[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]






 
   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

                                 ______

                    U.S. GOVERNMENT PRINTING OFFICE
58-959 CC                   WASHINGTON : 2000



                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
JOHN T. DOOLITTLE, California            (Independent)
HELEN CHENOWETH, Idaho


                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
           David A. Kass, Deputy Counsel and Parliamentarian
                      Carla J. Martin, Chief Clerk
                 Phil Schiliro, Minority Staff Director
                                 ------                                

Subcommittee on National Security, Veterans Affairs, and International 
                               Relations

                CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SOUDER, Indiana              ROD R. BLAGOJEVICH, Illinois
ILEANA ROS-LEHTINEN, Florida         TOM LANTOS, California
JOHN M. McHUGH, New York             ROBERT E. WISE, Jr., West Virginia
JOHN L. MICA, Florida                JOHN F. TIERNEY, Massachusetts
DAVID M. McINTOSH, Indiana           THOMAS H. ALLEN, Maine
MARSHALL ``MARK'' SANFORD, South     EDOLPHUS TOWNS, New York
    Carolina                         BERNARD SANDERS, Vermont 
LEE TERRY, Nebraska                      (Independent)
JUDY BIGGERT, Illinois               JANICE D. SCHAKOWSKY, Illinois
HELEN CHENOWETH, Idaho

                               Ex Officio

DAN BURTON, Indiana                  HENRY A. WAXMAN, California
            Lawrence J. Halloran, Staff Director and Counsel
                Robert Newman, Professional Staff Member
                Marcia Sayer, Professional Staff Member
                        Jonathan Wharton, Clerk
                    David Rapallo, Minority Counsel



                            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


   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 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 long-term 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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    [GRAPHIC] [TIFF OMITTED]58959.002
    
    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.
    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 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 
protection 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.
    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, 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.
    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.
    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.
    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?
    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 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----
    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 
anthrax 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 
long-term 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.
    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 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.
    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?
    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?
    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.
    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 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.
    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.
    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 single-blinded 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.
    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.
    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.
    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 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.
    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.
    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.
    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? 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. 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. 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?
    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.
    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 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 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 viability. 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 inter-connective--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 nature 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.
    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----
    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 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 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 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 
Gulf-era 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 my suspicion is that at least half of what was administered 
in England 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, suggests 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.
    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.
    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 1\1/2\ 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.
    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.
    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.
    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.
    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, 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-
of-duty 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, 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 high-cost 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.
    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 
all-volunteer 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.
    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.
    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----
    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 middle 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.
    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. Ninety-nine 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.
    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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