have clear data to

that fact. There is some data, as I said, in the sixties’ and seventies’ literature that it is erratic. And so someone can have a very

large local reaction with the first shot and it will be better with the

second or completely gone with the third.

And the other pattern, where it does seem to worsen from shot

to shot, is also observed.

Mr. SHAYS. OK. What’s on the table is the GAO has basically

said there is no evidence—excuse me, that six shots is an arbitrary

determination and what Major General Claypool has said is that

this is—they are following the FDA basic literature and not—excuse me, licensing. So let me have the FDA jump in here.

Ms. ELLENBERG. Well, I am not an expert on the anthrax vaccine. My understanding is that the original clinical trial that was

done that supported licensure, in that study, the people who received partial vaccination, but not the full series, that some of

those did develop anthrax, a small number. But nobody who was

fully vaccinated developed anthrax. So that there is some suggestion there that more than some number of doses provides more protection. But it is based on a small number of cases.

That is the clinical data that I am aware of.

Mr. SHAYS. OK. Dr. Chan, why do passive surveillance systems

result in adverse-event under-reporting?

Mr. CHAN. Well, it is a voluntary system, first of all. And this

is not just the case with this particular case of anthrax vaccine. It

is generally the case with most passive surveillance systems. And

there have been a number of studies done to look at that, and in

fact, even in applying it to the medical device where we found in

GAO’s own study found that less than 1 percent of the adverse

events using medical device have been reported to FDA. This is

post-1980’s. And we found that is the case.

So that is the first point. The second thing is that if a surveillance system also has in place a sort of a filtering process whereby

it requires individuals to determine whether it should be reported

or not, then you have an added problem of, you know, reducing

that total number.

And the third case is that, you know, a lot of people do not realize that this is really caused by the vaccine itself or whatever, and

so they may or may not report it.

A passive system, in a way, it is a sort of sentinel system. You

really don’t try to figure out, is there a larger portion of adverse

events that are occurring, but really what kind of event that is occurring.

So, if you decide that this is not something you want to report,

then you lose sight of the fact that the intent of that system is to

capture some extraordinary events that it is unexpected. And so,

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I think, you know, in listening to the way this VAERS system is

being applied for the anthrax vaccine, I think it suffers from a

number of these deficiencies to reach this level of reporting that we

find that’s different in the active system that we have noticed.

Mr. SHAYS. Now, bottom line, that would indicate to me that the

VAERS data should not be used as a source for determining adverse reactions rates.

Mr. CHAN. Exactly. And that is a pretty well-known fact. And

certainly we have talked with experts in CDC who have done studies of this kind, and as we stated, the former Commissioner for

FDA also noted the same thing, based on a 1997 study—1993

study, excuse me, to show that, you know, less than 1 percent of

adverse events are reported.

Mr. SHAYS. Let me just have you put it—I am going to ask you

the question this way, and I am going to go down the line here.

Why shouldn’t VAERS data be used as a source for determining adverse-reaction rates? I want you to tell me why it should not be

used.

Mr. CHAN. Well, because of the fact that people——

Mr. SHAYS. You have already said it, I just want you to respond

to the question as I have asked. So——

Mr. CHAN. Well, first of all, you need to track the number of

shots given. That means the denominator has to be given, very

clearly. Second, you need to have a system by which people do not

under-report. OK? And third, it requires someone not screened out

any possible other events that may be related to the vaccine. And

ultimately, to follow through on those cases.

Mr. SHAYS. I don’t understand the third one. Say that again. I

didn’t understand. I know you said it. I don’t understand it. You

will have to explain it to me.

You said, one, you need to track the number of shots. Two, you

can’t have under-reporting. Three, filtering? I don’t understand filtering.

Mr. CHAN. What I am saying is that you should not, you know,

theoretically you shouldn’t have a criteria by which you set out and

say this is our product insert, if these are the illnesses you have,

then it is possible.

Mr. SHAYS. I see. OK.

Mr. CHAN. But if it is not, most likely it is not, so let’s exclude

that.

Mr. SHAYS. Let me put it in my terms. In other words, we make,

we determine that only certain types of symptoms would be related

to anthrax vaccine, and if there are these others, then those are filtered out because they are not, we don’t accept them as being related. Is that what you meant by filtering?

Mr. CHAN. Yes.

Mr. SHAYS. OK. General Claypool, I am happy to have you defer

the question to someone else, but I would like to ask whether you

have confidence in the VAERS system?

Gen. CLAYPOOL. I have a great deal of confidence in the VAERS

system to deliver what it is supposed to deliver. And what the

VAERS system does, it provides, as we have said, the ability to

look at spontaneous events or, No. 2, is to pull from a large data

base to pick up infrequent circumstances. And as an example,

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which I think is very timely today, and Dr. Ellenberg may be able

to correct me, but, for instance, there is a new vaccine out for

rotovirus in children, and this is a new vaccine. And it has been

around a relatively short period of time. About 11⁄2 million doses

of this vaccine have been given.

Through the VAERS system, they have uncovered a cluster, I

think that is six or eight cases of children who have gotten this

vaccine who have developed a particular kind of small bowel obstruction known as intussusception. And so what this has done by

this large data base with its passive reporting system has allowed

the CDC to ask the question, you know, maybe we need to look at

this data as to whether or not intussusception is a problem with

the rotovirus vaccine.

So the VAERS system has allowed the identification, or the floating to the top, or the picking of this new problem.

Mr. SHAYS. OK, I am going to have my counsel—the committee

counsel, rather—ask a question. But I just need to be clear, as I

understand it. And the disadvantage is you are speaking to someone who is not expert on this issue. The advantage is, if I can understand it, the whole world can understand it.

And ultimately, we are going to get to that level. I was given

three reasons why the VAERS system is not appropriate to, as a

source of determining adverse-reaction rates. I was told, one, we

need to track the number of shots. Two, we can’t have under-reporting have it be valid, and we do have under-reporting. And we

have a filtering system.

I would like you to respond to that.

Gen. CLAYPOOL. The VAERS system is only one piece of the

equation. The other piece of the equation in terms of looking at adverse events has to do with an active surveillance system. And the

department is engaging in plans to use two modalities of active

surveillance. One of them, as I mentioned, is this large linked data

base, which looks at linking the two large data bases we have from

tracking the immunizations plus the Defense Medical Surveillance

System, which is this large tri-service located at Walter Reed.

And the ability to look at these two sources of data that will

allow us to identify people who have had the anthrax immunization

and to track that with various kinds of complaints or problems that

have occurred.

The other has to do with a cohort study; that is, to look at some

of the studies we are planning to design, and actually have done,

like the one at Tripler, where we do active surveillance, looking at

a cohort of people to look for specific side-effect problems.

We can’t do active surveillance on 2.4 million people. That isn’t

a common practice in civilian, where we would track every single

individual. That would require us contacting them, you know, after

each injection.

Mr. SHAYS. Yes, Admiral.

Adm. COWAN. If I could perhaps state that in a slightly different

way. What you said about VAERS as the single way to track is absolutely true. It doesn’t track the shots. It certainly will under-report side effects because it is voluntary and it could be a filter.

Back in the sixties, NASA taught us that if you want a system

to run right, you make redundant systems within systems. And so

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we have, as we have learned about this vaccine, we have been attempting to do that. We have a Hoffman survey and a Tripler

study following a population of people. We know where they are;

we watch them very closely. And we will end up with a statistically

significant and accurate rate of the side effects, the adverse effects.

The business of filtering is a very big one, and I am glad that

got touched on because it is the intent of the VAERS to find the

unexpected association. Nobody had the slightest idea when swine

flu came about that that would be associated with Guillane Barre.

And they started popping up. It is not a natural association. You

wouldn’t have predicted it. And so we want the sentinel out there

that guides us to the unexpected event. We want to do the measurements that tell us what the actual incidence of side effects is.

And then we track the shots for the denominator.

We have got very good numbers on the shots. So all of these

things packed together, we are gaining an ever-better sight picture

of exactly what is going on with our population.

Mr. SHAYS. Thank you. I am just going to have the counsel ask

a question.

The COUNSEL. Which leads to the question then, what is the adverse reaction rate for the anthrax vaccine. In planning the program from its initiation and planning it from here forward, what

do you assume the reaction rate to be? Therefore, how many patients do you expect to see? How many allergists will you need to

treat them?

Do you stick by the adverse reaction rates that are in the product

labeling, or have we learned something different in these studies?

Gen. CLAYPOOL. You know, I think this entire anthrax vaccination program represents a continuum which we continually try to

improve and make better. The product packaging, the information

that comes with it, is based upon the licensing of the vaccine when

it was given.

As we gather more information, we suspect, we feel confident we

will come up with a better estimate as to what indeed reaction

rates are.

As an anecdote, you know, at least three of us up here have had

at least a total of five shots each. So there have been 15 shots

given up here. If I were asked, if I were polled about whether I had

a reaction, I would say, yes, my arm hurt; I really felt achy for a

day. It swole up. I actually had trouble doing pushups because my

arm was aching. And so if I were in an active system, I would be

picked up as a mild local or maybe mild, even moderately systemic

reaction because I felt sick after the one shot.

But I wasn’t. I went through my duties. I went through the rest

of the immunization series without any problem. So my entry was

not recorded as an adverse system, as an adverse event.

So under an active surveillance system, these kinds of things

would be picked up.

The COUNSEL. And you have already found that the rate of mild

and moderate local reactions is higher than the product labeling indicates that. Correct?

Gen. CLAYPOOL. We say we have already found. We have done

a number of different studies, and Colonel Gerber may be able to

speak to them specifically. But we looked at different cohorts and

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differing populations, and, depending upon, you know, how you are

collecting the information, we do believe it will be higher. Yes.

The COUNSEL. And then, Dr. Engler, what is the, what can say,

what is the relationship between a higher incidence of local reactions and any suggestions or conclusions about the incidence of systemic reactions? Is there a relationship between the two?

Col. ENGLER. If your are talking about short-term, self-limited,

flu-like symptoms, low-grade fever, joint aches, muscle aches, as

people’s large locals increase, those may also be in tandem more

frequent, reflecting the vigorousness of the immune response. And

there are, at least in our experience and also in Colonel Hoffman’s

and Korea and the Tripler study, they resolve generally within less

than 3 to 4 days, and some instances, for comfort, respond very

well to non-steroidals, like Motrin or Tylenol.

Mr. SHAYS. Yes, Dr. Sharma.

Mr. SHARMA. Just, I want to make a few points here. First of all,

in the product inserts, the adverse reaction rates that we see are

from a different vaccine which has different contents and ingredients. And I think there is an issue that we had raised in our previous testimony; however, an assumption was made that the two

vaccines are identical and, therefore, the adverse reaction rates

would also be very similar. But this is an assumption which hasn’t

been tested.

Second, following the licensing of this vaccine, we really have

very little information about its use. So we have no post-licensing

experience with this vaccine. The only time we had was during the

Gulf, when records were not maintained, and we don’t know.

This is the first time you are using this vaccine, and if you compare the adverse reaction rates that DOD has presented based on

VAERS, which is 0.007, and they are true, by that token, it is the

safest vaccine. But when you look at the active surveillance systems, you see a range of reaction rates that, for some of these specific symptoms as many as 80 percent or 90 percent close to people

are reporting some adverse reactions.

Now, I agree that a majority of them are temporary and would

disappear, but it is striking the upper range.

And second, something that we didn’t know before, because during the licensing phase, the clinic that the field trial that was done

had some problem in the sense that individuals who were in that

study had received both the vaccine, and a determination could not

be made which of the reactions were attributable to the mark vaccine versus the current vaccine.

And second, and more importantly, the reaction-rate data could

not be differentiated with regard to the gender. So they really

didn’t know how women were going to—what experiences women

had. This is the first time we have learned from the active surveys

that women are responding differently, reporting twice the rate,

and I think this is a great revelation. And I think we would not

have learned if we did not have such active surveillance systems.

And this is the point that I just wanted to make it clear.

Adm. COWAN. If I could, sir, I would like to build on that just

a little bit. I think that is exactly right. We took the best information we had off of the insert and the data that had been done when

we started. And we advertised those as our adverse incidents. AdVerDate 11-MAY-2000 12:43 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00139 Fmt 6633 Sfmt 6633 C:\DOCS\65673.TXT HGOVREF1 PsN: HGOVREF1
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verse incidents, to my mind as a clinician, come sort of in three flavors. There is minor local reactions or minor systemic reactions

that are very short, self-limiting, don’t require any, if only minimal,

treatment.

If those become severe enough that they incapacitate a person

that he has to be treated, needs something more than simple aspirin, then that is sort of another issue.

But those are reactions. And whether they are to the severe end

or to the mild end, we expect those to resolve and not result in disease.

The thing that we are concerned about is the nasty surprise. The

association of a type of disease that is caused by, that could potentially be caused by something like this that would pop up, we want

to identify that as early as possible. And I think Dr. Sharma makes

the case for having all these different kinds of surveillances and

studies ongoing so that we learn very much up front from the numbers of people we vaccinate as we go, and we don’t miss cases or

have diseases go on or whatever, without knowing about it.

Mr. SHAYS. I am going to recognize Ms. Schakowsky, but I just

was trying to think, when we talked about the arbitrary number

of six, and we know that two is better than one, we probably can

agree that three is probably better than two, but we are not quite

sure, particularly from a military standpoint, they may ultimately

recommend it be three.

How many shots, when I was in elementary school in the fifties,

did I have in polio? Did I have one, and then one a year later, or

something? I don’t—I remember it was a dramatic event for me.

Adm. COWAN. Sir, mandatory vaccines for childhood illnesses are

profuse.

Mr. SHAYS. Much different?

Adm. COWAN. Well, no. They are very much the same. There are

ordinary vaccines like this is, but we started, probably most of us,

about 3 months. There are probably anywhere between 8 and 12,

depending on the State and the time, smallpox, diphtheria——

Mr. SHAYS. I had eight polio shots?

Adm. COWAN. No, sir. I don’t know how many polio shots. Dr.

Engler may have more information about that.

Col. ENGLER. It depends on what year. Do you remember getting

the shots. You were in the shot series.

I don’t know how young you are, sir.

Mr. SHAYS. What’s that?

Col. ENGLER. I said, I don’t know how young you are, sir. So you

might not have received the——

Mr. SHAYS. What is—I was born in 1945, and so I just kind of

remember them in the early 1950’s.

Col. ENGLER. Yes, the inactive—at that time, there was the

injectable polio——

Mr. SHAYS. It was injected.

Col. ENGLER. That means that it is the shot form as opposed to

the oral. You may remember the sugar cube.

Mr. SHAYS. No. I had a shot. And I just remember not having

a lot of them. I certainly didn’t have six of them.

Col. ENGLER. Well, at age 2 months and 4 months and 6 months,

you probably would not remember.

137

Mr. SHAYS. That was just a simple question. [Laughter.]

Ms. Schakowsky.

The record will note that I did not get an answer. [Laughter.]

That was simple.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. I wanted to explore

a little bit the difference of the reaction among women, and wondered if any of you have any information on why women might

have more adverse and stronger adverse reactions.

Dr. Engler.

Col. ENGLER. I will certainly be happy to speak to that. It is well

known in the science of immunology that immunologic responses of

women in the antibody-producing side, are enhanced. And there is

some survival value to that in that the mother transfuses her baby

with antibody, and that is the first way that you defend your baby

from infection after birth.

That also has the downside that 70 to 80 percent of auto-immune

disease occurs in women. That is, when the immune system gets

confused and inappropriately causes inflammatory destruction of

self, of some organ, whether it is the thyroid or, in lupus, multiple

organ systems.

Ms. SCHAKOWSKY. So the questions to Captain Piel or the comments that you are depressed, maybe you just want to have babies,

that she perhaps needs counseling, were not really scientifically

based, were they?

Col. ENGLER. Absolutely not. I think one of the challenges in

health-care delivery, both in and out of the military, has been how

women and their complaints presenting to the traditional medical

system are handled. And I think we are certainly a long way away

from where we were in that the experiences of Captain Piel are

less frequent than they used to be, but education continues to be

needed.

Gen. CLAYPOOL. I would like to say that each one of us was offended by that assertion. I mean that is not the kind of military

system that we are part of, and that is not——

Ms. SCHAKOWSKY. Again, I want to say, General, that I appreciate what you said at the beginning, too, that you really encourage

people to report adverse reactions and that you don’t want to have

a situation where people feel fear about it or feel that they will be

intimidated.

When I was in the State legislature and there was a hearing on

home-delivered meals, and I asked the presenter from the State, do

we have any waiting list.

And they said, no, we don’t have any waiting list. And then it

occurred to me to ask, do we keep track of people who are asking?

Do we know who is waiting?

And they said, no.

So, we don’t want to be in that kind of situation that we have

very few reports. And, in fact, we have testimony in the GAO report, which I had in front of me and now I don’t—here we go—that

a former FDA commissioner acknowledged the under-reporting of

adverse events and passive surveillance and cited one study showing that, ‘‘only about 1 percent of serious events,’’ attributable to

drug reactions are reported to FDA.

138

Are we making any estimates about the percent of reported adverse reactions in this instance?

Col. ENGLER. That is a very widely quoted statistic, and I would

just like to comment that we know that there can be substantial

under-reporting to these systems. These are not good places from

which to make estimates of rates because of that. But the underreporting rate varies greatly, according to a lot of different things.

Could relate to the newness of the product; it could relate to the

seriousness of the event of the time after the administration.

There are data from the CDC that suggest with regard to vaccines that the more serious the event, the less problem there is

with under-reporting. So I think it would not be accurate to assume

that this 1 percent rate relates to medical products across the

board. I suspect there is a great amount of variability.

Ms. SCHAKOWSKY. But still accurate to assume that it is greatly—there is a great deal of under-reporting.

Col. ENGLER. It is certainly accurate to assume that, I would say

for most products, there is a great deal of under-reporting, but as

the data from CDC suggests the under-reporting may not be so extreme for serious events after a vaccine. I suspect we get better reporting for vaccines than most drugs.

Ms. SCHAKOWSKY. Well, let me—as a result of the briefing that

I received yesterday, I think I feel clear about what the benefit is

to vaccinate against anthrax, that it is a threat and that in almost

cases it would be fatal. So we want to—but in evaluating the risks,

it seems yet appropriate to say, do we have to take as many risks

as we do to achieve that benefit?

And one of the really disturbing pieces for me is the production

of the vaccine itself and BioPort and its experience and whether or

not we are getting the kind of product under the circumstances

that we want from that company.

So just a couple of questions about that. Actually, I could have

a lot of questions about that.

In a June 30th hearing held by this subcommittee, BioPort officials testified that its facility was closed after repeated FDA violations and that they were delayed in reopening by, ‘‘unforeseen circumstances.’’ And they suggested that some of the unforeseen circumstances included FDA’s ‘‘new’’ requirements and evolving product standards.

So my question for the FDA is whether you implemented any

new requirements since the DOD contract was signed 9 months ago

that would not have been foreseen by BioPort and which would

have caused this delay?

Ms. ELLENBERG. I’m sorry, that is just totally beyond my ability

to respond. We will be glad to provide, to get to the right people

and get that response back to you.

Col. GERBER. Ma’am, could I just interject, that you mentioned

that BioPort, the predecessor or the aftermath of the MBPI plant,

was involuntarily closed. I think it is very clear that BioPort closed

their plant to reconstruct the production lines up there. They

closed voluntarily on schedule to renovate the plant.

Gen. CLAYPOOL. It was not because of the FDA findings. I mean,

it was part of the renovation to go ahead and address the renovation issue.

139

Col. GERBER. It was a scheduled closure to redo the production

lines.

Ms. SCHAKOWSKY. OK. I guess what I will need, what I need to

be convinced about is why it is that we have a single supplier that

has had a history for problems dealing with the quality of the product in the past that has been shut down that has overestimated,

underestimated by—is it—three times the cost that the taxpayer

would have to expend on this, that has had enormous investment

by the Department of Defense in terms of all the renovation, why

it is that we want to put all of our eggs in what seems to me to

be a fairly, given its history, unreliable basket.

And I don’t know, I suppose the devil is in the details, but I

would like to ask that general question.

Col. GERBER. Could I take a stab at this? You ask some very

good questions that we ask ourselves: Why all our eggs in one basket? And we are working to resolve that.

I think there is a little interesting history here that when you

go back to the vaccine industry here in the United States, back to

the 1960’s and 1970’s, when there were 60 or 70 vaccine manufacturer plants in America. After some of the early polio vaccine, even

the threat of a catastrophic lawsuit caused most of these vaccine

manufacturers to close.

In fact, it is commonly known today that there are four, or only

four, principal, major vaccine manufacturers, probably a dozen

total. There is, again, the mere threat of a lawsuit is enough to

cause vaccine manufacturers not even to get into that business.

So——

Ms. SCHAKOWSKY. So we have immunized them against that. We

have given them—they aren’t liable for mistakes, according to our

contract, are they?

Col. GERBER. If you are talking about the indemnification issue,

you know, in 1976 we started with the swine flu, when the national

swine flu vaccine, to indemnify that vaccine. But the fact of the

matter, most vaccines under the National Childhood Vaccination

Act are covered by Federal indemnification. So it is not an uncommon practice.

Mr. SHAYS. But the answer was yes.

Col. GERBER. Affirmative.

Col. GERBER. So that’s just a little history. There has been no

money in making anthrax in America, from the 1970’s to the 19—

to the modern anthrax vaccine program. BioPort, I understand,

sold about 6,000 to 7,000 doses annually to veterinarians, laboratory workers, so on, and so forth. So there was really no need to

have an additional vaccine plant.

Mr. SHAYS. Let me jump in if I could on this one and then I will

give you back the floor.

Ms. SCHAKOWSKY. OK.

Mr. SHAYS. When, and this relates to the question of sole source.

When did DOD begin work on a pure anthrax vaccine?

Col. GERBER. On a pure?

Gen. CLAYPOOL. I don’t when they began to work on it, but there

is ongoing work that sometime back in the early 1990’s, at least

probably 1993 or 1994, I’m guessing, is when the work began.

Mr. SHAYS. And when did you discontinue it?

140

Gen. CLAYPOOL. It hasn’t been discontinued. It is still ongoing.

I think what you are talking about is the recombinant PA vaccine.

Mr. SHAYS. General, could we be clearer on whether your definition of ongoing means that it hasn’t been discontinued but it is

going no where. Is this, is this, are we under active pursuit of a

pure vaccine.

Gen. CLAYPOOL. Yes. Let me add. I would like to address that.

I appreciate the opportunity to do that. Back in 1994, in about that

time period, at that point, when we did not have an AVIP program

to immunize the total force and we did have the current FDA-established vaccine and we didn’t have the program we have in place

and we didn’t have the ability to have the total force immunized,

we had an FDA fully licensed vaccine.

And so at that point, as you know Congress requires us to have

fiscal responsibility for our programs, there was dialog and discussions, and at that time the best decision was made, since we had

a fully licensed vaccine by the FDA, it may not make the most

sense at that point to go ahead and continue with the development

of a new vaccine, given all the other kinds of requirements that we

have.

As you know, things have changed. We now have a total force

immunization process, and so what we are doing is we are looking

at ways to take this vaccine, and, if we can, go ahead and——

Mr. SHAYS. OK. So the answer really is, that we don’t have an

ongoing program for a pure vaccine right now. We discontinued——

Gen. CLAYPOOL. No, sir, that is not correct.

Mr. SHAYS. OK, we are going to pin this one down because this

is really important. And let me just tell you where it leads me. We

were Camar and Great Britain, where they were surprised, I think

it is fair to say, that the United States made a determination to

take an old vaccine with impurities under old technology that

would probably not even get licensed today under FDA, and they

were surprised that we sought to use this old vaccine when it was

used for a few hundred a year and then ratcheted up to millions.

And the negative, obviously would be, by developing a pure vaccine, it would take time. The positive would be that it would be a

pure vaccine and you wouldn’t have as many adverse reactions.

And then this really gets to the point that Ms. Schakowsky is

raising. It is my understanding that the pure vaccine does not have

to be isolated, that it can be made in a plant where other vaccines

can be made. And, therefore, you are more likely to have other

players in this process. You wouldn’t have to have just this sole—

a facility just solely devoted to this.

So that is why I am going down this route. And what I think is

on the table, honestly, and if I am wrong then we will let the

record correct it, but it is important we be really accurate here. My

understanding was, the DOD was pursuing a pure vaccine and

made a determination that we need to act now, and the only thing

we had on the table right now was this older vaccine.

So we made a decision that we would go with that. And it is my

understanding that we are treading water right now in the development of a new vaccine. Treading water to me is basically going

nowhere. And that is my interpretation, and if I am wrong, I want

you to correct it.

141

Gen. CLAYPOOL. On Friday, this coming Friday, Mr. Dave Oliver,

who had the opportunity to appear before your committee recently,

has directed me to go ahead and convene a group of individuals

that will help look at the question about the feasibility of bringing

from farm to market, or bringing to production, this new capability.

So I am having a task force that includes members from MR——

Mr. SHAYS. That’s fair. That’s fair. But that is different than

what you said, it seems to me. That is saying that you are considering resurrecting this.

Gen. CLAYPOOL. Well, the research—excuse me, sir—the research

has been going on. I don’t know the details. It hasn’t received a lot

of funding, and it hasn’t received a lot of priority on the list of priorities. But it hasn’t been stopped, it hasn’t been stopped.

Mr. SHAYS. OK.

Now this testimony is from when?

I would love GAO to jump in on this because I am looking on

page 4, and you said: The vaccine was tested on animals, but clinical trials were not conducted in humans. DOD currently considers

such a vaccine an unfunded requirement.

Gen. CLAYPOOL. Can we take that for the record and come back

with specific numbers. I am going to get those.

Mr. SHAYS. Yes, I would like—we can get specific numbers, but

I would like to have a sense of where we are at.

Gen. CLAYPOOL. I mean, me personally, I can tell you that I am,

you know, because of the—I truly believe that in the environment

in which the decision was made, when it was made, it was made

with the best available information at that point. At this time,

given the fact that Representative Schakowsky identified the fact

that we have all of our eggs in one basket, not only with one producer but with one facility. And for national security concerns,

many of us have wondered whether or not we need to have another

facility just to be able to protect our source.

Mr. SHAYS. And that part is a valid concern.

Gen. CLAYPOOL. So, what I am saying is, is that I think the

equation has changed. And because of that, I think it is important

to look to see whether we can take this new vaccine, kick start it,

jump start the basic research that goes to the tech base, that gets

the production. And this is what we are trying to get at.

Mr. SHAYS. OK. I understand that, General. I am just—kick start

means it wasn’t started. And I just don’t want us to quibble over

terms. Whatever your understanding of the term and whatever my

understanding is, in the end we have to have one sense of it. And

I am not trying to put words in your mouth, but my sense is that

we have a dormant program, and you want to kick start it.

And if my word dormant—if you want to elaborate on that, but

let me first have GAO jump in because they were the ones who

kind of introduced that concern. And then let me give you some

time to think about what you want to say about it.

Mr. Chan.

Mr. CHAN. Let me try to answer this question. Give you a little

bit of perspective here. Since the alternative issue has been raised

about it. And then I certainly will ask Dr. Sharma to supplement

it.

The way I understand it is that as far back as——

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Mr. SHAYS. Talk into this mic here. OK? Turn it.

Mr. CHAN. Which way? This one? OK.

Mr. SHAYS. The bigger mic will pick it up, but the amplification

is in this mic here. OK? Thank you.

Mr. CHAN. The way I understand it, as far back as 1988, the Department of Defense with health affairs had decided that they

needed to pursue production of an anthrax vaccine, and at that

time, clearly, MBPI was the only producer. And they were the ones

that produced the vaccine for the Gulf war soldiers at the time.

In 1991, around September of that time, they decided to examine

the possibility of having a second source to produce the vaccine,

using the same manufacturing process as well as the same formula.

Mr. SHAYS. The old technology.

Mr. CHAN. Yes, and that is with NIH and PRI. That is how I understand it. But by 1993, they decided that they should not pursue

this course of action even though the building in Fort Detrick had

been prepared to supposedly produce such a vaccine.

Mr. SHAYS. You’re not talking about creating a new vaccine.

Mr. CHAN. No. It is the same thing. I am just trying to give a

perspective.

Mr. SHAYS. OK.

Mr. CHAN. Meanwhile, I think as late as 1980’s, everybody had

given some thoughts about it: This may not be the vaccine to go

in the long term and experiments had been done. As we stated in

our testimony that research had been done with a recombinant PA

vaccine, which is pure and clearly would not have, possibly, impurities and have a much better control and so on.

Mr. SHAYS. Let me interrupt you a second.

Mr. CHAN. Excuse me.

Mr. SHAYS. Excuse me, I am interrupting you.

The advantage of a pure vaccine is you will have less adverse reaction, one, and two, my understanding is that you would be able

to produce it in a plant that wasn’t totally dedicated just to this

vaccine.

Mr. CHAN. Exactly, the intent is to have a vaccine that is nonspore forming so that in fact it would be safe to produce it without

dedicated building for that purpose.

OK. And as I understand it, and now may I quote General Blank,

who told me that as of 3 or 4 years ago, they discontinued this effort to continue with, you know—so that is why we said there is

no further clinical trials being done on this particular approach.

So our understanding recently is that HHS is thinking about

pursuing this.

Mr. SHAYS. OK. But that is what is on the table, and then tell

us where you think that is accurate and where you think it is not.

Gen. CLAYPOOL. Yes, sir.

Adm. COWAN. I will make one quick comment. I think we need

to go back and find out exactly what is going on and bring it back

to you. I do know there is an $18,000 bonus of money that has been

given by the Joint Program Office for research in animal and assay

validation studies. Those are ongoing now.

It is likely, upon termination of that, at this point in time, there

are truly no more funds available for research going beyond there.

143

That should be resolved or get resolved at this upcoming meeting

that General Claypool said.

But we will get the accurate information back to you.

Mr. SHAYS. Well, well—yes, Dr. Sharma.

Mr. SHARMA. Let me just sort of give you a little detail. In 1995,

that was the last year funding was provided for the recombinant

vaccine. At that time——

Mr. SHAYS. And the combinant vaccine is the new vaccine?

Mr. SHARMA. Right. And at that time——

Mr. SHAYS. Recombinant, I’m sorry.

Mr. SHARMA. Recombinant vaccine. All the basic R&D work was

done and they were ready to go ahead for clinical trials. But since

the funding was stopped and it was considered to be not, you know,

a priority, the researchers stopped there.

Now, we had also spoken to the commercial manufacturers, because this was one of the issues that, you know, DOD was dealing

with. And we wanted to know two things: their, you know, comments and reactions about the current vaccine or their assessment,

and their willingness to join in the partnership with the Department of Defense or what their concerns were.

It is true indeed that the current vaccine requires the dedicated

facility, but Merck and Lederle and American Home Products told

us that if the Department of Defense would consider a recombinant

vaccine, that they would consider production. One of the major difficulties is because they don’t buy——

Mr. SHAYS. Let me just—we are getting off a little. I mean,

what’s on the table, I just want to nail down, is what I understand

is—and you have helped answer, Dr. Sharma—but I think we are

getting off a little here. The bottom line is we have the older technology in use, and that is the policy to use it. And we have a contract with a producer, the sole source.

And it is my understanding, based on the testimony of the GAO,

that this is—the program to go to the recombinant anthrax vaccine

is really basically on hold except, Admiral, for $18,000 continuing

research, which in my judgment is practically insignificant to almost irrelevant but important you mention it, just so it is on the

record.

And that, General, whether it is a glimmer in your eye or not,

it doesn’t make it an ongoing program. And so I think what is on

the table is that we aren’t able, we aren’t actively pursuing that

program as of now.

We may, and we probably should.

Col. ENGLER. Sir?

Gen. CLAYPOOL. Well I consider——

Mr. SHAYS. Now let me just say something. Before we all answer.

The deeply—Admiral, I am sorry, General, I am sorry to interrupt

you—but I just want to say to you that with no disrespect, we will

keep going down this road if you want to, and I am happy to. But

I am looking at the testimony today, and it seems pretty clear.

I don’t want to suggest you shouldn’t go further if you are comfortable, but——

Col. ENGLER. Sir, I would just like to add for the record that the

assumption that a recombinant DNA vaccine will have fewer sideeffect rates in terms of local reaction or systemic flu-like symptoms

144

is not necessarily true. The new recombinant DNA Lyme vaccine

has a very high rate of both local-reaction side effect and systemic

side effects. And there is a concern in regards to perhaps some people being at risk for auto-immune disease with that vaccine.

And we have, as an old vaccine person for many years, I can tell

you some of the, ‘‘newer and better recombinant vaccines’’ have actually had higher local-reaction rates because of some of the other

elements in—the concept that they are totally pure is not technically correct, sir.

Mr. SHAYS. OK. I don’t want to—I realize and I think it is important to be technically correct, but as a general rule, is it not true

that a newer vaccine is more likely to have benefits that will not

have the side effects?

Adm. COWAN. Sir, I think we all agree that we should do this.

I have—perhaps this can bring this to closure. Recently the National—this is one of the responses to the questions that you had

asked in preparation for this. Recently NI—the National Institute

of Allergy and Infectious Disease formed a working group on anthrax vaccines. NIH, FDA, USAMRIID were all there. Two meetings were held. The latest on February 19th. An NOU is being developed to develop this new vaccine. It is estimated that completion

of phase one and phase two studies and a surrogate model for proof

of efficacy could lead to licensure within 8 years.

So there is a current program. There is interagency development

under way. We are not going to have all the information here, and

so we will take the question. But it is under way, sir.

And we all agree we should do that.

Mr. SHAYS. General, did you have anything you wanted to say.

Do you have anything you want to add to this.

Gen. CLAYPOOL. No, sir.

Mr. SHAYS. I interrupted you, and I apologize for not letting you

finish. Is there anything that you wanted to add to this.

Gen. CLAYPOOL. No. I mean. I would repeat what Admiral Cowan

has said. I mean, I think that I consider this a live program in the

sense that we have been doing some things. Maybe we could do

more; we intend to do more. It isn’t a foregone conclusion that we

will be able to come up with a product, even in 5 to 8 years.

In the meantime, the anthrax vaccine that we have, venerable

though it is, is a safe and effective vaccine.

Mr. SHAYS. Just to make a point, this is an 8-year program, but

had we started in real aggressively it would be 3 years to go, as

my counsel has just whispered in my ear. And that is why he is

next to my ear.

Mr. SHAYS. So. All right.

Mr. CHAN. Can I add a couple points here, somehow.

Mr. SHAYS. Sure.

Mr. CHAN. I think it is important. When we talk about the disadvantages of the current vaccine, one clearly was the production

problem because of the spore form, and that limits you in terms of

getting greater participation for competitive production of that vaccine.

It is the second major problem, which I wish, you know, that we

should think about, is the fact that it is often used—the reason

why we cannot have a vaccine, IND-approved and all that, it’s beVerDate 11-MAY-2000 12:43 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00148 Fmt 6633 Sfmt 6633 C:\DOCS\65673.TXT HGOVREF1 PsN: HGOVREF1
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cause of the fact that we need human clinical trials. And we can’t

do that.

And the advantage, hopefully, with a new vaccine is that somehow you can, and as Admiral Cowan said, find a surrogate by

which you can correlate that fact that using animal study to show

that, in fact, it would give you the efficacy against humans, thereby

bypassing the human medical trials.

I think that is the major advantage of something new, if that is

doable. And they are looking into that, and there is some science

behind it, how it can be done and so on. And certainly I think it

is worthy of looking into because I think that is the other major

barrier for developing a new vaccines.

Mr. SHAYS. Dr. Sharma.

Mr. SHARMA. I would just like to add, I think one of the difficulties, we are saying things here for which I am not sure we have

complete evidence about its efficacy. Yes, it is true——

Mr. SHAYS. Sir, I am going to interrupt you a second.

[Chairman consults Ms. Schakowsky.]

Mr. SHAYS. Only one vote? Two votes?

I am sorry. Hold on 1 second.

[Consultation continues with counsel.]

Mr. SHAYS. I am sorry, we are going to be asking you to come

back. I think that we need to nail these down. I know you all have

been here a long time, but we are going to have two votes. We will

continue for a few more minutes, but I can’t let one go and then

come back, because we still have two votes. So I apologize for that.

I am sorry, why don’t you continue.

Mr. SHARMA. I think one of the problems with this vaccine is

that, you know, as Mr. Chan mentioned about the lack of correlates, and when this vaccine was licensed antibody levels were

considered to be a marker, but subsequently we have found that

there is no relationship between antibodies level and protection.

And that raises this whole issue about the number of the shots

itself.

I mean, the whole premise of number of shots is that if you reach

certain level of antibodies your body has, then it will protect you.

So for that reason, if you can attain, you know, a certain antibodies

level with two shots, you as much protected as with six shots.

And I think I have to really recognize Dr. Engler, who is in my

view an excellent clinician and researcher and from whom I have

learned quite a bit about the relationship between antibodies and

their implications.

With the recombinant vaccine, in addition to developing surrogate markers for protection for which whereby we could certainly

know for sure that the vaccine will work or not, it would also require fewer doses which certainly has, in the current vaccine, a

clear indication that the more shots you give, and logically you

would expect more reactions. So if you have fewer shots, and the

researcher that we have spoken to at USAMRIID and in Camar in

England, they certainly seem to believe that you could easily reduce the dosage to two, or at the most three. And that is quite a

bit of improvement over the current vaccine.

146

Mr. SHAYS. OK. Let me—we have about 8 more minutes. Do you

want to take about 5 minutes now and then come back or do you

want to just——

Ms. SCHAKOWSKY. Well, unless you want to follow this——

Mr. SHAYS. Yes, I am going to be asking you to come back. And

we are going to promise you that when we come back it will only

be 30 minutes, at the most. So you can judge how much time you

have left.

We have one vote, and then we have another. As soon as that

other vote is over, we will come back. And we have a few more

minutes if you want to just ask a few.

Ms. SCHAKOWSKY. I did want to followup on something that was

brought up by the other panel, and I am not sure who the appropriate person would be to answer: the issue of the concept of waiver, and if anybody is allowed to have one, under what circumstances, do they exist. What’s the policy?

Col. GERBER. If I could take that, ma’am. We refer to waivers

and deferrals, as you had asked us in your question, Congressman

Shays, we actually refer to those as exemptions. In the DOD we

have permanent and temporary exemptions, your terms for waivers

and deferrals.

In the DOD system, we have 11, I am sorry, 12 categories of permanent and temporary exemptions: 5 categories of medical exemptions and 7 categories of administrative exemptions. We are presently, all services inputting those permanent and temporary exemptions into the Defense Enrollment Eligibility Requirements, the

DEER system.

The Army was the first to input those. The Air Force is inputting

them now. And after the Air Force finishes, the Navy is the third

scheduled in line to input their medical and administrative exemptions.

Let me just speak for the Army. That was the first in line or the

first scheduled to dump their exemptions into the system. The

Army, for example, records 5,779 exemptions in the system; 92 percent of those, 5,700 exemptions, are for administrative reasons. For

example, a soldier has died. We want to take him out of the system

so he doesn’t count against compliance.

Ms. SCHAKOWSKY. That makes sense. [Laughter.]

Col. GERBER. The majority of those—well, the vast majority of

those are, for example, permanent changes of station: A sergeant

leaves my unit; while he is inbound to the next unit, I want him

to come off of my rolls so I am not beaten up for non-compliance.

And then we have 8 percent of the remaining 5,700 exemptions

that are there for medical reasons; 79 percent of those medical exemption categories are for a medical temporary pregnancy hospitalization or convalescent leave.

So, we are getting a very good handle on all the exemptions, both

medical and administrative.

Ms. SCHAKOWSKY. So, if someone exhibits some kind of an allergic reaction or serious adverse reaction, are they ever eligible for

an exemption?

Col. GERBER. Absolutely. I am going to ask Dr. Engler to expound on the medical aspect, but it is very common in our system

when our soldier, sailor, airman, Marine comes in and requires

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some sort of exemption. For example, he has had a heat injury or

he has had a cold injury, we frequently write permanent and temporary profiles to limit their duty for temporary or permanent periods of time.

It is a very common experience, and I will ask Dr. Engler to simply comment on——

Ms. SCHAKOWSKY. Well, let me just—then Captain Piel could get,

might be eligible or would be eligible for an exemption. Couldn’t fly

in those particular areas but would—could you explain this, it further?

Col. ENGLER. Yes. Anyone to any vaccine, travel vaccines and

other vaccines that may be indicated or required for deployment,

if there is a serious and persistent adverse reaction, and the majority of the adverse reactions that we see, we treat, and we continue

the immunization with certain interventions or special approaches.

So in that case, there is no need for a permanent medical exemption.

Really relatively rarely, if—and so none of these are filed until

the work-up is completed and the treatment is done. And I think

there may be some confusion in that initially a temporary exemption or temporary delay until the situation is clarified. And if then

it is deemed that the benefit risk ration does not justify continued

immunization, then there should be a submission of a medical exemption from that vaccine.

Mr. SHAYS. We have 41⁄2 minutes until the time is out. And they

will probably leave the machine open a speck longer. As soon as

the next vote, we will vote, and we will come back.

And we will get you out in 30 minutes, even if we want to go

further.

[Recess.]

Mr. SHAYS. I call this hearing to order again, and we are going

to get you out very quickly. Let me start with you, Colonel Engler.

And if you would tell me how many patients have you seen at Walter Reed—this is for Colonel Engler—how many patients have you

seen at Walter Reed who present symptoms that may be associated

with the anthrax vaccine?

Col. ENGLER. In terms of referrals for specific adverse reactions

or prolonged?

Mr. SHAYS. Yes.

Col. ENGLER. At this point, from all over, and we have a wide

referral base, we are—I don’t have the exact number—but it is in

excess of 40.

Mr. SHAYS. OK. How many have been sent from Dover Air Force

Base?

Col. ENGLER. At this point, my department has, I believe, had six

of those patients. And there are scheduled right now, the rest of

them to come down, not just to see my department but other departments based on their symptoms.

Mr. SHAYS. And the rest constitute about how many?

Col. ENGLER. The 40 that I mentioned to you are independent of

Dover.

Mr. SHAYS. All right. And then six——

Col. ENGLER. Then six from Dover to date.

Mr. SHAYS. And are you expecting more?

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Col. ENGLER. Yes.

Mr. SHAYS. How many more?

Col. ENGLER. The plan that I was informed because—I would be

happy to get specifics back to you cause I have been out due to the

death of my mother—but the plan is that all of them will come to

Walter Reed. If they have symptoms referrable to neurology or endocrinology they may not come to my department. So there is a

centralized plan for Walter Reed to respond to anyone who has a

problem.

Mr. SHAYS. I am very sorry to hear about your mother. Is this

something very recent?

Col. ENGLER. Yes.

Mr. SHAYS. It’s is good that you are willing to be here under

those circumstances.

I just would like to ask you, is the number closer to 30 from

Dover, because that is the number being bandied about?

Col. ENGLER. Again, I have been told that the spreadsheet that

is being maintained has 31, but, again, it is plus or minus,

please——

Mr. SHAYS. I know. Is there any commonality of symptoms in the

patients you are seeing?

Col. ENGLER. No. There are maybe two patients that have overlapping symptoms, you know, two here, two there, but for the most

part, they are distinct. What frequently, if you take the whole

group, not focusing on Dover alone, we see an awful lot of the more

severe large locals who have had flu-like symptoms that may have

persisted for a week, and the question is, continuance or not.

Mr. SHAYS. Are the symptoms, any of them related to the same

kind of symptoms we see in Gulf war illnesses.

Col. ENGLER. There are a few patients that I am aware of in detail that have overlapping symptomatology to Chronic Fatigue Syndrome and Gulf war illness-like symptoms.

As you know, the symptomatology with Gulf war is somewhat

heterogeneous in that there isn’t one single pattern of symptoms.

Mr. SHAYS. Let me just yield to the counsel.

The COUNSEL. Any commonality in terms of ears or, you know,

audic nerves? We heard about ear infection before. There is a lot

of reports about tinnitus and ear-ringing.

Col. ENGLER. Right. Ringing in the ears. In the spread sheet that

we are compiling on those folks that we are seeing, I have a total

of four patients who, as part of their symptoms, have had tinnitus.

I would say that at least two of them are still being tested as to

whether they have had some damage to their hearing just from the

noise exposure, you know, occupationally that they have had. So

that needs to be clarified.

But the patients have believed that their symptoms worsened

with a repeated dose of anthrax.

Mr. SHAYS. Thank you. Doctor, General Claypool, how many immunologists does DOD employ or retain as consultants?

Gen. CLAYPOOL. I would have to check the records. I don’t know.

Mr. SHAYS. OK. That would be a number we would like to have

a sense of. When we dealt with the Gulf war illnesses, we found

that illnesses related to chemical exposure, expertise in that area

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was rather slim. And I would want the same for the allergists. How

many you would employ as well.

Gen. CLAYPOOL. I will ask you a specific question. As immunologists, you mean—allergy and immunology is usually a conjoined

or one flavor. So, we will come up with some numbers.

Mr. SHAYS. I think you get the sense of the areas that we would

like. And we would like to just know if there is appropriate expertise or whether the military has the appropriate expertise in these

areas and the numbers.

Sorry.

Col. ENGLER. I was just going to comment that I think we need

to get to the numbers together cause they are in the research division, there are research immunologists who specialize in vaccine research. I am not privy to the exact numbers. And there are clinical

immunologists who manage clinics.

Mr. SHAYS. The logic to it is, if we are going to have 2 millionplus, we are going to have some people who are going to legitimately have symptoms and some severe reactions. And do we have

the expertise to cope with that. That is the basis for the question.

And we will leave that on the table that you will get back to us

on that.

Let me just as four more questions, unless there is a followup.

Let me—Ms. Ellenberg, if you would, you have said, according to

FDA, passive surveillance systems are essential to the discovery of

potential rare adverse consequences of medical products that may

not become evident until many thousands or millions of people

have been exposed to them. That is from your statement.

And, is the FDA satisfied the DOD’s surveillance efforts using

VAERS is being implemented consistently and thoroughly enough

to capture, ‘‘signal events or unexpected adverse reaction trends?’’

Ms. ELLENBERG. We don’t have a way of monitoring exactly how

this is being implemented. The plans that have been shared with

us in terms of the reporting, the basis for reporting, should be able

to get us reasonable numbers of what we would consider the serious events, if in fact all such events are reported. And we have

been told that the criteria that were originally put forward are

being expanded to include significant medical events.

Mr. SHAYS. But you do have some concern about the fact that

this data is passive, it’s not——

Ms. ELLENBERG. I wouldn’t use this kind of a system to give, to

come up with precise estimates of rates of adverse events. You really need, as has been discussed previously, a more active, more effort, a formal study to be able to produce those kinds of estimates.

Mr. SHAYS. Just as it relates, and I know that Ms. Schakowsky

had asked the question, particularly as they relate to women, a

number of them, but would you accept the VAERS data that says

that women have twice the negative reaction that men do or——

Ms. ELLENBERG. Well, we can’t make those kinds of estimates

right now from the VAERS data. We have a relatively small number of reports. The actual—in our reporting system, there are more

reports for men than for women. We don’t know what the balance

is in terms of who got the vaccine. So we really can’t make those

estimates from VAERS data.

Mr. SHAYS. OK. I am sorry. Dr. Engler.

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Col. ENGLER. I just thought it might be helpful to the committee

that the VAERS reports can be duplicative so that the numbers—

you know, there could be two or three for the same patient, or if

a person has a large local with mild flu symptoms for dose one,

two, and three, those are three VAERS reports. So the frequency—

it is not a system that will give you the data for the side-effect

rates that we put in a vaccine information sheet or educate the patient about what to expect.

That is done with solicited surveys.

Ms. ELLENBERG. But actually, we do search for duplicates. The

numbers that we are giving you, 215, were done after duplicate reports were taken out.

Mr. SHAYS. The challenge is that the VAERS gets attacked from

both sides, but the DOD, you know, uses it as viable information.

I mean, this is documents that you have. And so, it is just a little

unsettling to me that we would base much of anything on it, frankly.

Col. GERBER. Sir, could I just add that the chart that you see depicted comes out of our office and what we are reporting is the rate

of reporting. We are not using that chart to depict that that is the

number of adverse reactions or events. It is the rate of VAERS reports submitted, the VAERS form dash one.

Mr. SHAYS. Well, you basically, in the chart, say 65 adverse reactions of 890,888 cases of vaccinations given, 0.007 percent. I mean,

that is given to make people feel comfortable. And so, I think it is

being used differently than you think it is.

This is a PR document in favor of the vaccine.

Dr. Braun, is there anything that you want to say. I find that

people who don’t participate sometimes have very cogent observations cause they have been listening instead of talking. [Laughter.]

No reflection on you.

Dr. BRAUN. Not at this time. Thank you for the opportunity.

Mr. SHAYS. I am going to assume that you are brilliant. [Laughter.]

Ms. ELLENBERG. That is why I hired him.

Mr. SHAYS. There is this wonderful picture of Attorney General

Mitchell—this is off the record—when he was working with President Nixon, and he was described as the person who had created

the new Nixon. And he was described as brilliant. And he never

said anything. You just saw him sit in the biggest chair at the

White House. And then one day we got to see him speak at Watergate, and we all had a different feeling. [Laughter.]

OK, you are on.

Why did I say that? [Laughter.]

I’m counting on you, boss.

Ms. SCHAKOWSKY. A couple of things that I would like given to

me, one is, at an earlier hearing with different witnesses, I had

asked for a list of the producers of vaccines that also get the same

kind of indemnification. And maybe it is in the process to get to

me. But I haven’t gotten it yet. And the other is, I would like, Colonel Gerber, a copy of the waiver policy, and also you gave some statistics on who—not waiver, exemption policy. And I would like to

see that and also some of the numbers associated with that.

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Dr. Sharma, you had your hand up and I didn’t get to hear what

you had to say in regard to the issue of the differential between

men and women in their effect. I wondered if you had some comments on that, on the gender issue?

Mr. SHARMA. Yes, I think this is significant because if you take

a look at the percentages, we see two things. Overall reaction rate

in both men and women is in these active systems significantly

higher than what we had assumed it to be to date, and second,

these findings about differences in genders have very specific implications about the dosing or over-dosing in women. And I think I

would like to—I mean, there is nobody I know in this panel, perhaps there are, but at least I know Dr. Engler has tremendous expertise and we have talked to, and maybe she would like to comment on that. And she—I think it is more appropriate at this point.

Ms. SCHAKOWSKY. Thank you.

Col. ENGLER. I think the challenges of making a vaccination program like anthrax better as we learn and the science and immunology of female immune responses versus male is still somewhat in

the growing phase. But we already know that inter-muscularly the

anthrax vaccine, a large local reactions, are radically reduced. And

the preliminary data, as far as I understand, was presented in December 1998 to the FDA and they just asked for larger numbers

to allow us to change the route. And that also helped women in

terms of the large local reactions.

And then, the other issue is that we would like to address that

fact that in the female population are probably going to be more

what we call hyper-responders. And in other vaccine models we

know that hyper-responders do not need the full series. And in

many vaccine models over time, tetanus was an example, many of

you may remember we used to get a booster every 3 to 5 years,

now we get it every 10 because it was learned that it wasn’t necessary because there was such a high rate of hyper-response as you

continue.

And I think we are learning the same lessons with anthrax and

that the program will evolve in that knowledge-base to make it better.

Ms. SCHAKOWSKY. I think it is so important that we do carefully

examine this data because it is only in recent history that we have

even looked at the different impacts on women in clinical trials.

For years, only men were observed. And so I think it so important

that we don’t have a one size fits all when it comes to gender and

the application of this vaccine.

Gen. CLAYPOOL. And I believe in the license applications too—excuse me—but I don’t think that women were part of the study

when the initial license request was submitted. So that is a valid

thing that we are pursuing.

Ms. ELLENBERG. I actually—because we don’t have the data on

gender from the original study, nobody knows for sure, but there

are suggestions in the data that women were in fact included. But

I would have no idea what the ration was.

These were done in millworkers, and there is no reason to think

that there wouldn’t have been women.

Ms. SCHAKOWSKY. I am trying to remember what my final—oh,

I know what it was. OK, I got it.

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I don’t know what you call it again, that information sheet that

is included with any vaccine.

Col. GERBER. Product insert.

Ms. SCHAKOWSKY. The product insert, were you saying—was it

Mr. Chan or Dr. Sharma—that it was based on a different formulation? Is that legal? Are we allowed to do that, to put information

about a different drug in, you know?

Mr. SHARMA. I think I am not a lawyer and nor is Mr. Chan, but

perhaps the FDA could comment on that. However, to be fair, I

think there was an assumption made that these are two very similar vaccines. However, there is a difference between look-alike and

having the same gene. They are not identical, and we do know, for

example, there are some differences, some of them. Certainly there

is some suggestion from the clinical literature that they are associated with higher reactogenicity levels.

One of them is that this vaccine has higher PA content, and

there is some suggestion from the different vaccines using different

PA content level that higher content levels are associated with

higher reactogenicity, for example.

Second, this vaccine uses aluminum hydroxides, and there is

some suggestion that similar vaccines, other vaccines, that use aluminum hydroxides have higher reactogenicity. I think these are important differences which I am not sure, and again we are going

back to the history, to what extent they were looked or not looked.

We have, you know, documentation of the IND that was submitted

and any written documentation that existed, which is not much

compared to the current standard. So it is really hard to go back

and say why they made that assumption, but it is very clear they

made an assumption, and everything that we know about what is

mentioned there is about from the other vaccine, which was similar.

Ms. SCHAKOWSKY. It just seems to me, in terms of confidence in

the entire program, that it is really important that accurate information be given, that there is good access to information, that we

monitor accurately and fully inform, and that we process it well.

And in that regard, I feel the hearings that I have been at that I

don’t have that sense of confidence that really any of those things

happened.

Col. ENGLER. I would just like to add one comment to what you

just said that I think risk communication and communicating with

patients at a level that they can understand and that is meaningful

for what they experience following any therapy is a continuing

challenge for the health-care system in and outside of the military.

The CDC has for the standard vaccines, not the travel vaccines, a

whole staff dedicated to translating what we call vaccine information sheets cause the package inserts aren’t real helpful to patients.

And we are in the process, actually, right now of having a draft

document that is being reworked by the CDC to have the same

kind of equivalent information as we give to parents of children

who are coming for their polio or DPT that is a more balanced reflection of risk communication. And I think we all here recognize

that there is a need for improvement in risk communication.

And I think, like with the Lyme vaccine, there is no VIS yes, vaccine information sheet. So we are challenged in the clinical arena

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to make our own. And I personally think that before a vaccine is

licensed, not just a package insert but a VIS should be developed

and marketed with it because right now the clinicians are left a little bit to hang out to dry.

Mr. SHARMA. I think I would like to have a comment to follow

Dr. Engler. I think she mentioned about the management strategies that are available for other vaccines, and I think DOD has an

opportunity to develop such strategies, especially as they pertain to

women, especially as they pertain to people who are hyper-responders. And I think we could really, you know, learn something about

this vaccine as it, you know, the events are taking place.

But without those models, it is going to be very difficult to know

what is happening to people and something that we have learned,

I mean, people call us. Immediately after we started the study we

were getting about 100 calls a week between Mr. Chan and myself.

And these were calling from public telephones because they were

afraid, they didn’t want to be identified talking to us.

They see people there left and right are getting sick. Now, it may

be, you know, whatever, I am not questioning whether those events

were associated with vaccines or not, but they want to be heard,

they want to be managed, and such strategies would certainly help

gaining confidence of these individuals.

And DOD should consider using or developing models for anthrax

as they exist for other vaccines.

Mr. SHAYS. I think we can conclude here by just two questions,

and I would like to make an observation, and you might as well.

But the first question would be, on what basis, and this would be

to you, General Claypool, and others respond, on what basis does

the anthrax vaccine immunization program can deploy troops or

protect them from anthrax attack after two or three shots when the

FDA-approved regimen calls for six.

Gen. CLAYPOOL. We do believe that there is at least evidence to

suggest that there is some immunologic protection afforded after

two or three shots, but the issue is, is that would we wait until

they are fully immunized with six shots before we deploy them. No.

We can’t wait until, indeed, you know, a full force totally immunized back within the continental United States before we send

them to theaters where there are.

So, we understand that they are not fully protected, but we have

started on our road for total force immunization, and that speaks

to the issue as to why the whole force has to be immunized because

of the fact that we don’t have a short lead time. We need a long

time to get the force immunized. So that is why we are doing it.

Mr. SHAYS. Does Dr. Engler—excuse me, not Dr. Engler—Dr.

Ellenberg, if you would—I used to have a girlfriend named Ellen,

that is what is confusing me. [Laughter.]

Dr. Ellenberg, if you——

Ms. SCHAKOWSKY. Too much information. [Laughter.]

Mr. SHAYS. And that can be off the record too. [Laughter.]

Mr. SHAYS. It was legitimate. It was before—many years ago.

[Laughter.]

Dr. Ellenberg, would you confirm that there is indication that

two or three shots is going to provide protection?

154

Ms. ELLENBERG. I don’t have the numbers from that study in

front of me. The vast number of people who—I mean, all the numbers were relatively small—but the big majority of people who did

get anthrax in that study were people who did not get any vaccinations. There were a few who were partially vaccinated who also got

anthrax, and none with the full vaccination.

Now, I don’t have the numbers in front of me to remember there

were in each group, that is, how many got the full series, how

many got partial. So I can’t really—I would have to check that.

Gen. CLAYPOOL. I didn’t mean to imply that I think they are fully

immunized. In fact, you know, we deploy people after they have

one shot if they are going to a theater to start, so——

Mr. SHAYS. I know that. I know that.

Adm. COWAN. As a matter of fact, if I could share—well there is

some evidence, going back to the Brachman study, that there is at

least partial immunization. It is not our goal, and we feel that we

are running somewhat of risk, and we just don’t like doing this.

But it is an interim measure that we have taken as we go to the

total force. When we get to the end of the program, people will

come in as a condition of employment, and then we won’t have to

do things like this.

Mr. SHAYS. Yes, I hear you. What adverse reaction rate would be

too high? There must be some level in which we say, it just isn’t

worth it.

Do we have any documents or memos or anything that have tried

to wrestle with this problem?

Gen. CLAYPOOL. I think in part, it would have to be on what kind

of an adverse reaction rate it would be and how long it would last,

for instance, if indeed we found X percent had developed a significant neurologic problem that wound up in paralysis, of course, that

would obviously be the case.

I don’t mean to be vague. We don’t really have an answer.

Mr. SHAYS. That’s fair. I think of Captain Piel, and she wants to

fly. And one of the things I hope is that we all can find a way to

get her healthy again so she can fly.

And, she is a casualty cause she can’t—she can still serve, but

she can’t serve the way she was trained.

Let me ask if any of you would like to just make a closing statement or just an observation or something that you think would contribute to the hearing or you just think you would like to put on

the record.

We will start with you, Mr. Chan.

Mr. CHAN. Well, I think as you said, this is the third or fourth

hearing you have on this subject.

Mr. SHAYS. Fourth.

Mr. CHAN. Fourth, I’m sorry.

I would like to make one observation. It seems to me that if

there is a way for us to all agree with the data, the information

that is being given out, being transmitted, being told to the soldiers

are in fact of consistent and reliable nature. That, you know, to implement this program, I think partly requires a lot of effort in

terms of outreach and people who can speak to the soldiers because, as Dr. Sharma said, we have been partially the receiving

end of a lot of phone calls. And we understand a few of their pains.

155

And we cannot advise them anything further than go to the

VAERS system and report, and if they don’t want to, we couldn’t

force them. And as a result, I think, you know, the discussion

around the new vaccine needs to be clarified, if that is important

or not. The discussion about how do we get to where we are in

terms of the early Brachman study using a different formulation

basically showing cutaneous anthrax as the vaccine for that particular disease, and then applying it to inhalation anthrax, which

is currently what we believe to be a threat, we are using a different

formulation, using different strains.

The idea of the fact that the current vaccine may not be as efficacious against other strains in animal studies. The fact that there

are potentially concerns about reactions and reactivities, and the

differences among sexes, and all those things.

It seems to me that we clarify a lot of things, because this is really not a question of policy, what’s important, but rather, how would

you implement this program in such a way that in fact would not

affect the readiness of our forces. And that is where, you know, I

think it is a greater concern than the issue of the details.

Mr. SHAYS. OK. Thank you. Dr. Sharma.

Mr. SHARMA. No. I will pass.

Mr. SHAYS. General Claypool.

Gen. CLAYPOOL. I do have a couple of comments I would just like

to make for the record, for that terminology. First has to do with

what we were discussing about vaccine immunization indemnification. And, as I understand it and I am not an attorney, of course,

but as I understand it, the language that is very commonly used

in such indemnification talks about an unusually hazardous risk.

Mr. SHAYS. Yes.

Gen. CLAYPOOL. That unusually hazardous risk should be construed that it is a risk because of medical consequences of the vaccine. It is because of the financial risk to the company, for whom

the government is providing indemnification. And it is done, I

think, in sisterhood or partnership with the National Childhood

Vaccination Injury Act that led to——

Mr. SHAYS. So, in fairness to the military, the terminology is

more the legalistic term that is somewhat of a boilerplate. That is

your point?

Gen. CLAYPOOL. I believe the ‘‘unusually hazardous risk,’’ as I

say, is not from the vaccine, per se, but toward the financial risk.

Mr. SHAYS. OK.

Gen. CLAYPOOL. That’s the intent behind it. So, when the Secretary of the Army talks about that, he is not talking about the unusual risk from the vaccine.

Mr. SHAYS. OK. Fair enough.

Gen. CLAYPOOL. And No. 2 is, just to make an observation, and

that is, and we have talked about this, but it certainly is important

to evaluate all these individuals that are here and the ones that

are in Dover and the ones that are coming into the Walter Reed

clinic, but we ought not assume that there is, necessarily, a cause

and effect.

These individuals are ill and they need to have their medical conditions rendered, but the fact that it occurred temporally with relaVerDate 11-MAY-2000 12:43 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00159 Fmt 6633 Sfmt 6633 C:\DOCS\65673.TXT HGOVREF1 PsN: HGOVREF1
156

tionship of the vaccine doesn’t necessarily make it a fact that it is

due to the vaccine.

Mr. SHAYS. I think that is true, but, you know, if in doubt you

err on their side.

Gen. CLAYPOOL. Well, the thing we want to do is get them well

again and get them back in the cockpit. That is what we want to

do.

The third is, you asked us to provide a list of immunologists, and

we are certainly happy to do that. I just wanted to hope that you

don’t assume that—because it will be a low number. Dr. Engler

told me that within the Army I think there are like roughly on the

order of magnitude of 20 or so immunologists.

You don’t need immunologists to take care of people like this.

You need immunologists to help direct research and look at laboratory studies and that sort of thing. So, the important thing, I think,

is that we have the right specialty and the right mix and the right

mechanisms to take care of individuals who are ill. And that will

include immunologists, and we will provide that number for you.

The last thing is I think—not last thing, one more thing—is that

there is ongoing research, and we can get, if you want, numbers

and specificity, but there is ongoing research on two accounts that

we talked about. No. 1 is the characterization of the current vaccine, from the standpoint of the antigen that is there, the protective antigen, the concentration, as well as the other antigens that

are part of it. So we are looking at, this is the current vaccine.

And second, there is also ongoing characterization of a surrogate

animal model. That is how we are going to have to do business in

the future anyway with the FDA. We are going to have to do it

with surrogate models. That research is under way and ongoing.

Mr. SHAYS. Let me just say, as a courtesy to people when they

close, I like not to generally jump in, but on this one I just want

to say, I know the military, when they put their mind to it. So on

this level here, I think we are pretty much in a kind of a treading

water position, and I think you all need to determine where you

are going to go.

But I don’t have any comfort level that we are pursuing a new

vaccine and that this is on a fast track. I don’t even think it is on

a slow track.

That’s with all due respect, but your point is, it’s there to be considered and to be pursued and some element of progress is being

made.

Can we agree on that?

Gen. CLAYPOOL. Yes. I was trying to address more specifically

the GAO’s talk about looking at surrogate models. We are doing

that. We are working on it.

And last, I really do appreciate, sir, the opportunity to come before you. I am very, I am very much committed to this program.

I really do believe that the risk is real and that we have a safe and

effective vaccine when——

Mr. SHAYS. Just to clarify for the record: the risk of an enemy

using anthrax.

Gen. CLAYPOOL. Yes. And I think that the product that we have

has a profile of adverse events that is comparable to other vaccines.

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We are continuing to look for this, for anymore severe reactions,

but I think it is the right program for the country at this time.

Mr. SHAYS. Thank you.

Adm. COWAN. Sir, I am also grateful for the opportunity to be

here and speak. The only job I have ever held in my entire adult

life has been a Navy doctor, taking care of sailors and Marines, and

now being responsible for the other services too.

I am particularly grateful, and I feel obligated to comment about

the first panel, not only for their courage to stand up, but my dismay that they had to have that courage, my dismay that the leadership somehow stiff-arms people and that the medical department

pushes them away or makes access to care difficult.

And, frankly, that just, I find that, I don’t know, equal parts,

saddening and infuriating. And one of the major messages that I

go back with is my eyes opened up at our continuing problem of

getting our people in to do the right things for them.

So I thank you very much for that, sir.

Mr. SHAYS. Thank you. Thank you for those comments.

Yes, sir, Colonel Gerber.

Col. GERBER. Sir, I was also struck, impressed with your opening

premise that we are all interested in the safety and welfare of our

service members, and I think you can assume—I mean, that is job

No. 1, that is what we do for a living. I have been associated with

the anthrax vaccine immunization program everyday for the past

20 months. And the easiest part of my job is accepting the national

intelligence estimates that are validated every year by the five

war-fighting CINC’s that readily, beyond any reasonable doubt, depict an array of anthrax weaponized threat arrayed against our

servicemen.

The second part of my job is my overwhelming belief in the safety and efficacy of an FDA-certified vaccine that we know is safe,

it’s effective, just as safe, and as reactogenic as many of the national vaccines that we employ.

So, thank you very much for this opportunity.

Mr. SHAYS. Thank you very much. Colonel Engler.

Col. ENGLER. I also would like to thank the committee for the opportunity to participate, and for me, at least, a unique experience.

I would like to also, for the record, state that I think the anthrax

program and the lessons learned as we evolve it are very important

lessons that may someday have value added for the taxpayers’

money expended in a future flu pandemic.

As the ex-officio member to the National Vaccine Advisory Committee, I think there is a serious concern of how do you deliver a

vaccine rapidly and effectively to millions of people to save lives.

And a flu pandemic in the future, where in months we can see millions of people die, is an awesome thought. And how we, as a military, will play in that, some of the lessons learned from this program may add value to that experience.

Mr. SHAYS. Thank you. Ms. Ellenberg, doctor.

Ms. ELLENBERG. I would just like to say that we have made, and

will continue to make, the review of the VAERS reports on anthrax

a high priority. And we expect and are happy to continue working

with the DOD to enhance the effectiveness of the reporting programs.

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Mr. SHAYS. Thank you. Dr. Braun, would you like to make a

comment.

Dr. BRAUN. Thank you for the opportunity. I have no comment

to make right now.

Mr. SHAYS. Well, it has been a very helpful hearing. This committee wants to weigh in on the right side, and we, I think, we

have some sense of where we want to move, but it is a gigantic

issue. The threat, the terrorist threat is real, the threat that our

adversaries may use chemical or biological or even nuclear weapons to work their will is very real. Terrorist threats are extraordinarily real. So, this is a big deal.

Thank you very much.

And, my colleague, any comments you would like to make.

Ms. SCHAKOWSKY. Let me just say, for my part, in closing that

in our understandable zeal to protect our service men and women

from the threat of anthrax and ultimately to protect all Americans,

therefore, what I don’t want to see happen is that we are willing

to sacrifice good science, good medicine, good production methods,

and, ultimately, the good treatment of those individuals who truly

want to serve their country.

Mr. SHAYS. We will conclude by thanking the majority and minority staff for their good work, as always, and particularly, on

bended knee, to thank our court reporter, Ron Claxton, who is, who

I am at his mercy. [Laughter.]

We will now adjourn. [Laughter.]

[Whereupon, at 3:07 p.m., the subcommittee was adjourned.]

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