U.S. GOVERNMENT PRINTING OFFICE

58–959 CC WASHINGTON : 1999

DOD’S MANDATORY ANTHRAX VACCINE

IMMUNIZATION PROGRAM FOR MILITARY

PERSONNEL

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

APRIL 29, 1999

Serial No. 106–26

Printed for the use of the Committee on Government Reform

(

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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

JOHN T. DOOLITTLE, California

HELEN CHENOWETH, Idaho

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian

CARLA J. MARTIN, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS, AND INTERNATIONAL

RELATIONS

CHRISTOPHER SHAYS, Connecticut, Chairman

MARK E. SOUDER, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DAVID M. MCINTOSH, Indiana

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

HELEN CHENOWETH, Idaho

ROD R. BLAGOJEVICH, Illinois

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

JOHN F. TIERNEY, Massachusetts

THOMAS H. ALLEN, Maine

EDOLPHUS TOWNS, New York

BERNARD SANDERS, Vermont

(Independent)

JANICE D. SCHAKOWSKY, Illinois

EX OFFICIO

DAN BURTON, Indiana HENRY A. WAXMAN, California

LAWRENCE J. HALLORAN, Staff Director and Counsel

ROBERT NEWMAN, Professional Staff Member

MARCIA SAYER, Professional Staff Member

JONATHAN WHARTON, Clerk

DAVID RAPALLO, Minority Counsel

(III)

C O N T E N T S

Page

Hearing held on April 29, 1999 .............................................................................. 1

Statement of:

Chan, Kwai, Director of Special Studies and Evaluations, National Security and International Affairs Division, General Accounting Office, accompanied by Sushil K. Sharma, Assistant Director ................................. 6

Nass, Meryl, physician, Freeport, ME; Randi J. Martin-Allaire, Eaton

Rapids, MI; Roberta Groll, Battle Creek, MI; David Churchill, Battle

Creek, MI; and Michael Shepard, Savannah, GA ...................................... 104

Zoon, Kathryn, Director, Center for Biologics Evaluation and Research,

Food and Drug Administration; General Eddie Cain, Joint Program

for Biological Defense, Department of Defense; Robert Myers, Chief

Operating Officer, BioPort Corp.; and John Taylor, Senior Adviser for

Regulatory Policy, Food and Drug Administration .................................... 38

Letters, statements, etc., submitted for the record by:

Cain, General Eddie, Joint Program for Biological Defense, Department

of Defense, prepared statement of ............................................................... 64

Chan, Kwai, Director of Special Studies and Evaluations, National Security and International Affairs Division, General Accounting Office, prepared statement of ........................................................................................ 9

Churchill, David, Battle Creek, MI, prepared statement of ......................... 183

Groll, Roberta, Battle Creek, MI, prepared statement of ............................. 176

Martin-Allaire, Randi J., Eaton Rapids, MI, prepared statement of ........... 167

Myers, Robert, Chief Operating Officer, BioPort Corp., prepared statement of ........................................................................................................... 77

Nass, Meryl, physician, Freeport, ME, prepared statement of ..................... 108

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

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

Shepard, Michael, Savannah, GA, prepared statement of ............................ 193

Zoon, Kathryn, Director, Center for Biologics Evaluation and Research,

Food and Drug Administration:

Package insert ........................................................................................... 91

Prepared statement of ............................................................................... 41

(1)

DOD’S MANDATORY ANTHRAX VACCINE

IMMUNIZATION PROGRAM FOR MILITARY

PERSONNEL

THURSDAY, APRIL 29, 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

2247, Rayburn House Office Building, Hon. Christopher Shays

(chairman of the subcommittee) presiding.

Present: Representatives Shays, Mica, Souder, Terry, Tierney,

Allen, and Schakowsky.

Also present: Representative Metcalf.

Staff present: Lawrence Halloran, staff director and counsel;

Robert Newman and Marcia Sayer, professional staff members;

Jonathan Wharton, clerk; David Rapallo, minority counsel; and

Ellen Rayner, minority chief clerk.

Mr. SHAYS. I would like to call this hearing to order.

The plan to immunize 2.4 million men and women against

weaponized anthrax raises legitimate concerns about the safety

and efficacy of the current vaccine when used for that purpose on

that many people. To address those questions, we asked the General Accounting Office [GAO], to examine the data, supporting safety and efficacy claims and to gauge the impact of good manufacturing practice deviations on vaccine quality.

Their preliminary findings will be discussed today. Based on the

GAO study and other information obtained in the course of the

subcommittee’s investigation, the anthrax vaccine immunization

program [AVIP], seems a very broad undertaking built on a very

narrow foundation. The one study of safety and efficacy in humans,

which was conducted among textile workers in the late 1950’s, tested a different vaccine formulation than the one subsequently approved by the Food and Drug Administration [FDA], and used in

the AVIP.

Using data on one vaccine to support the approval of another is

problematic, particularly when there is no direct marker or correlate of human protection to use in comparing the two vaccines.

Lack of a surrogate for anthrax immunity also means efficacy

tests outcomes in animals cannot be extrapolated to humans. The

fact that vaccinated monkeys survived exposure to inhaled anthrax

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longer than guinea pigs or mice suggests, but does not prove, some

vaccine protection in man.

Later studies of the FDA-licensed vaccine also show wide variations in adverse reaction rates, suggesting safety issues that may

become apparent as usage grows from 200 or 300 people each year

to several hundred thousand. There have been no studies of longterm health effects.

Poor DOD recordkeeping prevented any systematic health surveillance of the 150,000 Gulf war troops who took the vaccine. Last

year, Congress directed the National Academy of Sciences to study

the association between Gulf war veterans’ illnesses and wartime

exposures, including the anthrax vaccine.

So it may be premature to conclude that the vaccine is as safe

and effective for use in a global protection effort as it might be for

use by a few thousand mill workers and veterinarians.

Other factors relied upon by DOD to support vaccine safety and

efficacy findings have been inflated to better match the scope of the

AVI program. DOD relies heavily on FDA approval of the vaccine

and FDA regulation of the manufacturer as an indicia of the vaccine’s safety and quality. But we now know that approval was

based on another vaccine in another time for use in another setting

against a different route of exposure.

FDA inspection reports portray an uncharacteristically passive

regulator tolerating numerous serious and persistent violations for

years at the Michigan production plant, now owned by the BioPort

Corp.

The DOD witness at our previous hearing pointed to the ‘‘independent review of the health and medical aspects of the overall

program by Dr. Gerard Burrow of Yale University Medical School,’’

but his report entailed no independent analysis of safety and efficacy data.

In a recent letter to the subcommittee, Dr. Burrow clarifies that

mischaracterization of his work, saying his charge was only ‘‘general oversight of the vaccination program.’’

The AVIP confronts many active-duty, reserve, and national

guard members with agonizing personal and professional choices.

They deserve answers to their questions about the effectiveness

and wisdom of this mandatory, invasive forced protection program.

They deserve to know the vaccine chosen to meet the preeminent

biological threats is as well tested and technologically advanced as

the best weapons systems.

They need to be assured claims of AVIP safety are based on more

than exaggerated interpretations of inconclusive data, and they

need to be assured claims of AVIP effectiveness are based on more

than wishful thinking about monkeys.

At this time, I would like to call on our colleague Ms.

Schakowsky to see if you have any statement. OK? And Mr. Terry.

I would invite our guest to the committee and invite Mr. Metcalf

if he would like to make a statement.

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

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Mr. METCALF. I would. Thank you, Mr. Chairman.

I want to thank the chairman and other members of the subcommittee for allowing me to participate in this hearing and express my concerns regarding the safety and effectiveness of the anthrax vaccine. I am deeply grateful that you have been willing to

conduct this examination of the Department of Defense’s anthrax

vaccine immunization program for all military personnel.

I have two outstanding Navy bases in my district. The men and

women assigned to carry out the missions of Naval Station Everett

and Naval Air Station Whidbey Island are some of our Nation’s finest. I want for them the very best in protection, training, equipment, and every advance of science and medicine that is at our disposal.

I understand the grave concerns which have been the catalyst for

the anthrax immunization program. I must question, however, the

decisions that have been made resulting in the current program.

From the time this program was announced, I have had serious

reservations.

It is my understanding that we have one source for the anthrax

vaccine, and that single source has had significant problems with

FDA violations. I also understand that the anthrax vaccine currently being used to vaccinate our active-duty force was produced

prior to renovations that are under way at the production facility.

The scientific research upon which FDA based its approval was

not conducted to assess protection against a weaponized version of

anthrax. Furthermore, the current vaccine was never intended for

widespread general use but rather for a very small, targeted population.

The monitoring system for reporting problems has been woefully

inadequate.

Those are just a few of the facts that cause me to question the

wisdom of this accelerated service-wide program.

I would like to make the committee members aware of the recently published GAO investigation that I requested regarding the

presence of squalene antibodies being found in the blood of some

sick Gulf war-era veterans.

I asked the GAO to determine if there was any possibility that

veterans had received an adjuvant formulation containing squalene

and to evaluate the validity of the independent research being reported. In their response, the GAO revealed the depth of research

that had been conducted using experimental squalene adjuvant formulations by both the Department of Defense and National Institutes of Health.

It also confirmed that the independent research is based on

sound scientific principles. The integrity of the findings convinced

the GAO that this issue needs to be pursued aggressively.

There are many troubling questions that have been raised as a

result of GAO’s squalene study. Many of you may have seen the investigative articles currently in the press. There have been even

suggestions that there could be a relationship to the anthrax vaccine.

I don’t know what we will find, but I do know that we have a

moral obligation to those who are suffering to stay the course until

this mystery is solved.

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On behalf of the extraordinary active-duty personnel and veterans in my district, I want to thank you, Mr. Chairman, for the

efforts of this committee. You have provided desperately needed

leadership on this issue. Your quest for accountability and the

truth is an example to all of us.

I am confident that our military force will be stronger as a consequence of this examination of the anthrax vaccine program.

I look forward to working with you on this.

Mr. SHAYS. Thank you. It is nice to have you here.

Let me just get some housekeeping out of the way.

I ask unanimous consent that all members of the subcommittee

be permitted to place any opening statement in the record and that

the record remain open for 3 days for that purpose. And without

objection, so ordered.

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

At this time, I would like to call our first witness. His name is

Mr. Kwai Chan, Director of Special Studies and Evaluations, National Security and International Affairs Division, General Accounting Office [GAO].

Thank you. And I believe you are accompanied by Dr. Sushil

Sharma. And I will swear in both of you, but, Mr. Chan, I think

you are the only one who will be giving testimony.

Mr. CHAN. Yes.

[Witnesses sworn.]

Mr. SHAYS. Note for the record that both have responded in the

affirmative.

Mr. Chan, what we are going to do is, we are going to have a

green light for 5 minutes, we are going to roll it over for another

5 minutes.

Mr. CHAN. OK.

Mr. SHAYS. And your testimony, obviously, is very important because it sets the stage for the rest of the hearing. So I want to

make sure you say everything you need to say.

So, if you are ready, let’s begin.

STATEMENT OF KWAI CHAN, DIRECTOR OF SPECIAL STUDIES

AND EVALUATIONS, NATIONAL SECURITY AND INTERNATIONAL AFFAIRS DIVISION, GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY SUSHIL K. SHARMA, ASSISTANT DIRECTOR

Mr. CHAN. Thank you, Mr. Chairman and members of the subcommittee and Congressman Metcalf. It is, indeed, my pleasure to

be here today. Before I present to you our findings on the safety

and efficacy of the vaccine, which we conducted at your request, I

want to introduce my colleague, Dr. Sharma, and also I want to acknowledge my staff, Dr. Howard Deshong and Mr. George Bogart

in helping me to prepare this testimony.

Let me first discuss the context. As you know, controversy has

surrounded the anthrax immunization program since DOD began

vaccinating the first of 2.4 million active-duty and reserve members. Some have questioned the safety and efficacy of the vaccine,

especially after they learned about the numerous problems FDA

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found during the inspection of the Michigan facility. Some Gulf war

veterans believe that their illnesses might have been caused by anthrax vaccines that they received during the war.

Let me turn to our results. With regards to safety, I have three

findings to report. First, the short-term safety of a vaccine was obtained from data collected for licensing and data on subsequent

use. The interpretation of pre-licensing data was complicated by a

switch from one vaccine to another while the study was under way.

Second, after licensing, this vaccine has been used by a small

number of individuals, unlike other vaccines. This number is too

small to detect rare and serious adverse events. In the 1970’s, FDA

did not have an adverse-effect reporting system in place for vaccines. From the available data, we can say that the reported numbers are based on how closely you monitor individuals who receive

this vaccine.

As shown in table one on page 7 of my statement—you see a

table there—which says that if you do not follow individuals closely

after they receive the vaccine, like in a passive system, the number

of significant adverse events are significantly lower. And when you

monitor individuals closely, then the number rises significantly,

this means that the adverse-event reporting system is really dependent on the data you collect, and on the way you collect the

data.

Third, the long-term safety of the vaccine has not yet been studied, and, therefore, one cannot conclude that there are no known

long-term effects.

In summary, then, concerning vaccine safety, studies have been

performed to examine the safety of both original vaccine and the

licensed vaccine. These two vaccines were made using different

processes and have different data to support their safety.

While these studies identify varying rates of adverse reactions

depending on the data-collection mechanism, be they passive or active, they did not question the safety of the vaccine. The long-term

safety of the vaccine had not been studied.

With regard to the efficacy of the vaccine, I have three findings

to report. First, the only human efficacy study conducted was done

on the earlier vaccine, not the licensed vaccine. This study on efficacy was done in 1962 by Brachman. The study demonstrated efficacy against cutaneous anthrax but not inhalation anthrax, which

is the current military threat.

In the 1980’s, the military collected efficacy data on animals specific to inhalation anthrax. All these studies have supported the

view that in those models the vaccine can protect against some anthrax strains, but not all.

Work using monkeys conducted in 1996 show for the first time

that non-human primates could be protected against inhalation anthrax. However, in both the guinea pig and the monkey studies,

protection did not correlate with the level antibodies to protective

antigen [PA].

More recent work done in 1998, by the military, came to the

same conclusion, ‘‘It is unknown what immune mechanisms are important in specific resistance to anthrax. Without a specific and

measurable immune correlate of protection, extrapolation of protecVerDate 11-MAY-2000 14:47 Apr 02, 2001 Jkt 066344 PO 00000 Frm 00011 Fmt 6633 Sfmt 6601 E:\HEARINGS\58959 pfrm04 PsN: 58959
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tion data to show that the vaccine is effective for humans, is of

questionable value.’’ Taking all the evidence into account, it is likely that the vaccine

does give some protection. But to what extent, against what

amount of anthrax, against which strains, and how long protection

last are not known.

In summary, on efficacy, I can say that studies on efficacy of the

original and licensed vaccines have been limited to a study of the

efficacy of original vaccines for humans and studies of the efficacy

of the licensed for animals.

The study on the original vaccine concluded that the vaccine offered protection against cutaneous anthrax. The studies on the licensed vaccine focus on the efficacy of vaccines in protecting animals against inhalation anthrax. These studies, while showing

some positive results, may not be extrapolated to humans.

DOD is planning to conduct such correlating studies.

With regards to FDA’s inspection of the Michigan facility, we

found that until 1993 FDA inspectors did not inspect the part of

the facility where anthrax vaccine was made because they were not

immunized with anthrax vaccine.

The 1996 and 1998 inspection by FDA of the MBPI facility is one

of a series that through the years have been problematic. The

Michigan facility has received warning letters and notice of intent

to revoke their facility license.

FDA’s inspection of the Michigan facility found a number of deficiencies, which fall into two categories. Those that, although serious, might affect only one or a limited number of batches that were

produced when the deficiency was extant and those of generic nature that could compromise the safety and efficacy of any or all

batches.

The manufacturing plant is currently closed for renovation.

Mr. Chairman, this concludes my remarks.

[The prepared statement of Mr. Chan follows:]

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Mr. SHAYS. Would you repeat your last sentence. I was—— Mr. CHAN. Yes.

Mr. SHAYS. Make your last point.

Mr. CHAN. The manufacturing plant is currently closed for renovation.

Mr. SHAYS. Right, but before that.

Mr. CHAN. Yes.

Mr. SHAYS. I just want to be clear on the dates. That is what I

was asking my staff. The plant was not inspected until when, thoroughly, by FDA? Mr. SHARMA. The FDA inspectors were visiting the plant and the

process has changed over time, but they were not able to enter the

facility where they were manufacturing the—— Mr. SHAYS. Dr. Sharma, I am going to have you get a separate

microphone, if you can. I am sorry. I should have asked you to do

that before. I apologize to our official reporter.

Yes. You can pull it down and put it in front of you please. Does

it reach?

There you go. Thank you, Jonathan.

Mr. SHARMA. FDA inspectors had been inspecting the manufacturing facility at routine intervals. However, while they looked at

other components of the GMP, they did not enter the manufacturing facility because they were told that they were not immunized.

The first evidence that we found from FDA records was in 1996,

when they were told, essentially, that they were immunized and

they could enter the facility, and which point in time they uncovered numerous problems.

Mr. SHAYS. So are we basically saying the anthrax portion was

never fully inspected until 1996?

Mr. SHARMA. That is correct. The other components of the anthrax production were looked at, at routine intervals such as, you

know, where they have the labeling——

Mr. SHAYS. No. I understand. OK.

Let me start out first by, Mr. Chan, talking about safety. I just

want to follow the flow of these questions. So you have responded

in part, but I want to make sure I am focused on it.

How different is the licensed vaccine from the earlier version

used in the study? Mr. CHAN. The original vaccine was developed in the 1950’s by

Dr. Wright in Fort Detrick, as I remember. And, the actual license

vaccine, MDPH at the time, the Michigan Department of Public

Health, was granted a license for a similar vaccine. But I think we

found at least there were three differences from the original vaccine.

First, the manufacturing process changed when MDPH took over,

and second, the strain of anthrax that Merck used—this is the

original license, I mean the original vaccine was produced by

Merck. The strain of anthrax that Merck used to grow the original

vaccine was changed, and another strain was used to grow the

MDPH vaccine.

And finally, to increase the yield of the protective antigen [PA],

the ingredient to make the vaccine was changed from the original

vaccine.

So, I think we see three different changes made.

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Mr. SHAYS. Do you consider the safety data on the earlier vaccine

relevant to the questionable safety of the licensed vaccine? I mean,

how relevant is this issue?

Mr. CHAN. I think it is relevant and also is important to understand, back in the 1970’s, when the requirement for licensure was

purely based on safety. I think that the way that it was done, and

later on maybe FDA can expand on this, it is based on the comparison of level of antibody generated, by the two different vaccines.

Mr. SHAYS. Excuse me a minute. I should be timed, Jon. Sorry.

I am sorry. Make your last point again, please.

Mr. CHAN. I am saying that I think the only possible similarity

that was produced is really based on the antibody reaction to PA

that was generated using the two different vaccines. So, in a way,

on the current standard, they are clearly two different vaccines.

Mr. SHAYS. OK. What basis did you find for the DOD statement

that no known long-term side effects are associated with the anthrax vaccine?

Mr. CHAN. Well, I think maybe the statement by itself is misleading because in a way I don’t believe and we have not found any

studies on long-term effects. So if you did not collect the data, certainly there will be no known side effects.

Mr. SHAYS. When you say you didn’t find it, could you just elaborate. I mean, do they exist? Did you make requests of DOD and

others?

Mr. CHAN. Yes, we have. Yes.

Mr. SHAYS. And they were not able to provide you any data that

would have shown you these studies.

Mr. CHAN. Right. We explain that they need to be actively monitoring those people to really determine that, and I may also say

that on other vaccines, such monitoring was not done either. But

for them to say that there are no long-term side effects, we cannot

find any studies to support that statement.

Mr. SHAYS. At all?

Mr. CHAN. No.

Mr. SHAYS. OK. Did you find any toxicology studies on the vaccine in animals?

Mr. CHAN. You want to expand on that?

[Mr. Chan speaks to Mr. Sharma.]

Mr. SHARMA. No, not from the earlier work. These were not the

requirement—— Mr. SHAYS. I am going to ask you to speak a little closer to the

microphone, and a little more slowly, if you would, Doctor.

Mr. SHARMA. It is my understanding, based on the review of

DOD documents that they provided to us, a need for such work was

suggested in 1996, or around that period, but to the best of our

knowledge, such studies has not been conducted.

Mr. SHAYS. Did you find any animal studies to evaluate any reproductive effects of the vaccine?

Mr. SHARMA. No.

Mr. CHAN. No.

Mr. SHAYS. Now, you explained the chart that you had.

Mr. CHAN. Yes.

Mr. SHAYS. But I am to basically infer that if they didn’t have

followup, then they didn’t have reports. But if they had followup,

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then there were serious side effects associated with the vaccine. Is

that correct?

Mr. CHAN. What we are saying is the following. If you have an

active data-collection mechanism, that means actually monitor people you can see that both the Pittman study and also the Tripler

study, TAMC, the numbers are numerically much higher.

Mr. SHAYS. OK, now the Pittman study shows 29, and the other

study shows 43. Is that 43 out of 536 and 29 out of—oh, this is the

percent?

Mr. CHAN. The percent. Yes.

Mr. SHAYS. Now, we are saying that 29 percent had side effects.

Is that correct?

Mr. CHAN. Systemic, mild side effects, yes.

Mr. SHAYS. They were fairly mild, and 43 percent had mild side

effects in the other study. In Great Britain, it is voluntary?

Mr. CHAN. Yes, it is.

Mr. SHAYS. In France, they don’t do it. Their force protection is

through protective gear.

Mr. CHAN. Yes.

Mr. SHAYS. In the United States, it is mandatory. In Great Britain, it is voluntary. And in France they don’t do it.

Now, in Great Britain we learned that you could improve the anthrax vaccine. In other words, this is an old vaccine that we have

now.

Mr. CHAN. Yes, sir.

Mr. SHAYS. And that there would be, they claim, less side effects.

But if you did that, wouldn’t you have to do a new study to determine if this next-generation vaccine were safe and effective and so

on?

Mr. CHAN. Yes, you do.

Mr. SHAYS. So basically what we have is we have a 1950’s vaccine, or a 1960’s vaccine that could be improved.

Mr. CHAN. Sixties. Approved in 1970. Yes.

Mr. SHAYS. If we did the work to improve it, it would take some

time, but then we would have to obviously test it.

Mr. CHAN. Correct. As I understand it, first of all, this vaccine,

as you know, was licensed in the 1970’s. And so improvement can

come in many different ways, one of which is really the reduction

of number of doses that is required.

Mr. SHAYS. OK.

Mr. CHAN. The six doses plus the booster.

Mr. SHAYS. Let me just indulge the committee just for two more

questions. And let me ask you: Why six shots?

Mr. CHAN. Well, we don’t know why either. We understood from

the beginning that in animal studies, only three shots were required to be done. But in the Brachman study, six shots were imposed. And from then on, it became sort of de facto, the number

of shots required were six.

I might add that the Department of Defense is interested in looking and examining why six shots, and could they, in fact, reduce

the second of the six shots.

Mr. SHAYS. Well, let me ask you: Why—what is the claim for the

six shots? There has to be some basis for it.

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Mr. CHAN. I do not believe there is a scientific basis for it, except

the Brachman study, of which they selected the six shots dose as

the regimen they adopted.

Mr. SHARMA. If I may just add to it. I think the way we understand is, the original experiments that were done on mice used the

three shots. And then, in the human studies, subsequently, when

three shots were used, they found three cases that were infected

with anthrax. Two of them had complete series. In one DOD document that they provided to us, it was stated that the investigator

arbitrarily decided to change it to six shots.

And that was the basis for the six shots series. We have not

found any other evidence, and that is because there is really no relationship between the level of immunity and the protection. So it

is not based on any scientific basis that I know of.

Mr. SHAYS. Well, we will ask our other witnesses.

And last, does the six-shot anthrax increase or decrease the safety of the vaccine?

Mr. CHAN. The safety of the vaccine?

Mr. SHAYS. Yes. In other words, if you take six—we are talking

efficacy and we are talking safety—but in terms of if you do it six

times, is it safer or less safe? We don’t know? We do know?

Mr. SHARMA. Well, we do know that each time you take shots

you have more pain. So the more shots you are going to give, you

are going to experience more adverse events—at least the probability increases. And this is one of the very strong limitations of

the current vaccine. The schedule is too long and heavy on the recipients without any scientific evidence of its needs.

Mr. SHAYS. Thank you. I appreciate the committee’s indulgence.

And Ms. Schakowsky.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman.

Has the current vaccine ever been studied in humans to determine its protection against inhalation anthrax?

Mr. CHAN. No it hasn’t.

Ms. SCHAKOWSKY. And are you aware of any other vaccines that

have been licensed by the Food and Drug Administration without

efficacy data to support the intended use in humans?

Mr. CHAN. I am not aware of that.

Mr. SHARMA. No. I have FDA credentials of this.

Mr. CHAN. Yes.

Ms. SCHAKOWSKY. Oh, OK. So you just——

Mr. CHAN. We are not aware of that.

Mr. SHARMA. We are not aware of this.

Ms. SCHAKOWSKY. OK. I am wondering if you are—if you do

know if the results of the efficacy studies in animals then can be

extended and extrapolated to reach conclusions about the efficacy

in humans?

Mr. CHAN. Well, what we found was that if you use the measure,

the so-called antibody, to the PA in animals, that different response

in terms immuno-degenecity by species; that is, what we find is

that there is no direct correlation to the higher the level antibody

implies that you are more likely to be protected among the animals. Although, the best one is really with the monkeys. They are

pretty good in terms of that relationship.

25

We do not have a scientific way to link between animals to humans in terms of a correlation. How does protection correlate in

terms of the level antibody to protect the antigens that are there,

to the antibody.

So, in a way, DOD is, and certainly CDC, are interested in pursuing and, examining this issue because that would be a real help

to science and development of vaccines in the future.

Ms. SCHAKOWSKY. The passive monitoring that DOD is doing

now, is there any active monitoring going on at all?

Mr. CHAN. Yes. In the table, you find the TAMC, 1998, the Tripler, so-called, is active monitoring. This is something that they are

doing now, with a small number of vaccinated individuals.

Ms. SCHAKOWSKY. Are these all DOD studies? Is that what you

are saying? First of all, mine says page 6 and then it has—— Mr. CHAN. I am sorry.

Ms. SCHAKOWSKY. There are four columns.

Mr. CHAN. Yes.

Ms. SCHAKOWSKY. DOD is at the bottom, and it says current

monitoring, and it says passive, 223,000.

Mr. CHAN. That is right.

Ms. SCHAKOWSKY. Are any of those other studies DOD studies or

are they all?

Mr. SHARMA. They are all DOD studies.

Ms. SCHAKOWSKY. They are all DOD studies?

Mr. CHAN. Yes.

Ms. SCHAKOWSKY. OK. I see.

So, what we are finding here is that passive studies in terms of

determining any kind of reactions at all seem to be fairly—not results are reported? Is that what you are saying?

Mr. CHAN. The result in DOD, the current monitoring, the last

column you find—— Ms. SCHAKOWSKY. I am looking at the last column, the passive

monitoring.

Mr. CHAN. Yes, right. And you find that, the level of so-called reported adverse events is very low in the nature of 0.006 to 0.007.

And the intent of this table is to show that, depending on how

you gather your information, you end up with different kinds of

numbers.

Ms. SCHAKOWSKY. OK.

Mr. CHAN. So, in a small way, the Tripler, the TAMC, data,

which is also being collected by DOD as well, is an active way to

reach and find out, are there adverse events, which is something

that DOD is pursuing.

Mr. SHARMA. Let me add to—I think it is very well known that

the VAERS, which is the system that apparently is in place under

FDA—strictly dependent upon the individuals physicians or

healthcare providers to report. It has been well agreed that it is a

signal system; that is, it tells you that something is happening with

this vaccine. It does not tell you how often, with what severity, or

does not establish causality. The limitations are very well accepted.

Mr. SHAYS. Excuse me 1 second. We don’t usually have this problem. Are we able to turn it down a little bit?

I am sorry, Dr. Sharma.

Jonathan, we are keeping you busy today, buddy.

26

Why don’t we do this. Why don’t you keep talking and we will

just ignore the red light, I am sorry to interrupt you.

Mr. SHARMA. I think the VAERS system has, as you know, a lot

of advantages, but if it is used as a basis to determine absolute

numbers, then it is, you know, certainly very misleading. And that

is what we are trying to convey. This is a vaccine which, up until

1991, when it first was used on a large scale of 150,000 people during the Gulf war, that was our first opportunity to learn about how

this vaccine works on large numbers. But we lost that opportunity.

And for the first time, now, we have another opportunity to learn

about this vaccine. However, if you are going to rely your safety information based on a passive system, and present that as an absolute number, you will be under-reporting the adverse events.

Ms. SCHAKOWSKY. No. When we do polls to determine public

opinion, we also have a degree of accuracy. I am wondering in

these other studies, when we talk about, for example the Pittman

study, where we had 29 percent saying they had a mild reaction,

14 percent severe or moderate, to what degree of accuracy can we—

what can we say in terms of——

Mr. SHARMA. These are absolute numbers. You know, it is not

like in that particular cohort 29 percent experienced that. There is

no confidence interval. It is actually——

Ms. SCHAKOWSKY. No. I understand that, but were these, the

number vaccinated, the 500 and—the sample, the universe. Was

that selected in any kind of scientific way?

Mr. CHAN. This is a group that they have. It is not a randomly

selected sample. So as a result, the confidence level cannot be provided. I mean, it could be done that way.

Ms. SCHAKOWSKY. We don’t have any studies that are done that

way so that we can——

Mr. CHAN. If you want to achieve generalizability, no. We don’t

have that. A passive system, potentially, could have that because

if everybody provided information, then you end up with a census

data without sampling. But if people are not encouraged to provide

events that they believe are attributable to vaccine and go through

the system of reporting, then you will have a very low rate of reporting, as a result.

If you want to do an active monitoring, you can do it by selecting

a sample of a few thousand people, and monitoring them over time.

The only question is that with vaccine is it difficult, to detect rare

events and disease or illness out of this small samples?

Unlike polls, it is always one or zero. But to capture a single

event that may occur in a very rare way, then it is difficult. And

so you have that conflict.

Mr. SHARMA. I think this is a very important point. One of the

rare events, Gullain-Barre syndrome, for example, about 1 in

100,000 people, when DOD currently started using this vaccine,

and after it was used in about 150,000 people, they had 1 case. So

there are these rare events that, even if you monitor a population

but if it is small, the likelihood of seeing those events is very, very

small, even in the active monitoring system.

Ms. SCHAKOWSKY. So what is the best way then for us to determine accurately the side effects, the safety hazards?

27

Mr. SHARMA. There are a number of models one could use, and

I think in our discussion with CDC they had provided and discussed with DOD some several options. But let me just talk to you

about how it is currently being done by some of the newer vaccines.

One, with Merck, varicella vaccine, they had voluntarily decided

to followup 100,000 individuals who are receiving this vaccine for

over—at least a start—10 year period. For another vaccine, CDC,

under contract, is following about the same number of individuals

in four HMO settings. And DOD has an excellent opportunity to

monitor because they are all in the system. And there are a number of ways one could do that. And I am sure they are aware of

it and would be able to comment on that.

Mr. CHAN. I think what we are saying is that if they want to do

it, it can be done, without greatly disturbing the system, the way

it is right now.

Ms. SCHAKOWSKY. Thank you.

Mr. SHAYS. I would like to call Mr. Terry, but I just want to

verify one thing on your chart.

Mr. CHAN. Yes.

Mr. SHAYS. Basically, in the Pittman study, 43 percent had either mild or more severe reaction when you monitored. In the

TAMC—and that stands for what, TAMC?

Mr. CHAN. Tripler.

Mr. SHAYS. OK. Right, Army Medical Corps.

They had 48 percent when they monitor it.

Mr. CHAN. Yes.

Mr. SHAYS. And now the DOD—current monitoring—they have

none. Are they, in fact, monitoring? Can we even put the word

‘‘current’’ monitoring? Or is that being a little disingenuous?

Mr. CHAN. Well, they have the VAER system, as we said.

Mr. SHAYS. They have a what?

Mr. CHAN. The VAER system, the passive system where people

can send in a form.

Mr. SHAYS. So, do they give out the forms?

Mr. CHAN. We have another study looking into that to see how

effective that is.

Mr. SHAYS. OK.

Mr. CHAN. But, nevertheless, it is still a passive system.

Mr. SHAYS. So we don’t really even know what kind of monitoring it is, if at all.

Mr. CHAN. If you look at footnote E here, it basically shows that

right now they are experiencing out of 223,000 vaccines you have

42 reports and so on.

Mr. SHAYS. No, but my point is they are not basically monitoring.

Mr. CHAN. Well, that is what we call data collection is passive.

You wait for people to come in and tell you rather than actively

go——

Mr. SHAYS. OK. I don’t call that monitoring, with all due respect.

Mr. CHAN. Oh. OK. I am sorry.

Mr. SHAYS. No. You can call it that. I don’t call it that.

Mr. CHAN. OK.

Mr. SHAYS. Mr. Terry.

Mr. TERRY. Thank you, Mr. Chairman. Some of my questions are

in regard to the Michigan production facility. I am reading your

28

statement, for the record and listened to your opening statement

and I just need to clarify a little bit of a timetable because it raises

some red flags with me.

In your statement, you say that the DOD had inspected the facility, or at least did an inspection in 1992, where it found just a generic statement of deficiencies, including the absence of stability

studies. My question is, just to verify the timetable, that study occurred by the DOD in 1992?

Mr. CHAN. That is correct.

Mr. TERRY. And then, in 1993, the FDA tried to do an inspection

and was turned away because they weren’t, they didn’t have their

immunizations. So the inspection didn’t occur until 1996. Is that a

correct timeline so far?

Mr. SHARMA. Yes. I want to qualify it. This is inspection of the

manufacturing plant. The FDA has been inspecting very regularly

and systematically documenting problems with other components of

the production facility. And these problems were very systemic and

persistent.

Mr. TERRY. OK. But they didn’t get the opportunity to get into

the plant to do the physical inspection until 1996?

Mr. SHARMA. Yes.

Mr. TERRY. And that raises my point here. Some red flags were

put up in 1992; more should have been put up in 1993, but yet they

continued to manufacture and use the vaccine. Correct?

Mr. SHARMA. That is correct.

Mr. TERRY. Until recently, when they, I guess, voluntarily have

closed down the plant for ‘‘renovation’’?

Mr. CHAN. Right. When we say, inspect the facility, we mean the

anthrax production facility because BioPort produces other vaccines

as well.

Mr. TERRY. Right, and that is what I am focusing on.

Mr. CHAN. And so——

Mr. TERRY. Well, we aren’t having a hearing on those others.

Mr. CHAN. I understand. But what I am saying is that FDA had

been inspecting them without entering into that particular production site and observing basic systemic problems in terms of the

processing for the other stuff as well. So they were noticing those

kinds of issues as well.

Mr. TERRY. That is part of my point. We had some of these red

flags popping up, but yet we went through from 1992 until sometime after 1996 but they were still manufacturing.

Mr. CHAN. Right.

Mr. TERRY. Right there that raises a concern with me, but the

issue then is the safety of the end product. Do the deficiencies that

were found then by the FDA in any way affect the safety or the

potency of the vaccine?

Mr. CHAN. As we stated in terms of vaccine, because it is biologic, it is important that you need to make sure safety is built into

the process itself and not just the end product tests. Right now, we

are really talking about the end-product test. And DOD had imposed on further supplemental testing after FDA had passed or released a lot.

So they are doing an extensive listing.

Mr. TERRY. OK. So I guess——

29

Mr. SHAYS. Could the gentleman just yield a second?

Is the answer yes to the question?

Mr. TERRY. Yes. That is what I was going to followup with,

Chris. I am still not sure if we, if I learned that the safety of the

product was jeopardized by these deficiencies. Who are you to

trust?

Mr. CHAN. I do not know.

Mr. TERRY. All right.

Mr. CHAN. I can’t answer that. But I can tell you that off the lots

that have been produced so far, I believe 31 lots—maybe I’ll get the

numbers incorrectly—but 8 of those lots have been released and

supplementary testing has been done by DOD to release it for vaccination.

And my understanding is that of those remaining lots, as many

as 20 lots have been quarantined for further testing. So, it is possible to examine those lots that are going through further testing

to determine where the problems lie in terms of the process. That

means you go backward to find it. That is possible.

I am not sure that has been done. To examine where did it fail.

It could be filtration, it could be something else. But nevertheless,

I cannot answer the question as to whether they are safe or not.

Mr. TERRY. Well, you had mentioned the lots. I think we could

spend a few more minutes dissecting your answer to that, but are

there lots that were quarantined? Is this pursued by the FDA?

Mr. CHAN. Our understanding is the lots had not passed for release, and have not been supplementary tested by—testing had not

been done. So it is awaiting for further testing.

Mr. TERRY. Thank you, Mr. Chairman. My time is up.

Mr. SHAYS. Thank you very much. I’m sorry, Mr. Allen you have

the floor.

Mr. ALLEN. Thank you, Mr. Chairman. Couple of questions. Have

there been any studies of the potential effects of the anthrax vaccine when used in combination with other vaccines or other drugs?

Any studies that—and a little bit of background. In hearings that

this committee held on the effects of Gulf War Syndrome, one of

the—you always hesitate to say it—conclusions, but one of the

views was that it was a combination of different kinds of chemicals

that might be responsible for the various maladies described collectively as the Gulf War Syndrome.

And so, what I am wondering is, it’s one thing to test an anthrax

vaccine all by itself, but it seems to me that typically our service

men and women get a variety of different vaccines. And I would be

interested in knowing whether there is any potential for interaction

of the anthrax vaccine with others that we should take account of?

Mr. SHARMA. To the best of my knowledge, there is one unpublished DOD study, which looked at the interaction effect with botox

and anthrax——

Mr. ALLEN. Between, what was the first?

Mr. SHARMA. The botulism toxide vaccine and anthrax. And I

will be very happy to provide you for the record our review of that

study.

Mr. ALLEN. OK. Good. I would appreciate receiving that. The

other, in the GAO report, you mention the Brachman study

claimed that the vaccine gave 93 percent protection against anVerDate 11-MAY-2000 14:47 Apr 02, 2001 Jkt 066344 PO 00000 Frm 00033 Fmt 6633 Sfmt 6601 E:\HEARINGS\58959 pfrm04 PsN: 58959
30

thrax penetrating the skin, but indicated that the tests on humans

with respect to inhalation are—there are too few cases to come to

any conclusion.

And in your report, on the next page here, it says that you conclude that testing still needs to be conducted on inhalation anthrax,

and you go on to mention some animal studies. How do you do

that? How would you do it? What kind of study could be designed

or should be designed to determine the efficacy of vaccine against

exposure to anthrax by inhalation?

Mr. CHAN. Well, in fact DOD is pursuing studies to examine

whether there is a correlate—that means define the ingredient that

provides protection. They do believe that in animal studies, the

protective antigen plays a major factor, but it is not the only factor.

So they are looking for other means to examine that, as I understand they are pursuing now in their own research.

Mr. ALLEN. Other means besides animal studies? Or—— Mr. CHAN. No. Looking at animal studies and see how it may be

correlated to the human response.

Mr. ALLEN. I see. OK. Thank you very much.

Mr. SHAYS. Thank you. I think it is Mark Souder. I think you

are next.

Mr. SOUDER. I am sorry, I read through your testimony. I’m

sorry I missed the testimony and the first part of the questions.

Are the side effects with this vaccine fairly typical for this serious

of vaccine? In other words, the 43 percent in the one study even

to have mild, that seemed pretty high, although other studies were

lower.

Mr. CHAN. Well, I caution, first of all, that the analysis had not

been done whether in fact it is directly related to the vaccination

itself. So that needs to be done, and then try to attribute it to the

vaccine. And then I think one can draw the conclusion whether it

is really caused by the vaccination.

Mr. SOUDER. Would that be true of other studies of vaccines,

however those——

Mr. CHAN. Yes, you need to do that because there could be other

reasons why it is causing the problem. But those are the kind of

observations you would expect. But the degree, in terms of numbers and so on, it appears to be high.

Mr. SOUDER. What about when it says ‘‘moderate or severe.’’ What does that mean? In other words, is it—I saw one reference

to fevers and chilling, or how frequent is that? Does it mean you

are debilitated? That you can’t ever recover? That you are more

prone—you said in your statement that we don’t know the longterm impact.

Mr. SHARMA. This is very typical of, you know, most bacterial

vaccines. You do recover, and what it—the difference between really mild and moderate and severe is discomfort and how it really

impacts your functioning. And when you are talking about mild to

moderate, this number is high. And, but also you have to recognize

this is a very old vaccine, and I think it will be very appropriate

for you to ask a PA, what their comment or reaction would be if

a newer vaccine would show these numbers. Would it be acceptable

to them?

I think they will be a much better position to address the issue.

31

Mr. SOUDER. Thank you for doing that question for us. [Laughter.]

I see in the testimony of Dr. Zoon that is coming there is a discussion in her testimony about the anthrax vaccine used on livestock workers, and it said that from this manufacturer, that between 1991 and present, 1.2 million doses were distributed. Have

you ever looked at that as to—that’s a pretty big universe to see

whether there are any side effects in that industry.

Mr. SHARMA. Well, let me comment. I think there are two things.

We have to make a distinction between the old vaccine and the licensed vaccine or the original vaccine. As far as we know, for the

licensed vaccine, post-licensure, approximately 60,000—2,000 doses

per year were distributed on average. But we have no information

how many individuals were vaccinated. So even if you assume

every shot went into a human body, we are talking about over 30

years period, approximately about 60,000 individuals at best.

However, in our discussion with scientists at Fort Detrick, the

estimates of the number of people who may have received this vaccine over a 30-year period, range from somewhere between 200 to

about 2,000, at the most. And we don’t know who those individuals

are. There has been no followup. No systematic followup has been

done.

So we really—I don’t know, you know, the context of, I have not

reviewed FDA testimony, but, you know, you have to make a distinction between the old vaccine and the new vaccine.

Mr. SOUDER. If there was any kind of systematic pattern of at

least beyond mild, to moderate, would that not have likely shown

up? In other words, in health journals and so on with the distribution.

Mr. SHARMA. If the vaccine use is on a very large number of people, you would expect some adverse reactions. But again, you have

to recognize the number of people prior to 1998 that were the target group for this vaccine were small. But in general, we would—

I would agree with you, if there was somebody who just dropped

dead or if a very serious event occurred, it would have been reported.

Mr. SOUDER. The symptoms that you described seemed like they

could also become confusing. In other words, depending on the

delay, you could be uncertain of the symptoms. Could that also

make for a reporting problem?

Mr. CHAN. Yes. That is why you need to gather information first

and minimize the screening process of what you believe to be vaccine-related or not, examine those, and pull out the ones it is not

and try to examine further. That is why I am saying there are a

number of steps. In here, we are just showing the immediate reaction of the number of adverse events. And I have to qualify those

numbers.

Mr. SOUDER. So there could be many people who don’t think it

was related to the vaccine and, in fact, it was. Or there could be

people in some of these studies who thought it was the vaccine and

it wasn’t because we haven’t gone——

Mr. CHAN. That’s right. If you have things such as swelling,

edema, around the vaccinated site, and you are going to attribute

32

to the vaccine, but other reactions such as fever, you may not be

able to attribute to it. Yes.

Mr. SOUDER. Thank you.

Mr. SHAYS. Just a small point. You were reading ahead to FDA’s

testimony. Most of the doses, I make an assumption, after 1991

were not with livestock workers. It was really the war in the Gulf,

I believe.

I think you will find that most would be that way, and maybe

we will have the FDA clarify that. But that is from their statement

on page 11. It is a minor point. But for many years, we didn’t have

that many people taking the vaccine until the war in the Gulf.

Mr. Mica.

Mr. CHAN. Oh, I see. Now I understand. The numbers I was a

little surprised by.

Mr. SHAYS. Yes. No, the statement basically says from 1974 until

1989, approximately 68,000 doses were distributed.

Mr. CHAN. I see.

Mr. SHAYS. In 1990, approximately 268,000 doses were distributed. Between 1991 and the present, we understand that approximately 1.2 million doses were distributed.

Mr. CHAN. All right.

Mr. SHAYS. But we will have that clarified.

Mr. CHAN. I understand.

Mr. SHAYS. Mr. Mica.

Mr. MICA. Thank you, Mr. Chairman. Just a couple of questions.

It is my understanding that the only study of the efficacy of the

vaccine was performed by the Brachman study?

Mr. CHAN. Yes, sir.

Mr. MICA. And it is also my understanding that the study gave

the vaccine a 93 percent protection against anthrax penetrating the

skin. It said a lower confidence level of 65 percent. Can you explain

this lower confidence limit, a 65 percent in this study?

Mr. CHAN. I think they had one case of cutaneous anthrax after

they received the vaccine. And you have to forgive if I am incorrect

with the numbers. Out of a total possible expected number of 13.5

or so, and so if you look at that then the actual protection turned

out to be 92.5 percent.

Now, since it is a small sample, they determine what is the uncertainty of that number. And so they end up with the expectation

of 92.5 percent protection but with a lower limit of, as low as 60-

some-odd percent.

Mr. MICA. Well, I also found——

Mr. CHAN. That’s against cutaneous anthrax.

Mr. MICA. Your report found the number of individuals who contracted anthrax by inhalation was too low to assess the efficacy of

the vaccine against this form. So, my concern is that we don’t have

that many experiences with human studies. They are fairly limited,

and from the information and analysis you have conducted, I am

wondering if, again, this forced vaccination is that effective. Do you

feel it is that effective and should be continued?

I mean, just basically, based on the reports and the studies that

have been done.

Mr. CHAN. Well let me answer the first question about why do

we say that it is a small number.

33

When the test was done—the study was done—and published in

1962, it was supplied to four different mills.

Mr. MICA. Right.

Mr. CHAN. And the only inhalation anthrax that occurred was in

mill A, where there were five of them occur, all in a span of 2

months or so. OK?

And the understanding at the time was that since in the mill

itself the air quality was poor, that everybody was exposed to inhalation anthrax. And what the data actually showed, aside from the

small number, that anthrax epidemic occurred in one plant and no

place else. This would suggest that whatever level of air quality

that they were exposed to, including those who did not get vaccinated, end up with inhalation anthrax.

And out of the 1,400, if I remember correctly, some 870 did not

get complete vaccinations. So what I am saying is that for that period, a year and a half or so, 5 cases out of 870 people did not end

up with inhalation anthrax.

So that is the rate you end up with even if you are unprotected.

Mr. MICA. But what this boils down to, I’m trying—— Mr. CHAN. I am sorry.

Mr. MICA. I am trying to get a simple determination, you know,

based on the experiments that have been done, the testing of this

vaccination. Of course, some of it, as you have said, is in a different

setting against different exposures.

The basic question here is, we have several millions of potential

folks that may be vaccinated in the future with this, is it that effective? Or are we going through this giving some sort of false security because it may not protect them?

Mr. CHAN. Well, potentially, you could. In our statement we state

that we believe in fact that it does provide some protection, although the problem, as we discussed before, is about the correlation between animal and human in responding to the challenge.

Mr. MICA. But there hasn’t been enough human testing to determine that under different circumstances. Is that correct?

Mr. CHAN. Yes.

Mr. MICA. And based on the reactions the folks have had, do you

think people should have an opportunity to opt out? Should this be

mandatory?

Mr. CHAN. I think you are asking a policy question. That’s the

DOD—— Mr. MICA. Well, no. OK, if you have your kid who is going to

serve in the military or you, based on what you know, you have

studied this, you are a scientist and have had scientists look at

this, would you recommend that folks have the opportunity to opt

out? Or are we using our service men and women as guinea pigs

in a big experiment that we are not sure really works?

And also, a concern that I have is that you give them some false

sense of security.

Mr. CHAN. I am hoping that we all, hopefully, in this hearing we

end up agreeing with what the data tell us. And the decision of

whether one is vaccinated should be based on a balance between

the risk and possible benefits. You are asking a question, does this

vaccine have a for the lack of a better word is, have a lot of limitation?

34

Mr. MICA. I am sorry.

Mr. CHAN. A lot of limitation, in the sense that it requires a

number of shots over a long period of time. So when you ask the

question of forced vaccination—mandatory vaccination, an issue—

is if you need an 18-month lead time to fully vaccinate, it is hard

for the commander to say I know precisely who is going to go

where in the future with the understanding potentially anybody

could be there in the future.

And then the second question is that this is really the only solutions they have, potentially. So when will you go?

The third thing I would say is that there are other possible alternatives because vaccination is not the only way to defend against

BW agent. You can put masks on; you can basically take antibiotics. Those are other possibilities, and generally we know that,

for example, over the next couple of years, both Department of Defense as well as Department of Energy are spending up to $200

million in terms of detecting both chemical and biological agents,

which will help you to speed up the time in detection and respond

to an attack.

I am not sure I can answer your question in the very precise

way.

Mr. MICA. Are you ready to be vaccinated?

Mr. CHAN. If you tell me exactly where to go next year, sir, I

would tell you that. As a private citizen, I don’t see that threat to

myself or my family, but if, in fact, I need to go to a place where

I do know the country has this, then I would consider that.

But let me also say there is research done where they examine

post-exposure treatments of people, using antibiotics, possibly with

this vaccine that, is licensed, there are some promising results with

animal studies. So those are other options I can have.

And certainly, as the chairman suggests, that we can also pursue

the second-generation vaccine.

Mr. MICA. Thank you. Thank you, Mr. Chairman.

Mr. SHAYS. Thank you. Mr. Metcalf, do you have a question or

two?

Mr. METCALF. Yes, I do. Thank you, Mr. Chairman.

Mr. Chan, as a result of your concurrent investigations of anthrax and squalene antibodies, have any suspicions been raised

about a potential connection between the two? And if so, could you

discuss this.

Mr. CHAN. I do not know the connection scientifically. I do know

that there are soldiers out there who had called us, both Dr.

Sharma and myself, with this concern. As you know, our study basically took the positions that we believe DOD should do some research to examine if indeed a valid assay can be developed to determine the presence of the squalene. I think that would really clear

up a lot of issues.

Mr. METCALF. Thank you. That sort of coordinates with my request for the DOD to do an in-depth investigation on this. If the

DOD acted on GAO’s squalene report recommendation, do you believe that this would allay the suspicions about a connection between squalene as a presence in a vaccine and the Gulf war illnesses?

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Mr. CHAN. Well, I think developing a valid assay is just the first

step of that. If in fact we find that it cannot be validated, then

clearly the associations cannot be pursued. But if in fact you can

validate it, indeed you find an antibody, I think a whole set of new

questions would be raised.

Mr. METCALF. Thank you.

Mr. SHAYS. Thank you. I just have a clarification of a question

that Mr. Terry asked, and that is in regards to the process. My understanding is that the process is important when you are developing a vaccine, and I am going to read what you said.

You said, vaccines have three distinguishing features that contrast—this is on page 4 of your testimony—that contrast with those

of chemical drugs. First, either they have no clear chemical-defined

composition or simple chemical analysis is insufficient for effective

characterization. Second, proper evaluation of them, qualitatively

or quantitatively, is usually done by measuring their effects in the

living organism. Finally, quality cannot be guaranteed from final

tests on random samples but only from a combination of in-process

tests and production tests and strict controls of the entire manufacturing process.

Isn’t it a fact that when you are dealing with biologicals, the

process is a very important element to determine both the safety

and effectiveness of the vaccine that you are developing?

Mr. CHAN. I believe the integrity of the process is a necessary

condition, but it is not sufficient to guarantee quality.

Mr. SHAYS. It is not, but you can take the inverse.

Mr. CHAN. Yes, sir.

Mr. SHAYS. And you can question the quality, and, therefore, you

have to raise gigantic concerns about whether the vaccine should

be used. Isn’t that true?

Mr. CHAN. I think that raises the question. Yes.

Mr. SHAYS. Yes, it does. And just this other point with the

Brachman study.

Mr. CHAN. Yes.

Mr. SHAYS. This was in 1955 and 1959, published in 1962. It was

in a wool mill. Isn’t the problem, we don’t know how they were, at

what levels they were exposed? We don’t know if there was any exposure. We make an assumption that in a wool mill there is going

to be some exposure, but don’t know what level. It could have been

the entire time, it could have been none or minimal exposure to anthrax. Isn’t that correct?

Mr. CHAN. Yes, that is my one comment I made about inhalation

anthrax. The uniqueness of the timing when it all occurred in one

place, in one short period of time when epidemic occur, it does not

suggest that the other plants have problems with air quality with

anthrax spores around.

Mr. SHAYS. Well, that means something to you. I want to put it

in my words, and then tell me if I am inaccurate here.

Mr. CHAN. Yes.

Mr. SHAYS. In my words, we have no control of the threat. First

we don’t know if the threat was the same to those who had the vaccine and to those who didn’t have the vaccine. That is one point.

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But the other point is we don’t know what level the threat was.

The entire time, there could have been minimal exposure. I mean,

there could have been there could not have been. Isn’t that correct?

Mr. CHAN. Yes, it is.

Mr. SHARMA. Let me just answer. We had a meeting on this issue

with Dr. Brachman. And we raised this issue, that was there any

environmental monitoring done. And his reply was no. In those

days, the standards were very different. And then we raised this

issue, how do you know that if no disease occurred it was because

bales were not contaminated. And he did say to us, that this was

one of the very fundamental problems in his study. He did not envision this problem in those days.

But as we discussed, he agreed, that there was no environmental

monitoring. They were equating absence of disease with the efficacy of the disease. Indeed, the only time they checked for the contaminant of the bales was when the epidemic occurred. And they

did find the bale was contaminated. But they did not look for every

single bale that these mills were receiving whether or not—— Mr. SHAYS. And we don’t know what level of contamination—— Mr. SHARMA. No. There was no monitoring at all.

Mr. SHAYS. So let’s—I could make a summation: One, there was

practically none or that there was some, and so this vaccine protects against low-level exposure but that if you had exposure, this

study would be meaningless.

I mean, I can infer that?

Mr. CHAN. Well, yes. I think, what you might be looking for is

sort of a dose response relationship: How many doses you—I believe, in fact, that, you know, with protective antigens, you cannot

protect a person ultimately in the sense that you can always overwhelm your immune system by having enough spores and so on.

So there is a limit here in terms of the level of protection.

That is why I think it is important to have the self-protection,

mask and all the other things that helps. It is really sort of like

giving you the first breath. Because if you just sit there and keep

on breathing this stuff, you get overwhelmed and can be in trouble

as a result.

Yes, you are right. And you are raising a question which we did

not, could not address with Brachman’s study because we don’t

know what the level of exposure was, and we really do not know

if at higher levels whether the vaccinated individual would be protected or not. I think that is a question.

Mr. SHAYS. When you say we, you mean generically we, including Mr. Brachman?

Mr. SHARMA. That is correct.

Mr. CHAN. Including him. Yes.

Mr. SHAYS. And that is not a criticism of him when he did his

study, but it is a criticism of applying this 1950’s study to potentially vaccinating 2.4 million Americans who will be ordered and

who are being ordered to take it.

Ms. Schakowsky.

Ms. SCHAKOWSKY. I just had one question. I was reflecting, Dr.

Sharma, on your response to the chairman’s question about how we

got to six doses. And you said, essentially, that some individual arbitrarily, I think was your word, decided on six doses. I want to go

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back to that just for a minute. So we have nothing to show that

there is any correlation between this six—these six doses and the

efficacy of it, the levels of protection. And nor do we know how this

may impact on adverse reactions on the safety—do we know anything about four versus six or one versus six or anything?

Mr. SHARMA. You have asked two questions. And the first question is about the multiple dose schedule: We do know that there

is a pending IND with FDA which is looking at a reduced-dose

schedule. However, one of the problems is we don’t know what the

level of immunity means in terms of the protection.

There is some animal data that DOD has collected that looks

promising, but what they need to do is to do the bridging studies

which shows what is the relationship between the level of immunity and protection. And then if they could develop those correlates,

then you can overcome this hurdle of, which is the second question,

that is how do you extrapolate those results to humans. And that

has not been done.

Now, with regard to your second questions on what is the relationship between number of dosages and adverse events, I don’t remember exactly, but, yes, there is one place where I have seen on

anthrax vaccine where they had looked at the adverse events by

number of shots. And they do increase with the frequency of the

dose.

Mr. CHAN. I think, if I may answer the question a little differently, I think if in fact one can have an IND whereby one can

reduce the six shots to even three shots, it would be a tremendous

tactical advantage logistically in terms of applying these vaccines,

the current licensed vaccine. Because that would mean, instead of

requiring 18 months for a full regimen of shots, it would be reduced

to 4 weeks.

So the surgeon general of the Army, you know, have been trying

to figure out how best to do that. I think they are initiating a study

to examine that. And it is significant in that sense.

Ms. SCHAKOWSKY. I just want to say that what we don’t know

is just so overwhelming. And in your answer—in your testimony,

it says several studies have shown no direct comparison of immunity and humans to that in monkeys, and the bridging, as you call

it, studies that haven’t been done and the studies of dosage and

how they relate to protection and safety—it is just dramatic, I

think.

Thank you.

Mr. SHAYS. I think we are ready to get to the next panel. Mr.

Chan, I appreciate your statement, and I also appreciate your

frank answers to our questions. Thank you, and Dr. Sharma.

Mr. CHAN. Thank you.

Mr. SHAYS. And obviously, I appreciate the panel No. 2 and No.

3 for their patience as well.

So at this time, I would call Dr. Katherine Zoon, Director, Center

for Biologics Evaluation and Research, Food and Drug Administration, more commonly called FDA, accompanied by Mr. John Taylor,

Senior Adviser for Regulatory Policy from FDA. And then we have

General Eddie Cain, Joint Program for Biological Defense, Department of Defense, and Dr. Robert Myers, chief operating officer for

BioPort Corp.

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Welcome them to come and, if you could remain standing just so

I could swear you in. As you know, we swear in all of our witness

who testify.

Now, let me ask as well. Is there anyone else who might assist

you, who you might prefer to answer the question? If they are here,

I would prefer they stand up as well so we don’t have to swear

them in again.

So if they are here, if there is anyone who might—even if you

end up not doing it, it is probably better to just get sworn in. That

helps us out. And then we will identify you for our recorder if, in

fact, you respond to a question.

And if you would, raise your right arms please.

[Witnesses sworn.]

Mr. SHAYS. Thank you. I recognize all the individuals who stood

up as responding in the affirmative. I think it is very important for

all of our—we have three people testifying, Dr. Zoon, also General

Cain and Dr. Myers, for you to feel that you can give a full statement. And also I have no problem with you responding to anything

you have heard. You have been very gracious in listening to the

testimony. And you may disagree with it, and you may have some

very helpful facts that would allay some of our fears as well.

So, we will start out with Dr. Zoon, then we will go to General

Cain, and then we will go to you, Dr. Myers. And I am going to

do a 5-minute clock. I am going to switch the clock again another

5 minutes. And we will see if that gives you enough time.

So, at this time, Dr. Zoon.

STATEMENTS OF KATHRYN ZOON, DIRECTOR, CENTER FOR

BIOLOGICS EVALUATION AND RESEARCH, FOOD AND DRUG

ADMINISTRATION; GENERAL EDDIE CAIN, JOINT PROGRAM

FOR BIOLOGICAL DEFENSE, DEPARTMENT OF DEFENSE;

ROBERT MYERS, CHIEF OPERATING OFFICER, BIOPORT

CORP.; AND JOHN TAYLOR, SENIOR ADVISER FOR REGULATORY POLICY, FOOD AND DRUG ADMINISTRATION

Dr. ZOON. Thank you, Mr. Chairman.

Mr. Chairman, members of the committee, and Mr. Metcalf, if he

comes back, I am Dr. Kathryn Zoon, Director of the Center for Biologics Evaluation and Research at the Food and Drug Administration. I appreciate the opportunity to discuss the safety and efficacy

of the anthrax vaccine currently manufactured by BioPort Corp.

Mr. Chairman, we are aware that some people question the safety and efficacy of the anthrax vaccine. Let me be clear, we believe

that for persons at high risk, the licensed anthrax vaccine is safe

and effective for the prevention of the often-fatal anthrax disease.

Our confidence in this vaccine is based upon four components.

First, the clinical trials and subsequent clinical laboratory experience with the vaccine. In this case, the Brachman trial and the

CDC trial, which I will discuss.

Second, ongoing inspections of the manufacturing facility based

on our CGMP requirements. Third, our lot release requirements,

which are another layer of protection, and fourth, our surveillance

of adverse event reports that serve as an early warning system.

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We continue all our efforts in all four categories of these areas

to help assure that only safe and effective products are on the market.

Anthrax is a highly infectious disease caused by spores of a bacterium known as bacillus anthracis. Untreated cutaneous anthrax

infection has a mortality rate of approximately 20 percent. Inhalation anthrax has a mortality rate of 80 to 90 percent or higher.

Mr. Chairman, the only known effective prevention against anthrax disease is the anthrax vaccine. The Centers for Disease Control and Prevention data on reported cases in the United States indicate a decline from 130 cases per year at the beginning of the

century, to zero cases per year in recent years. Use of the anthrax

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

I will describe the historical efficacy data for you. During the

1950’s, Philip Brachman and his colleagues conducted a singleblinded clinical trial involving workers in four mills in northeastern

United States. Mill workers were at risk because they routinely

handled anthrax-infected animal materials. By comparing the completely vaccinated population versus the placebo population, the

authors of the study calculated a vaccine efficacy level of 92.5 percent.

On April 14, 1966, CDC submitted an investigational new drug

application for the anthrax vaccine to the Division of Biological

Standards, which at that time was part of the National Institutes

of Health. Under this IND, the Michigan Department of Public

Health manufactured most of the lots of investigational vaccine

prepared in a similar, but not identical, manner to the vaccine used

in the Brachman study.

Data submitted to the Division of Biological Standards under

this IND describe CDC’s experience with approximately 7,000

study participants, including textile workers and laboratory workers. On November 10, 1970, the Division of Biological Standards

granted a license to the Michigan Department of Public Health for

the production of anthrax vaccine.

The data submitted by CDC met the provisions of the Public

Health Service Act, which require evidence of safety, purity and potency. After the Division of Biological Standards was transferred

from NIH to FDA, a panel review was initiated to verify whether

existing data supported the safety and efficacy of biological products. The panel on review of bacterial vaccines and toxoids evaluated all safety and efficacy from the CDC and Brachman trials.

The panel recommended that anthrax vaccine manufactured by

the Michigan Department of Public Health be classified as a category one product, meaning it was considered safe, effective and

not misbranded.

As the panel concluded, it would be virtually impossible to conduct an efficacy study today as the incidence of naturally occurring

anthrax in humans is low and sporadic in occurrence. The safety

data base developed by CDC under the IND, however, would be

considered a reasonable pre-licensure data base to evaluate such a

product today.

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The population that has been immunized to date represents individuals who are considered to be at risk for exposure. Approximately 7,000 patients were vaccinated during the CDC clinical

trials. While it is not possible to accurately report the precise number of people vaccinated between 1974 and 1989, approximately

68,000 doses were distributed. This is sufficient to vaccinate about

11,000 people.

Deviations from current good manufacturing practices have recently been documented during inspections of the anthrax vaccine

manufacturing facility. CGMP’s are only one of the several safeguards to assure product quality. Our surveillance includes information from testing and review of manufacturing records, which

showed lots of product available for distribution are safe and effective for immunizing individuals at risk.

The anthrax vaccine is subject to lot release. The lot-release program helps assure product safety by providing a quality-control

check on product specifications. Each product lot of anthrax vaccine

undergoes thorough testing, including purity, potency, identity, and

sterility. Manufacturers may release lots only after this testing is

documented and reviewed by the FDA.

FDA uses the vaccine adverse-event reporting system, VAERS, to

track adverse-event reports possibly associated with licensed vaccines. Any person, including a patient, can file an adverse-event report. Reporting adverse experiences associated with anthrax vaccine is voluntary for healthcare providers and mandatory for the

manufacturer. A report does not indicate that the vaccine caused

the adverse event, but only that the event occurred soon after the

vaccine administration.

From the time VAERS started operating in 1990, until April 1st,

1999, 101 reports of adverse experiences have been received regarding the anthrax vaccine. Of these, 87 were non-serious and 14

were considered serious events. As the number of people immunized with vaccine increased, the number of adverse-event reports

may also increase.

Data from the VAERS system can serve as a useful tool in identifying potential problems with the vaccine. Thus far, the reports received on the anthrax vaccine do not signal concerns about the

safety of the vaccine.

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

persons at high risk, the licensed vaccine is safe and effective for

the prevention of anthrax—disease.

I can assure you that FDA will remain vigilant in its oversight.

I appreciate the subcommittee’s interest in this very important

topic, and I will be happy to answer any questions.

Thank you.

[The prepared statement of Dr. Zoon follows:]

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Mr. SHAYS. Thank you very much.

General Cain. Thank you.

General CAIN. Chairman Shays and other distinguished committee members, I am honored to appear before your committee

today to address the production and supplemental testing of the

Department of Defense, the DOD’s, vaccine program. I am Brigadier General Eddie Cain, Joint Program Manager of the Joint Program Office for Biological Defense, and I have served in this position since June 1998.

I have provided the committee with a more detailed written

version of my testimony that I would like to submit for the record.

Today, I will address the specific questions raised in your letter to

Secretary Cohen that are in my area of responsibility.

The Joint Program Office of Biological Defense plays a major role

in force protection with DOD by providing detection equipment and

medical products to all service members. One aspect of my mission

is to provide centralized program management for the advance development and production of all DOD biological defense vaccines,

including anthrax vaccine.

This responsibility includes licensing, testing, and stockpiling

these biological defense vaccines. As was stated during the March

24th hearing, anthrax is a major biological warfare threat faced by

our armed forces. More than 10 countries, including Iraq, have or

are suspected of developing a biological warfare capability.

Anthrax is the biological weapon most likely to be encountered

because it is highly lethal, easy to produce in large quantities, and

relatively easy to weaponize. If anthrax is used as a biological

weapon, disease will most likely occur by inhalation of anthrax

spores. Death is the usual outcome once clinical symptoms appear

regardless of any post-exposure treatment.

Death from anthrax, however, is preventable by immunization

with the licensed vaccine, thereby enhancing force protection. On

a personal note, I have received four of the six shots, and I can tell

you that I have no reservation about taking the vaccine, and I have

had no adverse reaction.

Protection of the total force against anthrax was initiated by Secretary Cohen in December 1997. One of the conditions required before implementation of the immunization plan was that supplemental testing had to be accomplished to assess sterility, safety,

potency, and purity of the vaccine lots in the stockpiles. The FDA

has previously released all lots in the stockpile. DOD, however, for

added assurance, directed the Joint Program Office to contract the

Michigan Biological Products Institute, now BioPort, to conduct

supplemental testing on all lots of anthrax vaccine in the DOD

stockpile.

Whereas, BioPort conducts the actual testing, Miretek Systems

Inc., a DOD contractor, provides independent oversight of this testing. Miretek staff observes all aspects of the supplemental testing

and provides a written report to the Joint Program Office on the

acceptability of the testing and test results.

The Joint Program Office then reviews all data prior to releasing

any lot for shipment and use. Only those lots in the original stockpile that have passed supplemental testing have been approved for

use for immunization.

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Supplemental testing began in January 1998. As of April 1999,

eight lots have passed all supplemental testing requirements. Detail status of the remaining lots is outlined in my written testimony.

I will now discuss the anthrax vaccine production facility, which

is the only FDA licensed manufacturer in the world. Before implementation of the immunization plan and the November 1996 inspection, a DOD task force evaluated the anthrax vaccine capabilities at the facility. It was determined that the facility would require substantial renovation to meet production and FDA regulatory requirements.

Let me reiterate that the decision to renovate the facility was

made before the 1996 FDA inspection. Production was stopped in

January 1998 to begin the renovations. The physical aspects of the

renovation were completed in January 1999. Completion of the renovation also requires validation of the manufacturing equipment

and the production process. The process validation includes producing several lots of anthrax vaccine for review by the FDA.

We expect new vaccine to be available by January 2000.

With respect to current vaccine availability, there is sufficient

anthrax vaccine to support the Secretary of Defense anthrax immunization program through December 1999. Beyond 1999, both the

remaining doses in the stockpile and new vaccine produced in the

renovated facility will ensure that DOD has sufficient doses to

meet force-protection requirements.

In conclusion, anthrax vaccine is a key element in protecting

service members against a lethal threat of anthrax. The DOD will

continue to work with BioPort and the FDA to ensure there is a

sufficient supply of safe and effective anthrax vaccine.

Mr. Chairman, this concludes my statement. Although I did not

address your question regarding adverse reaction reports, I have

included a statement in my written testimony from the Office of

the Surgeon General regarding this topic.

I am ready to address any questions that may fall in my responsibility at this time.

[The prepared statement of General Cain follows:]

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Mr. SHAYS. Please summarize that Surgeon General’s report.

General CAIN. In summary, Mr. Chairman, the surgeon general

just concluded that it is safe and effective—that the vaccine is safe

and effective.

Mr. SHAYS. That is a real summary. [Laughter.]

I was hoping for a little meat in there, a little detail. Are you

prepared to give anything more than that summary?

General CAIN. I am not at this time.

Mr. SHAYS. Dr. Myers.

Dr. MYERS. Mr. Chairman and distinguished committee members, my name is Dr. Bob Myers, and I am the chief operating officer of BioPort Corp. And thank you for making my stay here in

Washington as pleasant as possible.

I am proud to come before you today and tell you about our experiences as the manufacturer of the first and only routinely used defense vaccine in our country. I am pleased to have this opportunity

to personally assure you of our vaccine’s safety and effectiveness.

Indeed, this vaccine, instead of being criticized, should be welcomed

as a safe and effective counter to biological warfare in today’s highly threatening global environment.

I have worked for the lab since 1978, when it was owned by the

Michigan Department of Public Health. I have been involved in,

largely directed, the manufacture of all doses of anthrax vaccine

being used in the Department of Defense, by the Department of

Defense in its anthrax vaccine immunization program.

Let me be clear at the outset. I don’t set policy; I make vaccines.

And I am totally committed to providing the very best protection

possible against the anthrax threat. BioPort has worked closely

with the FDA to license and manufacture a quality vaccine, and we

are working closely with the DOD to build and test a stockpile of

vaccine that meets their important force-protection requirements.

As you have heard this morning, anthrax is by far the most likely bio-weapon we will face in the near future. The vaccine has been

produced in Michigan since the mid-1960’s, when the Federal Government came to the Department of Public Health and asked them

to develop and produce an anthrax vaccine which was badly needed

in the textile industry as well as to protect laboratory workers

studying anthrax.

The Michigan lab had a long and outstanding history as one of

the leading vaccine developers in the country, had an excellent

working relationship with the CDC and the DOD, and last, but by

no means least, they were willing to do the work on a vaccine that

would protect people against anthrax at a time when there was no

interest.

While the anthrax vaccine was licensed in 1970 on the basis of

efficacy already presented to you today by FDA, and this was before I started working at the lab, I routinely review information relating to its safety and effectiveness. So I note the efficacy of

BioPort’s vaccine was confirmed in 1985 by an expert panel, which

found that from 1962 to 1974 no cases—let me repeat, no cases—

occurred in fully vaccinated individuals despite continued cases in

unvaccinated mill workers.

The FDA panel concluded that the anthrax vaccine is safe and

effective.

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And let me just point out by example here, in way of answering

some questions that may arise—I will start out by saying yearly

deaths for the United States for 6 or 7 years, 1990, one; 1991,

three; 1992, one; 1993, three; 1994, six; 1995, four; 1996, four.

None of these deaths occurred in vaccinated individuals, and the

vaccinated individuals receive either three or five doses. Now, the

example that I am describing is an example that is not anthrax,

but rabies.

We give fives doses of rabies after exposure. Do we know we need

to have five doses? No, but when the studies were done, five doses

worked. If you don’t get vaccinated for rabies, you die after you

have been exposed.

Five doses of DTP are given to children between the ages of birth

and 5. Would four doses work? While there is some evidence to

show that for newer vaccines, perhaps four doses would, and you

wouldn’t need a fifth.

Why are there six doses for anthrax vaccine? Because six doses

work to stop disease, and there haven’t been incidences of disease

that are large enough since then to study.

Mr. SHAYS. Let me just make sure I am clear on that. Are you

saying in general, Dr. Myers, that six doses is the norm for all vaccines?

Dr. MYERS. No I am not. I am saying that five doses for rabies

vaccine post exposure works. Nobody wants to take a risk at cutting that back to four. Five doses of DTP are given between birth

and 5 years of age. There is some evidence to show that the fifth

dose may not be needed, but it is still given. And we know that six

doses of anthrax vaccine worked in clinical studies, and since the

incidence is so small, no additional studies have been done. Six

works; we stay with six.

Mr. SHAYS. Let me just let you continue, and then I will have

you come back.

Dr. MYERS. Thank you.

Mr. SHAYS. Thank you. I am sorry I interrupted you.

Dr. MYERS. Thank you.

The FDA and DOD have already spoken to adverse events that

have been reported to them. And my written testimony fully covers

this topic as well.

I would like to make several additional comments. Let me describe a study that you may not be familiar with. It is a study of

about 400 individuals whose reactions were actively solicited after

three doses—for each of three doses: Redness, any, 21 percent.

Soreness, any, 68 percent. Swelling, any, 11 percent. Arthralgia,

any, 16 percent. Fatigue, any, 33 percent. Headache, any, 37 percent. Headache, severe, 2.8 percent. Rash, any, 5.2 percent. Rash,

severe, none. Fever, 99.5 degrees Fahrenheit or greater, 2.26 percent.

Seems like a rather high reaction rate. Listen carefully. What is

striking is that this was part of a study done with one of the most

recently licensed FDA vaccines, a vaccine licensed to protect

against lyme disease. But most striking, the reaction rates I just

described to you were from the placebo group, not the vaccine.

If you actively solicit reaction rates to injected vaccines, because

they use needles, they break the skin, they break nerve fibers, they

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create inflammation. You will have side reactions. Most will be

local. Some will be severe. Generalized reactions can also occur.

I have personally had many doses of the vaccine over the years,

more than you, General Cain, and have had nothing worse than

the sore arm experienced by many others. If the anthrax vaccine

were available for my wife, my children, and my grandson, I would

have absolutely no reservation in administering the vaccine to

them, including my eldest daughter who is of child-bearing age.

One of the ways the safety and efficacy of vaccines are ensured

is through periodic inspections of manufacturing facilities to determine if they are operating in accordance to their license and according to good manufacturing practices.

Our labs have been inspected at least 48 times since 1969, including several recent inspections that reported serious deviations

of GMP’s. BioPort takes this matter very seriously.

I would like to point out that contrary to the testimony of the

GAO, the manufacturing facility was inspected in January 1993.

That is the anthrax manufacturing line. It is not a plant. It is not

even a building. It is a floor in a building at a campus that has

about 20 buildings, most of them two stories or more.

This facility, on the basis of that inspection, was approved in

July 1993. Two inspections in 1998, one in February and the other

in October, concentrated heavily on the anthrax vaccine, the lots in

the stockpile, and related GMP issues. We expect another inspection this summer as part of the FDA’s review of our renovated anthrax facility that many have already discussed this morning.

After the February 1998 FDA inspection, we voluntarily quarantined, as a precautionary measure, 10 lots previously released by

the FDA. An 11th lot had been quarantined before the inspection.

These lots will remain in quarantine until any outstanding issues

are resolved to the satisfaction of BioPort and the FDA. If satisfactory resolution is not obtained, the lots will be rejected.

In conclusion, the anthrax vaccine being provided to our troops

is safe and effective. It’s a typical vaccine. It is not the exception.

BioPort is fully committed to making safe and effective vaccine. I

am greatly concerned about the unsubstantiated comments made

by those who, for whatever reason, are opposed to this important

protection against one of the most serious biological threats in the

world today.

The anthrax vaccine is an essential component of force protection

in our military, and we at BioPort are committed to providing the

men and women who serve our country with the highest quality

vaccine.

Thank you for the opportunity to be here today. I would be happy

to answer any questions you might have.

[The prepared statement of Dr. Myers follows:]

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Mr. SHAYS. Thank you. Dr. Myers, let me just say, since your

company produces the vaccine, that if we ask questions of others

and you think something is not stated correctly that even if we did

not ask you, I want to make sure that you let us know you want

to respond and jump in.

Dr. MYERS. Thank you very much. I will.

Mr. SHAYS. Let me start with you, Dr. Zoon.

Would FDA approve a new anthrax vaccine today based on data

from a different vaccine?

Dr. ZOON. FDA would look at the data supplied by the manufacturer and, depending on the data submitted, that possibility exists.

Dr. MYERS. If I could just add to that as a manufacturer? There

are many vaccines that are licensed without direct efficacy studies

in humans. The rabies vaccine, formerly manufactured by the

Michigan Department of Public Health, was licensed in 1998— 1988—based on post-exposure-simulation studies not exposure in

actual field conditions with known rabid animals.

Mr. SHAYS. OK. I am happy to have you jump in. I just want to

pursue the question, and then you are welcome to jump in.

Dr. MYERS. I am sorry.

Mr. SHAYS. Dr. Zoon, is it your testimony that the FDA will approve a new vaccine based on data from a different vaccine? Do

they do that?

Dr. ZOON. As I said, Mr. Chairman, we would look at the entire

data base—— Mr. SHAYS. No. That is not what I asked. I want you to answer

the question. I asked, can you give me examples of other times that

you have done that in the past.

Dr. ZOON. We have approved materials in which study was done

with another product, which was developed by a different company,

and then there were changes during the initial production—major

manufacturing changes during the course of the study.

Mr. SHAYS. What was that product?

Dr. ZOON. The product was Avenex.

Mr. SHAYS. And so all the studies were on the old vaccine. And

then they were allowed to change it and you approved it based on

the studies of the older vaccine?

Dr. ZOON. The pivotal study was done with the original material.

Yes.

Mr. SHAYS. OK. There were studies done afterwards, before

you——

Dr. ZOON. There were, there were——

Mr. SHAYS. Let me just say something. I don’t want you to answer quickly, I want you to speak more slowly because this is your

field, not mine. And I don’t want to get lost.

Dr. ZOON. Right. OK.

Mr. SHAYS. What I am asking is, did you, before you licensed

that product, even though you did the pivotal studies, you said, on

an older vaccine, did you continue to do studies on the new vaccine

before you approved it?

Dr. ZOON. The material was continued in other clinical studies.

Mr. SHAYS. Before you approved it?

Dr. ZOON. That is correct.

Mr. SHAYS. OK.

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Dr. ZOON. However, those studies weren’t the pivotal efficacy

studies.

Mr. SHAYS. But the bottom line is you still did studies before you

approved it.

Dr. ZOON. We did studies—the material was put in humans. Yes.

Mr. SHAYS. OK. And has FDA licensed any other vaccine without

human efficacy data, and I think Dr. Myers responded. But I want

you to respond.

Dr. ZOON. Has FDA—excuse me.

Mr. SHAYS. Has FDA licensed any other vaccine without human

efficacy data?

Dr. ZOON. Efficacy data? I am not prepared to answer that question. I don’t have all the information with me today. I would have

to go back and look at my records to get back to you on that.

Mr. SHAYS. But none comes to mind. I realize that there may be

many. But none comes to mind right now?

Dr. ZOON. To be honest with you, Mr. Chairman, I focused my

concentration on anthrax vaccine for this hearing, and I would be

happy to go back and check the records for that.

Mr. SHAYS. OK. Did you want to make a comment, Dr. Myers?

[Myers indicates he doesn’t.]

Mr. SHAYS. OK. Why did FDA conclude that you needed six shots

for anthrax? Dr. Zoon, why did the FDA conclude you needed six

shots, not seven, not five, not four. What was the basis, what study

was done that showed the six was what you needed to do?

Dr. ZOON. Mr. Chairman, I will answer your question. I wanted

to make one clarification for the record, is that the product that I

described, Avenex, is a therapeutic, not a vaccine—just to make

sure that that is clear.

Mr. SHAYS. OK. Then let’s back up. Tell me a vaccine.

Dr. ZOON. I don’t have any other examples here right now.

Mr. SHAYS. OK. Is there anyone else in FDA here who could tell

me of any vaccine that has been approved by, where a study has

been done on one and then approved on another? I would be happy

to swear you in. I am not saying it doesn’t exist. We just want it

on the record.

Ms. GOLDENTHAL. I am Karen Goldenthal.

Mr. SHAYS. Why don’t you sit down. And I thank you. And feel

free to catch your breath a second. Move that water out of the way,

and we are in no rush.

Ms. GOLDENTHAL. I am Karen Goldenthal with FDA.

Mr. SHAYS. And let me request that you leave your name with

the recorder.

Ms. GOLDENTHAL. Certainly.

Mr. SHAYS. Thank you. Nice to have you here. Thank you.

Ms. GOLDENTHAL. Thank you, Mr. Chairman. The Merck hepatitis A vaccine underwent a very major manufacturing change between the time of the pivotal efficacy trial and the time of approval. And this involved a scale-up and actually change in the procedure of how the hepatitis A virus was grown. So that is an example that comes to mind. And it actually took the sponsor several

years to work out all of the issues with the new manufacturing

change.

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And then they did a comparison with the material from the efficacy trial.

Mr. SHAYS. Did they do new studies with the new vaccine?

Ms. GOLDENTHAL. You know, I would have to go back at the file

and detail to give you that information, but I believe that they did

one study where they looked at the immunogenecity of the new material.

Mr. SHAYS. I don’t know what that last sentence——

Ms. GOLDENTHAL. The antibody response.

Mr. SHAYS. OK. Thank you.

Mr. SHAYS. Let me just ask two more questions here.

Does the FDA require immune correlate protection in an animal

model as the basis for extrapolation of efficacy findings to humans?

Dr. ZOON. Excuse me, Mr. Chairman, can you——

Mr. SHAYS. We are trying to find—I want to know if you have

to find a correlate between what you do in an animal versus its impact on a human being.

Dr. ZOON. There are not good animal models for all studies. However, there are a number for many systems, and with vaccines,

often animals are used to look at protection and looking for evidence of correlation with protection as well as human data. And

when we can do studies in humans, we also look for correlates of

protection.

Mr. SHAYS. Do you look for them, or do you actually demand that

they exist before you license?

Dr. ZOON. In vaccine trials, you had asked earlier about why six

doses. In the field of vaccinology, much of it is determined empirically; that means you pick a regimen, you study the regimen.

[Microphone wires knocked out.]

Mr. SHAYS. Let me just finish my question then. I am sorry.

Dr. Myers, and then I am going to come back for a second round.

But if the vaccine is demonstrably safe, why would the company request and receive an indemnification from DOD against the risk of

liability due to the possible adverse reactions and failure of the

vaccine to convey immunity?

Dr. MYERS. The answer to that is the same reason that there is

a National Vaccine Injury Compensation Program now. It is to control tort. In 1985, the——

Mr. SHAYS. Speak slowly. You are going to get your chance to say

everything. I just want to——

Dr. MYERS. I want that 20-minute break. [Laughter.]

Mr. SHAYS. Yes, sir.

Dr. MYERS. I am sorry. In 1985, the price of a dose of DTP vaccine went from 15 cents to $11 and above because of the tort activity, the litigation that was uncontrolled and unpredictable. I am

happy to say now that the cost of a dose of DTP is much, much

less as the Federal Government has very wisely funded a program

to adjudicate, deliberate, and pay reasonable award to people injured.

There is no such program for anthrax vaccine.

Mr. SHAYS. OK. But, let me understand. Is it comparable? Why

wouldn’t you be given the same protection as others? This seems

like it is greater protection. I may be wrong.

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Dr. MYERS. I would welcome and encourage all vaccines to be included in the National Vaccine Injury Compensation Program, but

today they are not. And the anthrax vaccine is not included in that

program, federally mandated program.

Mr. SHAYS. You make other products, like tetanus and others for

DOD?

Dr. MYERS. That is correct. Not for DOD.

Mr. SHAYS. OK. But do you have—explain to me—do you have

that same exemption?

Dr. MYERS. Not from the DOD. We are in the Department of

Treasury-administered National Vaccine Injury Compensation Program, and we pay a surcharge; that is, an excise tax, on each dose

that is distributed. That funds the program in the case of the rare

but possible event that there is injury.

Mr. SHAYS. OK. Working backward, and then obviously, the seller pays the cost. In other words, am I to infer, trying to answer

the question for you, that is your testimony in essence if you are

under that program, you would just charge the DOD that much

more?

Dr. MYERS. I don’t have my legal counsel here today, and I think

it is a matter for legal counsel to determine whether the choice

would be to go with National Vaccine Injury Compensation Program or to continue to pursue indemnification.

Mr. SHAYS. Well, during this break, I will give you a little bit of

a homework assignment. If you would just find out why this seems

a bit broader, and I would just love to know why. And maybe there

is an explanation. And if you would call your counsel and find out

the answer to that.

Dr. MYERS. Let me just say—could I complete the answer. At the

highest level, this vaccine is getting serious criticism. These hearings have added to that criticism. I think much of that criticism is

unfounded.

Mr. SHAYS. It may be.

Dr. MYERS. And I think people would be—anybody who is trying

to protect their business would be scared to death of not having indemnification with such loud and unfounded criticism occurring.

Mr. SHAYS. Well, let me just respond to that because there are

two sides to every story. This is a mandatory vaccine. This is not

voluntary. This is 2.4 million people, not a few hundred, and this

committee and others have every requirement to examine the facts.

And I asked a very simple question, and I don’t think it is a hard

question to answer. And in fact, I think you may have answered

it. All I want to know, is this unique for this particular vaccine

that gives you an added advantage that didn’t exist for others and,

if so, why? And if it isn’t, then the question is a simple answer and

on to the next question.

General Cain, maybe you could respond to why you decided to do

this.

General CAIN. What was the question?

Mr. SHAYS. Yes. The question is: The DOD decided to basically

give BioPort blanket indemnification, hence risk of liability due to

the possibility of adverse reaction or failure of the vaccine to convey immunity. And I need to know why DOD decided to do that?

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And if you want to think about that and give us an answer when

we come back. The question is, have you done it for others as well?

And we will have a 20-minute break. Thank you.

[Recess.]

Mr. SHAYS. I would like to call this hearing to order. I could ask

some more questions, but I am just going to kind of make a comment that hopefully puts this hearing in some context.

I chaired the Subcommittee on Human Resources before I

chaired this subcommittee, both in Government Reform. And we

oversaw FDA. We have done a lot of work, the former committee,

on Gulf war illnesses. I candidly have suspicions that raise my concerns, but I will first state, I don’t know if in the end the military,

the DOD, is correct in, one, having this policy. I will say to you

that there are soldiers that have do not want to take this vaccine,

General Cain.

So I don’t know whether they are correct or not. And when I ask

these questions, I think we could be in a conflict and our soldiers

could be exposed to anthrax and do I want to be the person that

somehow moved our Government to not do this?

So there are questions on both sides. In my mind, the jury is out.

Where the jury is not out for me is, that given some of our concerns

that this is a mandatory program and not a voluntary one. It would

seem to me that until some questions are answered, this should be

a voluntary program.

So I will obviously acknowledge to myself and for the record that

I believe this should be a voluntary program until some questions

are answered and that then the military should be required to convince their men and women that it is in their best interest, and

then let the men and women of our forces come to some conclusion.

I will also say that one of my problems is that I did not like how

the FDA handled pyridostigmine bromide [PB]—I didn’t say it correctly, but I can say PB—and that for the use in the military it was

a nerve agent, and it was used and licensed for that. And we used

it as a prophylactic, which was not the way it was designed for,

and I am critical of FDA for, one, being so lax in what they allow

the military to do.

The military was supposed to keep records, and it didn’t.

So, yes I have those suspicions that I bring to the table. So, I

have questions. Dr. Myers, I have questions that we have only one

plant, you are the sole source. I have questions that there may be

easy answers to, and then you can feel relaxed and we go on to the

next thing.

You know, one is the indemnity, another is, why are we funding

the plant. There can be reasons for that. We are not even going to

get into that. One thing I can say is that this is not the last hearing. So I don’t have to have all my answers now.

But I can say to the FDA, I need to know, because it is unfair

for you, Dr. Zoon, for me to expect that you would be able to know

other cases where you have handled it the same way. But I have

a suspicion that when it comes to the Government, we allow the

Government to have one standard and the private sector to have

another.

And in my past, I found that to be true. So I want to make sure

it is the same standard. And so, would you just explain to me, Dr.

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Zoon, when you say if a person is at high risk, the vaccine is safe

and effective. Why did you use the word high risk?

Dr. ZOON. Because that is what the package insert labeling recommends it for.

Mr. SHAYS. So, is it not safe and effective for those people who

aren’t at high risk? So I guess effectiveness is moot, but is it safe?

Dr. ZOON. The vaccine labeling lays out the population for which

this vaccine has been recommended. And, in fact, in the labeling,

sir, it does say who those populations are. I can review that for you

if you would like.

Mr. SHAYS. No. I just need to know the concept of high risk.

Dr. ZOON. Well, high risk was intended as the data showed from

the study—— Mr. SHAYS. Why don’t you, one, put the document in the record,

and then—— Dr. ZOON. The package insert? I would be delighted to.

[The information referred to follows:]

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Mr. SHAYS. OK. And then, now, I’m sorry——

Dr. ZOON. And so in that case, the package insert defines some

of the high risk population and makes reference to others, but it

discusses the issues surrounding the general population, where it

is not recommended.

Mr. SHAYS. OK. What is left on the table from the GAO’s statement is that basically there has been only one study of human

beings. And, one, I need to know if that is in fact true. I think, Dr.

Myers, you mentioned a study of 400, which I am not really familiar with, but I don’t think that was a study related to licensing.

Dr. MYERS. That is correct, sir.

Mr. SHAYS. OK. But what is—all three of you, General Cain as

well—what is your reaction to the fact that basically there is one

study but that study involved a wool mill that we don’t know, as

he said, the environment, we don’t know the exposure level of anthrax, the disease, in that environment.

One, do you concur with that?

Dr. Zoon first.

Dr. ZOON. I am sorry, can you repeat the question, sir?

Mr. SHAYS. Yes. I am going to start with you, and I am just going

to let Dr. Myers respond.

I want you to respond to the GAO’s report. I mean, frankly, if

we leave it on the table as it is, it is a pretty strong indictment

against the—and I don’t think it was intended to be as strong as

it was—but in the end, with their response to the questions, they

are basically saying they had a study that took place in the 1950’s,

reported in the early 1960’s, and, the Brachman study, that basically had some who were, had the vaccine and some who didn’t,

and made certain conclusions.

But they made conclusions without knowing the environment

and without knowing the exposure to disease. It could, in fact, have

been very little exposure. So I just need to let you respond to that.

Dr. ZOON. OK. I would like to just review some of the data that

we have. I can’t respond to the GAO report because we haven’t

seen the report. We have just heard this morning, their testimony.

We had a meeting prior where some issues were——

Mr. SHAYS. But I want you to respond to their testimony. Let’s

just respond to their testimony. You have heard them.

Dr. ZOON. OK. I would say there are the Brachman studies and

then there are the CDC studies, which are the major studies that

we are looking at. In the Brachman study, it wasn’t——

Mr. SHAYS. Was that the only one relating to humans?

Dr. ZOON. No. The CDC study and the Brachman study both involved humans.

Mr. SHAYS. OK. And the CDC study was when?

Dr. ZOON. The CDC study began in 1966 and lasted until 19—

actually was followed out through probably close to 1974 with some

of the followup.

Mr. SHAYS. OK. Why don’t you talk about the Brachman study

first?

Dr. ZOON. The Brachman study was a controlled field study. It

was single-blinded, means that the individuals who received the

vaccine and or placebo, did not know which ones they were getting.

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And then there was also an observational group that had no treatment.

As was stated, there are four mills in the Northeast in which

these studies were done. The incident rate of anthrax back then

was about 1.2 cases per 100 employees. So the trial was conducted

in that environment.

In looking at the cases of the data from the Brachman study, a

number of things were revealed. And as a result of the study— when they looked at the—there were 26 cases of anthrax reported.

And, of those, 21 were cutaneous cases; 15 of those cases were in

the placebo; one, as stated by the GAO, was in the vaccinated

group, and two were in the partially vaccinated group, and three

were in the observational group.

Mr. SHAYS. What is the observational group?

Dr. ZOON. The observational group is the group that received no

treatment.

Mr. SHAYS. OK. But those with placebo received no treatment

but thought they were.

Dr. ZOON. Right. That is correct.

Mr. SHAYS. OK.

Dr. ZOON. So those studies were done in the controlled studies.

They monitored adverse events as well as the efficacy to look at the

safety and efficacy of the vaccine.

In the CDC study, this—— Mr. SHAYS. Before you go into that, you didn’t answer the question.

Dr. ZOON. Well, I am going through the data. I think that is important.

Mr. SHAYS. No. I don’t want you to go through the data. I want

you now to react to the fact that is it true and is that important

that the, we don’t know the environment, we don’t know the level

of disease that they were exposed to. Obviously you can’t

control—— Dr. ZOON. I think there is a little bit of a difference of opinion

on that. Our review of the information in this area, suggests that

there was environmental monitoring of some—of a certain degree

going on. In fact, Dr. Brachman had published a report on the mill

and, regarding an inhalation anthrax outbreak, and we would be

happy to submit that paper to the record.

[NOTE.—The information referred to is held in the subcommittee

files.]

Dr. ZOON. And in those cases they believe they were looking at

what were in the environment in those cases.

Mr. SHAYS. Well, do they know the level of exposure? They don’t.

I mean, I think I can say that and I am not even a doctor.

Dr. ZOON. Right. I am just telling you what the information is

that is available in the literature, and I think while one can never

guarantee what the exposure rate is, there was some information

and data regarding what was in the environment, and, in fact,

those were published.

Mr. SHAYS. Then how do you react to Mr. Chan, I think it was

him saying that he spoke with Mr. Brachman—Dr. Brachman—

and that the doctor acknowledged that they didn’t know the environment?

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Dr. ZOON. Yes. I am just saying what information we have available, Mr. Chairman.

Mr. SHAYS. OK. Well you have information that that is what he

said.

Dr. ZOON. No. I said that is what was reported in the literature.

Mr. SHAYS. If you found that the environment—that can’t assess

the environment, does that make you look at the study differently?

Dr. ZOON. I think it would depend on the context of the whole— one of the things when these studies were done, we do know what

the case rate was for that environment at that time as a gestalt,

which was about 1.2 cases per hundred employees. We also know

that——

Mr. SHAYS. Dr. Zoon, you don’t know at what level they were exposed. You don’t know that.

Dr. ZOON. I personally don’t know that. Yes.

Mr. SHAYS. No. But aren’t you being a little disingenuous, with

all due respect. How would they have determined exposure in

1950?

Dr. ZOON. You have a case rate—— Mr. SHAYS. Is there someone else who can answer the question?

I just want it on the record.

It seems to me, what you would have said is, no, we don’t know.

And it would seem to me that if you don’t know what the environment is, then the study isn’t as valid. That would seem to me the

straightforward answer to the question.

And I don’t know, are we playing a game here?

General CAIN. Could I comment?

Mr. SHAYS. Sure.

General CAIN. I think one of the points I have incorrect, and

somebody can correct me. It is impossible to do human efficacy

testing right now because you have to expose a human to the anthrax virus.

Mr. SHAYS. I am not arguing that we should do that. I am just

taking some question as to why we could claim the study should

satisfy, because that is what DOD did, that the study should satisfy us because we did it with humans and then when we look at

the study in, hopefully, a relatively intelligent way, we raise questions.

And then there should be answers to them.

Dr. MYERS. Mr. Chairman?

Mr. SHAYS. Yes.

Dr. MYERS. Could I comment from a manufacturer’s perspective?

Mr. SHAYS. Sure.

Dr. MYERS. Let me give whooping cough as an example. Many

times, you don’t know——

Mr. SHAYS. Before you give another example, I am just interested

in this. And then believe me, you can give—you can say that is

true but it is true in a lot of other cases. I just want to

establish—— Dr. MYERS. That’s true, but it is true in a lot of other cases.

Mr. SHAYS. No, but is it true? Is it true that we didn’t know the

environment? I just want to establish that point and then we will

get on to the next.

Dr. ZOON. Yes.

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Dr. MYERS. We knew that goat hair was contaminated with anthrax spores.

Mr. SHAYS. At what level?

Dr. MYERS. I am not sure we knew that level.

Mr. SHAYS. OK. That is fair. And it may——

Dr. ZOON. Right. But——

General CAIN. For me, as a deployed soldier, if I am deployed to

an area, and I do know that we have no detection capability to detect or warn at this time, which will tell you to put your mask on.

There is nothing out there to tell you. And if I know that in that

area there are anthrax spores, the only recourse I have is to have

an anthrax vaccine shot.

Mr. SHAYS. Well, I know, that would be the way you see it, but

with all due respect, we need to know that this shot will protect

at a level that you would be exposed at. We would need to know

that.

And it may have been that in this case that the levels were low

and, therefore, this vaccine is effective for low levels, but maybe

not at the levels, sir, that you would encounter in warfare.

Dr. Zoon, Dr. Myers I am going to let you——

Dr. ZOON. I just wanted to reaffirm that we did have the historical data on the number of cases of anthrax that the employees got

at the mills, and that was the historical data base that in which

we were comparing the frequency of anthrax. So, while we don’t

have the exact levels that were in each bale, and the technology

probably didn’t even exist for that then, we did have the number

of cases——

Mr. SHAYS. Let me just interrupt you. That is fine. I am not saying that they didn’t do their job. I am just saying then let’s put it

on the record. That’s all.

Dr. ZOON. Yes, but we do have the information, sir, that——

Mr. SHAYS. You have historic data: how many and how much.

Dr. ZOON. Yes. We have historic data that there are 1.2 cases of

anthrax per 100 employees.

Mr. HALLORAN. Cutaneous?

Dr. ZOON. I don’t have the breakdown, but most of them would

be cutaneous.

Mr. SHAYS. Dr. Myers, you have been very patient. Thank you.

And I am happy that—when you talked about rabies, it got my interest. So there may be other things that you want to share.

Dr. MYERS. In doing clinical trials for efficacy, I, as a student of

those, cannot speak to environmental contamination versus case

rate in isolation as a single, as a single item. There are many avenues for the determination of the amount of exposure. A very commonly accepted avenue is the case rate in a population. And that

is what was done in this case.

And I was only going to point out, sir, that with whooping cough,

we don’t know how many organisms our babies breathe when we

do tests for whooping cough vaccines. We simply understand the incidence of the disease in the population being studied.

Mr. SHAYS. Right. The only difference I would say to you, is that

we are ordering people to take a vaccine who may be at potential

high risk if an enemy exposes them to this disease, but we don’t

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know at what level they would expose us. And I don’t think we

have any tests that would be able to answer that question.

So I realize we are just——

Dr. MYERS. I appreciate that point. I think it is a matter or policy, and it is probably central to the issue: Should vaccination be

mandatory? And I am not going to offer an opinion on that other

than to say I believe the vaccine works. And if people are exposed

to anthrax by an airborne route, and they are not vaccinated, 9 out

of 10 of them will probably die. Some will die even if they are given

antibiotic for long-term. On the other hand, if they are vaccinated,

I am as confident as we will ever be at this time that most people

will survive.

Mr. SHAYS. Let me, before going to John Tierney, would you just

elaborate on rabies. You had mentioned it and I interrupted you.

Dr. MYERS. Oh, I had mentioned rabies in that there seems to

be some parallels, in fact. If you don’t take rabies vaccine after exposure, whether the animal was known rabid or not, and you find

out later that the animal was rabid, you will be dead. The disease

occurs at a very low rate. As I pointed out in the testimony, one

or two deaths, perhaps four deaths, a year. So the contention by

the GAO that the disease occurs at such a low rate, therefore you

can’t tell if it is effective, I guess could be alleged for rabies vaccine, and probably a couple other vaccines as well.

So it seems that, as I listened to the GAO testimony, that the

GAO was striving to set apart anthrax vaccine without placing it

in context with all other licensed vaccines, with respect to manufacturing, with respect to clinical trials, with respect to post-licensure surveillance, and with respect to the status of the vaccine

today.

And last, I would just like to point out that as we grapple with

the mandatory immunization issue or policy issue, if you will, for

anthrax vaccine, we should also consider the 9 or 10 other vaccines

that are given to recruits during basic training and ask the question should those be mandatory as well. And really drill down to

the reasons we think they should be mandatory.

There will probably be that there is a reasonable belief that at

some point in deployment, or before deployment even, these people

will be at risk to diseases that these vaccines protect from. If they

get sick, their troop efficiency will be lowered, their unit strength

will be lowered. So we vaccinate for hepatitis B for all recruits.

These sorts of things.

And I just want to make sure that when we think about anthrax

vaccine, we think about it in the context of all vaccines.

Mr. SHAYS. Yes, the only caveat I would say to you is, sir, that—

and this is what we will find out—is the vaccines that our soldiers

have that aren’t anthrax, have had a history of wide use before

they became mandatory?

And this is not a subtle difference. And there is wide use now;

whereas, before there wasn’t.

Dr. MYERS. Could I just make one final comment about that?

Most vaccines are licensed on clinical safety trials that aren’t that

different in magnitude than those done in the 1960’s. And it is only

after license, and it begins to be used in widespread use that you

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may or may not detect those kinds of events that occur at the level

of 1 in 1 million or 1 in 3 million.

Now, you are never going to get there with a vaccine if it is never

in widespread use, and I’ll go back to rabies again. Maybe there are

15,000 post-exposure treatments a year. So you might be looking

at 15,000 people. But these people believe strongly in that. Just

like anthrax, if you are exposed, you die if you don’t get vaccine,

just like that. They believe that the benefit of taking five doses, not

over a year, but five doses over a 28-day period, day 1, 3, 7, 14,

and 21 or 28, far outweigh the risks of developing a lethal disease.

Mr. SHAYS. That is helpful. Thank you. Mr. Tierney.

Mr. TIERNEY. Thank you. I only have one. Dr. Myers, is it—am

I accurate in thinking the Department of Defense is now financing

the renovation of some of your facilities?

Dr. MYERS. The DOD may want to answer that directly, but the

financing of the renovation is largely funded by contractual funds

from the DOD.

Mr. TIERNEY. And can you tell me why that is? Why they are

funding a private corporate facility?

Dr. MYERS. Well, we are a private corporate facility, but we are

not selling hardly any anthrax vaccine in the private sector. Our

facility capability for making anthrax vaccine is almost entirely reliant on DOD funds. We are a 6-month-old company. As we move

into the private sector, we believe that there are possibilities not

only for defense vaccines but our other products as well. And our

goal is to become entirely non-reliant on DOD funding for the defense vaccine sector.

In order to do that, we must be healthy.

Mr. TIERNEY. So you are telling me that you think Department

of Defense moneys are going into your facilities in order to help you

get healthy. I mean, is that—— Dr. MYERS. As long as these moneys are going in and there was

what is called, you may be familiar with this term, GFE, Government furnished equipment, there are strict regulations and constraints on the use of that equipment, such that we can’t take Government equipment and make, chug out vaccine, if you will, and

sell it to the private sector. That is just not legal in this country

with GFE.

Mr. TIERNEY. Doctor, you are the chief operating officer of the

corporation. Are you also a member of the board of directors?

Dr. MYERS. Yes I am, sir.

Mr. TIERNEY. And are you one of the principals of the corporation?

Dr. MYERS. Will you define principal?

Mr. TIERNEY. Are you one of the owners of the shares of stock

in the corporation?

Dr. MYERS. I am a minority shareholder of a company called

Michigan Biologic Products Inc. And Michigan Biologic Products

Inc. is a minority shareholder of BioPort.

Mr. TIERNEY. Thank you.

General CAIN. Could I comment on that, on DOD perspective?

Mr. SHAYS. Go ahead.

General CAIN. Given that BioPort is the only source available for

the anthrax vaccine, it was imperative that DOD maintain their viVerDate 11-MAY-2000 14:47 Apr 02, 2001 Jkt 066344 PO 00000 Frm 00102 Fmt 6633 Sfmt 6601 E:\HEARINGS\58959 pfrm04 PsN: 58959
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ability. The SECDEF immunization program, FDA inspections, and

privatization mandated that DOD put forth an aggressive effort to

maintain industrial capability. In addition to the routine program

management functions, DOD, on a short-term basis, is providing

resources to assist the manufacturer in achieving full compliance

with FDA regulatory requirements.

A few examples include a transition team that assists in development of their strategic plan, a regulatory specialist to oversee the

FDA compliance documentation, and a construction engineer that

orchestrated renovation of the production line.

As a result of DOD support, there has been marked improvement

in the facility, and I am confident that in the near future BioPort

will be able to function without our assistance.

Mr. TIERNEY. Thank you.

Mr. SHAYS. Let me ask one point, Dr. Myers, that you were making that I found very interesting. You were suggesting that people

had adverse effects in another case where they didn’t even have— they were placebos or something?

Dr. MYERS. They were placebos. That is correct.

Mr. SHAYS. It is for the record, and we would look at this. So I

just want you to be as precise as possible about it. What are you

referring to?

Dr. MYERS. The product insert is public knowledge and I would

be happy to put it—— Mr. SHAYS. It’s not public knowledge to me, so just put it on the

record again.

Dr. MYERS. Yes. In the study, approximately 400 individuals

were given three doses of a vaccine.

Mr. SHAYS. Right.

Dr. MYERS. And these individuals were actively solicited for the

identification of reactions: Did you have a sore arm? Did you have

redness? They do this with a diary or a nurse interview, either in

person or by telephone. And you find that even for placebo preparation, for the reason I pointed out, you are injecting something with

a needle, you are breaking nerve fibers, you are expanding interconnective—connective tissue within those nerve fibers with that

dose.

Mr. SHAYS. You know, when they give us a shot, they never describe it that way. [Laughter.]

Dr. MYERS. I apologize for the detail. [Laughter.]

Mr. SHAYS. But the bottom line to it is, that what?

Dr. MYERS. The bottom line to it is that even with placebo preparations, you have local reactions that are as much as 60 percent.

And with general reactions, when asked did you have headache,

did you have fatigue, did you have fever, you find that those reaction rates are very high as well, even for preparations that don’t

contain active vaccine ingredients, the placebo.

Mr. SHAYS. That would seem to—sorry to interrupt you. That

would seem to speak to the issue of the monitoring, the active

versus passive monitoring. So I would infer that you are suggesting

that if someone was—when the Pittman study in 1997 was done

and 29 percent said they had a mild reaction and others had more,

14 percent had a more severe, you might—and yet with DOD, there

really is very little response, you would suggest that is just the naVerDate 11-MAY-2000 14:47 Apr 02, 2001 Jkt 066344 PO 00000 Frm 00103 Fmt 6633 Sfmt 6601 E:\HEARINGS\58959 pfrm04 PsN: 58959
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ture of the shot. And if you asked someone right after a shot, they

would respond that way.

Dr. MYERS. Yes. And I think there is a further point that I believe in. And that is, just like I know I had a sore arm, because

you get a sore arm when you have a vaccine shot into your arm

with a needle, that most of the military personnel now understand

that. Goodness, they were given vaccines, many vaccines, as basic

recruits. They know what an arm feels like after a vaccine, not just

anthrax vaccine, but any vaccine.

So probably, it is because they understand the nature of inflammation for a vaccine that is injected that this passive surveillance

is so low, not because it is being hidden or they care, or there is

a serious problem, it is just that they understand. They are used

to getting more shots in the army in basic training than most

adults are over several decades. It is no big deal.

Mr. SHAYS. OK. I knew that needed to be put on the record since

we have the other issue, and I am happy to have it put on the

record. Let me just ask you, General Cain, and then I think we will

go to the next panel. And then I will certainly ask any of you to

make comments.

Mr. Taylor, I would also say that sometimes someone who sits

and just listens to questions ends up with the best answers in the

end. [Laughter.]

And so I am going to invite you to make any comment you want

at the end as well.

This is to you General Cain, how many lots of anthrax vaccine

are awaiting the completion of the supplemental testing?

General CAIN. What was that again?

Mr. SHAYS. How many lots of anthrax vaccine are awaiting the

completion of the supplemental testing? If that is an answer—— General CAIN. Eight from 31. So—— Mr. SHAYS. Eight are finished?

General CAIN. Eight are finished.

Mr. SHAYS. Right. And is that a question that you can answer

for us, Dr. Myers?

Dr. MYERS. I can answer it.

Mr. SHAYS. OK. You have that. OK. And I also want to know

what went wrong with the potency tests. Is that something you

want to answer, Dr. Myers?

Dr. MYERS. I can.

Mr. SHAYS. And then, general, when you are ready, you can answer the first question.

Are you prepared to answer that one?

Dr. MYERS. Which one?

Mr. SHAYS. The question is what went wrong with the potency

tests. Can you answer that?

Dr. MYERS. Yes.

Mr. SHAYS. OK. Answer it please.

Dr. MYERS. There was an increased level of testing.

Mr. SHAYS. Speak slowly though.

Dr. MYERS. That was required as a result—[laughter as Dr.

Myers slows his speech.]

I am having a problem. I guess I am just emphatic. I will try to

slow down.

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Mr. SHAYS. No. But this is to your advantage, isn’t it? To put it

on the record?

Dr. MYERS. Yes.

Mr. SHAYS. OK.

Dr. MYERS. During the increased level of testing in the spring of

1998, we found inconsistent results in control vaccine values across

several tests with several different dilutions of vaccine. It is a test

you know something is not behaving properly when your control

vaccine is not behaving properly.

We suspended potency testing, first in the spring of 1998 for a

short period of time, and then in the fall of 1998 for a longer period

of time while we stepped back to design and evaluate possible

sources for the inconsistent results in the potency tests. Those

studies have pretty well been completed now. The potency test is

behaving again as it should be. And we have assignable causes for

the erratic results previously experienced.

Mr. SHAYS. Thank you. So the first question I wanted to ask,

how many lots of anthrax vaccine are awaiting the completion of

supplementary testing? The other question I wanted to ask is, are

lots produced under conditions FDA found in violation being released without supplemental testing?

So who can answer that question?

General CAIN. There are 24, 24 lots right now, that are awaiting

supplemental testing.

Mr. SHAYS. OK.

General CAIN. Most of those are, in fact, for potency. The other

three, serial D purity, and has been completed in safety. There are

three lots that have been quarantined voluntarily by BioPort themselves, 3 of those 24.

Mr. SHAYS. So this last question? The question is, are lots produced under conditions FDA found in violation being released without supplemental testing?

General CAIN. No.

Mr. SHAYS. Your answer is no?

General CAIN. That is no.

Mr. SHAYS. OK. Is that consistent with everybody else’s position?

Who would be qualified to answer this besides you, General Cain?

Dr. Zoon.

Dr. ZOON. Well, once they have passed the lot release testing and

are available and have met all the criteria, they are available for

distribution.

Mr. SHAYS. So, in other words, your initial concern, once it is

dealt with, then they are released?

Dr. ZOON. Yes. As long as there are no other, as was reported

earlier, there were some lots in quarantine. And those are currently in quarantine because of some observations that we had on

inspection. Those observations that we had on inspection need to

be investigated by BioPort. Depending on the outcome of those investigations, those lots may or may not be distributed.

Mr. SHAYS. And then they are reviewed by you before a decision

is made?

Dr. ZOON. Yes.

Mr. SHAYS. OK. Any other final——

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Dr. MYERS. If I might just add a small point to clarify. When the

vaccine is released by the FDA, the DOD pays for the vaccine. So

they own it at that point. And we store it onsite for them. The

DOD has requested for their vaccine that they already own that

supplemental testing be done for 32 lots that were in a stockpile

at a point in time. And I just wanted to clarify that is not an activity that is at all directed by the FDA. It is the DOD.

Mr. SHAYS. OK. Got you. Any other comments before we get to

the next panel? Mr. Taylor. Dr. Zoon, we will let you go.

Dr. ZOON. Yes, Mr. Chairman, I just want to correct one fact

that, for the record, that FDA did do inspections for anthrax prior

to 1996. I think Dr. Myers alluded to one, but there were a number

of inspections for the anthrax.

Mr. SHAYS. On the site seen all parts of the production—I understand that it is part of the building, but it is certainly contained

part of the building. Correct?

Dr. ZOON. Right. We were in the production facility several

times. Often, though, there was an active manufacturing going on

when we were there, but we were actually in the facilities where

the anthrax was manufactured, being manufactured.

Mr. SHAYS. The statistics in the beginning, Dr. Myers, though,

you were talking about the FDA being there, not necessarily just

for anthrax. Right? We are focusing on anthrax.

Dr. MYERS. Well, what I pointed out in my oral testimony was

that in January 1993, not so very long ago, the FDA inspected the

second floor of the building that is the anthrax vaccine sublot manufacturing area where fermentation, bacterial culture, and purification is done. That is the isolated part of the facility. They were

there, January 1993, because of facility renovation that had recently been completed, which was approved in July 1993.

Mr. SHAYS. And then—— Dr. MYERS. And I am surprised that the GAO didn’t have that

report.

Mr. SHAYS. OK, but from 1993 to 1996, did the FDA get into the

site?

Dr. MYERS. Between 1993 and 1996, did the FDA go to the second floor of this building where the sublots are made?

Mr. SHAYS. Yes.

Dr. MYERS. To my knowledge, they did not during that 3-year period.

Mr. SHAYS. Right. You know, that shouldn’t be. Right? I

mean——

Dr. MYERS. We, as I said, have received 49 inspections since 19—

or at least 48 inspections since 1969. Up until very recently, it has

been the agency’s position to do one inspection at least once every

2 years for each of three areas: bacterial vaccines and toxoids, viral

vaccines, and plasma derivatives.

We have all three types of manufacturing operations; therefore,

it could be expected that we would have one and a half or so inspections per year.

Dr. ZOON. If I could just clarify one point, and make one other

point. We have had inspectors in there. We have inspectors who

were immunized with anthrax vaccine to do the inspection. And

they were in there in 1990, looking at it, during the time of Desert

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Storm, and also in 1993 to look at both the records and looking at

some of the areas in the site.

So I just wanted to make sure that the record was corrected.

Mr. SHAYS. Would you also make sure the record—when did the

Army—excuse me, when did the DOD make a determination to

have a mandatory policy on anthrax and engage the plant, whether

it was mandatory or not? When did that take place? General Cain?

General CAIN. I believe in December 1997.

Mr. SHAYS. And since then, how many times has the plant been

inspected?

Dr. ZOON. I didn’t hear his comment.

Mr. SHAYS. Since 1997, December 1997.

Dr. ZOON. Oh, I can give you those numbers. Do you have those,

John?

Mr. TAYLOR. Yes. The facility has been inspected twice, in February 1998 and in October 1998.

Mr. SHAYS. And, it is not operating now. So——

Mr. TAYLOR. That is correct. It is not operating right now; however, I believe as Dr. Myers alluded to, we will re-inspect the facility, and once they are up and running, they are right now producing consistency lots with the hope that they will resume full

production by the end of the year. And obviously, we will go in and

make sure that they are producing the vaccine in compliance with

our regulations.

Mr. SHAYS. Thank you. Is there anything else that any of you

would like to say?

Mr. TAYLOR. Yes, Mr. Chairman, I want to clarify, or address one

point that you made after the break. FDA is obviously cognizant

and sensitive to the criticism that was leveled against us in regards

to the Gulf war. And I can assure you that we are regulating

BioPort and the anthrax vaccine the same way we would regulate

any other manufacturer. So I just wanted to address that point.

Mr. SHAYS. Thank you.

General, I asked you to do—indemnification. I am trying to think

of the question that I asked before I left.

General CAIN. Yes, I think, why we have a blanket indemnification of BioPort. Two reasons. One, if we had not, it would have

added 50 more cents per dose for the vaccines.

Mr. SHAYS. Right.

General CAIN. So, from an economic standpoint, it was smart to

do it that way. But more importantly, 2 years ago, when we submitted out interest from industry, not a single industry—manufacturer—wanted to get involved unless there were an indemnification

clause.

Mr. SHAYS. OK. Fair enough. Was there another question that I

asked someone else to check out before the break or was that the

only question?

OK. I think that was it. Thank you very much. And——

Did you have something you wanted to say, Dr. Zoon. I am sorry.

Dr. ZOON. Yes. I just wanted to assure the chairman that, as

FDA, we believe this vaccine is safe and effective for high-risk individuals, but we are committed to being vigilant, in both the review

of activities surrounding this vaccine, and vigilant on monitoring

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the adverse event reports. And we will continue to do so to the best

job we can.

Mr. SHAYS. Thank you very much. Anything else?

Dr. MYERS. I just wanted to say that I applaud you and your

committee for holding these hearings and for allowing me to be

here today to speak as the manufacturer. I think it is very important that you listen to the next panel. I think it is very important

that we recognize that there are people who suffered ill effects from

the Gulf war. I just want to say that I hope that we concentrate

on diagnosing their diseases and adequately funding their care,

and that we make certain that we not dwell too long because it

would be a disservice to them on the issue of anthrax vaccine because I truly believe it is unfounded.

Mr. SHAYS. OK. Thank you very much. And I will assure you

that you will always have an opportunity if you hear of a hearing

and you want to come back and put something on the record, you

are more than welcome. [Laughter.]

Thank you very much.

Dr. MYERS. Thank you, Mr. Chairman.

Mr. SHAYS. This time, I am going to ask Dr. Meryl Nass, physician, Freeport, ME; Ms. Randi J. Martin-Allaire, Eaton Rapids, MI;

Ms. Roberta Groll, Battle Creek, MI; Mr. David Churchill, Albion,

MI; and Mr. Michael Shepard, Savannah, GA, ask them all to come

forward and ask them to remain standing so I can swear them in.

It goes Nass, Martin-Allaire, Groll, Churchill, and Shepard.

[Witnesses sworn.]

Mr. SHAYS. Note for the record that everyone has responded in

the affirmative, and one of the advantages of the last panel is—the

disadvantage is you have to wait, the advantage is you get to hear

other testimony. And I am happy to have you summarize your testimony and speak to the questions that were asked and the answers that were given. Or you can give your testimony, and we are

really grateful that you are here. So thank you.

Dr. Nass, we will start off with you. And we will get the clock.

One final note, Jonathan is leaving and is going to work for me in

Connecticut. He has done a tremendous job for me, but I think that

you probably left yesterday mentally with all of these distractions

today. [Laughter.]

Dr. Nass.

STATEMENTS OF MERYL NASS, PHYSICIAN, FREEPORT, ME;

RANDI J. MARTIN-ALLAIRE, EATON RAPIDS, MI; ROBERTA

GROLL, BATTLE CREEK, MI; DAVID CHURCHILL, BATTLE

CREEK, MI; AND MICHAEL SHEPARD, SAVANNAH, GA

Dr. NASS. Thank you. To start off, I wanted to clarify some of the

statements made earlier about safety. We have several studies that

were presented that looked at adverse effects. But those studies

only lasted from 7 days to 30 days following vaccinations. So what

we had were short-term effects only. And there is a significant

amount of data on that. But it really tells us nothing about what

we are interested in, which is, is there chronic illness due to anthrax vaccine?

Now, although none of the studies looked into that, one of them,

the IND study, which was just done and submitted by Dr. Myers

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to FDA, would have been an ideal study to look into long-term effects because they collected blood from service members on at least

an every 2-month basis for a period of 2 years, but only inquired

about adverse effects over the first 30 days of that study.

Now, when you are wondering what exists that we can look at

to try and determine if there is a problem with the vaccine over

the long-term, one looks to several cohorts that might be useful.

The first, of course, is the workers at Fort Detrick for whom this

vaccine was in fact originally developed. There is some obfuscation

about this.

But two workers at Fort Detrick died in the 1950’s from inhalation anthrax. And it was determined that if Fort Detrick were to

continue to do work on offensive biological weapons, they would

need to vaccinate their employees so they wouldn’t lose them to the

diseases they were studying.

And it was for that purpose—this was a high-risk group subject

to inhalation anthrax—it was not in any way developed for mill

workers or livestock workers who were used as an experimental

study group and who were not given the vaccine subsequently. And

there was no need for them to have it because they only developed

cutaneous anthrax, which is easily treatable with a zero mortality

rate with oral antibiotics.

When you look at the Detrick workers, there are actually three

studies in existence. These workers were multiply immunized with

a number of vaccines. The studies were published in 1958, 1965,

I believe, and 1974. They suggest that there were, in fact, some

chemical differences in the blood of multiple vaccinees as opposed

to controls, suggest that there were some people who developed

cancer of the immune system that might have been related to multiple vaccination. But the actual effects of the vaccines were not

clear.

Now in the subsequent 25 years, nothing has been published on

these employees at Detrick. I don’t know whether the Army, for

whom they have worked, has done any studies, but this would be

very useful to find out.

Another group, obviously, is the Gulf war veterans and the Gulfera veterans who were non-deployed but vaccinated and whose only

exposure was to vaccines, not necessarily only the anthrax vaccine.

No studies have been done in the United States and published

that look at the relationship between anthrax vaccine or multiple

bio-warfares vaccines and subsequent Gulf war illness. Now there

is data that could be examined to look into this question.

I know Han Kang of the VA has this data. He told me about 4

or 5 months ago that he would try to do the correlations but has

told me since that he hasn’t had the time.

In England, one study has been published, Catherine Unwin, is

the first author, and that did show a statistically significant relationship between vaccination for anthrax alone and multiple vaccinations, and then subsequently onset of Gulf war illness. This

was British veterans. It was a study based on recall. The British

veterans apparently used some British-made anthrax vaccine, and

some United States-made.

We really don’t—I don’t know how much of which they used, but

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land was the American vaccine. And I think that may be supported

by some statements that were made earlier, that suggest that

268,000 doses of United States anthrax vaccine were available at

the time of the Gulf war.

Certainly studies that look into this for U.S. veterans are critical.

One of the reasons we don’t have them is the issue of missing

records. I have provided a declassified document that suggests that

the Army, in fact, does have some immunization records that have

been classified, that might help us to relate anthrax vaccine and

Gulf illness.

But so far, no one that I know of has access to this data.

Seventh-Day Adventists, in fact, have been asked to participate

in a recent study, out of Fort Detrick again. These folks were vaccinated up until the early 1970’s and, as far as I know, they were

not looked at since. But late last year, in September and October,

they were asked to now provide information about any symptoms

or disease they may have been diagnosed with in the interim. And

when one looks at the survey, they are being asked about symptoms of Gulf war illness.

So it is very interesting. I guess the military hasn’t figured out

yet whether the vaccine may contribute to Gulf war illness. As far

as I know, they have not publicized the existence of this study, but

they are interested in finding out.

Is a new epidemic emerging from the current round of vaccinations? I am sorry to say that this does seem to be the case. Both

the features of the illnesses that have been reported to me, and the

official military response to these illnesses, echo the plight of ill

Gulf war vets who remain today without a defined illness and without meaningful approaches to treatment.

Another issue I would like to just touch on is that of legal questions with regard to this vaccine. One of those is whether the vaccine, the order to vaccinate is a lawful order. And I suggest that

it may not be, based on the preconditions that Secretary Cohen

stipulated at the time he ordered the anthrax vaccine immunization program, several of which do not appear to have been met.

Second, in my looking at the FDA inspection reports between

1993 and 1998, I see the anthrax line only mentioned in the 1998

report. It wasn’t mentioned earlier. And the late 1996 report suggests that the Army was performing the anthrax inspections and,

therefore, FDA did not have the responsibility to do so. I am not

sure that this is supported by the law, which requires FDA to investigate at least every 2 years, and more often if there are problems. And certainly the problems have been well documented at

MBPI, now BioPort.

The third and most interesting legal issue is that of whether the

currently licensed anthrax vaccine is the only anthrax vaccine to

have been given to service members, and if in fact other vaccines

may have contributed to illness. An unlicensed vaccine can only be

given to a service member if informed consent is obtained. And I

have not met a service member or Gulf war vet who tells me that

informed consent was sought from them at the time they were vaccinated.

However, this article, written in 1990 by Ernest Takefuji and

Philip Russell, who were both administrators at Fort Detrick, sugVerDate 11-MAY-2000 14:47 Apr 02, 2001 Jkt 066344 PO 00000 Frm 00110 Fmt 6633 Sfmt 6601 E:\HEARINGS\58959 pfrm04 PsN: 58959
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gests that in fact unlicensed anthrax vaccines were administered to

service members. And a letter inquiring about this to DOD last

year that Mark Zaid and Pat Eddington wrote got an answer that,

in fact, the anthrax vaccine mentioned here is not the same anthrax vaccine as the licensed vaccine that service members are currently receiving, suggesting that at least one other has been given.

Dr. Zoon talked about the VAERS reporting and how this produces information about adverse effects suffered shortly after vaccination. I would submit that this is the weakness of the VAERS

system. What one really needs is active surveillance over a long period, of a significant enough number of vaccinees to find out whether there is chronic illness. It just doesn’t matter what you find out

in the first week or the first 30 days if people get over it.

And we are not doing proper surveillance of vaccines if this is all

we focus on.

I provided an addendum to my testimony today which asks the

general question, is vaccination a good defense against biological

warfare? Even if the vaccine were 100 percent effective against all

strains of anthrax, which nobody claims, it still would be a porous

defense because an enemy would simply choose another biological

agent, one that occurs naturally or one created using genetic engineering.

William Patrick, who formerly headed the offensive program at

Fort Detrick, had this to say, ‘‘It takes 18 months to develop a

weapons-grade biological agent and 10 more years to develop a

good vaccine against it.’’

I submit that it is impossible to produce vaccines that will keep

up with the rate of development of new bio-warfare agents, and

that vaccines should clearly not be the first line of defense in this

or any case against the threat of biological warfare.

Despite the fact that vaccines are unlikely to provide this

defense——

Mr. SHAYS. We need to get you to——

Dr. NASS. Thank you. May I have 1 minute? Thanks.

Congress appropriated $322 million in 1997 for the Joint Vaccine

Acquisition Program. Its goals are to develop new vaccines for more

than 10 known bio-warfare pathogens and administer the vaccine

to all U.S. service members. The anthrax program can be regarded

as the introduction to this much larger and less well known program.

The FDA has publicly stated that it intends to expedite licensing

for these new bio-warfare vaccines.

Are we already embarked on a misadventure that will dwarf the

anthrax vaccine program in cost, futility, and medical repercussions? What will it take to call a halt to the current round of vaccinations and, of at least equal importance, what will it take to investigate these illnesses and develop treatment protocols that are

serious about getting answers and providing care?

Thank you.

[The prepared statement of Dr. Nass follows:]

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Mr. SHAYS. Thank you, Dr. Nass. That is very comprehensive

and helpful. Thank you.

Now our next three witnesses are civilians who have taken the

anthrax vaccine. Is that correct?

Ms. GROLL. Correct, sir.

Mr. SHAYS. And we will start with you, Ms. Martin-Allaire.

Ms. MARTIN-ALLAIRE. I would like to thank Congress for expressing an interest to the anthrax vaccination immunization program

and allowing me the opportunity to speak about my experiences of

adverse reactions to the anthrax vaccination and problems seeking

medical care I have incurred as a civilian.

My name is Randi Martin and I am a civil service technician at

the 110th Fighter Wing Air National Guard Base, located in Battle

Creek, MI. I received my first anthrax injection on September 18,

1998, for a volunteer overseas deployment, which was scheduled to

deploy on November 11th, 1998. The second injection was administered on October 2nd, and a third on October 16th.

According to my shot record, all injections were from lot FAV030.

During this timeframe our base was preparing for an operational

readiness inspection, which was scheduled for October 17th to the

23rd, 1998. I felt tired, sluggish, and slow during this timeframe,

but associated it to the numerous hours of overtime and stress that

comes with any inspection with the military.

On March 14th, 1999, I received my fourth injection. The lot

number I received is yet to be determined. The next couple of days

after my injection I felt sluggish, tired, and a little disorientated.

However, I considered that to be normal with past experiences of

inoculations. On March 17th, I realized this was no longer normal.

I was so tired I could not get out of bed. My days for the next week

consisted of numerous hours of sleeping. I was awakened only to

eat.

The following 2 weeks, I attempted going to work a couple of

times, but lasted only for a couple of hours each day and then had

to leave. The reasons were I was too tired, my head felt like it was

going to explode, my abdominal cramping had me doubled-over, or

I was just too disorientated.

I began to notice that my memory seemed to be getting worse as

I could not remember passwords to programs that I use everyday

at my work.

On March 31st I went to the emergency room with the complaints of abdominal cramping, my body was running hot and cold

in temperature, a severe headache, shortness of breath, and feeling

nauseated. I told the doctor I thought it was a reaction to the anthrax vaccination. The doctor inquired why I was not at a military

hospital as they did not know anything about the anthrax vaccination.

I informed him of our situation at our base, where there is no

full-time medical physician available. In his willingness to help, he

looked through the immunization pamphlets but could find nothing

on the anthrax vaccination. This is the second time on the civilian

side I have run into this. The doctor called the CDC only to get the

answering machine. He left a message, told me to go home and he

would call me back when he had an answer.

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I left the emergency room with no answers, but at least had a

prescription for Motrin. While waiting for a call from the hospital,

I was having a conversation with my father. I could not complete

sentences without having to stop and gasp for air. I was so winded

I literally felt as though I was going to pass out. The hospital

called me in about an hour with the number the CDC gave them

to give to me.

I called the number but did not catch where I called. I was talking to a woman by the name of Kathy who seemed very nice and

wanted to know what my symptoms were. When I started stating

them, she interrupted me to say that some of the reactions had not

previously been reported as adverse reactions from the vaccine, so

she was not going to report some of my symptoms as being any

type of adverse reaction.

Her response was I must have caught a virus because symptoms

associated with the vaccine last 2 to 3 days and not 2 weeks. I told

Kathy of my situation, that doctors were not aware of the anthrax

vaccination and did not know what to do for me. Kathy’s response

was, they haven’t heard of the anthrax vaccine? You must live in

a small town. Don’t they watch TV?

I asked where I called, and she told me the Department of Defense. It then became clear to me how the DOD can state there are

few adverse reactions associated with the vaccine. How can you

begin a trend of adverse reactions when the DOD states they will

not report them?

On April 2nd, our vice wing commander, Colonel Seidel, called a

meeting with individuals from the group who received the fourth

injection. It was discussed during this meeting that actions were

taking place to get us down to Wright Patterson Air Force Base,

located in Ohio, the closest military hospital. There seemed to be

a lot of legality issues, considering we were civilians and this was

a military issue.

Colonel Seidel stated that the soonest we were able to get to

Wright Patterson to see a military allergist was April 23rd. However, he was trying to get us in sooner as he found this date to be

completely unacceptable.

On April 7th, the first group of four left Battle Creek Air National Guard Base at 7:45 a.m. to Wright Patterson to see the military allergist. During my examination, the allergist examined my

ears, eyes, nose, and throat, felt my abdomen, checked my reflexes,

and examined my VAERS report. I received a chest x ray at my

request. I was told I was fine. During this time, the allergist was

aware of my symptoms. The allergist stated in my medical record

that I had a local reaction and to followup with my civilian doctor.

Subsequently, two civilian physicians that I have seen so far know

nothing about this vaccination. We returned to our base at 11:30

p.m. still with many questions and no answers.

April 14th in the morning I was feeling very ill. I had abdominal

cramping, a headache, and was feeling extremely nauseous. I went

in at 8 a.m. to inform my boss that I was leaving ill. The response

was that I needed to watch my sick leave as I was in the hole. My

sick leave available balance seemed to be the only concern, even

though she was previously made aware of the problems I was experiencing from the vaccination.

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My position at work requires you to be multi-task orientated.

Since coming back to work, I am unable to accomplish this. I can

now only do one task at a time, as it takes every bit of concentration to focus on just the task at hand. One month after the injection, I am still having continuous headaches, which medication no

longer has any effect on. I am still having abdominal cramping; I

am still feeling nauseous; I am experiencing memory problems; and

I am continuously tired. I cannot walk up a flight of stairs without

becoming winded. My joints are achy when they are bent for longer

than a couple of minutes. I have extreme lower back pains, and

just recently have developed back spasms. I have gained nearly 20

pounds in 11⁄2 months. I have absolutely zero tolerance for anybody

or for anything. I do a lot of typing at my job. Normally I can type

75 words per minute. Now if I type more than 5 minutes, I find

myself needing to stop as all of my fingers seem to tighten. I am

only 25 years old and this should not be happening. I was off work

for nearly a month with the only explanation being I have caught

some kind of a mysterious virus that no one can explain or yet detect.

I was on antibiotics at the time I received my fourth injection,

and was never asked if I was on any type of medication or antibiotics. A VAERS form was never shown to us or offered. We found

our own VAERS form on the internet, filled it out ourselves, and

sent it forward. I never even knew a VAERS form existed, and I

have been in the military for 8 years. I have recently learned that

our base clinic was never aware of a VAERS form due to the fact

that it is not a military form. The lack of knowledge for a mandated program that has been displayed by the ‘‘key personnel’’ has

been completely appalling.

The medical treatment that was given down at Wright Patterson

to myself was nothing short of get her in and get her out. The Department of Defense’s response of not reporting some of my reactions I find very troubling. Due to the fact that I was cutoff from

the DOD, I never even finished stating all of my symptoms.

I have found the situation I am in puzzling, that consideration

on what to do if a technician or Guardsman becomes sick was

never taken. This seems like an important step missing considering

it is now mandatory for military personnel, active duty or civilian.

There seems to be no answers to my questions on why I am feeling the way that I am feeling. The only responses are the vaccine

is safe, has been routinely used for 30 years, and will protect me

in bio-warfare. My concerns from this vaccination are legitimate

concerns. If reactions get worse after each injection, with what I

have experienced on the fourth injection, what am I going to have

to look forward to on the fifth injection? The sixth? The annual

boosters? Why are my symptoms being categorized as local, which

consists only of swelling from the elbow to the shoulder and a sore

arm when there are clearly more reactions involved? How many

other soldier’s reactions are being classified lower than what they

really are? There are too many unanswered questions associated

with this program. And there are too many vague responses.

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I am neither a medical physician nor a scientist; however, I feel

I am the most qualified to know what is going on with my own

body. I know what my health is now as opposed to where it was

before I started taking the anthrax injections. There is a massive

difference, and there is something wrong.

Thank you.

[The prepared statement of Ms. Martin-Allaire follows:]

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Mr. SHAYS. Thank you very much. That is a very powerful statement. And I am sorry for what you have encountered. At least information should be available to you.

Ms. Groll.

Ms. GROLL. Mr. Chairman and members of the committee, I sincerely thank you for your interest in the anthrax vaccine immunization program and for allowing me to testify today on the effects

and obstacles I have faced since starting this vaccine program.

Please note that any opinions I express are my own and in no way

reflect the opinions of the Michigan Air National Guard or those

of my superior officers.

I am currently a technical sergeant in a civil service GS–9 management and systems analysis, assigned to the 110th Logistics

Squadron, Battle Creek, MI. I received my first of the anthrax series on September 18th in preparation for a possible voluntary deployment to Qatar. The deployment was voluntary, and the vaccine

was a prerequisite to the deployment. I acted on blind faith in the

Department of Defense, my superiors, and trusted in the individuals I felt qualified to administer the vaccine.

Following the first two shots of the series, I noticed I was extremely fatigued and nauseous; however, during the same period of

time I was working numerous hours in preparation for an upcoming operational readiness inspection. I attributed the symptoms to

the extra hours and stress, not to the vaccine.

On October 16th, I receive No. 3 of the inoculation series. Coincidentally, this inoculation coincided with the beginning of the ORI.

The third inoculation not only enhanced the same symptoms, but

I also noticed I was becoming increasingly short-tempered, emotional, nauseous, experienced loss of appetite, and achy joints. Once

again I attributed this to the stress and the long hours of our inspection.

For the following month, my health continued to become progressively worse, until finally I sought medical attention on November

12. I was then placed on antibiotics and antidepressants for chronic

fatigue.

On March 14, I was notified that our clinic was waiting for our

group to report to the clinic for our fourth anthrax vaccination.

Upon our arrival at the clinic, the medical personnel were quite

agitated and appeared unorganized. For the first time, I felt apprehensive about receiving this or any other vaccine. We questioned

the medical staff as to why we were receiving our shot early. We

were told that it was OK as long as we received it within a 24-hour

window.

We were given our inoculation and sent to the holding area.

While waiting to be released, I noticed that my shot record indicated the date of inoculations as March 16th. This was March 14th.

I compared my records with the other individuals present and

theirs also reflected the 16th.

Sergeant Martin questioned Major Jermeay on why the date read

the 16th. He appeared upset, collected our shot records, and disappeared. When he returned with our shot records, the dates had

been changed to reflect the date of inoculation as March 15th. It

is still the 14th.

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We once again questioned him on this, and we were told the date

was within the 24-hour period recommended by DOD so that it was

OK. My shot records also indicate that I have received all four lots

from lot FAV030, which would indicate that my final inoculation to

be from an expired vaccine.

Mr. SHAYS. Excuse me a minute.

[Pause in testimony while chairman confers.]

Ms. GROLL. That evening I started to feel ill: chills, fever, and

nausea. My symptoms increased over the next few days to include

headache, dizziness, diarrhea, and abdominal pain. On Wednesday,

March 17, as non-commissioned officer in charge of the base honor

guard, I was rendering services—honors at a memorial service for

a former member of the U.S. Air Force. During the memorial service, I developed tremors and dizziness. I went home immediately

following the services. The next few days were again spent in bed.

By Friday, March 19, my symptoms had increased to include

shortness of breath. Once again I sought medical attention. During

the medical evaluation, I stated that I had received my fourth anthrax inoculation on Sunday, March 14th. My physician immediately ordered blood work, urinalysis and referred me to an infectious disease and pulmonary specialist. Upon consultation with

him, he in turn referred me to neurologist for my tremors and advised me that I was having an adverse reaction to the vaccine and

that I needed to inform my supervisors so they could complete the

necessary paperwork. He also advised me not to have any further

vaccinations.

Later that day I informed my supervisor, the first link in my

chain of command, what I had been told by my doctor. He in turn

passed it up the chain. The following day, March 24th, I received

a phone call at home from my supervisor stating the information

had been passed along to the chief of supply, the Group commander, and also to the senior medical technician. He further requested that I call senior master sergeant Keller as he indicated

that she was confused as to why the clinic would need to complete

forms, the VAERS forms.

He further stated that I should not have to use my civilian leave

for this illness since it was related to the military and that the clinic, in his opinion, should be completing a line-of-duty investigation.

He also informed me that he had discussed the situation with

Lieutenant Colonel Allen and that he would have our squadron

commander, Major Karen Dvorak, research the issue once she returned from Texas on March 30th.

I feel it is important to recognize at this time that we as a group

were placed on annual training order for each of our inoculations

with the exception of the fourth inoculation, which we were in unit

training assembly status. We were told originally that we needed

to be on military status to receive the vaccine. This is in case we

had an adverse reaction——

Mr. SHAYS. Let me say that you are trying to accommodate us

by reading fairly quickly, and so I realize that you—you can slow

down just a spec, but it is very interesting testimony.

Ms. GROLL. Thank you, sir.

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We were told that we needed to be in military status to receive

the anthrax vaccine. In case we had an adverse reaction to the inoculation, the military would be responsible for our medical care.

On April 7, I was scheduled for a 1 o’clock appointment with

Colonel Dr. Garramone from Wright Pat Air Force Base. Dr.

Garramone questioned me thoroughly concerning my symptoms

and performed what I thought to be a thorough examination, including a pulmonary exam. I feel it is important to note that out

of the 11 individuals that were examined by the medical personnel

at Wright Patterson Air Force Base, I was the only one Colonel

Garramone examined.

Colonel Garramone recommended that I be examined by a neurologist and personally escorted me to the neurology clinic. However, they were unable to see me until the next day at 8 a.m. Colonel Garramone then telephoned Battle Creek at 2 p.m. and talked

with Lieutenant Colonel Barker, support group commander, requesting that I be allowed to remain until the following day to be

examined by the neurologist and to have further blood and urinalysis work completed.

By 4:45 p.m., the others had completed their examinations and

their laboratory work. However, we were still waiting for a decision

from Battle Creek on if we could stay for further testing the following morning. It was inevitable that—obvious, that supervision

could not make that decision.

Between 4:45 and 5:15, Colonel Garramone made the decision

that he was going to send us home. He prescribed a pain medication and completed an Air Force form, form 422, a physical profile,

indicating that I had a possible neurological reaction to the anthrax

vaccine and to also rule out fibromyalgia.

He talked further with Colonel Seidel and informed him, since he

was sending us home, that I needed to be followed up with a military neurologist. We arrived home in Battle Creek at 11:30 that

night very exhausted. It was very apparent that very little preparation had gone into preparing us for this trip.

The remaining few weeks since my fourth inoculation had consisted of several more doctor visits, all civilian, and numerous diagnostic tests being performed. As of this writing, I have worked 19

hours since March 17th, 1999, and have used close to 400 hours of

my civilian leave overall due to what I feel is due to the anthrax

vaccination.

I am still suffering chronic fatigue, shortness of breath, memory

loss, weight loss, mood swings, abdominal pain, occasional nausea,

and diarrhea, and tremors in my right arm.

Today, I have not been notified of if or when I will be scheduled

up for the followup with a military neurologist that was recommended on April 7th by Colonel Garramone at Wright Pat.

I am not, and would never profess to be, a qualified medical professional; however, I do feel as though I am in touch with my own

body and I know that something is wrong. I have taken my career

seriously, devoting 14 years of my life playing a role in the defense

of our great Nation. Throughout my tenure with the 110th Fighter

Wing, I have always been amongst the first to volunteer to support

the mission, always challenged myself to go above and beyond what

is required of my position.

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Unceasingly devoting numerous hours to the base honor guard

and to other community service events. However, the events of the

past few weeks have tarnished my faith in my unit and in the Department of Defense. I feel as though I have been misinformed and

betrayed by the same country I seek to defend.

It is my impression through my own research that the anthrax

vaccination immunization program belongs to and the success lies

with the line commanders, yet, whenever a question has been addressed to our commander, they have repeatedly gone unanswered.

Furthermore, I find it extremely disheartening that the only superior officer within my unit who has shown any concern for us whatsoever has been Colonel Roger Seidel. The response, lack of knowledge, and inaccurate recordkeeping from the medical squadron has

been deplorable.

I consider trust, integrity, and accountability to be a vital link

between all leadership and employees. Is it possible that leadership

is not taking an active role in these three values? Is it possible that

this is why service men and women are choosing to defy a lawful

order and not to be inoculated with the anthrax vaccine?

I personally was very hesitant to testify in this hearing today for

fear of reprisal. It is only through the encouragement of my family

and friends that I was convinced that I need to come forward with

my experiences. The reality is that numerous individuals are becoming ill following the anthrax vaccine. Numerous individuals are

afraid to come forward for fear of reprisal, loss of income, inability

to support their families.

It is for my fellow members of the services that I testify before

you today. I pray that others will also have the strength now to

come forward.

I again thank you for the honor and privilege of testifying before

you today. I ask that the subcommittee seriously considers as a

minimum, a moratorium on the anthrax vaccination program until

all questions concerning safety and health of our service men and

women are answered.

Thank you.

[The prepared statement of Ms. Groll follows:]

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Mr. SHAYS. Thank you, Ms. Groll.

Let me just comment on both the testimonies we have heard. We

could make an assumption that you are typical of many others that

are suffering, or we could make an assumption that you are the exception to the rule. But in either case, you are, once you agree to

take on the mission, required by your Government to take these

vaccines.

Ms. GROLL. Correct.

Mr. SHAYS. This is really a message that we will convey to the

DOD, you need to be assured that every need that you have is addressed and that if, in fact, like the statistics say, there will be

some who will suffer. A vast majority won’t, if the statistics are

right. And you tend to be the very few under their view that are

suffering. You shouldn’t go under this kind of experience. You

should be—your every concern should be addressed.

And I apologize that it hasn’t been as a member of the Government.

Ms. MARTIN-ALLAIRE. May I add something?

Mr. SHAYS. You may add something and then we will get to Mr.

Churchill. Yes. Why don’t you put the microphone right next to

you.

Ms. MARTIN-ALLAIRE. I just wanted to add, being as how you

were talking about numbers, that there were 12 at our base that

got this injection, starting back on September 18th, and out of the

12, there were 9 of them that had very bad, adverse reactions.

Mr. SHAYS. That is very helpful to know. Thank you.

Mr. Churchill.

Mr. CHURCHILL. Mr. Chairman and subcommittee members,

thank you for allowing me to testify today. I am here today under

my first amendment right, and this testimony does not reflect anything against the U.S. Air Force and the Michigan Air National

Guard.

I work for the Michigan Air National Guard as a civil service

technician. I am a technical sergeant for the Air National Guard

and also I have served on active duty my first 3 years of service.

I have served in the U.S. Air Force in some capacity for the past

17 years this December.

I have volunteered for numerous trips, including Southern Watch

both in 1994 and 1996, and I volunteered for this trip that we were

talking about to Qatar last November. As a prerequisite for this

Qatar trip, 10 other civil service technicians along with two traditional Guardsmen were required to receive several anthrax vaccinations before we were allowed to go, the same vaccinations

which brings me here today to testify about.

I would now like to testify before you about the medical complications that I have experienced, complications that I believe are directly attributed to the anthrax vaccination that I received. Mr.

Chairman and subcommittee members, we have no full-time medical doctors at our unit. This being the case, we had to turn to the

civilian medical community.

A little background on me. I have studied karate for quite a few

years and I am an avid speed walker and do numerous activities

to stay in shape. However, I have noticed since I received my

fourth injection on March 14 that, when I went to my karate class,

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I have no stamina. I just thought I was out of shape. I spent the

next 2 days after I did my class, which is a 2-hour karate class,

trying to recuperate.

Anything as far as sitting for a period of time, then standing, my

legs ache, my joints in my hips, knees, and ankles crack and snap.

I have a pain in my lower back, which comes and goes, I have

found blisters inside my mouth. The last one I wasn’t sure what

it was. So I pinched it with my fingers and filled my hand with

blood.

I have little red bumps all over my body, mostly concentrating

on my torso. My skin will turn red and hot at any time, but then

I will get chills. My hands and feet sweat excessively, and I have

a tightness in my chest that comes and goes. My hands have little

bumps under the skin, and the skin around my fingers is peeling

off, including the palms of my hands. I have been having sinus

troubles with a lot of drainage in the morning, sometimes with a

blood-like mixture. And I have and continue to experience memory

loss, irritability, and shortness of attention span and abdominal

cramping.

I am not tolerable of the cold weather. My hands and fingers

hurt extremely when they are cold. I have also found that my skin

sunburns now under very little exposure.

On about March 27th, I received a medical questionnaire from

Dr. Meryl Nass and it raised concerns. I was told from Dr. Nass

about the vaccination adverse events recording system forms on the

Internet. She suggested that I fill it out immediately and fax it to

the CDC. I then scheduled myself for an appointment to find out

if these things I was feeling could have anything to do with the

fourth injection.

On March 29th, I went to my physician for an answer to my

symptoms. The doctor’s words were, it is not anthrax, you would

be incapacitated and on the floor. We know nothing about this vaccine. The military gave you the shot, the military needs to find out

what is wrong with you.

March 31st we had a meeting with our squadron commander,

Major Dvorak. We were told that it was impossible for a line-ofduty orders without a physician’s recommendation. And concerns of

the lot number and the dates were addressed as administrative errors. The shot records would be collected, and the right information

would be annotated on the shot records. Along with the shot

records, the other major concern was that those individuals that

were being treated by civilian doctors would have to sign a medical-release form for the clinic so that they could obtain the information that the civilian doctors had accumulated.

With no concern of personal health being taken, I was stunned

at what I was being told. I decided to become proactive, and started

calling as many people as I could to see who would be interested

in helping us. I could not believe this many people were sick with

no concern being displayed to the well-being, other than fixing administrative errors.

At 3 o’clock on that same day, I sent an email to Senator Carl

Levin’s office and House Representative Nick Smith with concerns

of individual health and care for our unit. At 5 o’clock, Tech Sergeant Groll and I met with Colonel Seidel, the vice commander,

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and discussed the following issues: No. 1 was the people and their

health; No. 2 was the clinic; and No. 3 was the commander’s concern.

On April 6th, I was informed that Martin, Groll, Stewart, and

myself would be going to Wright Patterson Air Force Base on the

7th to see an allergist. We were to make sure that we turned in

a copy of the VAERS form to the clinic before we left so that they

could input the information into the military immunization tracking system. When we arrived at—when we arrived, we checked into

the allergy department.

The doctor looked over my VAERS and took down my symptoms.

He then checked me out pretty thoroughly and asked me if I had

been near any animals in Qatar. He then told me he was going to

order my blood drawn, a urinalysis, and a chest x ray. I was told

after review of my blood, urinalysis, and chest x rays that I was

OK.

On April 13th, Tech Sergeant LaMore and Staff Sergeant Frank

went to Wright Patterson also. The doctor told Tech Sergeant

LaMore and stated in his medical record that he was having a systemic reaction. The doctor recommended after the next injection, if

the same symptoms occur, to cease the rest of the series. Tech Sergeant LaMore has been the only person diagnosed with the systemic reaction although he had the same symptoms as the rest of

the individuals involved.

Some individuals, in fact, had worse reactions.

We are told people at high levels of the Guard that they are

working on issues such as us using our civilian and technician sick

and annual leave, our insurance payments, to include some highcost prescriptions that my insurance does not pay for. There are a

number of us that are getting our blood taken to have it sent for

testing for squalene.

I hope these symptoms can be diagnosed and treated. These

symptoms because I do not know if they are short-term, long-term,

or treatable. Will they affect any of my future children? Or will

they affect any of my family members?

In talking to Lori Greenleaf and Meryl Nass and others that

have much more time and sources in this, they tell me there is a

cure for the way that I feel. I cannot believe that I have received

more information from people that have no interest in me other

than the concern for another human being. This is appalling to me,

considering my 17-year commitment to the U.S. Air Force and the

Air National Guard.

I have taken more sick leave from work in the past 4 months

than I have over the last 3 years. This statement is very true for

just about all of the individuals involved in this situation. I ask

that you please keep pursuing the truth into this vaccination. The

information is there. There are just too many questions that nobody can answer at this time.

I again thank you, Mr. Chairman, subcommittee members. I will

accept any questions at the end of this testimony.

[The prepared statement of Mr. Churchill follows:]

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Mr. SHAYS. Thank you, Mr. Churchill. I hope that you are finding

that you are getting a better response now than you were getting.

Are you finding that?

Ms. GROLL. No, sir.

Mr. SHAYS. OK. We will address that.

Mr. Shepard. Excuse me, nice to have you here, sir.

Mr. SHEPARD. Good afternoon, Mr. Chairman. Thank you for

your indulgence. I am going to be as short as possible, but I really

think the message I have is really important and needs to be heard

in its entirety.

Mr. SHAYS. Well, that is why you are here.

Mr. SHEPARD. My name is Sergeant Michael Shepard. My family

and I are residents of Potter County. That is in the 5th Congressional District in rural north-central Pennsylvania. Congressman

John Peterson represents us. I am currently finishing a 4-year enlistment as a military intelligence analyst in the U.S. Army. I am

proud of my service and deeply respect the military and the great

freedom it defends everyday.

I am here to speak for what I believe is a silent majority in the

armed forces on the anthrax vaccine immunization program. At

this point, I want to make it clear for the record that my opinions

on this issue are not tied in any way to the possibility of me being

deployed. I am not on deployment orders, have not been in the past

year, and do not intend to be deployed in the near future. However,

I am prepared to deploy at a moment’s notice.

Furthermore, my service record is impeccable at this time. I have

never been accused of misconduct, given non-judicial punishment,

or even given a negative counseling statement. My record demonstrates achievement far and beyond my peers in such a short period. These statements are to totally disarm the suggestions that

have been made or will be made in the future regarding my motivation or my fellow soldiers’ motivation who oppose the AVIP.

My testimony today expresses my convictions and is not intended

to reflect or represent the Army’s policies or views. My comments

regarding safety and efficacy today are meant to communicate the

situation that faces the average enlisted soldier. My credibility does

not lie in what I know about science, but what I know about soldiers.

We have heard opposing views regarding the safety of this vaccine on several fronts. The first, no long-term studies available.

The second, the nature of the FDA approval. The third, serious

questions regarding the production facility. Fourth, the current reactions of the service members. And fifth, circumstantial evidence

linking vaccinations, possibly anthrax, to Gulf war illnesses.

In addition, the efficacy of the vaccine has been debated in regards to it being developed for cutaneous anthrax exposure.

The exacerbating element of the AVIP is the shrinking credibility

of the DOD. Since your last hearing, the Army has changed its

AVIP brochure to retract its claim that veterinarians routinely use

this vaccine. In addition, the publication of the investigation in

Vanity Fair on the anthrax vaccine’s possible tie to Gulf war illnesses has further damaged the DOD’s credibility, even if you dismiss half of the article as sensationalism.

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Finally, the military’s heavy-handed tactics for producing a ‘‘successful’’ program have been brought to light by the reversal of the

decision—or it is in limbo now—regarding PFC Lundbom’s, you recall from your last hearings, discharge. It was announced here in

your committee hearing and then changed when he returned to his

unit.

Any service person that has completed basic training recognizes

that the DOD’s claims to this committee and the congressional

staff, which it is vociferously lobbying, that this vaccine is, ‘‘as important as carrying a rifle or gas mask’’ or is a vital piece of ‘‘body

armor,’’ as you heard in the first hearing, are quizzical at best. In

fact, aren’t these claims troubling when you consider that these

senior leaders are expecting us to believe that the crude technology

of the 1950’s and 1960’s is the body armor, my body armor of the

next millennium?

Is this the best we can do as the most modernized military in the

world? Why aren’t we researching and developing the best protective gear that combines a more effective protective mask with protective clothing that allows for more flexibility to accomplish the

mission?

If we are this concerned with an imminent attack, we need to

make it the highest priority to obtain the best protective equipment

and tightly control the national stock so that we are always ready

to go to war.

In light of these real concerns, I believe the information available

to soldiers and the lack of candor exhibited by DOD officials when

pointedly questioned on the information leaves the enlisted soldier

two options. The soldier can blindly trust the DOD and accept the

shots at his own risk, or refuse the shots and accept the current

contextualization of this act as disobeying an order.

If this were all an academic discussion, then it would certainly

be intriguing at this point. However, even as we speak, men and

women in uniform are facing very serious and difficult choices that

have long-term consequences just like this vaccine.

You see, this issue is about class too. Most members of an allvolunteer force are from the middle and lower classes of society.

This service is generally comprised of citizens from urban and rural

America, rural districts just like my own. These people are barely

paying their bills with their paychecks.

Place yourself in the boots of a 23-year-old PFC who is a single

mother struggling to get by on her salary and additional assistance. She has followed the AVIP issue until it is her turn. She is

faced with these very serious, legitimate, and real questions regarding the effects on her health on the one hand and loss of her

livelihood, educational benefits, and loss of an honorable characterization of her loyal service to the U.S. Army on the other.

What does the specialist who is getting married this summer do?

He needs leave in June and he needs the GI bill to provide for his

wife and family. What about the soldier who has three kids and 10

years in service, like most enlisted soldiers, barely making ends

meet and cannot even imagine a fine, let alone the loss of rank.

These personnel may initially refuse, but after continual threats

and consideration of their future, will yield to the harassment and

submit their bodies because of a dollar bill.

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In my personal experience, I am aware several initial AVIP refusers who were threatened with military punishments and then

complied with the program. Every soldier I speak to has reacted

substantially to these shots, with several suffering diarrhea, abdominal cramps, malaise, flu-like symptoms, including fever, headache, and, in some cases, vomiting.

In addition, local swelling has lasted longer than any shot they

have ever taken. It is a big deal.

Some soldiers’ arms have stayed swollen for over 2 weeks. I

asked these soldiers about using the VAERS forms. They did not

know it existed and were not issued one when vaccinated. Nor were

these soldiers briefed on how to report the actions or the importance of reporting these reactions for the very success of this program.

In essence, you are not getting the truth: ‘‘Passive monitoring,’’ is being generous.

At my level, my observations on the impact of this program as

you asked me as a first-line supervisor include the following. First,

soldiers overwhelmingly distrust the DOD on this issue because of

the available information. Second, soldiers put their career, livelihood, and educational benefits before their legitimate concerns for

their health.

Third, soldier morale and trust in our leadership is suffering due

to the obvious steamrollering over legitimate concerns and questions. They will continue to do so if this program is allowed to continue unabated, and if future vaccination programs follow this particular model, this will affect retention in both direct and indirect

ways.

Fourth, soldiers are confused with the sudden paranoia about

NBC attacks in the public and private sector. The defense establishment has known about weaponized anthrax and other elements

since at least 1990 if not long before. The threat has always been

real, but taking action for action sake does not help the situation.

It seem more like a Band-Aid than strategy. Those of us at the lowest echelons in the intelligence community have taken time to

pause because we are confused. The nation of Israel, arguably the

greatest enemy of our current adversaries in the Gulf region, is not

scrambling like the United States to inoculate their civilians and

soldiers. They have protective equipment ready for use if necessary.

And the fifth is 200,000-plus compliant service persons are not

an endorsement of the AVIP. The silent majority does not want to

take these shots based on the legitimate concerns that were

present before this committee investigation began and still have

not been answered by this probe.

Soldiers are not disputing that they are in the armed forces and

must respect the orders of superiors. Trust and respect work both

ways. In times of peace, the military must train as they fight in

order to be confident that in the day of battle each soldier will understand their duty and will execute without question upon order.

However, let us make sure we keep the AVIP in context. You

were told in your first hearing that soldiers, ‘‘cannot choose which

order to follow.’’ Very true. But how do you expect soldiers to trust

the orders of their superiors on the day of battle when, during

peace, they poorly plan and execute programs like this one.

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To add injury to insult, they attempt to convince the American

people and us that this 1950’s technology is my, ‘‘body armor,’’ and

is important as my gas mask for attacks of biological-chemical

cocktails.

Soldiers are not fooled and I hope you will not be either.

This issue will affect me personally in the near future. I do not

want to risk my personal health for this program that is extremely

suspect, at best, in light of the current information available. There

are legitimate concerns as we have outlined them.

I have contacted both Senators and my Congressman, John Peterson, regarding the issue. I am not aware of any written policy

regarding service personnel with less than 18 months. When I am

forced to choose whether to take the shots in June, I will have only

10 months left in the Army. Even if I suspend critical analysis of

the situation and blindly trust the DOD and take the shots, I will

have no recourse if it causes my family or I future problems—

health problems. This is because of the legal precedent of the early

1950’s commonly referred to at the Feres doctrine.

The doctrine has held that the Government is not liable for the

effects of military service. The lawsuits stemming from birth defects in children of Gulf war veterans have been dismissed based

on the Feres doctrine in the past 2 years.

The most I could hope for if I take the shots and suffer future

health problems is treatment from the Department of Veterans Affairs, if my income is low enough. Therefore, in light of the current

information, I do not feel compelled to comply with the AVIP.

The consequences of not complying, if I do not comply, will likely

be demotion, fines, and threats of a prejudicial discharge. I do not

want to face these consequences; however, I will do so if I am

forced to. I will do it not only for me but also for my fellow service

members and citizen soldiers in my congressional district that are

without a voice.

The majority of service personnel in my unit and, if surveyed, the

entire military do not want to take the vaccine. The majority of a

volunteer force is from the lower portions of our society in terms

of affluence. This means that the majority of service personnel cannot take the financial hardship of fines. In addition, a discharge

that is not honorable will take away the soldier’s GI bill, which is

why many young Americans of modest means join the military

service, a promise of access to education to build a brighter tomorrow for themselves and their families.

In my opinion, with so many questions outstanding at this time,

it is wrong, even immoral, to force service personnel into choosing

between these alternatives. It is time for Members of Congress, especially Members representing districts like mine, to step forward,

take a principled stand, and ask that this program be halted, made

voluntary, or, at minimum, suspended until the deliberative bodies

of the U.S. House and Senate complete their reviews of the AVIP

and report their findings.

Thank you, Mr. Chairman.

[The prepared statement of Mr. Shepard follows:]

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Mr. SHAYS. Thank you, Mr. Shepard.

Mr. Shepard—I am going to refer to him as Mr. Shepard. You

are in uniform but you are testifying as a private citizen? Is that

correct?

Mr. SHEPARD. I am testifying—I can testify as a member of the

Service with the invite that you gave me. I checked with legal

counsel. And testifying as an enlisted person as well as a private

citizen——

Mr. SHAYS. You are in uniform and you are a sergeant. Correct?

Mr. SHEPARD. Yes, sir.

Mr. SHAYS. OK. Let me just say to you that I would not want

you to in any way infer from these hearings that it would be our

recommendation that you not comply based on your orders. This

would be clearly a personal decision, and I would respect your personal decision. But I just want to make sure that you wouldn’t feel

false cover by coming to this committee and then taking that stand

and inferring—because I have concerns about it being mandatory

and voluntary, and maybe concerns that go deeper than that, that

I not mislead you.

Mr. SHEPARD. I appreciate that, Mr. Chairman. I recognize it is

a personal choice and all the personal consequences that may follow will fall upon my head.

Mr. SHAYS. Well, your statement was very articulate and extremely well thought out and impressive, as were all the testimony.

I am just going to say it again, and that is, we are trying to determine whether this is the right policy for the military. We are

trying to determine whether we can feel comfortable that the anthrax vaccine is safe. We are trying to determine whether or not—

how we want to weigh in on this.

The one thing I feel pretty convinced about is, given what I

know, that it should be voluntary and that you shouldn’t be, Mr.

Shepard, placed in the situation you feel placed in.

And the other thing I know is that we don’t even have to get into

a debate on the issues that we heard from Ms. Martin-Allaire and

Ms. Groll and Mr. Churchill about the fact that you have taken the

vaccine and you do know your bodies, you know how you felt before, and you know how you felt afterwards. And you shouldn’t be

left in this vacuum, trying to fend for yourself. Your employer, your

government should be by your side, helping you in every way, and

you shouldn’t even have even a speck of feeling somewhat deserted

and betrayed.

And if nothing else, I certainly would want to weigh in on that

side of it. I am going to just ask any of you—your testimonies are

pretty comprehensive, they are fairly consistent. In the case of Ms.

Allaire, Ms. Groll, and Mr. Churchill, you are also making a statement besides the fact that you do not feel well. And you describe

symptoms that are quite similar. You are making the statement

that others you work with are encountering the same problem.

Out of how many? If you would, Ms. Martin-Allaire. Why don’t

you move that microphone over a little bit further.

Dr. Nass, you kind of got us into this whole issue, but I am just

going to focus on those that have been on the firing line right here

as——

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Ms. MARTIN-ALLAIRE. In our group this past time, around in September, there was 12 of us that started receiving the shots.

Mr. SHAYS. And how many are not—are feeling the effects?

Ms. MARTIN-ALLAIRE. There was nine.

Mr. SHAYS. Nine out of 12.

Ms. GROLL. Sir?

Mr. SHAYS. Yes.

Ms. GROLL. I think it is important to note too that we are the

first, we are the, say, guinea pigs. But they have called us the

guinea pigs, too. We are the first ones at our base to receive the

shots. We are the first group of individuals to receive them.

Mr. SHAYS. It kind of makes you wonder too though if you don’t

have a batch that is not up to the level it should be. Well, we will

be pursuing that as it relates to the 12 of you.

Mr. Churchill, you are not part of the same—— Mr. CHURCHILL. Yes, sir.

Mr. SHAYS. So you are three of the nine? OK.

Mr. CHURCHILL. Also, I would like to make mention that on

Tuesday, before we came down here, I had called our clinic because

I wanted to get a copy of my VAERS form that I sent to the CDC.

And there is a lot of debate about these VAERS forms that they

are taking their numbers from.

When I called our senior health technician at our clinic, I had referred to if I had my copies still in my medical records before I

went to Wright Patterson, and she said yes. And I had questioned

if I could get a copy of that form from her, and she said sure. Well,

I in turn had mentioned what had happened to the other forms

that were filled out for all the other individuals that were sent to

Wright Patterson, being all 12 of us, and she said she still had

them and the only ones that were probably sent out she didn’t

know what to do with them still, other than she had inputted the

information into the military immunization tracking service. But

she never forwarded them to anybody else.

So they are still sitting in our unit since they were filled out the

second week in March.

Ms. GROLL. The only VAERS forms that the CDC has received

have been from the three of us, and that is because we independently either faxed them or I personally mailed mine. And I have

a confirmation. I included that as part of my written testimony

from VAERS that they received my vaccine. The rest of the individuals that counted on the clinic to forward them on, it has never

happened.

Mr. SHAYS. Tell me what you think the significance is of the

misdating, that it was just carelessness or intentional?

Ms. GROLL. What was the question?

Mr. SHAYS. The misdating of the shots.

Ms. GROLL. I personally feel it was intentional. As I stated in my

statement, sir, that it is their impression, and it is also out on I

believe it is the DOD Web site, there’s a 24-hour window. By giving

us the shot on Sunday, and this an impression, sir, and an opinion

of my own—— Mr. SHAYS. I understand. That is what I am asking for.

Ms. GROLL. By giving it to us on Sunday, we were on annual, in

UTA status. So we were in a military status. To get it in the midVerDate 11-MAY-2000 14:47 Apr 02, 2001 Jkt 066344 PO 00000 Frm 00201 Fmt 6633 Sfmt 6601 E:\HEARINGS\58959 pfrm04 PsN: 58959
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dle of the week, when we were supposed to receive it, they would

have had to once again put us on orders and also to bring in a physician. And they didn’t want to have to do this. That is why the

decision was made at—we didn’t even receive our shots until

almost—— Mr. SHAYS. I am sorry. I don’t understand the significance of why

they would have to have a physician—I mean what is—— Ms. GROLL. They would have to bring someone in because we do

not have any full-time nurses or physicians at the base.

Mr. SHAYS. But how does the misdating exempt them from that?

Ms. GROLL. Because they gave it to us 2 days early while we

were in a military status.

Mr. SHAYS. Oh, I see. So the implication was that it was done

while you were—— Mr. CHURCHILL. We were on drill status on the weekend.

Ms. GROLL. Right. They needed to give it to us in a military status, otherwise it would have cost them significant amount of

money. As when we were sent to Wright Patterson, we were also

sent to Wright Patterson and we had to take annual leave from our

civilian side. As a GS employee, we had to take annual leave, and

they sent us to Wright Patterson in a non-paid duty status.

Mr. SHAYS. That is interesting.

Ms. GROLL. We sit before you very broken.

Mr. SHAYS. What is that?

Ms. GROLL. We sit before you very broken and frustrated.

Mr. SHAYS. Yes. I know.

Ms. MARTIN-ALLAIRE. Sir, can I add something to that too?

Mr. SHAYS. Sure.

Ms. MARTIN-ALLAIRE. On the dates of the shot records, I have

since during all of this time, contacted the Pentagon and asked

them what the requirements were on if you could be given the

shots early. And if you can, you know, whatever. And the response

that I got back from the Pentagon was that you can’t even get the

shot 24 hours early.

Mr. SHAYS. See, the problem for us in Government, you know, on

this side, is that we are told, that this is what the need is, this is

how we do it, and it sounds a lot more efficient than the real-life

story of how you encounter it. And it sounds a little more, when

you have those who are involved in implementing it, they—you get

the sense that it has a little bit more feeling and compassion to it

than the kind of experiences that each of you have put on our congressional record.

Mr. Shepard, tell me what—summarize what is motivating you

to be so out-front here?

Mr. SHEPARD. I had—Mr. Chairman, I had no intentions of being

out front. My conversation with your staff indicated that my strategy was to keep my concerns close to my vest until I had to make

this very personal decision. I was collecting information in regards

to this issue. I wanted to find out what this committee was doing

so I could give the pertinent information to my elected representatives.

So in that process, my concerns, as indicated here, were communicated with your staff and thus they obviously conferred with you

and issued an invite to me.

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I had a decision to make at that point, whether to stay private

or to go public.

Mr. SHAYS. No. I realize that we asked you to be here. So——

Mr. SHEPARD. Right. Well——

Mr. SHAYS. I want the record to state that. You came at our request.

Mr. SHEPARD. The reason being, the reason I am speaking is because I have, quite frankly, I have a limited ability to withstand

the financial punitive measures, and if I decide to make that decision, I will have the ability to weather that type of storm. Ninetynine point nine percent of the people that I am speaking—that I

work with cannot—that is the first thing, that they can’t even deal

with these legitimate concerns that are here because of the dollar

bill that they need to pay their next paycheck with.

Mr. SHAYS. You know, your reference to paying the next paycheck, our committee oversees the defense and intelligence community and State Department for waste, fraud, and abuse. We don’t

pass laws. We investigate, make recommendations, and then work

very hard to have the committees of jurisdiction make changes to

the statute or the appropriators fund the money.

But one of the things that we are looking at is the working conditions of our military. Why we don’t have the recruitment success

that we have had? Why are we not having people re-enlist?

And one of the things that has been a real eye-opener for me is

the pay scale that so many of our men and women have to abide

by and live by. So it is very poignant for you to——

Mr. SHEPARD. You will get the type of compliance that you have

been—that has been reported to you if you deal with what everybody understands, including the DOD, and obviously Congress

deals with it, money.

And obviously, at the lower rungs of society, at the lower levels

of affluence as I have indicated, that in an all-volunteer force you

are going to get socio-economically, you can contextualize not wanting this shot and then refusal as disobeying an order. That speaks

volumes because the other side has nothing to speak.

Mr. SHAYS. Well, I have been very impressed with the men and

women that I have seen in our service, at all levels of command.

But it really gives you cause with your kind of testimony.

Dr. Nass, what is your reaction to what you have heard? Let me

just say to all of you, I am going to kind of close this up because

I think your statements speak volumes and now it will be our job

to personally follow, in particular, the four of you as you sort this

out. And we will try to do our best to help and also, given that you

are 9 out of 12, it sort of gives us a pocket to look at. It will tell

us a lot.

I want you to make sure, if I don’t say this to you later, that you

feel very willing to be back in touch with our committee, and, if you

are not satisfied, and I know you will be, but if you are not, with

what the committee is doing, to call my office personally. And let

me know that personally.

Dr. Nass.

Dr. NASS. I am not quite sure what question you are asking.

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Mr. SHAYS. Well, I am asking you a very general one. You gave

a testimony in the beginning. Were you surprised by what you

heard? Do you think this is typical? Do you have any——

Dr. NASS. Yes.

Mr. SHAYS. OK. So I am just asking for a general but not long

answer to the question.

Dr. NASS. Based on purely anecdotal evidence, which is all that

exists, reports of probably from 50 to 100 people, some who filled

out questionnaires and some who only wrote me a little bit about

their symptoms, I believe that the syndrome that these three people have described is fairly typical, although they may be more severe than most.

From what I know, there are two lots in particular, each lot

being approximately 200,000 doses, that have caused the majority

of symptoms and that those people who report to me also—when

they are ill and they survey other people who receive vaccine at the

same time that they did, they find that a large number of those

people also seem to be having chronic symptoms——

Mr. SHAYS. Yes. Let me interrupt a second to say: Are you told

the lot numbers when you are given the shot?

Ms. GROLL. It is indicated in our shot records, sir. And I believe—I know I did, I submitted copies of my shot record. And they

are all FAV030 is what it is recorded.

Mr. SHAYS. OK. We will trace that. I am sorry.

Dr. NASS. So, anyway, what I hear is that 020 and 030 are the

major problems. But we know that only six or eight lots passed

testing. We don’t know how many of those lots have actually been

used. So there may only be four lots that have been used and whatever.

It may be that, you know, when the generals say they haven’t

had any adverse effects, I believe them. And I hear from some people on board ship that hardly anyone has had an adverse effect,

and then on another ship everybody has had an adverse effect. So

I think what we need is active surveillance, which has not yet

taken place.

I don’t know what the numbers will be in the end. You know, it

is hard to even say how many people are suffering severe symptoms from Gulf war illness, although over one-seventh of those who

went to the Gulf have reported problems.

It is impossible to say at this point how widespread this is going

to be, but I—I mean I have a list from one base where 38 names

were given to me of people who are ill.

So——

Mr. SHAYS. Well, that is a helpful way to kind of wrap this up.

And I would like to acknowledge and thank Dr. Myers for staying

and listening to this testimony. I frankly think that is a fine thing

for you to have done.

And with that, we will, unless there is any other comment. And

I would welcome any other comment. We will call this hearing adjourned.

[Whereupon, at 2:17 p.m., the subcommittee was adjourned.]

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