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



 
                   ANTHRAX VACCINE ADVERSE REACTIONS

=======================================================================

                                HEARING

                               before the

                   SUBCOMMITTEE ON NATIONAL SECURITY,
                  VETERANS AFFAIRS, AND INTERNATIONAL
                               RELATIONS

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 21, 1999

                               __________

                           Serial No. 106-131

                               __________

       Printed for the use of the Committee on Government Reform


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

                                 ______

                    U.S. GOVERNMENT PRINTING OFFICE
65-673 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 
HELEN CHENOWETH, Idaho                   (Independent)
DAVID VITTER, Louisiana


                      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
                           Jason Chung, Clerk
                    David Rapallo, Minority Counsel



                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on July 21, 1999....................................     1
Statement of:
    Chan, Kwai-Cheung, Director, Special Studies and Evaluation 
      Group, Natonal Security and International Affairs Division, 
      U.S. General Accounting Office, accompanied by Sushil K. 
      Sharma, Assistant Director, Special Studies and Evaluation 
      Group, National Security and International Affairs 
      Division, U.S. General Accounting Office; Major General 
      Robert Claypool, Deputy Assistant Secretary for Health 
      Operations Policy, U.S. Department of Defense, accompanied 
      by Rear Admiral Michael Cowan, Deputy Director for Medical 
      Readiness, Joint Staff, U.S. Department of Defense; Colonel 
      Frederick Gerber, Director, Health Care Operations, Office 
      of the Army Surgeon General, U.S. Department of Defense; 
      Colonel Renata Engler, chief, Allergy-Immunology Service, 
      Walter Reed Army Medical Hospital; and Susan Ellenberg, 
      Director, Division of Biostatistics and Epidemiology, 
      Center for Biologics Evaluation and Research, Food and Drug 
      Administration, accompanied by Dr. Miles Braun.............    74
    Piel, Captain Michele L., U.S. Air Force, Stevensville, MD; 
      Lieutenant Richard Rovet, U.S. Air Force, Dover, DE; 
      Sergeant Robert Soska, U.S. Army, Fort Stewart, GA; Captain 
      Jon Richter, U.S. Air Force, Annapolis, MD; and Lieutenant 
      Colonel John Jensen, Great Falls, MT.......................     6
Letters, statements, et cetera, submitted for the record by:
    Chan, Kwai-Cheung, Director, Special Studies and Evaluation 
      Group, Natonal Security and International Affairs Division, 
      U.S. General Accounting Office, prepared statement of......    77
    Claypool, Major General Robert, Deputy Assistant Secretary 
      for Health Operations Policy, U.S. Department of Defense, 
      prepared statement of......................................    97
    Ellenberg, Susan, Director, Division of Biostatistics and 
      Epidemiology, Center for Biologics Evaluation and Research, 
      Food and Drug Administration, prepared statement of........   121
    Jensen, Lieutenant Colonel John, Great Falls, MT, prepared 
      statement of...............................................    41
    Piel, Captain Michele L., U.S. Air Force, Stevensville, MD, 
      prepared statement of......................................    10
    Richter, Captain Jon, U.S. Air Force, Annapolis, MD, prepared 
      statement of...............................................    35
    Rovet, Lieutenant Richard, U.S. Air Force, Dover, DE, 
      prepared statement of......................................    19
    Shays, Hon. Christopher, a Representative in Congress from 
      the State of Connecticut, prepared statement of............     3
    Soska, Sergeant Robert, U.S. Army, Fort Stewart, GA, prepared 
      statement of...............................................    26



                   ANTHRAX VACCINE ADVERSE REACTIONS

                              ----------                              


                        WEDNESDAY, JULY 21, 1999

                  House of Representatives,
       Subcommittee on National Security, Veterans 
              Affairs, and International Relations,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:05 a.m., in 
room 2154, Rayburn House Office Building, Hon. Christopher 
Shays (chairman of the subcommittee) presiding.
    Present: Representatives Shays, Souder, Terry, Schakowsky, 
and Tierney.
    Also present: Representative Gilman.
    Staff present: Lawrence Halloran, staff director and 
counsel; Robert Newman, professional staff member; Jason Chung, 
clerk; Bill Ochs, intern; David Rapallo, minority counsel, and 
Earley Green, minority staff assistant.
    Mr. Shays. Good morning and welcome.
    In April, we heard testimony from three members of the 
Michigan Air National Guard unit who suffered serious health 
effects after receiving the anthrax vaccine. Their personal 
stories conveyed the concerns of many men and women in our 
armed forces about the long-term safety of a little-used 
vaccine.
    Their testimony also raised important questions about the 
willingness and ability of the Department of Defense, DOD, 
anthrax vaccine immunization program [AVIP], to acknowledge the 
side effects and adverse reactions caused by the vaccine. We 
address those questions today.
    All vaccines cause reactions. In fact, that is their 
purpose, to stimulate a response from the immune system. But in 
doing so, vaccines also cause in some people varying degrees of 
negative health consequences ranging from a sore arm to 
potentially fatal hyper-sensitive or allergic reactions.
    Due to its composition and the number of inoculations 
required, the anthrax vaccine causes local and systemic 
reactions at what DOD once called problematic rates. Some 
reactions may become apparent as vaccine usage expands from a 
few hundred people each year to 2.5 million members of the 
military.
    To capture the true rate of health effects and to detect 
unexpected reaction trends, AVIP surveillance systems must be 
sensitive and receptive to adverse events reports.
    Are they?
    Military doctors must be advocates for their patients, not 
purveyors of program orthodoxy.
    Are they?
    Those receiving the vaccine must be free to seek medical 
advice and pursue suspected associations between the vaccine 
and their illnesses without fear of retribution or ostracism.
    Are they?
    Many think not. Service members report massive vaccination 
sessions during which little medical information is imparted, 
little medical history elicited, and no questions or doubts are 
tolerated. They describe a program that often fails to offer 
legitimate medical exemptions from the inoculation, glosses 
over potential side effects, and aggressively denies any 
attempt to link adverse events with the vaccine.
    Others, like the Michigan National Guard members who 
testified in April and those who are here today, face 
intimidating official resistance when they ask whether the 
vaccine may be a cause of their medical problems. As a result, 
the number of AVIP-related cases in the Food and Drug 
Administration [FDA], Adverse Event Reporting System, referred 
to as VAERS, seems purposefully and implausibly low.
    Despite the under-reporting inherent in a passive 
surveillance system, VAERS is a tool DOD could use to gather 
important data about the impact of the AVIP on troop health and 
readiness. Instead, illnesses subsequent to vaccination are 
attributed to coincidence or pre-existing conditions in the 
interest of protecting the anthrax program rather than the 
patient.
    The practice of medicine, not public relations, should be 
driving the adverse event reporting process. Whether the 
adverse reaction rate is two-tenths of 1 percent or 21 percent, 
DOD has an obligation, a profound obligation, to protect those 
in the military force, in the force made ill by this force 
protection program.
    If women suffer adverse health effects at twice the rate of 
men, DOD has an obligation to acknowledge and ameliorate those 
effects. If a pure vaccine or fewer than six inoculations would 
provide protection while causing fewer reactions, DOD again an 
obligation to pursue FDA approval of those options.
    We are going to proceed from the premise all our witnesses 
share one interest, the health and safety of those in service 
to the Nation. That is going to be our premise.
    Thank you all for your time and your testimony this 
morning. And again, welcome.
    [The prepared statement of Hon. Christopher Shays follows:]
    [GRAPHIC] [TIFF OMITTED] T5673.001
    
    [GRAPHIC] [TIFF OMITTED] T5673.002
    
    Mr. Shays. At this time, I would ask if Mr. Tierney has any 
opening statement he would like to make for the record.
    Mr. Tierney. I do not. Thank you.
    Mr. Shays. Thank you, Mr. Tierney.
    So at this time, let me first get some business out of the 
way. And that would be to ask unanimous consent that all 
members of the subcommittee be permitted to place an opening 
statement in the record, and the record remain open for 3 days 
for that purpose.
    Without objection, so ordered.
    And I ask further unanimous consent that all witnesses be 
permitted to include their written statements in the record. 
And without objection, so ordered.
    And I am further going to ask unanimous consent to insert 
in the hearing the record written statements from Randy Martin-
Allaire, Roberta Groll, and David Churchill, members of the 
Michigan Air National Guard, who testified before the 
subcommittee in April. And we asked them to update us on their 
health and their efforts to determine whether the anthrax 
vaccine played a role in their illnesses.
    I am happy to report their health has improved somewhat, 
but they remain very frustrated and disappointed over the DOD 
response to their plight.
    And without objection, we will put that in the record as 
well.
    Now we will welcome our first panel. We have five witnesses 
who will testify. Captain Michelle Piel, U.S. Air Force; 
Lieutenant Richard Rovet, U.S. Air Force.
    Captain Piel is from Stevensville, MD, and Lieutenant Rovet 
is from Dover, DE.
    Now we also have Sergeant Robert Soska, U.S. Air Force--
U.S. Army, I'm sorry--Fort Stewart--excuse me, Sergeant--and 
Captain John Richter, U.S. Air Force, Annapolis, MD, and 
Lieutenant Colonel John Jensen, Great Falls, MT, and he is with 
the Montana Air National Guard.
    We welcome all of you here today, and as is our practice, 
we swear in our witnesses, this being an investigative 
committee. We do it for Members of Congress as well when they 
testify before us. And we would welcome you to stand and we 
will administer the oath. If you would raise your right arms 
please.
    [Witnesses sworn.]
    Mr. Shays. Thank you. For the record, all five have 
responded in the affirmative.
    And I think we have you seated according to the way we are 
going to proceed. We will start with you, Captain Piel.
    And what we do is, we have the light on for, it will be on 
for 5 minutes. We will roll it over another 5 minutes, and 
certainly ask you to finish before that second roll-over is 
done. And do know that your record will be--your full statement 
will be in the record if you care to leave out some parts.
    Capt. Piel. Yes, sir.
    Mr. Shays. I am also going to say to all of you before you 
testify, I have served in Congress 11 years, and I know for a 
fact that military personnel do not like to come before 
Congress. This is not something you look forward to. It is not 
something you enjoy. And you do it with some recognition that 
you put your careers in some jeopardy, even when we say you 
don't.
    And we certainly keep track of our witnesses and do our 
best to make sure they are treated fairly as they complete 
their career. But we know you are here at our request, and we 
thank you for being here.
    Captain Piel.

    STATEMENTS OF CAPTAIN MICHELE L. PIEL, U.S. AIR FORCE, 
  STEVENSVILLE, MD; LIEUTENANT RICHARD ROVET, U.S. AIR FORCE, 
DOVER, DE; SERGEANT ROBERT SOSKA, U.S. ARMY, FORT STEWART, GA; 
    CAPTAIN JON RICHTER, U.S. AIR FORCE, ANNAPOLIS, MD; AND 
        LIEUTENANT COLONEL JOHN JENSEN, GREAT FALLS, MT

    Capt. Piel. Good morning, Mr. Chairman and members of the 
committee.
    Mr. Shays. I am sorry, Captain, I am going ask you to move 
that mic a little closer to you. If it kind of gets in the way, 
you could lift it up a speck if you wanted. Is it all right? 
Can you----
    Capt. Piel. It is fine.
    Mr. Shays. OK. That is better. We hear your voice better. 
Thank you.
    Capt. Piel. First of all, I would like to thank you for 
interest in the anthrax immunization program and also for 
requesting my testimony today. The views which I will express 
will be my own and in no way reflect those of the Department of 
Defense, the Air Force, or my superior officers.
    I am a C-5 pilot at Dover Air Force Base, DE. I hold the 
position of aircraft commander and I am also a flight commander 
within my squadron. My whole life I have wanted to fly and 
serve my country. And as a graduate of the Air Force Academy, I 
was able to achieve both.
    I have had a very rewarding 13-year career, and I am 
grateful to everyone who has helped me along the way. Today I 
am going to talk to you about my experiences.
    In October, I was healthy and flying operational missions. 
I became ill the first of November and then again in December 
following my first and second anthrax immunizations. On October 
1st--excuse me, on October 21st I received my first 
immunization from Lot 030. It wasn't until weeks later, while I 
was flying a mission in support of Hurricane Mitch relief 
efforts, that I became ill.
    The right side of my head filled up with fluid while I was 
on a return leg to Pope Air Force Base. After landing, the 
flight surgeon grounded me. I had otitis media, which is an 
inflammation, or an infection of the middle ear. And I also had 
a very bad head cold.
    These symptoms persisted for 3 weeks. My doctor back at 
Dover and I discussed whether or not I should receive an 
immunization at this time, and we felt that it would be 
improper and that we should wait until I had fully recovered.
    On November 30, I went to the flight surgeon's office to 
get put back on flying status. He returned me to flying status 
and I went straight to the immunization clinic to get my next 
vaccination. Following the second vaccination, I felt fine 
directly afterward. But later that afternoon, I began to feel 
very tired.
    I went home, straight to bed, and I did not wake up until 
the next morning. I awoke feeling very ill, and I returned to 
the doctor. The doctor was very surprised at my condition, the 
change from the day before to that day. And, of course, I went 
back on non-flying status.
    And he asked me, what did you do differently between 
yesterday and today? And I told him, the only thing that I 
could think of was that I had my anthrax immunization.
    In December, I had dizziness to the point it affected 
everything that I did. I could not drive; I could not read a 
page of paper; I could not concentrate. At the lowest point, my 
vision blurred, which is very critical to me because it affects 
my career as a pilot.
    During this time, the diagnosis was viral labrynthitis, 
which is an inflammation of the inner ear, and it can cause 
dizziness because it affects your balance system.
    I do not know exactly what was happening to me, but the 
doctors assured me that within 4 to 6 weeks I would recover 
from viral labrynthitis. Well that did not happen.
    I saw many doctors over the course of the next 6 months, 
and nobody could, I don't feel, adequately address my problem. 
It wasn't until I began going to Walter Reed at the decision of 
my wing commander, Colonel Greider, that I began to get my 
problems recorded in my medical records and receive blood 
tests, which would help try to determine what was causing my 
symptoms. I have had a very slow recovery, with periods of 
regression, but I strived to maintain a positive mental 
attitude and recover my flying status and career.
    I would like to talk to you know about deferral criteria. 
The only information I was given at the time of the shot was 
the trifold pamphlet, which we are all familiar with, what 
every service member should know.
    Although I did not have deferral, I have not received any 
shots since November, during the first few months of my 
illness, doctors asked me if I would like to continue my 
anthrax immunizations. They even suggested taking incremental 
doses to see what would happen.
    Because I was still ill, I felt that this was unwise, and 
no one pushed the issue. At this point, I was in a gray area.
    There was no diagnosis, and yet I was still ill. I valued 
my career, but I also couldn't afford to jeopardize my health, 
because without my health, I have no career.
    No I will talk about the VAERS system, Vaccine Adverse 
Event Reporting System, and how that was communicated to me.
    The doctors did not file a VAERS report on me. It wasn't 
until May that I learned about the VAERS system. At that point, 
I felt it would be wise for my doctor and I to file it together 
because I wanted it to be accurate.
    When I went to the chief flight surgeon at Dover Air Force 
Base, my request met reluctance. I thought that any loss of 
duty over 24 hours should be reported in VAERS. But he did not 
agree that I had had a reaction.
    So then I asked him what he did think was reportable under 
VAERS. And he listed things like difficulty breathing, rash, 
sweating, fever, nodules, and anaphylactic shock. My case 
clearly did not fall within those criteria.
    I asked him, what about effects on the immune system and 
the nervous system, because I felt that maybe that was 
happening to me. But I had no answer to that question.
    At this point, I was confused because I was too sick to fly 
and I was too sick to get another shot. But I wasn't sick 
enough or in the right ways for it to be reportable.
    There would be no data collection at Dover Air Force Base 
if it wasn't for the fact that Lieutenant Rovet pursued the 
issue. He followed up on all of our cases; he tried to help us 
out. And all of his efforts were met with resistance and 
discouragement.
    However, when we reported our symptoms to our commanders, 
it went up the chain of command to Colonel Greider. And when 
our wing commander, Colonel Felix Greider, found out what was 
happening at his Air Force base, he took the health of his wing 
very seriously. That was when we had the series of briefings, 
and we got a lot of attention at our base, to say the least.
    The information that we got in the first briefings wasn't 
adequate. And, dissatisfied, Colonel Greider decided to call a 
timeout until our health issues could be addressed properly. 
This is important to the collection of data because before he 
called the timeout, there was no VAERS data from Dover Air 
Force Base. There was no collection or reporting.
    No one knew what was happening outside of our base.
    I would also like to say that as far as diagnosis and 
treatment within the medical community at Dover, I did not get 
directed to Walter Reed. I got directed to from Colonel Greider 
and put in touch with the immunology clinic, where they began 
to actually record my symptoms in my medical records and give 
me blood tests to try to determine what may have, what may be 
wrong with me, besides the fact that I had an ear infection.
    What they did find was that I had a positive ANA marker, 
which is an auto-immune disorder, an indication of that. It is 
not that I have been diagnosed with a specific disease; 
however, my symptoms are consistent with having immune system 
problems.
    The last few months I have felt some improvement; however, 
the fatigue is affecting how I live, and it is also affecting 
whether or not I am capable of flying. I also have periodic 
returns of the dizziness, which I also cannot fly in that 
condition. And I also have headaches and other things which 
affect me to a lesser degree.
    I missed several weeks of work in January; I missed all of 
work in December; I missed 3 weeks of work in November. I 
missed a lot of work. And none of this was reported.
    However, now it is. An IG complaint was filed at Dover 
because when the VAERS reports were finally filed, they were 
filed inaccurately. The most egregious error is that they 
marked that the reports were self-filed, indicating that I and 
the others that they filed reports on had filed it ourselves, 
when, indeed, we had nothing--I had nothing to do with my VAERS 
form. I saw it later, and I noticed that there were some 
inaccuracies on the form.
    What's happened since then is we have gone back and 
corrected what is wrong with those forms. So at least adequate 
information is making it to the FDA right now.
    VAERS is important because it is our only way of tracking 
this illness or I should say adverse events that may be 
connected to the vaccine. I realize that a diagnosis and 
treatment in cases of unexplained illnesses are complex. And I 
know that the doctors had a very difficult time, and they did 
not, or were not, fully prepared to take care of me at the 
time.
    But right now I am receiving excellent medical care. I do 
not know the cause or impact of the ANA antibodies in my blood, 
but my focus is on flying and getting healthy. I want my whole 
life back.
    I have testified today at your invitation because I believe 
our military's health is critical to our Nation's war-fighting 
readiness.
    That concludes my statement. Do you have any questions?
    [The prepared statement of Capt. Piel follows:]
    [GRAPHIC] [TIFF OMITTED] T5673.003
    
    [GRAPHIC] [TIFF OMITTED] T5673.004
    
    [GRAPHIC] [TIFF OMITTED] T5673.005
    
    [GRAPHIC] [TIFF OMITTED] T5673.006
    
    [GRAPHIC] [TIFF OMITTED] T5673.007
    
    Mr. Shays. Thank you. Captain, we are going to have 
everyone testify, and then we are going to be asking you 
questions. And your testimony is very important. I didn't want 
to interrupt it, but I know that Mr. Gilman, the senior on this 
full committee, would be chairman if he chose to, but he is 
chairman of the national--international committee.
    If the other members don't mind, I would welcome you to 
give a statement.
    Mr. Gilman. Thank you, Mr. Chairman. Thank you for allowing 
me to intervene. I have to go back to the floor to conduct our 
hearing on our major bill that's before the house, and I was 
very much interested in Captain Piel's testimony, and I have 
been glancing through the other testimony. And I hope to get 
back to the committee at the earliest possible opportunity.
    I want to thank you, Chairman Shays, for convening this 
hearing today as part of your series of ongoing hearings 
related to the Department of Defense anthrax vaccination 
program. I think it is an important hearing.
    I recall serving under subcommittee in the last Congress, 
where we held a series of very productive hearings on the 
subject of the Gulf War Syndrome. Those hearings led to much-
need legislation, providing valuable assistance to our Persian 
Gulf war veterans and their families. And hopefully, these 
series of hearings on anthrax will do the same.
    While I no longer serve on your subcommittee, I have 
followed your previous three hearings with great interest. And 
after reviewing the background material from these hearings, I 
find myself with more questions when I finished than before we 
started.
    It appears that this vaccination program was initiated in a 
hasty manner, before a proper amount of research on the 
effectiveness and safety of the vaccine was completed.
    Even more distressing has been the reports of deliberate 
down-playing of adverse reactions among our military personnel 
who have received the shots to date. These reports, of course, 
are all too familiar for those of us who investigated the Gulf 
War Syndrome issue.
    Then as now, there was the all-too-frequent case of 
commanders who are more interested with following the official 
public relations message rather than being concerned with the 
welfare of the personnel under their command.
    Mr. Chairman, these hearings are important, as they help 
keep the Department of Defense focused on an uncomfortable 
issue and remind both officials at the Pentagon and the members 
of the public of Congress' determination to fully address this 
subject.
    Mr. Chairman, I commend you for your efforts and look 
forward to today's testimony in our ongoing investigation.
    Thank you, Mr. Chairman.
    Mr. Shays. Thank you, Mr. Chairman. You need to get back to 
that floor. I would just like to, before calling Mr.--
Lieutenant Rovet, just to acknowledge the presence of Janice 
Schakowsky. I don't know if you have a statement, but she has 
been a very active member of the committee, and a very helpful 
one, besides Mr. Tierney. And also, we have Lee Terry, who has 
been very active on the committee as well as the vice chairman 
of the committee, Mark Souder.
    Do any of you have any statement you would like to make.
    [All nod in negative.]
    Mr. Shays. OK. Thank you, because that helps. We will get 
right back to our witnesses.
    Lieutenant.
    Lt. Rovet. Good morning, Mr. Chairman----
    Mr. Shays. Good morning.
    Lt. Rovet. And members of the subcommittee. Thank you for 
inviting us here today. It is an honor to appear before you on 
this important issue. But I must say at the onset that these 
are strictly from my perspective at Dover Air Force Base and 
don't reflect the views of the Air Force of the Department of 
Defense.
    I am a veteran of 14 years of service. I come from a wide 
variety background in the Air Force. I was prior enlisted. I 
worked my way up through the ranks, and it is an honor to be a 
commissioned officer and serve in the Air Force.
    And my job at Dover entails what we call health-care 
integrator. And in that capacity, what I do is clinical 
nursing, case management, and patient advocacy. All those are 
very important to me. One that came to the forefront with this 
issue is patient advocacy because you have to be a voice for 
someone when they don't feel like they are being heard.
    And that is not a knock against the folks of the medical 
group or the Air Force at large. They are good people.
    Some of the things we have seen at Dover at the onset were 
a reticence upon the medical community to touch this issue. It 
was viewed as let's say politically sensitive, professionally 
risky to veer off the line on this issue.
    I, myself, felt that in the beginning, but once I saw 
people coming forward, I had some questions. And I voiced those 
to my superiors. And I was not quite comfortable with the 
answer, although I smartly saluted and about-faced and went 
back and did my job.
    Next, I started hearing some rumblings, and more people 
came forward. Then it became a matter of core values, it became 
a matter of, well, you are a patient advocate, you need to 
start looking into this issue.
    What I would like to do is just briefly outline for the 
committee some of the adverse reactions at Dover, what we have 
seen. So far, we have reported 30, but there will be 5 to 6 
more within the next week. And it is fair to say, out of these 
30, there are unexplained illnesses. That may not sit well with 
the public relations machine or whatever have you, but if they 
are not diagnosed, we have no answer to these peoples' 
question, then logic states that they are unexplained 
illnesses. These people are all being worked up for anthrax, 
possible anthrax reactions.
    I also would like to say that the vast majority of people 
it seems can tolerate the vaccine, and this may be a vital link 
to force protection, but I think we need to hash out these 
problems here that weren't put up forth in the beginning, at 
the onset of this program.
    OK, for individuals, we have--some of these are multi-
symptoms that people may exhibit--6 report dizziness; 6 report 
ringing in their ears; 10 report joint pains; 3 report muscle 
pain; 3 report memory impairment; 2 report constant fatigue; 3 
report numbness and tingling in various parts of their body; 1 
reports photosensitivity, which the lights in this room are 
probably bothering the individual right now; one reports having 
a miscarriage post-vaccination, although the individual did not 
know she was pregnant at the time.
    One individual reports what they call having gray-outs. 
That is like a pre-seizure, or it is something that we just 
don't know. But he calls it a gray-out. One complains of 
swollen and painful testicles; two report cardiac problems; one 
reports chills and fever greater than 48 hours post-
vaccination; three report rash, swelling, and nodule at the 
injectionsite; two report non-localized persistent rash; one 
reports hyperthyroidism.
    Again, when we say report, these are bona fide medical 
work-ups. They do have hyperthyroidism.
    OK, according to the anthrax vaccine insert, we have, right 
now, according to the rhetoric that is out there, two mild 
reactions, three moderate local reactions, and three systemic, 
characterized by chills, fever, lassitude, and malaise.
    Mr. Shays. Excuse me for interrupting you. Just so I 
understand the testimony. You are saying what's reported is the 
official documentation of the effect of the anthrax vaccine at 
Dover? Is that what you are saying?
    Lt. Rovet. It is not official yet, but according to the 
insert, if we were to apply what's in the package insert, and 
strictly this is my testimony, it is not the Air Force's, so it 
is not official yet. I am just saying, if we were to apply the 
package insert to what we have here right now, this most likely 
would be what we have. But it is not a confirmed, they are not 
confirmed reactions.
    There is significant confusion in relation to these 
categories, and especially in regard to what constitutes 
systemic reaction. This I hope will be looked into further to 
seeing that these are things that were not originally thought 
through in the beginning as systemic reactions.
    I would like to speak briefly about the medical cultural 
climate that we see. I speak about the reticence upon the 
medical community, and I am not painting wide brush across all 
of the medical community, but providers, medical providers, 
view this issue as politically sensitive and like to avoid it.
    One clinical supervisor stated on July 15, 1999, my 
providers won't touch this. They want nothing to do with it.
    Initially, patients were thought of as malingerers, liars, 
and hypochondriacs, that this is some sort of mass hysteria 
akin to the polio vaccine when it came out. I don't, I cannot 
see these honorable men and women coming forward all over the 
country making this up or having some massive psychosomatic 
illness.
    Sir, this needs to be looked into for the health of our 
country, for the morale and welfare of our troops. There are 
too many questions that are left unanswered.
    This vaccine was sold with a 28-year track record of safety 
and efficacy. Now we notice that they say we don't know the 
long-term effects. Things seem to be fluctuating daily, 
recantations of statements. It was given to veterinarians on a 
widely used basis. We found that is not true.
    This is such a sensitive issue post Gulf war era. We have 
veterans who are still sick and dying across this country, and 
some are making the link to the vaccine. I am not doing that 
here, but I find it interesting that we have unanswered 
questions with that. We have similar complaints to Gulf war 
illness appearing all over this country, and yet, we don't have 
the foresight in some areas, and I am not finger-pointing, to 
know that this was going to come up?
    I work in an emergency downtown. I moonlight in the 
evening. And I met an individual, a retired individual, who 
injured himself. And we got to talking afterwards. And he knew 
I worked in flight medicine.
    He started to bring up the anthrax vaccine program. And I 
listened, and I told him that it is obviously a hot topic. He 
explained to me his symptoms that occurred a little bit close 
to 9 years ago, and he perfectly described another individual 
who is in this room today. Instead of using the word gray-out, 
he used the word ``episode.''
    His wife was in tears, and they were afraid to--and I said, 
well you need to come forward and be evaluated. He goes, I am 
afraid I will lose my benefits.
    Speaking of fear, all through the squadrons on base, people 
are afraid to come forward for they are going to lose their 
flying status and lose their career if they come forward. For 
every one individual that comes forward, there are three 
individuals that will not.
    These are many unanswered questions, sir. I just hope that 
for the good of the country and the good of the morale of our 
volunteer force that we will find some answers soon and press 
on and get back to business.
    Thank you, sir.
    [The prepared statement of Lt. Rovet follows:]
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    Mr. Shays. Thank you. Lieutenant Rovet.
    Sergeant Soska.
    Sgt. Soska. Congressman Shays, members of the committee, 
thank you for inviting me to testify today.
    This last year has been difficult for my family and me 
because of the adverse effects I experienced after receiving 
the DOD-mandated anthrax vaccinations. I receive the injections 
as ordered on three occasions. The vaccine that I received came 
from lot FAV 020.
    These ordered injections were administered during my 
deployment to Kuwait in support of Operation Southern Watch in 
1998. Upon returning from Kuwait on June 10, 1998, I developed 
problems with my right arm, and a sore spot in my right wrist 
led to severe muscle spasm in my upper arm. These symptoms 
advanced to burning sensation in my fingertips, radiated to my 
left arm, and throughout the remainder of my body.
    The pain in my ankle and joints at times is excruciating. 
On many nights, I am unable to sleep through the night because 
of the pain. I have trouble keeping food in my system. I have 
problems such as joint-muscle pain, swelling on my hands and 
feet, dizziness, memory loss, sleep disorders, one blackout, 
night sweats, chest pains, and shortness of breath.
    Environmental changes cause the symptoms to increase with 
severity.
    My condition continues to worsen. Problems and ailments 
have developed throughout most of my body. As with most long-
term illnesses, some days are better than others, but the pain 
is always there as a constant reminder of the hardship and 
headache suffered by my family and me.
    Although I continue to try to stay active and in shape, I 
am afraid I could be fighting a losing battle. As mentioned in 
my letter to Congressman Shays on April 29, 1999, many other 
soldiers are having similar problems, flu-like symptoms, 
chronic pain, and so forth.
    The DOD reports that there are a low number of adverse 
reactions while they report a high rate of success for the 
AVIP. I have included in my reports that I sent to the Vaccine 
Adverse Events Reporting System [VAERS], as an attachment to my 
written statement. I hope those reports plus my testimony will 
cast doubt on the DOD claim that the AVIP is a successful 
program.
    Soldiers who are getting sick are reluctant to report their 
symptoms out of fear of reprisal. The uncooperative spirit of 
military doctors makes bringing these symptoms to light seem 
like a lost cause to soldiers. The feeling is that there is a 
reluctance and even denial on behalf of the medical staff to 
inform their superiors so that proper treatment can commence.
    Many soldiers have approached me with concerns for my 
condition. Our conversations, more often more of them realize 
they have many of the same symptoms. These symptoms are 
becoming prevalent in soldiers who did not even deploy to 
Kuwait but underwent AVIP.
    I addressed my concerns over the AVIP during the Persian 
Gulf outreach meeting conducted by Mr. Rostker's staff at my 
duty location. I was present for three meetings. All I heard 
them say was, we need you to come forward; we want to know what 
is happening to you.
    However, in my opinion, the only thing that was really 
accomplished was a reiteration that the vaccine is safe. I was 
not the only person present that felt the meetings were an 
ineffective mode of covering up the truth about the anthrax 
vaccinations.
    Soldiers are not being informed of the adverse effects as 
stated on the product inserts, nor were they being told about 
the various forms. I am charged with accomplishing the mission 
of looking out for the health and welfare of my soldiers. How 
can I accomplish my mission when the people who treat my 
soldiers are turning a deaf ear to their reports?
    I have been told to come forward and let you know what is 
happening. I am here before you now, and like many, I am 
telling what I know but I feel my testimony is falling on deaf 
ears within the DOD.
    My case is also unique. Since the onset of my symptoms, I 
have been persistent to investigate both my physical ailments 
and the program itself. I have written several Members of 
Congress. I have had the backing of my chain of command and the 
help of some outstanding doctors. I am one of the lucky ones. I 
am now being sent to the clinics to find out what is wrong with 
me.
    But my question is, what will become of soldiers who have 
not aggressively sought diagnosis and treatment but accepted 
their plight? What will be done to ensure that they are getting 
the same care?
    Being an NCO is a rewarding career. I have invested 17 
years in the proud service of my country. I have no regrets. I 
did what was asked of me, and now I am sick. I must stand up 
for what I feel is moral and ethically right. I am here to 
testify that this program is wrong.
    Procedures are not being followed as spelled out in the 
AVIP documents. Soldiers are getting sick at an alarming rate. 
Soldiers should not be made to feel afraid to come forward with 
their medical complaints; soldiers need to come forward and 
inform responsible and caring physicians of their symptoms.
    When they do come forward, they should not be told the 
symptoms are all in their heads or that there is nothing to 
worry about.
    Soldiers deserve better.
    This concludes my opening statement, Mr. Chairman.
    [The prepared statement of Sgt. Soska follows:]
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    Mr. Shays. Thank you, Sergeant Soska.
    Captain Richter.
    Capt. Richter. Good morning, Congressman Shays, committee 
members. Thank you for the invitation to appear before you. 
Yes, my name is Captain Richter, and at this point I am really 
happy I suffered through Public Speaking 101 in college. 
[Laughter.]
    I, too, am a C-5 pilot in the U.S. Air Force Reserve at 
Dover Air Force Base in Delaware. Like my father and my 
grandfather before me, who are both career Naval officers, the 
military has been an integral part of my life. For over 12 
years now, I have served as an aviator in both the Navy and the 
Air Force.
    I am not a malcontent nor do I have any personal vendetta 
against the military. On the contrary, I have served proudly 
and faithfully through Desert Storm in the Navy and through 
Operation Provide Comfort and Northern Watch in the Air Force.
    I am not here representing the Air Force or the Department 
of Defense. These are my view and opinions only. I am simply 
here to tell you my story.
    In June 1998, I left the active-duty Air Force as a special 
operations pilot at Hurlburt Field, Florida. I was accepted 
into the Air Force Reserve and went to C-5 Galaxy pilot 
training, which I completed in January 1999. Upon the return of 
my unit in Dover, I was told that all personnel needed to start 
the anthrax vaccine series of shots if they had not already 
done so.
    I had heard a few of my peers discussing the vaccinations 
and possible unpleasant side effects in various cases and how 
they would quit before being forced to take it. I dismissed the 
talk as rumors and innuendo, thinking that the military 
wouldn't vaccinate the troops with something unsafe or 
unproved.
    I took my marching orders, saluted smartly, and went to the 
clinic for the first of my shots on February 3, 1999. I was 
injected with lot number FAV 030. I had no noticeable negative 
reaction. No one at the squadron asked me, nor did anyone at 
the clinic question me if I had experienced any negative 
reactions before I went in for my next injection.
    On February 19, 1999, I submitted to the next shot in the 
series, which were to be 2 weeks apart. I was again injected 
with lot number FAV 030. Approximately 5 days later, the 
problems began. My right shoulder joint started to ache, much 
like when I had played catch as a kid without properly warming 
up.
    A few days later I noticed my left shoulder joint aching. I 
thought it was odd. About a week later, I experienced pain in 
the center of my spine, to the point that I had some difficulty 
getting out of bed in the morning. These aches and pains lasted 
for several weeks each before dissipating.
    Again, there was no followup from any medical personnel to 
discuss any possible negative reactions to the vaccine.
    In April, my ankles and feet began to hurt as well as my 
left thumb and index finger joints. I noticed swelling in my 
hand. I was not starting to register genuine concern. I could 
not get out of the bed without limping with pain for the first 
few hours until my body loosened up.
    Today the pain has stabilized mostly in my feet and left 
hand, with an occasional flare-up somewhere new in my body. 
Last week it was my hip joints; next week it may be something 
else. I awaken and ease into my day with a couple of over-the-
counter Motrin. I cannot walk without a limp and severe 
discomfort for the first hour.
    Furthermore, if I am stationary for more than an hour 
during the day, my joints and muscles stiffen, making movement 
extremely unpleasant.
    I have lost flexion in my left thumb, and it is still 
swollen. I am a 36-year-old man with no previous history of 
arthritic symptoms, and I was perfectly healthy before my first 
anthrax shot.
    In May, I learned that Colonel Felix Greider, 436th Airlift 
Wing Commander, at Dover Air Force Base had boldly decided to 
suspend all further vaccinations until information was 
available on the vaccine and the concerns of his people were 
addressed. I quietly applauded this gallant decision, as I 
decided that taking a third shot in the series was not in my 
best interest.
    Shortly thereafter, the Air Force surgeon general, 
Lieutenant General Charles Roadman, came to Dover to discuss 
the anthrax vaccination program and hopefully assuage the 
doubts of base personnel. I was not in attendance, but learned 
through a few people who were that Lieutenant General Roadman 
assured everyone the vaccine was completely safe and that only 
a minute percentage of those military personnel inoculated had 
a negative reaction.
    Meanwhile, I was encountering more of my squadron mates who 
were vaccinated that said they too had experienced various 
reactions, including tinnitus, dizziness, muscle and joint 
pain, and, in one case, gray-outs.
    However, most were attempting to keep it low-profile and 
did not readily discuss these matters for fear of reprisal.
    In June, as I became more and more concerned that my 
condition was not getting better, I took the initiative to 
discern what is going on in my body. I learned from what is now 
a full-scale anthrax information network among my peers that 
1st Lieutenant Rovet and Tech Sergeant Domm were taking 
information on anthrax vaccine reactions for entry into the 
VAERS data base.
    After meeting with Tech Sergeant Domm and speaking to 1st 
Lieutenant Rovet over the phone, they convinced me to come 
forward and go public, so to speak, about my condition and to 
encourage others who were vaccinated and are having problems to 
do so as well. They also gave me the number of the Allergy-
Immunology Clinic at Walter Reed Army Medical Center.
    On June 23, 1999, I called the immunology clinic at Walter 
Reed and was seen that same day. After discussing my symptoms 
and stating my concerns about continuing the anthrax 
vaccination program, the doctor ordered a series of blood 
tests.
    In paraphrasing our conversation, he told me he could take 
blood tests to determine that I do not have rheumatoid 
arthritis, but there are no tests that could positively link my 
condition to the injection of the anthrax vaccine. The doctor 
then gave me a temporary waiver from taking the next anthrax 
injection until my blood-test results were returned for review.
    He later informed that the results of the blood test 
revealed that I was not positive for rheumatoid arthritis 
factor.
    Therefore, he stated, that he would in all likelihood 
ultimately have to recommend that I continue the anthrax 
vaccination shot series.
    I told him that put me in a very tenuous situation, and one 
that left me with only one clear option. The doctor went on to 
say, and I am again paraphrasing here, that the threat of being 
exposed to anthrax while on a deployment outweighed the 
possible negative reactions that some military personnel might 
have to the vaccination and that it was not a matter of if but 
when some of our troops would come in contact with it.
    I am unsure if this was his opinion or Department of 
Defense policy. Apparently there is an unusually high level of 
acceptable risk with this vaccine.
    The squadron policy and I assume the 512 Airlift Wing 
policy was clearly and unequivocally stated in June. We were 
told the next time a drilling reservist comes into drill, he or 
she will commence the anthrax vaccination series or continue 
with the next injection if the series was already begun.
    This policy was re-emphasized on or about July 7, 1999, 
when I got a phone call at my home from my unit saying the next 
time any reservist planned to drill he or she had to take an 
anthrax shot or turn in an Air Force Form 1288, which is a 
resignation form, or be subject to Uniform Code of Military 
Justice Article 15 procedures.
    Currently, approximately 60 percent of my squadron's pilots 
are quitting the Reserve military because they have been forced 
to make a decision to gamble with their health. I can only 
assume that the people in the other specialties required to 
execute the mission of an airlift airplane such as the C-5 are 
leaving as well.
    Word travels fast. Morale is at an all-time low. People are 
trigger-shy about coming forward with their symptoms. There is 
an air of fear and distrust prevalent throughout.
    By coming here today, I have most assuredly fallen on my 
sword. I recently made the rank of major, but I never expect to 
be able to wear it because I will resign before I take another 
anthrax injection. This is sad because I like my job. I love my 
country. The military has always been a part of my life, and I 
had planned on continuing to serve in it.
    I am just a captain and a very small cog in the huge wheel 
of the military, but I am the guy in the trenches of the DOD's 
implementation of the anthrax vaccination program.
    I am not a medical professional, but I am medically 
qualified to discuss one thing, and that is the status of my 
own health.
    I was healthy before, now I am not. I know what is good for 
me and what is not. And right now, taking another shot is not 
part of the John Richter health-care program.
    Those in command seem to have shrugged their shoulders at 
the numbers of people leaving military with the attitude that 
an order was given and it should be carried out. We are growing 
tired of the denials that everything is OK when, in fact, it 
isn't.
    Over 12 years ago, I raised my right hand and solemnly 
swore to support and defend the Constitution against all 
enemies foreign and domestic and to obey the orders of the 
officers appointed over me. I took that oath freely and 
willfully. I knew that I could and would give my life for my 
country, and on several occasions during the course of my 
military flying career, I almost made that sacrifice, as have 
many others.
    But at no time did I ever agree to be slowly poisoned, 
however well-intentioned, under the guise of being combat ready 
so that every day is one filled with pain. That wasn't part of 
the contract as I know it.
    I have defended my country and I have obeyed the orders of 
the officers over me, but taking another anthrax shot is not an 
order I can carry out.
    Thank you.
    [The prepared statement of Capt. Richter follows:]
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    Mr. Shays. Thank you, Captain Richter. How many years have 
you served in the military, sir?
    Capt. Richter. Almost 13.
    Mr. Shays. Thank you.
    Lieutenant Colonel Jensen. You will conclude.
    Col. Jensen. Yes, sir. Mr. Chairman, distinguished members 
of the subcommittee, I am Lieutenant Colonel John Jensen, wing 
chief of safety for the 120th Fighter Wing, Great Falls, MT, 
Montana Air National Guard.
    I am here today in response to your invitation seeking my 
views and experience with regards to the AVIP program. The 
views expressed in my testimony are my personal views and not 
meant to be taken as those of the DOD, Air Force, Air National 
Guard, or my command.
    As a military member since 1979, I was raised in a family 
of military service, with my grandfather serving in World War I 
and my father serving during the Korean conflict as a Marine 
fighter pilot. I joined the Marine Corps in 1979, following in 
my father's footsteps and am continuing to serve my country 
today in the Air National Guard.
    In my opinion, one of the biggest challenges to the success 
of the AVIP program is understanding all of the issues and 
perceptions that exist out there, even those perceptions that 
do not follow the party line. I feel that if commanders in 
senior leadership do not understand the intricacies of the 
issues that have arisen out of the anthrax vaccine, they will 
be ill-equipped to meet the concerns raised by the field.
    Accurate, consistent, non-conflicting information is the 
key. In my research to enhance my knowledge and understanding 
of these issues, I have come across two areas that concern me 
greatly. First, there appears to be a perception in the field 
that they are not being given accurate, consistent information 
on the vaccine, to include its safety and efficacy, and as a 
result, they are losing or, in some cases, have lost their 
trust in the DOD. Second, it is perception or lack of trust may 
be impacting our force readiness.
    The following is provided in hopes that the committee can 
better understand and fully appreciate these two significant 
challenges that I feel we face today.
    Before proceeding, I would like to offer my view of those 
who serve in the military today, as I believe this is a key 
element in meeting the challenges cited above. There is no 
doubt in my mind that those volunteers who serve their country 
today are the most educated and best trained in our country's 
history. They are trained and qualified to work, maintain, and 
employ some of the world's most sophisticated equipment in the 
most demanding of environments.
    They are taught such things as risk-management, ethics, law 
of armed conflict, and the importance of accountability. Since 
my written testimony covers in great deal those items that 
bring to light the concerns and challenges cited above, I will 
address only a few in this testimony.
    Acknowledged: The threat of a biological attack of anthrax 
has existed since 1990. There is a vaccine available that 
either by itself or in conjunction with chemical warfare gear 
and/or post antibiotic treatment should significantly increase 
one's survival rate if subjected to an anthrax attack.
    Concern: Anecdotal evidence indicates the reaction rate of 
AVA exceeds the product insert and what the field is being 
told. Anecdotal evidence shows the AVA is at least temporally 
associated with systemic reactions, hospitalization, cardiac 
events, and symptoms similar to those suffered in Gulf War 
Illness Syndrome.
    The anthrax vaccine will not be completely safe based upon 
the above concerns and/or due to the improper manufacturing 
procedures identified by the FDA and testified to by the GAO.
    Examples that I feel are fueling the perception that the 
field is not being given consistent, up-front, accurate 
information: The VAERS reporting system used to substantiate 
the adverse reaction rates cited by DOD is perceived as not 
being impartial. The FDA requests and encourages VAERS reports 
on all reactions, even those that only temporally associated 
with vaccines.
    The AVIP program filters the VAERS system. It requires the 
reporting of events that only result in hospitalization or 24 
hours loss of duty. AVIP requires recording severe local 
reactions and systemic reactions in the medical records but 
directs that these will not be reported unless contamination of 
the lot is suspected.
    VAERS forms do not go directly to the FDA. They are 
reviewed at least once more prior to reaching the FDA. This 
filtering has one tremendous downside, it does not allow for 
the identification of less severe reactions which may indicate 
a problem that may be occurring in large numbers across the 
population.
    The public recently learned that the Secretary of Army 
granted indemnification to the anthrax vaccine manufacturer in 
1998. The DOD states this is a normal procedure to reduce 
insurance costs to the company.
    A Pentagon spokesman is reported in the paper as saying 
that the last time an indemnification was given for a vaccine 
was in 1976 for the swine flu.
    Next, a letter of indemnification appears on the web, 
signed in 1991 by the Secretary of the Army, granting 
indemnification to PRI for the production of anthrax vaccine to 
be shipped to MDPH, where MDPH was to bottle, label, and test.
    This indemnification states, quote:

    The obligation assumed by PRI under this contract involves 
unusually hazardous risks associated with potentially severe 
adverse reactions and the potential lack of efficacy of the 
anthrax vaccine. These concerns stem from: a) the limited use 
of the vaccine to date, i.e., tests prior to the approval of a 
vaccine by the Food and Drug Administration are too small a 
scale to permit accurate assessments of the types and severity 
of adverse reactions. Only widespread use can provide this 
assessment. And b) insufficient experience in mass immunization 
programs to truly evaluate the efficacy of the vaccine. 
Moreover, there is no way to predict whether the pathogen 
against which the vaccine may be used will be sufficiently 
similar to the pathogen used in tests to ensure vaccine 
efficacy.

    Mr. Shays. Is that still a quote?
    Col. Jensen. Close quote. Yes, sir.
    Mr. Shays. All of that is from the indemnification letter?
    Col. Jensen. Yes, sir. I have a copy, if the committee 
would like.
    Mr. Shays. We do too. Thank you.
    Col. Jensen. How does a health-care worker or commander 
respond to this when presented it by a troop?
    Unfortunately, accurate vaccine records identifying the 
approximately 150,000 individual vaccinated during the Gulf war 
with AVA do not exist. I have read that this vaccine's systemic 
reactions are no worse than those of hepatitis A or typhoid or 
other vaccines.
    This may be true. But shouldn't the issue be, are the 
actual reaction rates in line with the expected rates and types 
for which the FDA licensed it, not how they compare to other 
vaccines?
    Some people say the benefit outweighs the risk. My only 
question of this, and hopefully the committee can provide an 
answer, is, what exactly is the risk.
    My first impression of the vaccine's side effects were 
those stated in the product insert and quoted by numerous 
officials. Are those the risks? Or is the risk ending up like 
those individuals that have previously testified before this 
committee and those testifying here today, assuming the anthrax 
vaccine is the cause of their ailments.
    Finally, will this yet undefined risk increase or decrease 
over time as the number of those vaccinated increase, thereby 
increasing our data base.
    Greatest fears: AVA, a potentially valuable force 
protection tool may not be available: The program may be killed 
by Congress due to poor communication, i.e., the field 
perceives they are not being provided the whole story.
    Force readiness is being compromised, the trust issue. The 
following are some of the effects that the AVA program appears 
to be having on our retention. I would offer that those leaving 
over this have made a benefit-outweighs-the-risk assessment, 
and their version is, the risk does outweigh the benefits.
    Dover Air Force Base, supposedly 30 to 40 percent of the 
air crew--pilots, flight engineers, loadmasters--have or intend 
to resign vice take the vaccine.
    Connecticut Air National Guard, eight pilots forced to 
resign after they refused to take AVA. Note, some of these 
pilots were part of a information-gathering team directed by 
the commander. They refused to take the vaccine after the 
issues raised in their research could not be answered.
    Wisconsin Air National Guard, the story ran in the Madison 
Newspapers, Inc., June 19, 1999: At least six pilots are 
expected to refuse the vaccine. Note, one was in line to be the 
next squadron commander.
    Travis Air Force Base, 17 tanker air crew resigned from the 
79th. Thirty-one pilots out of the 301st have submitted 
resignations. The number is expected to climb to over 60 
percent by the end of fiscal year 1999. That is 429 years of 
flying experience gone.
    I am told an IG complaint is pending due to an individual's 
1288 reflecting job conflict as the reason for leaving, vice 
AVA.
    From the above, it appears that before units are even 
moving to enter the theater where anthrax may or may not be 
used, their combat readiness is being compromised, in some 
cases, by as much as 50 percent.
    Important note: People are not leaving because they have 
read some article on the dark side of the web. They are leaving 
because they have seen people with whom they have served for 
years, and in some cases combat, take the vaccine, become ill, 
and no reason given to as why other than we know it is not the 
vaccine.
    To the end, those with whom I have talked, state that they 
are leaving because of the vaccine and that they have lost 
their trust in their leaders.
    In closing, I would ask not only the committee but those 
commanders who read and hear this testimony to take an honest 
look at the AVIP program, the issues raised above, and those 
being raised in the field.
    My purpose in testifying here today is not to kill the AVIP 
program. I welcome a vaccine that would protect not only myself 
but those whom I am entrusted to lead into battle, provided it 
is truly safe and effective.
    It troubles me deeply to watch outstanding service members 
leave in the fashion that they are.
    Finally, it would be irresponsible of me as both an 
American citizen and military officer had I chosen the easy 
path and declined your offer to testify here today.
    Mr. Chairman, integrity begets loyalty, loyalty does not 
beget integrity.
    Thank you.
    [The prepared statement of Col. Jensen follows:]
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    Mr. Shays. Well, we have heard some very powerful testimony 
from five very patriotic members of our country and of our 
service. We thank you all.
    Mr. Terry.
    Mr. Terry. Thank you, Mr. Chairman. Indeed, powerful. 
Captain Richter, I think all of us up here love our country, 
and that is why we are here as you have spent 13 years in the 
military. As I have sat here over the last hour listening to 
testimony, I think if it was a condition to serve as a Member 
of Congress we had to take the vaccination, I too would 
probably take the same path that you are choosing.
    Mr. Chairman, our hearings, at least, no pun intended, my 
exposure to this vaccine has been more on the academic side. We 
have studied protocol, testing, side effects or what has been 
tested by the manufacturing process, quality control, and today 
I think is the first time that we have truly seen the human 
side, although it has been certainly why you have undertaken 
this process.
    The testimony we have heard here today is powerful, and 
there are so many areas, so many questions that I want to ask 
all of you, but I am going to narrow it down into two areas. 
And, Lieutenant Rovet, I am going to start with you because you 
are the first one that said it, the first one to ask really the 
true magnitude of which our service personnel are experiencing 
symptoms. And you know more than I do in the sense that 
medicine has become more of a science than an art and that it 
has to fit into specific pigeonholes and have certain labels 
placed upon it, and that probably more the discussion, as the 
lieutenant colonel has said, needs to focus not on 
hospitalization for 24 hours but just the symptoms that we have 
heard here today of a variety of different symptoms.
    But you said, and Sergeant Soska also said, that probably 
one of every three have come forward or voiced concerns. And 
certainly I think that is probably more anecdotal than 
scientific, the one in three. But why don't you explain and 
draw out how you were able to base a conclusion that Captain 
Piel, there's three others out there that are in the same 
position that have refused to come forward.
    The second part of my question is going to be, why have 
they refused to come forward? But let's talk about, first, how 
do you base that one in three?
    Lt. Rovet. If I understand your question correctly, sir, 
it's when an individual comes forward and we start seeing what 
we believe is a trend, we go back and look at some of the 
symptoms, the symptomatology of what they are presenting with.
    My job as a case manager also, I was privy to data 
throughout the air crew members that were sick for long-term. 
So I would start looking and saying, well, we have a person 
here who has a long-term illness who has not been really 
diagnosed with something concrete. There is no concrete 
etiology. So we would start drawing conclusions in our mind, or 
just asking questions, not conclusions. It was more of a 
hypothesis in the beginning.
    And when they came in, we discussed, we listened, and it 
was opened up to us from the air crew members that there were 
more people out there experiencing the same side effects.
    Mr. Terry. So these folks have reported some sort of 
illness, gone to see a doctor, but reported symptoms that 
weren't necessarily associated to the vaccine?
    Lt. Rovet. Right. They were--I know Captain Piel, who was 
captain at the time, had come forward with problems with 
balance, what they call labrynthitis or otitis media, and that 
was originally diagnosed as just strictly a medical problem 
that we had a concrete etiology on. But also it was the timing 
relation to the anthrax vaccine and the persistent dizziness 
that started raising some questions. And then we saw other 
people coming forward with this timeframe event of the vaccine 
administration and illness and subsequent no concrete etiology 
for their illness.
    Mr. Terry. So there is, for these other three folks, there 
is some medical record that will document an ailment or a 
symptom?
    Lt. Rovet. Yes, sir, there is.
    Mr. Terry. All right. I was concerned when you said, or 
envisioned when you said that one in three is that three knew 
they were symptomatic but refused to come forward for fear of 
some reprisals.
    But what we are talking about is that one out of three is 
not being associated with the vaccine.
    Lt. Rovet. Right.
    Mr. Terry. I mean that only one of three is associated.
    Lt. Rovet. No. There hasn't been any conclusions drawn in 
that area yet, but about the fear to come forward, there are 
some people that have expressed it over the phone that they are 
afraid to come forward.
    Mr. Terry. All right. So when you testified that there were 
30 cases currently and about five or six in the pipeline----
    Lt. Rovet. Yes, sir.
    Mr. Terry. First of all, how big of a field are we talking 
about?
    Lt. Rovet. Well, I don't have exact numbers.
    Mr. Terry. Is it 30 out of 300; 30 out of 60?
    Lt. Rovet. Right now, out of 1,100 people, a little over 
1,100 people at Dover who had been vaccinated, these are what 
we have now, the number 30.
    Mr. Terry. All right. And then ballpark it based on your 
earlier testimony there are probably about 90 folks that you 
think probably have symptoms associated with the vaccine.
    Lt. Rovet. Yes, for me to make that leap right now, without 
scientific data, would probably be incorrect, but as a gut 
feeling----
    Mr. Terry. Anecdotal based on your experience though.
    Lt. Rovet. Yes, sir.
    Mr. Terry. It is a fairly significant percentage.
    Lt. Rovet. Yes it is, sir.
    Mr. Terry. Can I have just a couple more minutes?
    Mr. Shays. Yes.
    Mr. Terry. Captain Piel, I want to start with you. We have 
heard discussion about reprisal, and we have heard it really in 
two different categories. One was, as Captain Richter and 
Lieutenant Colonel Jensen pointed out, is that one reprisal for 
not taking the vaccination is mandated resignation. But you 
hinted there may be reprisals for simply even reporting or 
voicing concern that some of your symptoms may be related to 
the vaccination.
    Can you tell me where you would feel that? How, if you 
could kind of focus or pinpoint that for me.
    Capt. Piel. Yes, sir. First of all, I would like to say a 
lot of people don't come forward because they have seen what 
has happened to the people that were ill and then it become 
know that it might be possibly due to the vaccine. In other 
words, they have seen what has become of me in the medical 
system and they realize----
    Mr. Terry. Called a malingerer, a liar, and those type of 
things.
    Capt. Piel. And it appears a dead end. So why risk your 
flying status if you are just suffering some of the mild 
symptoms of joint pain or you feel a little bit tired. Why 
should you go to the doctor if you feel you can continue to 
operate airplanes? And that is why people don't come forward.
    As for myself, this whole time period it really didn't seem 
to matter what the doctor said because I thought it would just 
be a few more weeks before I felt better. But it became 
apparent that these comments were starting to erode my 
character. And I was not being--sometimes I wasn't being 
examined when I went into the doctor's office.
    So that does not encourage one to go try to seek more help 
from the same individuals that will not, that don't seem to be 
helping you in the first place. And they dealt with me as if 
they believed in their office and then sometimes I would hear 
later that they didn't believe me.
    But my commander and others believed me. And I think part 
of the reason why it is easy for people to believe me in my 
squadron because many people have felt mild symptoms.
    Mr. Terry. All right.
    Sergeant, would you answer that same question: What type of 
reprisals from reporting, basis of your fears of reprisals, and 
also from whom. And maybe your opinion of whether you think the 
reprisals are what I would classify as a malicious nature of 
trying to--I don't want to use the word cover-up because 
everybody likes to use that conspiracy-minded terminology--but 
if you think it is even related to minimizing the impact of 
side effects from this vaccination.
    Sgt. Soska. Mr. Terry, I can only tell what I have been 
seeing with my soldiers.
    Mr. Terry. All right. That is what we want to hear.
    Sgt. Soska. A lot of the soldiers who are new to the 
military--I am a career soldier; I have better benefits than 
they do--if soldiers that are getting married and coming in 
with family members that have various obligations that they are 
just struggling to get by to begin with--several of the people, 
many of the people that went with me to Kuwait during Operation 
Southern Watch during 1996, we came back and we started cross-
talking amongst each other. I guess I was the worst of the 
group with my condition.
    And others started taking notice to that. I have told many, 
you need to go, you need to get it checked out, you need to do 
this, you need to do that. Many have listened, many have not.
    Many are afraid to come forward, and I kind of feel like 
the guy being pushed out the door with the door slam shut 
behind me right now. But, you know, this is me and that is 
them. I can only do what I feel is right.
    Several of the soldiers have--I can tell you for a fact 
there has been a survey on the web trying to characterize 
systemic reactions, fibromyalgia and stuff like that they have 
filled out. And others flat refuse because they are afraid that 
if they do say something or if their name is used, that it is 
going to have an impact on their career.
    Now, what goes on in their head, I have no idea. But they 
are afraid to come forward, if that answers the question, sir.
    Mr. Terry. Well, it does. I think the fear is probably 
real, but part of our job up here is to determine if that is a 
personal opinion or whether that is a problem in the military. 
Unfortunately, that may be as tough to decipher as it is 
scientifically to link these symptoms back to the vaccination.
    Appreciate the opportunity, Mr. Chairman.
    Mr. Shays. Thank you. Mr. Tierney.
    Mr. Tierney. Thank you, Mr. Chairman.
    Mr. Chairman, I want to thank you for having these 
hearings. They are obviously important, and hopefully we will 
be able to come to some resolve that will address these issues.
    Captain Piel, I wanted to ask you, were there any pre-
existing conditions that your doctor suspected you might have 
had or discussed with you before the vaccination was given?
    Capt. Piel. No, there weren't any.
    Mr. Tierney. And was there any talk amongst your medical 
people afterwards that they thought perhaps they had overlooked 
some, or any conversation about that?
    Capt. Piel. No, there hasn't been any conversation about 
that to my knowledge.
    Mr. Tierney. You indicated that you got good support from 
your chain of command but you felt you didn't get good support 
from the medical people that you went to. And how does that 
work on your base? Where do the medical people fall in that 
chain of command?
    Capt. Piel. Well, they fall outside of--they have their own 
chain of command on the base. So they don't report to my boss, 
and he doesn't have anything to do with the medical group 
either.
    Mr. Tierney. And that is true all the way to the top of the 
non-medical people at your base?
    Capt. Piel. Well, I am not sure. I think the medical group 
falls underneath the wing commander, but other than that, there 
is nothing--that's where it meets, that's where the operational 
side meets the medical side.
    Mr. Tierney. Now your wing commander has been supportive?
    Capt. Piel. Yes, sir, he has, and he has been trying to 
help me get the right medical treatment.
    Mr. Tierney. And Lieutenant, with respect to your wing 
commander and his involvement with the medical people on base, 
have you witnessed any interaction between them, any action by 
the wing commander to try and address this issue with the 
medical people?
    Lt. Rovet. He has shown significant interest, sir, in the 
health and welfare of his wing, as should be. A man of amazing 
core values and personal fortitude and strength. Just wish you 
could clone him. But he has--yes he has been very involved with 
my medical group commander and my squadron commander, who both 
are very wonderful people also who I know have been putting in 
long nights, sleepless nights, over this program.
    And just like to make a statement concerning our medical 
program at Dover. Originally, we had some bugs to work out with 
the adverse reaction reporting. There was--it just came so fast 
and furious, the reactions and what not. And we may have not 
handled things appropriately in the beginning. And as humans, 
we learn our lesson. But I do believe that under the leadership 
of Colonel Greider and Colonel Buck and Colonel Luna and down 
through the AMDS squadron where I work, including public 
health, we have a pretty good system now. And we have 
identified some of the short falls, and we will be 
aggressively, I can assure you, pursuing a cogent reporting 
that can be very valuable to not only our service men but to 
our country at large.
    Mr. Tierney. Would you be a little more specific about what 
has changed with this vaccine program on your base. Originally 
there was a high threshold. What I mean by high threshold, when 
patients were to come in, they would be--there was that 
reticence in the beginning that I was talking about. The 
threshold, a doctor would be viewed as a filter. The doctor 
would say, if they would go ahead and check the box up in the 
right-hand corner--I forget the box on the VAERS form--that 
would be a provider saying, my gosh, you know, that is a bona 
fide reaction; I kind of believe this. So that would lend 
validity to the report.
    To date, no provider has ever signed a VAERS form or 
checked the box off.
    OK.
    Mr. Tierney. That hasn't changed? That continues to be the 
case?
    Lt. Rovet. That continues, but what we have now is lowering 
of the threshold when more people come forward. And I think, 
and I am not an epidemiologist, sir, but I think that will 
statistically even out the more reports that we get coming 
forward if we can start--the researchers at Brooks Air Force 
Base, at the FDA, at Walter Reed--that's a problem in itself, 
it is so spread out. Bureaucracies have a tendency to do that, 
I guess.
    Mr. Tierney. So I hear.
    Lt. Rovet. But what I think what we are going to do is see 
it work its way out in the end. The more data we get, we'll let 
the numbers just work themselves out. So it is changing. It is 
a lower threshold, and the medical group at Dover now is right 
on it.
    Mr. Tierney. Well, Captain Piel, do you think somebody in 
your circumstance would be treated better today than you were 
treated?
    Capt. Piel. I definitely hope so, sir. I would suspect that 
they would be treated better after everything that has 
happened. Things have changed.
    Mr. Tierney. Do you think they have made some positive 
adjustments as a result of your situation and others.
    Capt. Piel. I think that they are working on it.
    Mr. Tierney. With room to go?
    Capt. Piel. It is a very difficult problem, and it is not 
something you can just solve or correct overnight.
    Mr. Tierney. What might you suggest that could be done on 
your base that would make it easier for somebody in your 
circumstance? Going back to the beginning of your circumstance, 
what would have made your experience----
    Capt. Piel. Well, I think if my case had been forwarded to 
Walter Reed sooner, that definitely would have helped because 
Dover doesn't have a lot of doctors. We have a pretty small 
clinic. It is not necessarily one of your large medical centers 
where they can deal with all different types of problems. There 
aren't specialists that you can go see. You get farmed out to 
everyone else.
    So if I had been forwarded to the immunology clinics at 
Walter Reed sooner, that would have helped. You know, in the 
process, I kept getting referrals to ear-nose-throat doctors, 
and they can take care of my ear, but they can't take a look at 
my whole body.
    Mr. Tierney. OK. Thank you. Sergeant Soska, do you have a 
feeling that there is a difference at your base also between 
the way the medical professionals treated individuals and the 
way that the chain of command did?
    Mr. Tierney. Mr. Tierney, I can tell you from a personal 
standpoint that and what I have went through for the last year 
and the acceptance by both the division surgeons, both the 
outgoing and the incoming, have been, they have been there for 
me. In talking with Lieutenant Colonel Carrigan, who is our new 
division surgeon, 3 hours on 2 separate days, took an active 
interest in my situation after speaking out before the Anthrax-
Persian Gulf Illness Outreach program meeting we had there.
    They took an active role in it. I would like to comment on 
similar problems she had where it took so long to get to the 
right areas. It was here, go here, and there was always a long 
wait in between.
    Yes, the doctors were trying. They didn't have the answers. 
But it is just the way the system is set up, sir.
    I feel that in my situation and in talking with Lieutenant 
Colonel Carrigan, who apparently was a member of that hundred-
doctor meeting in Fort Detrick, my indication I got after 
talking to him was that I think they realized there is a 
situation here and they are trying to make an effort to just 
see how big it is.
    I can't say anything negative on that aspect about them. I 
think there is genuine concern within the ranks and the leaders 
themselves. They are seeing this happening more and more. And 
just like myself--and I may add, the comments I make here are 
mine, I am just saying what is happening to me and what I have 
witnessed. And that is the impression I have been given, sir.
    Mr. Tierney. Thank you. Lieutenant Colonel Jensen, you have 
some particular problems in your division, I assume, because of 
the Guard, those units having a different access to medical 
attention than others do. Do you want to talk a little bit 
about that?
    Col. Jensen. If I understand you correctly, sir, our access 
to medical care basically the shot in the Guard--my unit has 
not received the shot yet. We are not due to receive it until 
May 2000; however, due to operational commitments, I believe we 
have approximately 100 individuals who have received the shot, 
or the series.
    In the Guard as in the Reserves, you are placed on active 
duty for the shot. And that is for, my understand is I am told, 
a medical requirement so if something happens to you, you can 
come back and provide you. It also has the opportunity, 
obviously, if you are on an active duty status, then you can be 
given a direct order should you choose to refuse the vaccine.
    For instance, if somebody were to have a reaction the next 
day, if they were a traditional Guardsman or civil service 
employee such as myself, primarily I would have to go and seek 
medical care through the civilian community and/or come back to 
the military community and attempt to file what they call a 
line-of-duty statement in which--and that would only be filed 
if the, as I understand it, if the medical community deemed 
that the vaccine was causal to the condition.
    The line-of-duty statement is filed if you have a loss of 
duty. For instance, a hypothetical situation, or I will give 
you a real case situation, if I may.
    We have an individual that was in that series shot and he 
was on active duty, placed on orders, I believe, or on a 
Reserve active duty status, RUTA as they call it, and the next 
day he took 24 hours of sick leave. He is a fireman and he is 
on a 24-hour schedule out of his own sick-leave time due to 
flu-like symptoms that he placed on his sick leave form as 
caused by the anthrax vaccine.
    He did not seek medical attention. OK? And as such, 
basically he ended up taking 24 hours of sick leave. An 
important note here, I believe, is that even if he followed the 
line of duty status on that, the way I am told by my finance 
officer is he would not be reimbursed for the sick-leave time. 
He is only reimbursed if he physically or she physically has a 
loss of pay.
    So if you have sick leave, you haven't lost any pay.
    Does that answer your question, sir?
    Mr. Tierney. Yes. Captain Richter, does--secondarily to 
obviously the medical implications of all this, the 
individuals, it is disturbing to hear about the loss of trust 
that you talk about in the--I'd like to hear your ideas of how 
that trust might be restored in this instance.
    Capt. Richter. Well, at this point I don't know. That is a 
hard question to answer. I don't know if the trust can be 
restored. The obvious thing would be at least, first of all, 
come out and say there is a problem. Acknowledgement would be 
99 percent of it. Continuous denial that these symptoms are 
from some other cause is not helping matters. Like I mentioned, 
Colonel Greider, our wing commander, went and stopped all the 
vaccinations for a period of time until he could address the 
situation, find out what was going on, try to allay everybody's 
fears, and get it rolling again.
    I don't know what the outcome of that--again, I am just a 
reservist. So I am there only part time, unlike my counterparts 
who are there all the time--active duty. But I got a feeling he 
was called down to Washington and called on the carpet because 
shortly thereafter Lieutenant General Roadman came up and said: 
Hey, take the vaccine. There is no problem with it. The 
percentages of people having problems is minuscule. These are 
your marching orders.
    So I think just an admission that well, maybe there are 
more than just a few people having these problems would help. I 
mean, that would start the ball rolling to be sure.
    Mr. Tierney. Thank you. I just want to echo the chairman's 
words that all of you show great courage coming forward here 
today. And patriotism doesn't always take place on the 
battlefield.
    I want to thank you for your courage.
    Mr. Shays. Congresswoman Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. And I too want to 
thank you for your personal courage in coming forward and all 
the things that led up to today, and also express my concern 
regardless of what one thinks about the vaccine that it takes 
so much courage just to speak out on these issues.
    I have a number of questions. I wanted, Captain Piel, to 
note that in testimony that I don't believe that you read, that 
you were told by some doctors things, comments such as, you're 
depressed; maybe you just want to have babies; called a 
malingerer; perhaps you need counseling.
    These clearly are very demeaning kinds of things and would 
contribute to your feeling of not being believed for sure, but 
you also say that you still don't have--even now, I still don't 
have a waiver. Can you tell me about waivers? How does one get 
one? What do you mean by a waiver?
    Capt. Piel. Well, a waiver, what I mean is to get a waiver 
from further anthrax immunizations.
    Ms. Schakowsky. And how does that happen?
    Capt. Piel. I have no idea exactly the process for that.
    Ms. Schakowsky. There is such a thing though? Can anyone 
answer that?
    Capt. Piel. Well, that is just under the guise that there 
are waivers for everything. [Laughter.]
    Ms. Schakowsky. Oh, OK. Can any of you testify to that?
    Capt. Richter. I can comment on that. I am on a medical 
waiver right now. It is just a temporary one, but I am on a 
temporary medical waiver, and I do not have to take the next 
injection until they figure out the results of my first visit. 
I am now scheduled to see a rheumatoid arthritic doctor at 
Bethesda next month. So I have a waiver that will take me 
through August, until I go see him and he discusses what my 
problem is.
    Ms. Schakowsky. And while on waiver, are you allowed to 
carry out your other duties. For example, would Captain Piel be 
able to fly?
    Lt. Rovet. Ma'am, I really think I could answer this one 
cause it is in my department where we work.
    Ms. Schakowsky. Take your time.
    Lt. Rovet. Excuse me, Captain Richter, I didn't mean----
    Capt. Richter. Go for it.
    Lt. Rovet. What a waiver actually is, is more than just a 
verbal granting of like a person has a doctor's note that says 
you can't fly. It has to be sent up headquarters and has to be 
evaluated and blessed and filter back down.
    What they are looking at right now, and this is again my 
perspective. It is not policy, but I think this is going to be 
a logistical problem and a personnel problem that is going to 
crop up here shortly. So we need to be pro-active on this 
issue.
    If individuals are seen and evaluated, and again the key 
word is evaluated--who is going to be the actual medical body 
that is going to evaluate and say this individual cannot 
receive the vaccine? What they do is they put on the profile. 
At that point, it is an official profile. And then they get 
given a medical board.
    What they are looking at doing is giving these people a C 
code, waiver C code, which means they can continue out their 
duties and fly, but they won't be able to go into Southwest 
Asia or Korea, areas where high threat of bio-attack or 
chemical attack. That is going to present its own nightmares.
    Just a scenario, if a pilot's air crew member is in 
Mildenhall, England, and that's OK. He can fly there. Then they 
get a tasking to say go down range to Southwest Asia--there is 
going to have to be a centralized tracking system of which 
pilots are on C codes. So they will have to bump that air crew 
member, put on somebody that can fly down there, who has the 
anthrax vaccine, to complete the mission.
    This is going to present some problems.
    Ms. Schakowsky. But I did want to establish that there is 
some kind of individual waiver policy that could exempt certain 
people currently.
    Lt. Rovet. Not right now in the Air Force. And, again, that 
is just my opinion. But we are still looking for answers on 
that, ma'am.
    Ms. Schakowsky. OK. We'll try and establish that.
    I wanted, Sergeant Soska, to ask you, you testified the 
procedures are not being followed as spelled out in AVIP 
documents. What did you mean?
    Sgt. Soska. Well, ma'am, in my written testimony, on 
January 27th I was given an MGC meningococcal, I believe is the 
name of it. This was after--I was graciously overlooked; my 
chain of command knew I was having problems after the first 
three shots that I received. When I went down there for that, I 
explained to the NCOIC in charge that hey, I am under B-12 
replacement shots. For some reason my system will not retain B-
12.
    And she concluded that, yes, it would be a bad time to do 
it. But I did have to get what I call the MGC or meningococcal 
shot.
    Up to this point I was having problems all along in my 
testimony, but after I got that vaccination, on the 29th, went 
to PT, I did my normal profile PT thing, went home from work, 
had two cups of coffee, was coming back into work, and started 
feeling rough. After formation, I managed to get to the troop 
medical clinic, which is right next door.
    I remember being escorted back to the treatment room, and 
then I don't remember much after that cause I was out of it. I 
totally locked up. I didn't know what happened. I was out.
    And, my understanding, I was reading some of the AVIP 
documents and what else, and I don't fault the doctors. I think 
they are outstanding doctors that have been taking care of me. 
I just think there is a lot of areas that, you know, we're not, 
we don't do all the time or we don't practice all the time. And 
some of the stuff is falling through the cracks.
    But it is in my medical records, but how come it wasn't 
reported. It wasn't until later that I spoke up in the Persian 
Gulf Illness meetings that, you know, the attention--my 
attention got to the division surgeon, and they started really 
looking into it.
    So, forgive me if I ramble, I have problems staying on 
track some times.
    That's what I say, it's really not being reported like it 
should. Others that have been with me, have been to Southwest 
Asia and that have came back, are having similar problems. And 
I reiterate, they are afraid to say something.
    But, you know, the problem, the problem is there.
    Ms. Schakowsky. Captain Richter, you said in your 
testimony, ``The threat of being exposed to--the doctor went on 
to say that the threat of being exposed to anthrax while in 
deployment outweighed the possible negative reactions that some 
military personnel might have to the vaccination'' and that it 
was not a matter of if but when some of our troops would come 
in contact with it.
    So I want to get to the issue of threat versus the risk of 
the vaccine and wonder what your feeling is that if the threat 
is so great and if 99 percent of those who inhale anthrax 
spores would die, which seems to be the science there, then at 
what level do you feel the risk is acceptable? I mean, how 
serious--if the threat is so great, at what point should the 
Department of Defense say, well, this is what we have to do?
    Capt. Richter. I don't know if I am qualified to answer 
that really. For me, I can only speak for myself, I go in, I 
drill once a month, I maybe take a trip down to the Middle 
East. I have another job. I am an airline pilot out in the 
commercial sector as well.
    My health is my life, and the odds that I am going to go 
down range to the Middle East somewhere and get exposed to 
anthrax, I think, is probably pretty minute. If I was called on 
active duty, it would be a different story, but, having said 
that, my--at this point I just can't afford to gamble because I 
have to feed myself with mostly my outside endeavors, my 
outside job.
    I think what he was trying to really lay out was the policy 
of the DOD. I don't think that was really his opinion. When I 
was discussing this with him, we were kind of in a continuous 
tail chase. I kept telling him, well, if I feel this bad and I 
pretty darn sure it came from the anthrax, then what is the 
point in me taking another one if ultimately I am not going to 
be any good to the military if I am not functional.
    And that is when he was saying, you know, that a few people 
may have a negative reaction; however, overall, we need to 
protect the troops en masse, and that risk is worth taking, to 
vaccinate everybody with the expense of a few.
    Ms. Schakowsky. Well, maybe part of the answer then is in 
my next question to Lieutenant Colonel, maybe you can answer 
it. You said in your testimony, you would welcome a safe and 
effective vaccine. I don't know if we are all in agreement here 
that that is an important goal. I would think that we are, that 
there is a real threat.
    I had a wonderful briefing yesterday that convinced me that 
there is enough reason to think that we need to find a vaccine.
    Are you saying that we need to do more to develop a safe 
vaccine?
    Col. Jensen. Based upon what I have heard, what people have 
told me, the anecdotal evidence, I think there is a tremendous 
concern out there that the safety of the vaccine may not 
entirely be what it was made out to be. You talk about what is 
the risk. We are in a timeframe of dwindling budgets, where we 
are constantly told that we are going to have to do more with 
less.
    If you take Dover, for example, if the numbers, if I 
remember correctly in testimony here today, you have about 
1,000 people that were vaccinated there. And out of those 
folks, you have got six, is my understanding, that are still 
permanently denef, some over 6 months after taking the vaccine. 
The cause is still unknown.
    You have got 30 people that are potentially being worked up 
at Walter Reed. You heard testimony that related to the 
potentially three times those folks that are out there are 
having similar reactions but are not reporting them for a 
variety of reasons.
    That creates a far greater concern too that whether it is 
caused by the anthrax vaccine or not, I have individuals out 
there that are not being provided proper medical treatment, and 
therefore we may have a false sense of security as their 
ability to perform their job, thinking that they are 100 
percent capable when, in fact, they are not.
    You heard the numbers cited for those that are leaving the 
Reserve squadron, let alone. So you may have, you know, if you 
take the threefold, you may have upwards of 100 people or 10 to 
12 to potentially 15 percent of your combat force which may not 
be ready to enter or perform the mission that we are assuming 
they are capable of.
    And you have not even entered a theater yet before you can 
be exposed to the vaccine--excuse me, exposed to the threat of 
the weapon.
    Ms. Schakowsky. So on the question of readiness, we need to 
be concerned about the effect of the vaccine itself?
    Col. Jensen. Yes, ma'am, I think it is the classic risk-
management or risk-analysis that has been preached by the Army 
program that was developed and the Air Force has adopted, is 
truly look at what are the cause and effects across the board 
in that fashion.
    Ms. Schakowsky. Thank you very much.
    Mr. Shays. We have a system where, in the United States, as 
a force protection we require, at least in phase one, for our 
military personnel to take the anthrax vaccine for those who 
are in areas that may require them to be protected. And then 
there is a question of whether we go to phase two, which would 
be the military personnel who aren't directly anticipated to go 
into areas where they might even be exposed.
    We have another country, Great Britain, that has decided to 
use the vaccine and made it voluntary. And we have the French 
who looked at the vaccine and decided that this would be a 
mistake, at least so far.
    And, I am struck by a lot of feelings as I listen to you 
all make your testimony, and I heard the excellent questions 
and responses to those questions, the questions asked by my 
colleagues.
    And I am also reacting to the varied circumstances each of 
you have. Captain Piel, you are in the active duty. You aren't 
a reservist; you are not in the National Guard; you don't work 
for a commercial airline. But you are a pilot.
    Capt. Piel. That is correct.
    Mr. Shays. And my understanding is you fly C-5's?
    Capt. Piel. That is also correct.
    Mr. Shays. Yes. And someday, when you are out of the 
military, there is the potential that you might continue to 
fly. Is that also a possibility?
    Capt. Piel. Sir, I was hoping to fly the rest of my life.
    Mr. Shays. Yes. Sometimes, not often, but sometimes we have 
had witnesses come before us, say with the Gulf war illnesses, 
and you heard very important stories. But you kind of doubted--
sometimes I am just saying to myself, I didn't, I wasn't fully 
convinced of every witness that came before us when it dealt 
with the Gulf war illness.
    So I believed the vast majority of them. And that is why 
this committee moved forward.
    But there is not a scintilla of doubt in my mind about the 
testimony I have heard from you and others. You want to fly. So 
you don't want to be sick, and yet your illness was at a point 
where you must have made a determination that you might 
endanger the command of your plane. So you stepped forward.
    There are others who might be on the margin, who, if they 
could have the faith that they would be treated with respect, 
would step forward. And if they doubted--even if that doubt 
isn't, if it's a doubt that they believe, even if it is not 
justified, the doubt would lead them not to do what action they 
should take.
    You did the right thing. You weren't well and you came 
forward. And now you are paying for it big-time.
    Others saw that, and they are going to say, I am going to 
do whatever I can to avoid coming forward.
    So first and foremost, I just want to say, I really accept 
the fact that you are dealing with some heart-wrenching 
concerns.
    Captain Richter, I will say to you, if I was a commercial 
pilot, besides being a Reserve pilot, there is no doubt in my 
mind. I wouldn't take the chance. And that doesn't pre-judge 
how ultimately this committee is going to decide.
    We have had three hearings. This is the fourth now. And we 
don't know ultimately what we are going to recommend, but we 
are going to be recommending some course action of the 
committee itself.
    But I have to tell you, I would do the same thing you are 
doing. I would not jeopardize for a minute that source of 
income that provides you the opportunity to support your 
family.
    And so it raises a lot of questions for this committee. Do 
we suggest that this program be totally discontinued? We have 
one source provider. We have old technology. Another is, do we 
suggest to be voluntary? Another is, do we suggest that if you 
are going to do phase one, you do it for the people who are 
clearly going to be in the theater, but others you are not 
going to phase two.
    We are wondering why it is all right for the military to 
deploy you in an area of concern, in a theater of concern, 
after beginning the first shot--you can now be deployed. So the 
military is given the option that they can send you into harm's 
way, but you don't have the ability to say ``no'' to the shot.
    You are not given that other option.
    It would be interesting to know, and we will ask our next 
panel, are you given the option since the military says you 
need six shots that you should not be deployed until you get 
six shots.
    Another question that is raised is, what kind--how are they 
treating people who, military personnel who have had the first 
shot and have reacted negatively to it. Shouldn't that give you 
additional rights to say ``no.''
    So a lot of questions are being raised. And it is also a 
fact that you have been very respectful of your command. All of 
you have. And the problem we have is knowing how far we push 
you without putting you in a different kind of harm's way. 
Because no one could listen to anything you have testified and 
say you haven't--in a sense, we are a command too. And we asked 
you to be here and you accepted our request.
    And, but you all have been very respectful.
    It fascinates me, Mr. Rovet, that you have, you are not, 
you a medical personnel. You are in that area. And so you are 
stepping forward. Have you been asked to take this vaccine?
    Lt. Rovet. No, sir.
    Mr. Shays. So you are stepping forward because of what you 
know, and if you didn't step forward and things happened in the 
future, you would have to live with that the rest of your life.
    Lt. Rovet. Yes, sir.
    Mr. Shays. So, we appreciate you stepping forward for that 
reason, among others.
    So we have someone in active duty; we have someone who has 
a medical background and has seen how it is operating and it's 
not a pretty story. Sergeant, we appreciate your testimony as 
well.
    We have two pilots. What fascinates me is, in the area 
where I have the most conviction that if I spent a good chunk 
of my life learning to become a pilot, I would do nothing to 
jeopardize my not continuing to fly. And yet we have in the 
National Guard and Reserves, we have a plethora of talented, 
capable people who are saying, I am not going to take this 
vaccine; I am leaving.
    And I have to believe that leaving--that you enjoy, Captain 
Richter, and I will just--tell me the difference: You are 
serving your country, that is clear, but do you meet all your 
flying--tell me the difference of being in the Reserve and 
being a commercial pilot.
    Capt. Richter. Well, first and foremost, it isn't as much 
fun.
    Mr. Shays. Which way?
    Capt. Richter. Being in a military pilot is probably more 
fun than being a commercial pilot. I guess the most gut-
wrenching thing I have had to face, that while I saw myself 
continuing to serve in the next 8 years, I am being forced into 
a position where I take this shot and perhaps my condition will 
get worse, perhaps it won't. I don't know.
    But it is that fear of the unknown that will not only 
affect my military flying, but it will also affect my 
commercial flying. Everybody needs to be healthy to do their 
job. We, as pilots, need to be 100 percent healthy to do our 
jobs. And if there is any question or any doubt about what 
something is going to do to you, at least----
    Mr. Shays. What do you fly as a commercial pilot?
    Capt. Richter. I am a prop pilot out of Dulles. I fly for 
Atlantic Coast Airlines.
    Mr. Shays. And in the military you fly?
    Capt. Richter. C-5 as well.
    Mr. Shays. Lieutenant Colonel Jensen, what do you fly?
    Col. Jensen. I fly F-16's, sir. I am an instructor-pilot 
with nearly 2,000 hours in the F-16.
    Mr. Shays. OK. The bottom line to both of your testimonies 
is we are losing a lot of good pilots. Is that not correct?
    Col. Jensen. That's correct.
    Capt. Richter. That's affirmative. A lot of them.
    Mr. Shays. Yes. OK.
    Capt. Richter. They just can't afford to take the gamble. 
And most of them can afford to give this job up, as much as 
they don't want to. Because it is, like I as I said, it's a 
good, fun thing to do to be still serving your country.
    Mr. Shays. I am going to have--the counsel is going to ask 
a question that Mr. Souder wanted to ask, but beforehand I 
just, I am going to do two things. One, I read again Mr. 
Jensen--Colonel Jensen--what you read. This is a memorandum of 
decision, and it deals with the authority under Public Act 85-
804 to include an indemnification clause in the contract.
    And I am just going to read it again, and I am just going 
to think of what people think who are being asked to take this 
shot: The obligation assumed by MBPI under this contract 
involves unusual hazardous risks associated with the potential 
for adverse reactions in some recipients and the possibility 
that the desired immunological effect will not be obtained by 
all recipients.
    Which, that in a sense means, the whole clause means it may 
hurt you and harm you, and in the end, it may not even work. 
And the company is being indemnified.
    I understand why, but I can understand the concern when you 
read that.
    Now, I will end my part by just asking if any of you would 
like to make a closing statement, because really you answered 
the questions. I was able to get more into a monolog because 
you really answered the questions of my colleagues.
    Would any of you like to make a closing comment?
    Captain Piel.
    Capt. Piel. Yes, sir. There is one thing I would like to 
say. I understand that we can make decisions based on 
acceptable risks; however, I feel that we need to know exactly 
what those risks are. And the VAERS system doesn't seem to be 
adequately providing information.
    And that is all I wanted to say.
    Mr. Shays. Thank you. Lieutenant.
    Lt. Rovet. Mr. Chairman, I would like to echo that. 
Informed consent is based upon having information up front. I 
know there may be some legalities that military may not need 
informed consent. I am not quite aware of that. But I think if 
this comes to light that the reaction rates are much higher, 
and now the rhetoric is changing to the risk outweighs--I mean 
the benefit outweighs the risk, we are opening up a moral 
pandora's box that is worse than any dusting with anthrax 
vaccine.
    Mr. Shays. OK. Sergeant Soska.
    Sgt. Soska. Congressman Shays, on a personal note. My son 
told me about 4 or 5 months ago--excuse me if I get a little 
emotional on this one--he says, dad, mom told us to pray about 
you. And I asked him, why. He says, because she sees you 
getting sick and it worries her. That hit home, sir.
    It is not just about me. This is affecting a lot of people 
that are having problems. And I encourage all soldiers in all 
branches, and as a mentor, my command sergeant major said to 
me, sergeant, don't put yourself in a position where things can 
be misconstrued. They are having problems, and they are not 
getting the help they need, they need to bring it to the chain 
of command. The only thing you can do is advise them what to 
do, nothing more, nothing less.
    And I thank him for that.
    That is all I have to say, sir.
    Mr. Shays. Thank you, Sergeant. Captain Richter.
    Capt. Richter. I think I have said enough, sir. I have 
nothing else to add.
    Mr. Shays. Thank you. You have been very helpful.
    Colonel Jensen.
    Col. Jensen. Sir, if I may take a moment to address the 
question that was posed about risk and benefit?
    Mr. Shays. OK.
    Col. Jensen. I think one of the things when you get into 
that risk versus benefit analysis is a true analysis of the 
efficacy of the vaccine. And for that, I would offer this as an 
area to explore.
    On the DOD anthrax web page, they talk about the vaccine 
efficacy, excuse me, has been tested against numerous anthrax 
strains in animal models. They talk about the guinea pig and 
the mice are poor animal models for anthrax vaccine testing. 
However, they consider the rabbit to be a more appropriate one, 
and the monkeys are considered the best. Yet I see nothing in 
documentation that equates that to the studies that say, this 
is why these are better models.
    For example, yet mice are labeled to be poor, numerous 
guinea pigs and mices have been tested and their reaction rates 
or survival rates can range anywhere from 10 to 90 percent. The 
rabbits I am unaware of what the rates are, but I am told they 
are extremely good survival rates.
    The few monkeys that have been tested have a very high 
rate. Is the reason that the monkey and the rabbit are being 
viewed as the more appropriate models because they appear to 
survive the vaccine better? Or is there an actual study to 
support that?
    And on an interesting side note, the guinea pigs and the 
mice that are considered poor animal models for this exposure 
against inhalation anthrax, the mice have been used extensively 
by the Air Force with regards to the Air Force Office of 
Scientific Research, the folks that are doing the inhalation 
studies right now, and have been for the last 4 to 5 years out 
of the University of Arizona under Air Force contract.
    They have been using mice extensively to examine the 
respiratory effects that inhalation of jet fuel, in particular 
JP-8, have. And they use that as the model to compare to human 
studies. Mice are also used extensively, I am told, in cancer 
research because of the ability to--or their life expectancy is 
so short they can see that.
    Guinea pigs, they state again, are poor animal models, and 
yet my understanding is the guinea pig is used pretty much 
exclusively to test the potency or the efficacy of the vaccine 
before the lot is released.
    So, you know, I kind of sit here and beg the question. OK, 
in some cases, why is it good here, why is it not good there? 
And just looking for the published studies that indicate, 
because I have also seen other folks or heard statements by 
folks out of the medical field that question truly what is the, 
you know, have the models been actually made.
    Mr. Shays. I'm beginning to think I should hire you as one 
of our staff members. [Laughter.]
    Col. Jensen. Do you have F-16's that I can fly here, sir. 
[Laughter.]
    Mr. Shays. OK. Well, I am just going to say one last point, 
and that is that there is something we can do before our 
report, and that is that we can encourage the military to make 
sure, in their chain of command, they encourage proper 
reporting and don't discourage people to step forward.
    We can do that.
    And I believe that would be something that we could have 
some positive result on. And that would be something we can do 
now.
    Thank you very much. Been wonderful witnesses. Appreciate 
you being here.
    We will get to the next panel.
    Our next panel is comprised of Kwai Chan, Director of 
Special Studies and Evaluation Group, National Security and 
International Affairs Division, U.S. General Accounting Office, 
accompanied by Dr. Sushil K. Sharma, Assistant Director from 
the same division.
    Our second testimony will be from Major General Roger 
Claypool, Deputy Assistant Secretary for Health Operation 
Policy, U.S. Department of Defense, accompanied by Rear Admiral 
Michael Cowan, Deputy Director for Medical Readiness, Joint 
Staff, U.S. Department of Defense; Colonel Frederick Gerber, 
Director of Health Care Operations, Office of the Army Surgeon 
General, and Colonel Renata Engler, chief, Allergy and 
Immunology Service, Walter Reed Army Medical Center.
    And our third testimony is from Susan Ellenberg, Director 
of the Division of Biostatistics and Epidemiology, Center for 
Biologics Evaluation and Research, Food and Drug 
Administration, commonly referred to as FDA.
    I want to make sure we have enough seats there and that 
everyone is comfortable. There will be one or two others who--
--
    [Pause.]
    Mr. Shays. Everybody I called, are they represented up 
here. Is there anyone who is not sitting at the front desk.
    OK. Whoever isn't at the front desk but will potentially be 
asked to come forward, I will be asking them to step forward.
    Do we have enough room there?
    Yes. OK.
    Are we OK, Jason?
    OK. Is there anyone who is up who was not called but will 
be potential witnesses so we have their name to give----
    OK. Could you state your name please?
    Dr. Braun. Dr. Miles Braun.
    Mr. Shays. Doctor, I am going to have you, just so the 
recorder can get it--do you have a card? Did you give your card 
to the reporter?
    Dr. Braun. Yes.
    Mr. Shays. Just state your name again, sir.
    Dr. Braun. Miles Braun.
    Mr. Shays. Dr. Miles Braun, thank you very much.
    If I could, I would invite you all to stand.
    If you would raise your right arms, please.
    [Witnesses sworn.]
    Mr. Shays. Thank you.
    I am going to state one bit of prejudice first and then 
invite the testimony. And that is, I think the thing that 
causes me the greatest concern and can make you a bit annoyed 
is the thought that our soldiers and other military personnel, 
our pilots, our airmen, and so on, our Navy personnel, Marines, 
would feel in any way intimidated from stepping forward if they 
thought they had an adverse effect.
    And I am just going to go under the assumption that that 
would trouble you as much, any of those of you--and that from a 
military standpoint that this will be something that you will 
make clear would not be treated well if you thought that any in 
the chain of command were a part of that, and that just as you 
might be, challenge someone who think they have an adverse 
effect and you think they have not done it in a proper way, you 
would be just, if not harder on those who would make someone 
feel intimidated to step forward.
    I do welcome this panel. It is an excellent panel. And we 
will start with you, Mr. Chan, and we will then go to you, 
Major General Claypool, and we will then go to you, Susan 
Ellenberg.
    Is it Doctor, am I? I am sorry.
    Usually my staff corrects me. And I just have this feeling 
you must be a doctor. So you can give me that check.
    OK. Let's start.
    Thank you, Mr. Chan.

 STATEMENTS OF KWAI-CHEUNG CHAN, DIRECTOR, SPECIAL STUDIES AND 
 EVALUATION GROUP, NATONAL SECURITY AND INTERNATIONAL AFFAIRS 
DIVISION, U.S. GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY SUSHIL 
 K. SHARMA, ASSISTANT DIRECTOR, SPECIAL STUDIES AND EVALUATION 
 GROUP, NATIONAL SECURITY AND INTERNATIONAL AFFAIRS DIVISION, 
U.S. GENERAL ACCOUNTING OFFICE; MAJOR GENERAL ROBERT CLAYPOOL, 
 DEPUTY ASSISTANT SECRETARY FOR HEALTH OPERATIONS POLICY, U.S. 
  DEPARTMENT OF DEFENSE, ACCOMPANIED BY REAR ADMIRAL MICHAEL 
COWAN, DEPUTY DIRECTOR FOR MEDICAL READINESS, JOINT STAFF, U.S. 
  DEPARTMENT OF DEFENSE; COLONEL FREDERICK GERBER, DIRECTOR, 
  HEALTH CARE OPERATIONS, OFFICE OF THE ARMY SURGEON GENERAL, 
   U.S. DEPARTMENT OF DEFENSE; COLONEL RENATA ENGLER, CHIEF, 
ALLERGY-IMMUNOLOGY SERVICE, WALTER REED ARMY MEDICAL HOSPITAL; 
 AND SUSAN ELLENBERG, DIRECTOR, DIVISION OF BIOSTATISTICS AND 
  EPIDEMIOLOGY, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, 
  FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY DR. MILES BRAUN

    Mr. Chan. Thank you, Mr. Chairman.
    Mr. Chairman and members of the subcommittee, it is indeed 
my pleasure to be here today to share the results of our work 
on the anthrax vaccine. And may I also introduce my colleague, 
Dr. Sharma, and my staff in the back of me, Dr. Howard DeShong, 
who helped me with this work.
    As you know, many questions have been raised about the 
Department of Defense anthrax immunology program. We have 
previously reported to you a number of concerns regarding the 
safety and efficacy of the vaccine. Today, I will present our 
findings on four issues.
    First, the extent to which data support the need for six 
initial shots and annual booster for the anthrax vaccine. 
Second, the relationship of--the relative merits and weaknesses 
of passive surveillance system for monitoring adverse events. 
Third, available data on differences on adverse reaction rates 
between men and women. Finally, the disadvantages of the 
current vaccine and the status of Federal efforts to develop an 
improved anthrax vaccine.
    With regard to the first question, what is the support for 
the current regimen of six-dose schedule and an annual booster 
shot? We found that the current six-dose schedule was 
arbitrarily determined. No studies have been done to determine 
the optimum number of shots required. And although annual 
boosters are required, the need for this frequency and amount 
of the booster dose have not been evaluated.
    Second, with regards to what are the relative merits and 
weaknesses of passive surveillance systems? That is the VAERS 
system that you have heard about, which DOD used to determine 
the rate of adverse events. We found that this system has 
several advantages as well as disadvantages.
    The advantages: It alerts FDA and CDC to previously 
unreported or unexpected increases in reported adverse events. 
It is also a relatively affordable way to supplement the data 
collected on vaccines before they are licensed.
    However, there are several disadvantages. Studies show that 
adverse events are often under-reported in a passive 
surveillance system. A former FDA Commissioner acknowledged 
that under-reporting of adverse events in such systems and 
cited one study showing that, ``Only about 1 percent of serious 
events,'' are attributable to drug reaction reported to FDA. 
That means 99 percent are not reported.
    Also, outcomes with delayed onset after vaccination are 
outcomes not generally recognized to be associated with 
vaccination are often under-reported.
    There is no mechanism within VAERS for a 1-, 3-, or 10-year 
followup to evaluate vaccine reactions that have a long latency 
period.
    The limitations of VAERS suggest it is not a valid source 
for assessing the rate of adverse events.
    With regards to the third question, on gender differences, 
we identify three DOD efforts which examine gender difference 
with regards to adverse events. Data from these efforts show 
that women reported twice the rate of adverse reaction than men 
for both local, for example swelling, and systemic reactions, 
for example malaise and chills. And we observed some 
reactions--these reaction rates to increase with each 
successive shot.
    In addition, a high proportion of women than men reported 
making an outpatient medical visit after a vaccination, and 
more than twice the percentage of women reported that they 
missed one or more duty shifts after their vaccinations than 
men.
    Finally, with regards to your fourth question, we found 
that the current vaccine has several disadvantages. It is an 
impure mixture of bacterial products using outdated technology. 
The amount of protective antigen in the vaccine cannot be 
precisely measured, and it varies from lot to lot as you 
produce them.
    There is some evidence that the current anthrax vaccine may 
have diminished efficacy against certain virile strains of 
anthrax. Also, the requirement for a six-dose schedule and 
annual booster shots complicates the logistics of inoculating 
all of DOD's troops and increases the cost of the vaccine 
program.
    Knowledge of anthrax infection in studies of experimental 
anthrax vaccine indicate that a second-generation vaccine with 
a more precise amount of protective antigen could be developed 
and that fewer doses of the vaccine could be required.
    In 1995, the U.S. Army Medical Research Institute of 
Infectious Diseases developed a second-generation recombinant 
vaccine against anthrax. The vaccine was tested on animals, but 
clinical trials were not conducted in humans.
    DOD currently considers such a vaccine an unfunded 
requirement. The Department of Health and Human Services has 
allocated funds to develop a second-generation recombinant 
vaccine because of a perceived bio-terrorism concern.
    In developing this second-generation recombinant anthrax 
vaccine, researchers believe they will need to address the 
additional problem of whether deliberately engineered or 
natural strains of anthrax can overcome the protective immunity 
of such a vaccine.
    Mr. Chairman, this concludes my statement.
    Thank you.
    [The prepared statement of Mr. Chan follows:]
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    Mr. Shays. Thank you very much.
    Major General Claypool. Thank you.
    Gen. Claypool. Chairman Shays, Representative Schakowsky, 
Mr. Tierney, it really is a pleasure to appear before this 
committee, and I would like at the beginning to acknowledge the 
first panel. I truly do recognize that they are heroes and it 
took a great deal of courage for them to come before this group 
to testify.
    I really think this kind of openness that your hearing is 
provoking is indeed one of the things that help make America 
great. And from the standpoint of the department in terms of 
its encouraging individuals to come forward, in the department 
policy, of course, is that individuals who have concerns about 
their health care and health-care system should come forward 
with their own individual complaints and we will do what we can 
to solve them and fix that.
    Mr. Shays. Could I just interrupt you a second to thank you 
for making that statement. And also to thank you for not 
objecting to having the military personnel speak first and that 
you were here for two-plus hours to listen to them.
    That is not always usual. Sometimes people of your rank, 
out of protocol, say, I would like to go first. So, on behalf 
of all three of us, I appreciate, one, your being here, and 
second I appreciate your statement.
    Gen. Claypool. We found it very illuminating, actually. And 
it has been a long time since my kids say that I was a real 
doctor. So the opportunity to sit and listen to individuals 
with their medical problems was very illustrative to me, and I 
would like to offer to any of them that any of us on the panel 
here, the DOD members, that can help them get access to the 
evaluation or care that they need--it looks like they are 
already plugged into the right system. But we will do our best 
to do so.
    Mr. Shays. Thank you.
    Gen. Claypool. I would like to focus the testimony 
initially on five points about our program that I would like to 
emphasize. No. 1 is that we know that anthrax exists this very 
day as a weaponized agent in arsenals of countries hostile to 
the United States. And as such, it presents a clear and present 
danger to the U.S. forces around the world.
    No. 2, the cornerstone of our defense against this biologic 
agent is the anthrax vaccine, which has been licensed by the 
FDA for nearly 30 years. The vaccine has an excellent safety 
record and is highly effective.
    Three, to date nearly 300,000 service men and women have 
received nearly 1 million anthrax immunizations. And while side 
effects do occur in some people, they tend, and I say, they 
tend to be temporary, confined to an area around the 
injectionsite and mild or moderate in most people.
    In this age of no-notice worldwide deployments, immunizing 
the total force is the only way to assure force protection 
against this biological warfare agent, which, in the form it 
would be used against us, is as deadly as the ebola virus.
    And fifth, this is not a medical program. It is a 
commander's program to prevent combat casualties and keep our 
forces ready for battle. It is also a program for our soldiers, 
sailors, airmen, Marine, to fulfill our national obligation to 
do everything in our power to keep them safe and free from the 
consequences of biologic war.
    A number of studies listed in our written statement have 
shown that the anthrax vaccine is a safe vaccine with an 
incidence of adverse events that is comparable to other 
commonly used vaccines.
    On either side up here, there is a histogram that depicts 
several vaccines, both new and old vaccines, and I think there 
are sort of three points to take from this chart.
    No. 1, systemic complaints such as headache, fever, joint 
pain, fatigue, are common kinds of system complaints that we 
see with the anthrax vaccine as well as the commonly used 
vaccines.
    Second, the incidences of these side effects to the anthrax 
vaccine is comparable of that to the Lyme vaccine, diphtheria, 
tetanus and pertussis, which is a common child immunization 
agent, the typhoid vaccine, as well as hepatitis A.
    The third interesting observation is, you can see--Colonel 
Gerber made these slides, and I think he challenged my 
vocabulary for knowledge of color--but one very tall vertical 
bar, which I guess I will call turquoise, shows fever. With the 
exception of fever, I think the other interesting feature is 
the fact that the Lyme placebo, the placebo immunization used 
in the Lyme product, shows a significant incidence as well.
    And so we expect to have system effects, not uncommonly, 
with a number of vaccines. And the anthrax vaccine is 
comparable to those.
    It is important for everyone to understand that any vaccine 
carries with it a degree of risk. And the decision whether or 
not to use this particular agent, as we have heard, must be 
based upon an analysis of weighing the risks from the side 
effects against from the risk from the disease the vaccine will 
prevent.
    In the case of the anthrax vaccine, the scales of balance 
are clearly tipped in favor of its use to protect our military 
forces.
    Furthermore, in the case of protecting the entire force 
against anthrax, the risk versus risk decision is not one that 
can be left to the personal choice of each service man or 
woman. An analogy is that the risk versus risk decision for 
childhood diseases results in several mandatory vaccinations 
for schoolchildren. This is because the risk of not immunizing 
presents a public health threat that extends beyond personal 
health concerns.
    In the military, the risk of not immunizing affects the 
capability----
    Mr. Shays. Excuse me. Just hold off 1 second.
    [A series of vote buzzers go off.]
    Gen. Claypool. It's not an anthrax attack, I assume. 
[Laughter.]
    Mr. Shays. My astute counsel said that is six bells.
    Gen. Claypool. Now, could I bargain for a little more time 
to talk, or is that--[laughter.]
    Mr. Shays. What we are going to do is have you finish your 
statement, and we are going to have a few others so we may get 
a little lunch break here. We will see. But let's have you 
finish your statement.
    OK?
    Gen. Claypool. Yes, sir.
    Mr. Shays. Thank you.
    Gen. Claypool. The point I was trying to make is the risk 
of not immunizing presents a public health threat that extends 
beyond personal health concerns, and for the military, the risk 
of not immunizing affects the capability of the entire military 
unit and the success of the military mission.
    Secretary Cohen and General Shelton said it more succinctly 
when they wrote, ``Our commanders must know that all, not 
simply some fraction of their forces, are protected from this 
biologic threat. Soldier, sailors, airmen, and Marines fight in 
teams. And they need to know that all team members are 
protected from the anthrax.''
    While we are aware of isolated, unexplained persisting 
systemic conditions that have appeared in relation to the 
administration of the vaccine, we are not aware of any pattern 
of long-term side effects from the anthrax vaccine.
    As is typical for other vaccines licensed at the time the 
anthrax vaccine was licensed, the FDA did not require long-term 
studies to be conducted after licensure was awarded. The 
standards for recently released vaccines include provision for 
post-marketing evaluation.
    As we have gained additional experience with this vaccine, 
we have come up with questions of our own, the answers to which 
we feel would allow us to improve an already excellent vaccine. 
And so the Department is convening at the end of this month a 
team of military and civilian experts to design a set of 
studies to better evaluate the long-term safety of anthrax 
vaccine as well to answer some of these questions which we have 
raised.
    We are conducting these additional studies of the FDA-
licensed vaccine to conform with present-day, post-marketing 
practices. It is important for all of us to establish every 
reasonable degree of confidence in the minds of Americans, who 
are all stakeholders in this important force health-protection 
issue.
    I would like to spend a minute talking about how we collect 
data, that is about passive surveillance versus active. One 
kind of surveillance is active surveillance in which all of 
them, or more commonly, a cohort, are evaluated as to whether 
or not they have had any side effects from the vaccine. This is 
a tool that is often used in post-marketing situations.
    It would be labor-intensive, cost-prohibitive, and would 
not conform to civilian expectations for us to use this in all 
2.4 million service personnel whom we will administer the 
vaccine to. It is one method we have used in some of our 
studies and will use in cohort manner in our ongoing studies.
    Another type of active-surveillance method advocated by the 
CDC in post-marketing evaluations is the large, linked data 
base. DOD will utilize this approach in our research efforts 
through accessing our immunization tracking program's data 
base, the DEERS system, and through the large medical data base 
residing at a tri-service defense medical surveillance system 
here in the National Capital region of the Walter Reed 
installation.
    Passive surveillance is a common surveillance method 
employed for the collection of adverse events. We know that it 
does not give a picture of the total number of adverse events, 
but it does provide a large pool of vaccine recipients from 
whom we can collect information regarding the emergence of 
spontaneous or infrequent reactions whose low numbers would 
otherwise slip through a focused active surveillance system.
    DOD uses a passive surveillance system developed 
collaboratively by the FDA and CDC called the VAERS system. DOD 
requires its providers to report through the VAERS system all 
cases of loss of duty of more than 24 hours, hospitalization 
for any reaction, or suspected contamination of the vaccine 
lot.
    However, it encourages all health-care professionals to 
report all adverse events that they consider important and 
clinically relevant, even if they don't meet the aforementioned 
criteria.
    It is also important to mention that patients themselves 
are encouraged to and can input information into the VAERS 
system, and many of them have already done so.
    The department has set up a process to have all VAERS 
reports, those reported by providers as well as by patients, to 
review by an independent external review panel, called the 
Anthrax Vaccine Expert Committee [AVEC]. The AVEC consists of a 
special panel of experts from the Health Resources and Services 
Administration, a component of Department of Health and Human 
Services vaccine injury compensation program.
    The AVEC uses explicit criteria for attributing causality 
to adverse events coincidentally associated with the 
administration of anthrax vaccine.
    As of July 1, 215 VAERS reports have been received, of 
which 174 have been review by the AVEC. They have found no 
pattern of causality stemming from the use of the anthrax 
vaccine.
    In conclusion, the department is and will continue to be 
vigilant in our surveillance for any unexpected reactions to 
anthrax immunization. We are committed to fully investigating 
all concerns or all questions on the safety of anthrax vaccine, 
and will continue full and complete disclosure of all risks 
based on objective evidence.
    We know anthrax kills immunization protects. We know death 
from anthrax is vaccine preventable, and that the Department of 
Defense has a safe and effective vaccine to protect its service 
members.
    Immunizing men and women we place in harm's way to prevent 
death or a serious injury is our moral and ethical duty, a 
leadership responsibility we perform with great confidence. It 
would be unconscionable for us not to do so.
    Thank you, sir.
    [The prepared statement of General Claypool follows:]
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    Mr. Shays. Dr. Ellenberg, I think that we have three votes. 
The machine is going to close in about 10 minutes and takes 
about 8 minutes. I think what we will do is let people know 
that they can have some lunch or something, and we will start 
sharp at 10 of, barring they keep us on the floor. But I think 
we will be out before then.
    So we will start sharp at 10 of. Is that OK with you? 
That's when we will start.
    So we will reconvene at 12:50. We will recess, if you need 
to get some lunch or something. Let's do that.
    [Recess.]
    Mr. Shays. Call this hearing to order. And I think we have 
one remaining testimony from you, Dr. Ellenberg.
    No, just slide that whole thing. Do you have enough room? 
It is kind of difficult there. Are you OK?
    Ms. Ellenberg. Yes, I think it is OK.
    Mr. Shays. OK. Let me say, the bigger mic is not the one 
that amplifies. So--that's it. Thank you.
    Ms. Ellenberg. Mr. Chairman and members of the committee, I 
am Dr. Susan Ellenberg, director of the Division of 
Biostatistics and Epidemiology in the Center for Biologics 
Evaluation and Research at the Food and Drug Administration. I 
am accompanied by Dr. Miles Braun, a medical officer in our 
Epidemiology Branch. I appreciate the opportunity to discuss 
with you today FDA's Vaccine Adverse Event Reporting System 
[VAERS], which is designed to receive and evaluate reports of 
adverse events following vaccinations, and in particular, VAERS 
reports related to anthrax vaccine.
    My written testimony is more detailed and I ask it be 
included in its entirety in the record. I would also like to 
say that we very much appreciate the testimony of those on the 
previous panel and wish to assure them that we will continue to 
review and monitor these reports and that we encourage anyone 
developing any medical problems following any vaccination to 
report those to VAERS.
    Vaccines are among the most significant public health 
achievements of all time. They have been responsible for saving 
millions of lives and improving health worldwide and are 
extremely safe. Nevertheless, like all other medical 
treatments, vaccines are not entirely risk free. While serious 
complications are extremely rare, they can occur because 
vaccines are administered to healthy individuals and because of 
the virtual universal exposure of our population to different 
vaccines, it is important to identify even these very rare 
adverse reactions.
    VAERS is a joint program of FDA and CDC. It receives 
reports from vaccine manufacturers, health professionals, State 
and local health clinics, and vaccinees themselves. To 
encourage reporting of any possibly vaccine-induced adverse 
event, the criteria for reporting to VAERS are deliberately 
non-restrictive. The system accepts and includes any report 
submitted, no matter how unlikely the connection with 
vaccination might seem.
    Such reporting system----
    Mr. Shays. I am going to ask you to slow down just a little 
bit. I think General Claypool was speaking a little more 
quickly because of the bell, but we have time.
    Ms. Ellenberg. We have more time. OK.
    Such reporting systems are essential to the discovery of 
potential rare adverse consequences of medical products that 
may not become evident until many thousands or even millions of 
people have been exposed to them. There are important 
limitations, however, to the interpretations of the data 
collected by such systems, as I will discuss later.
    VAERS receives 11,000 to 12,000 reports per year. About 15 
percent of these reports describe a serious event, defined as 
an event that is fatal, life-threatening, requires or prolongs 
hospitalization, results in permanent disability, or, in the 
judgment of the physician, could lead to such an outcome in the 
absence of medical intervention.
    Most of the remaining 85 percent of the reports describe 
self-limited transient events such as injectionsite reactions, 
allergic reactions, and fever, and such events as irritability 
and prolonged crying in infants.
    Currently, all reports of serious events are followed up in 
detail by a health professional. Medical staff carefully 
monitor trends in adverse event reporting for vaccines. It 
should emphasized that adverse-event reports can be submitted 
by a health-care professional or a patient or anyone else. FDA 
protects the confidentiality of individuals reported to have 
experienced adverse events.
    VAERS performs a critical function by generating signals of 
potential problems that may warrant further investigation. It 
is especially valuable in assessing the safety of newly 
marketed vaccines, but it is important to recognize that VAERS 
data alone are usually inadequate for drawing firm conclusions 
or providing a basis for regulatory actions.
    Probably its greatest limitation is its inability to 
establish causality for most reports of serious events. This is 
because most of the types of serious problems reported to VAERS 
occur in unvaccinated as well as vaccinated individuals. When 
large numbers of individuals are vaccinated, some of them by 
chance alone will experience adverse medical events within a 
few days of vaccination.
    For this reason, the fact that an event happens to occur 
shortly after a vaccine has been administered cannot by itself 
lead to the conclusion that the event was caused by the 
vaccine.
    As of July 1, 1999, 215 reports of adverse events 
associated with the use of anthrax vaccine have been reported 
to VAERS. Of these, 22 are considered serious events, as 
defined earlier. These reports describe diverse conditions with 
no clear pattens emerging at this time. Some of these events 
are described in detail in my written testimony.
    The remaining reports describe a variety of symptoms, 
including injectionsite pain and swelling, rash, headache, and 
fever. With the exception of injectionsite reactions, all of 
these reported adverse events can occur in the absence of 
immunization.
    I will skip any comment on the Anthrax Vaccine Expert 
Committee, as that has already been described by the previous 
panelist.
    While the date gathered from the VAERS system can serve as 
a useful tool in identifying potential problems, the reports on 
anthrax vaccine received thus far do not raise any specific 
concerns about the safety of the vaccine. As more people 
receive the vaccine, the number of adverse events reported will 
increase. The agency will continue to closely monitor and 
investigate these reports.
    FDA continues to view the anthrax vaccine as safe and 
effective for individuals at high risk of exposure to anthrax. 
Vaccine safety is a high priority of the Food and Drug 
Administration.
    I thank you for this opportunity to discuss VAERS and our 
efforts to monitor and ensure the safety of licensed vaccines.
    [The prepared statement of Ms. Ellenberg follows:]
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    Mr. Shays. Let me say to you, I have a number of questions 
that we have written down. I am going to follow the script 
somewhat cause these are very important questions for our study 
and I don't want to have my staff tell me later on that I 
should have asked that question and that we need to get it 
later.
    So I am going to ask you, Mr. Chan, how does the number of 
shots affect adverse reaction rates?
    Mr. Chan. The six shots that are given over 18 months 
period--what we found based on the--first of all, there are 
differences between active monitoring and also passive 
surveillance systems.
    Mr. Shays. Bring the mic a little closer to you.
    Mr. Chan. I am sorry.
    Mr. Shays. Yes. Yes.
    Mr. Chan. For the three efforts that we mention in our 
testimony, I think we found that certainly the number of not 
only the number of adverse events increase as after the first 
one to the second one to the third one and so on, but also that 
there is a type of adverse reactions very similar. They are 
consistent, but really had not analyzed whether these things 
are significant or not. I think it does suggest though that, 
you know, DOD is pursuing looking at a possibility of reducing 
a shot out of those six.
    Mr. Shays. I am not quite sure what your answer is. I 
asked, how does the number of shots affect adverse reaction 
rates. And your are not giving me a very clear answer.
    The followup question was after which shot in the series do 
more people experience serious local or systemic reactions.
    Mr. Chan. Yes.
    Mr. Shays. After which shot in the series do more people 
experience serious local or systemic reactions?
    Mr. Chan. Well, first of all, I guess, to answer this 
question, it's six shots, as we stated, was it was established 
in an arbitrary manner. OK, so from a scientific point of view, 
it went from a three-shot regimen through the animal study, 
whereupon they found that in applying to humans, they found 
that they had three cases of anthrax contracted.
    So, that number has been raised from three to six, 
particularly in the early study, in 1962 of Dr. Brachman's 
work.
    Mr. Shays. What GAO has done is basically look at what's on 
the table, the documentation on the table. And it is your 
testimony before this committee that the six shots is 
arbitrary.
    Mr. Chan. Yes.
    Mr. Shays. That there is, what, no scientific evidence that 
six is better than three?
    Mr. Chan. What we were looking for was how was that 
determined in terms of is it based on the antibody to the 
antigen or protecting antigen, as we use, or is it based on a 
tradeoff between what is the difference in reaction, you know, 
in terms of the antigen level from three shots, to four shots, 
to five shots, and six shots and see which one came out with 
the right answer for you, looking for the optimum number of 
shots. And we didn't find that.
    Mr. Shays. OK. Major General Claypool or any of the people 
with you, are you able to respond to that?
    Gen. Claypool. I will take a crack at it. I mean, I think 
this is a vaccine, as we said, that is 30 years old. Back in 
the 1970's, when it was submitted for licensing, we do think 
probably that--I think ``arbitrary'' may be a word that has 
boundaries to it. I mean, certainly we don't think you need to 
have 40 shots; we don't think one shot is sufficient. But six 
shots is what the FDA has, indeed, states, goes along with 
license assurification. And that is why we follow the FDA 
guidelines in our program.
    Now we do believe that there may be a case to be made for 
fewer doses, and that is why we have developed a protocol, as I 
think you know, to look at reducing the number of shots. And we 
are currently working with the FDA to see if we can bring that 
into reality.
    Mr. Shays. I am going to make an assumption, General, that 
you would welcome anyone else on your staff joining in.
    Gen. Claypool. Yes, sir.
    Mr. Shays. So I am not going to specifically ask. So, and I 
am also going to make the assumption that if we have slight 
disagreements that there won't be silence on it because, for 
instance, Admiral Cowan, if what General Claypool is saying, 
and you have some medical disagreement with that, I am going to 
assume that if you don't disagree, you agree.
    Adm. Cowan. Yes, sir. Certainly.
    Mr. Shays. OK. OK.
    Col. Engler. Sir?
    Mr. Shays. Yes.
    Col. Engler. I thought I might be able to help clarify the 
answer to your question.
    Mr. Shays. Thank you.
    Col. Engler. All vaccines series, i.e., more than one dose, 
are based on some immunologic science of priming the immune 
system and then solidifying the immune response to create 
immunologic memory that will protect you long-term. And so it 
is a standard that many vaccines, you need more than one dose 
to optimize the long-term protective response to the vaccine.
    And as that immune response enhances with booster doses, 
you will see more large local reactions. And some people who 
are genetically predisposed to be what we call hyper-
responders, will make very robust immune responses, which many 
manifest in some systemic symptoms, like low-grade fever or 
chills that last only a few days.
    Mr. Shays. So if you have someone who, Colonel, who has 
reacted negatively on the first one, it is likely that they 
will find it even more difficult with the second one, or the 
third, or the fourth?
    Col. Engler. That is true in most vaccines, but in the old 
anthrax literature, it is described that the person who has a 
reaction--we are mainly talking about local reactions with dose 
one--may not have it with dose two, or may have it with dose 
two and not dose three. And in actual fact, the local and self-
limited systemic reactions go down on the fourth dose, where 
there is a time interval of several months. And the immune 
system basically lowers again, because it is not being 
challenged.
    Mr. Shays. You use the word ``old literature''----
    Col. Engler. I am talking about in the sixties.
    Mr. Shays. Yes, that is old literature.
    Col. Engler. For us, yes.
    Mr. Shays. Given the kind of advances we make in medicine 
and with vaccines, that is old literature, but we have an old 
vaccine that we are dealing with. And it is basically your 
testimony that it doesn't always follow but that the answer--
let me re-ask the question: Are you saying, in response to my 
question, that if you have an adverse reaction with the first 
one, that is not an indication that you might not have it, that 
it is an indication you are more likely to have it with 
followup?
    Col. Engler. At the present time, we don't have clear data 
to that fact. There is some data, as I said, in the sixties' 
and seventies' literature that it is erratic. And so someone 
can have a very large local reaction with the first shot and it 
will be better with the second or completely gone with the 
third.
    And the other pattern, where it does seem to worsen from 
shot to shot, is also observed.
    Mr. Shays. OK. What's on the table is the GAO has basically 
said there is no evidence--excuse me, that six shots is an 
arbitrary determination and what Major General Claypool has 
said is that this is--they are following the FDA basic 
literature and not--excuse me, licensing. So let me have the 
FDA jump in here.
    Ms. Ellenberg. Well, I am not an expert on the anthrax 
vaccine. My understanding is that the original clinical trial 
that was done that supported licensure, in that study, the 
people who received partial vaccination, but not the full 
series, that some of those did develop anthrax, a small number. 
But nobody who was fully vaccinated developed anthrax. So that 
there is some suggestion there that more than some number of 
doses provides more protection. But it is based on a small 
number of cases.
    That is the clinical data that I am aware of.
    Mr. Shays. OK. Dr. Chan, why do passive surveillance 
systems result in adverse-event under-reporting?
    Mr. Chan. Well, it is a voluntary system, first of all. And 
this is not just the case with this particular case of anthrax 
vaccine. It is generally the case with most passive 
surveillance systems. And there have been a number of studies 
done to look at that, and in fact, even in applying it to the 
medical device where we found in GAO's own study found that 
less than 1 percent of the adverse events using medical device 
have been reported to FDA. This is post-1980's. And we found 
that is the case.
    So that is the first point. The second thing is that if a 
surveillance system also has in place a sort of a filtering 
process whereby it requires individuals to determine whether it 
should be reported or not, then you have an added problem of, 
you know, reducing that total number.
    And the third case is that, you know, a lot of people do 
not realize that this is really caused by the vaccine itself or 
whatever, and so they may or may not report it.
    A passive system, in a way, it is a sort of sentinel 
system. You really don't try to figure out, is there a larger 
portion of adverse events that are occurring, but really what 
kind of event that is occurring.
    So, if you decide that this is not something you want to 
report, then you lose sight of the fact that the intent of that 
system is to capture some extraordinary events that it is 
unexpected. And so, I think, you know, in listening to the way 
this VAERS system is being applied for the anthrax vaccine, I 
think it suffers from a number of these deficiencies to reach 
this level of reporting that we find that's different in the 
active system that we have noticed.
    Mr. Shays. Now, bottom line, that would indicate to me that 
the VAERS data should not be used as a source for determining 
adverse reactions rates.
    Mr. Chan. Exactly. And that is a pretty well-known fact. 
And certainly we have talked with experts in CDC who have done 
studies of this kind, and as we stated, the former Commissioner 
for FDA also noted the same thing, based on a 1997 study--1993 
study, excuse me, to show that, you know, less than 1 percent 
of adverse events are reported.
    Mr. Shays. Let me just have you put it--I am going to ask 
you the question this way, and I am going to go down the line 
here. Why shouldn't VAERS data be used as a source for 
determining adverse-reaction rates? I want you to tell me why 
it should not be used.
    Mr. Chan. Well, because of the fact that people----
    Mr. Shays. You have already said it, I just want you to 
respond to the question as I have asked. So----
    Mr. Chan. Well, first of all, you need to track the number 
of shots given. That means the denominator has to be given, 
very clearly. Second, you need to have a system by which people 
do not under-report. OK? And third, it requires someone not 
screened out any possible other events that may be related to 
the vaccine. And ultimately, to follow through on those cases.
    Mr. Shays. I don't understand the third one. Say that 
again. I didn't understand. I know you said it. I don't 
understand it. You will have to explain it to me.
    You said, one, you need to track the number of shots. Two, 
you can't have under-reporting. Three, filtering? I don't 
understand filtering.
    Mr. Chan. What I am saying is that you should not, you 
know, theoretically you shouldn't have a criteria by which you 
set out and say this is our product insert, if these are the 
illnesses you have, then it is possible.
    Mr. Shays. I see. OK.
    Mr. Chan. But if it is not, most likely it is not, so let's 
exclude that.
    Mr. Shays. Let me put it in my terms. In other words, we 
make, we determine that only certain types of symptoms would be 
related to anthrax vaccine, and if there are these others, then 
those are filtered out because they are not, we don't accept 
them as being related. Is that what you meant by filtering?
    Mr. Chan. Yes.
    Mr. Shays. OK. General Claypool, I am happy to have you 
defer the question to someone else, but I would like to ask 
whether you have confidence in the VAERS system?
    Gen. Claypool. I have a great deal of confidence in the 
VAERS system to deliver what it is supposed to deliver. And 
what the VAERS system does, it provides, as we have said, the 
ability to look at spontaneous events or, No. 2, is to pull 
from a large data base to pick up infrequent circumstances. And 
as an example, which I think is very timely today, and Dr. 
Ellenberg may be able to correct me, but, for instance, there 
is a new vaccine out for rotovirus in children, and this is a 
new vaccine. And it has been around a relatively short period 
of time. About 1\1/2\ million doses of this vaccine have been 
given.
    Through the VAERS system, they have uncovered a cluster, I 
think that is six or eight cases of children who have gotten 
this vaccine who have developed a particular kind of small 
bowel obstruction known as intussusception. And so what this 
has done by this large data base with its passive reporting 
system has allowed the CDC to ask the question, you know, maybe 
we need to look at this data as to whether or not 
intussusception is a problem with the rotovirus vaccine.
    So the VAERS system has allowed the identification, or the 
floating to the top, or the picking of this new problem.
    Mr. Shays. OK, I am going to have my counsel--the committee 
counsel, rather--ask a question. But I just need to be clear, 
as I understand it. And the disadvantage is you are speaking to 
someone who is not expert on this issue. The advantage is, if I 
can understand it, the whole world can understand it.
    And ultimately, we are going to get to that level. I was 
given three reasons why the VAERS system is not appropriate to, 
as a source of determining adverse-reaction rates. I was told, 
one, we need to track the number of shots. Two, we can't have 
under-reporting have it be valid, and we do have under-
reporting. And we have a filtering system.
    I would like you to respond to that.
    Gen. Claypool. The VAERS system is only one piece of the 
equation. The other piece of the equation in terms of looking 
at adverse events has to do with an active surveillance system. 
And the department is engaging in plans to use two modalities 
of active surveillance. One of them, as I mentioned, is this 
large linked data base, which looks at linking the two large 
data bases we have from tracking the immunizations plus the 
Defense Medical Surveillance System, which is this large tri-
service located at Walter Reed.
    And the ability to look at these two sources of data that 
will allow us to identify people who have had the anthrax 
immunization and to track that with various kinds of complaints 
or problems that have occurred.
    The other has to do with a cohort study; that is, to look 
at some of the studies we are planning to design, and actually 
have done, like the one at Tripler, where we do active 
surveillance, looking at a cohort of people to look for 
specific side-effect problems.
    We can't do active surveillance on 2.4 million people. That 
isn't a common practice in civilian, where we would track every 
single individual. That would require us contacting them, you 
know, after each injection.
    Mr. Shays. Yes, Admiral.
    Adm. Cowan. If I could perhaps state that in a slightly 
different way. What you said about VAERS as the single way to 
track is absolutely true. It doesn't track the shots. It 
certainly will under-report side effects because it is 
voluntary and it could be a filter.
    Back in the sixties, NASA taught us that if you want a 
system to run right, you make redundant systems within systems. 
And so we have, as we have learned about this vaccine, we have 
been attempting to do that. We have a Hoffman survey and a 
Tripler study following a population of people. We know where 
they are; we watch them very closely. And we will end up with a 
statistically significant and accurate rate of the side 
effects, the adverse effects.
    The business of filtering is a very big one, and I am glad 
that got touched on because it is the intent of the VAERS to 
find the unexpected association. Nobody had the slightest idea 
when swine flu came about that that would be associated with 
Guillane Barre. And they started popping up. It is not a 
natural association. You wouldn't have predicted it. And so we 
want the sentinel out there that guides us to the unexpected 
event. We want to do the measurements that tell us what the 
actual incidence of side effects is. And then we track the 
shots for the denominator.
    We have got very good numbers on the shots. So all of these 
things packed together, we are gaining an ever-better sight 
picture of exactly what is going on with our population.
    Mr. Shays. Thank you. I am just going to have the counsel 
ask a question.
    The Counsel. Which leads to the question then, what is the 
adverse reaction rate for the anthrax vaccine. In planning the 
program from its initiation and planning it from here forward, 
what do you assume the reaction rate to be? Therefore, how many 
patients do you expect to see? How many allergists will you 
need to treat them?
    Do you stick by the adverse reaction rates that are in the 
product labeling, or have we learned something different in 
these studies?
    Gen. Claypool. You know, I think this entire anthrax 
vaccination program represents a continuum which we continually 
try to improve and make better. The product packaging, the 
information that comes with it, is based upon the licensing of 
the vaccine when it was given.
    As we gather more information, we suspect, we feel 
confident we will come up with a better estimate as to what 
indeed reaction rates are.
    As an anecdote, you know, at least three of us up here have 
had at least a total of five shots each. So there have been 15 
shots given up here. If I were asked, if I were polled about 
whether I had a reaction, I would say, yes, my arm hurt; I 
really felt achy for a day. It swole up. I actually had trouble 
doing pushups because my arm was aching. And so if I were in an 
active system, I would be picked up as a mild local or maybe 
mild, even moderately systemic reaction because I felt sick 
after the one shot.
    But I wasn't. I went through my duties. I went through the 
rest of the immunization series without any problem. So my 
entry was not recorded as an adverse system, as an adverse 
event.
    So under an active surveillance system, these kinds of 
things would be picked up.
    The Counsel. And you have already found that the rate of 
mild and moderate local reactions is higher than the product 
labeling indicates that. Correct?
    Gen. Claypool. We say we have already found. We have done a 
number of different studies, and Colonel Gerber may be able to 
speak to them specifically. But we looked at different cohorts 
and differing populations, and, depending upon, you know, how 
you are collecting the information, we do believe it will be 
higher. Yes.
    The Counsel. And then, Dr. Engler, what is the, what can 
say, what is the relationship between a higher incidence of 
local reactions and any suggestions or conclusions about the 
incidence of systemic reactions? Is there a relationship 
between the two?
    Col. Engler. If your are talking about short-term, self-
limited, flu-like symptoms, low-grade fever, joint aches, 
muscle aches, as people's large locals increase, those may also 
be in tandem more frequent, reflecting the vigorousness of the 
immune response. And there are, at least in our experience and 
also in Colonel Hoffman's and Korea and the Tripler study, they 
resolve generally within less than 3 to 4 days, and some 
instances, for comfort, respond very well to non-steroidals, 
like Motrin or Tylenol.
    Mr. Shays. Yes, Dr. Sharma.
    Mr. Sharma. Just, I want to make a few points here. First 
of all, in the product inserts, the adverse reaction rates that 
we see are from a different vaccine which has different 
contents and ingredients. And I think there is an issue that we 
had raised in our previous testimony; however, an assumption 
was made that the two vaccines are identical and, therefore, 
the adverse reaction rates would also be very similar. But this 
is an assumption which hasn't been tested.
    Second, following the licensing of this vaccine, we really 
have very little information about its use. So we have no post-
licensing experience with this vaccine. The only time we had 
was during the Gulf, when records were not maintained, and we 
don't know.
    This is the first time you are using this vaccine, and if 
you compare the adverse reaction rates that DOD has presented 
based on VAERS, which is 0.007, and they are true, by that 
token, it is the safest vaccine. But when you look at the 
active surveillance systems, you see a range of reaction rates 
that, for some of these specific symptoms as many as 80 percent 
or 90 percent close to people are reporting some adverse 
reactions.
    Now, I agree that a majority of them are temporary and 
would disappear, but it is striking the upper range.
    And second, something that we didn't know before, because 
during the licensing phase, the clinic that the field trial 
that was done had some problem in the sense that individuals 
who were in that study had received both the vaccine, and a 
determination could not be made which of the reactions were 
attributable to the mark vaccine versus the current vaccine.
    And second, and more importantly, the reaction-rate data 
could not be differentiated with regard to the gender. So they 
really didn't know how women were going to--what experiences 
women had. This is the first time we have learned from the 
active surveys that women are responding differently, reporting 
twice the rate, and I think this is a great revelation. And I 
think we would not have learned if we did not have such active 
surveillance systems. And this is the point that I just wanted 
to make it clear.
    Adm. Cowan. If I could, sir, I would like to build on that 
just a little bit. I think that is exactly right. We took the 
best information we had off of the insert and the data that had 
been done when we started. And we advertised those as our 
adverse incidents. Adverse incidents, to my mind as a 
clinician, come sort of in three flavors. There is minor local 
reactions or minor systemic reactions that are very short, 
self-limiting, don't require any, if only minimal, treatment.
    If those become severe enough that they incapacitate a 
person that he has to be treated, needs something more than 
simple aspirin, then that is sort of another issue.
    But those are reactions. And whether they are to the severe 
end or to the mild end, we expect those to resolve and not 
result in disease.
    The thing that we are concerned about is the nasty 
surprise. The association of a type of disease that is caused 
by, that could potentially be caused by something like this 
that would pop up, we want to identify that as early as 
possible. And I think Dr. Sharma makes the case for having all 
these different kinds of surveillances and studies ongoing so 
that we learn very much up front from the numbers of people we 
vaccinate as we go, and we don't miss cases or have diseases go 
on or whatever, without knowing about it.
    Mr. Shays. I am going to recognize Ms. Schakowsky, but I 
just was trying to think, when we talked about the arbitrary 
number of six, and we know that two is better than one, we 
probably can agree that three is probably better than two, but 
we are not quite sure, particularly from a military standpoint, 
they may ultimately recommend it be three.
    How many shots, when I was in elementary school in the 
fifties, did I have in polio? Did I have one, and then one a 
year later, or something? I don't--I remember it was a dramatic 
event for me.
    Adm. Cowan. Sir, mandatory vaccines for childhood illnesses 
are profuse.
    Mr. Shays. Much different?
    Adm. Cowan. Well, no. They are very much the same. There 
are ordinary vaccines like this is, but we started, probably 
most of us, about 3 months. There are probably anywhere between 
8 and 12, depending on the State and the time, smallpox, 
diphtheria----
    Mr. Shays. I had eight polio shots?
    Adm. Cowan. No, sir. I don't know how many polio shots. Dr. 
Engler may have more information about that.
    Col. Engler. It depends on what year. Do you remember 
getting the shots. You were in the shot series.
    I don't know how young you are, sir.
    Mr. Shays. What's that?
    Col. Engler. I said, I don't know how young you are, sir. 
So you might not have received the----
    Mr. Shays. What is--I was born in 1945, and so I just kind 
of remember them in the early 1950's.
    Col. Engler. Yes, the inactive--at that time, there was the 
injectable polio----
    Mr. Shays. It was injected.
    Col. Engler. That means that it is the shot form as opposed 
to the oral. You may remember the sugar cube.
    Mr. Shays. No. I had a shot. And I just remember not having 
a lot of them. I certainly didn't have six of them.
    Col. Engler. Well, at age 2 months and 4 months and 6 
months, you probably would not remember.
    Mr. Shays. That was just a simple question. [Laughter.]
    Ms. Schakowsky.
    The record will note that I did not get an answer. 
[Laughter.]
    That was simple.
    Ms. Schakowsky. Thank you, Mr. Chairman. I wanted to 
explore a little bit the difference of the reaction among 
women, and wondered if any of you have any information on why 
women might have more adverse and stronger adverse reactions.
    Dr. Engler.
    Col. Engler. I will certainly be happy to speak to that. It 
is well known in the science of immunology that immunologic 
responses of women in the antibody-producing side, are 
enhanced. And there is some survival value to that in that the 
mother transfuses her baby with antibody, and that is the first 
way that you defend your baby from infection after birth.
    That also has the downside that 70 to 80 percent of auto-
immune disease occurs in women. That is, when the immune system 
gets confused and inappropriately causes inflammatory 
destruction of self, of some organ, whether it is the thyroid 
or, in lupus, multiple organ systems.
    Ms. Schakowsky. So the questions to Captain Piel or the 
comments that you are depressed, maybe you just want to have 
babies, that she perhaps needs counseling, were not really 
scientifically based, were they?
    Col. Engler. Absolutely not. I think one of the challenges 
in health-care delivery, both in and out of the military, has 
been how women and their complaints presenting to the 
traditional medical system are handled. And I think we are 
certainly a long way away from where we were in that the 
experiences of Captain Piel are less frequent than they used to 
be, but education continues to be needed.
    Gen. Claypool. I would like to say that each one of us was 
offended by that assertion. I mean that is not the kind of 
military system that we are part of, and that is not----
    Ms. Schakowsky. Again, I want to say, General, that I 
appreciate what you said at the beginning, too, that you really 
encourage people to report adverse reactions and that you don't 
want to have a situation where people feel fear about it or 
feel that they will be intimidated.
    When I was in the State legislature and there was a hearing 
on home-delivered meals, and I asked the presenter from the 
State, do we have any waiting list.
    And they said, no, we don't have any waiting list. And then 
it occurred to me to ask, do we keep track of people who are 
asking? Do we know who is waiting?
    And they said, no.
    So, we don't want to be in that kind of situation that we 
have very few reports. And, in fact, we have testimony in the 
GAO report, which I had in front of me and now I don't--here we 
go--that a former FDA commissioner acknowledged the under-
reporting of adverse events and passive surveillance and cited 
one study showing that, ``only about 1 percent of serious 
events,'' attributable to drug reactions are reported to FDA.
    Are we making any estimates about the percent of reported 
adverse reactions in this instance?
    Col. Engler. That is a very widely quoted statistic, and I 
would just like to comment that we know that there can be 
substantial under-reporting to these systems. These are not 
good places from which to make estimates of rates because of 
that. But the under-reporting rate varies greatly, according to 
a lot of different things. Could relate to the newness of the 
product; it could relate to the seriousness of the event of the 
time after the administration.
    There are data from the CDC that suggest with regard to 
vaccines that the more serious the event, the less problem 
there is with under-reporting. So I think it would not be 
accurate to assume that this 1 percent rate relates to medical 
products across the board. I suspect there is a great amount of 
variability.
    Ms. Schakowsky. But still accurate to assume that it is 
greatly--there is a great deal of under-reporting.
    Col. Engler. It is certainly accurate to assume that, I 
would say for most products, there is a great deal of under-
reporting, but as the data from CDC suggests the under-
reporting may not be so extreme for serious events after a 
vaccine. I suspect we get better reporting for vaccines than 
most drugs.
    Ms. Schakowsky. Well, let me--as a result of the briefing 
that I received yesterday, I think I feel clear about what the 
benefit is to vaccinate against anthrax, that it is a threat 
and that in almost cases it would be fatal. So we want to--but 
in evaluating the risks, it seems yet appropriate to say, do we 
have to take as many risks as we do to achieve that benefit?
    And one of the really disturbing pieces for me is the 
production of the vaccine itself and BioPort and its experience 
and whether or not we are getting the kind of product under the 
circumstances that we want from that company.
    So just a couple of questions about that. Actually, I could 
have a lot of questions about that.
    In a June 30th hearing held by this subcommittee, BioPort 
officials testified that its facility was closed after repeated 
FDA violations and that they were delayed in reopening by, 
``unforeseen circumstances.'' And they suggested that some of 
the unforeseen circumstances included FDA's ``new'' 
requirements and evolving product standards.
    So my question for the FDA is whether you implemented any 
new requirements since the DOD contract was signed 9 months ago 
that would not have been foreseen by BioPort and which would 
have caused this delay?
    Ms. Ellenberg. I'm sorry, that is just totally beyond my 
ability to respond. We will be glad to provide, to get to the 
right people and get that response back to you.
    Col. Gerber. Ma'am, could I just interject, that you 
mentioned that BioPort, the predecessor or the aftermath of the 
MBPI plant, was involuntarily closed. I think it is very clear 
that BioPort closed their plant to reconstruct the production 
lines up there. They closed voluntarily on schedule to renovate 
the plant.
    Gen. Claypool. It was not because of the FDA findings. I 
mean, it was part of the renovation to go ahead and address the 
renovation issue.
    Col. Gerber. It was a scheduled closure to redo the 
production lines.
    Ms. Schakowsky. OK. I guess what I will need, what I need 
to be convinced about is why it is that we have a single 
supplier that has had a history for problems dealing with the 
quality of the product in the past that has been shut down that 
has overestimated, underestimated by--is it--three times the 
cost that the taxpayer would have to expend on this, that has 
had enormous investment by the Department of Defense in terms 
of all the renovation, why it is that we want to put all of our 
eggs in what seems to me to be a fairly, given its history, 
unreliable basket.
    And I don't know, I suppose the devil is in the details, 
but I would like to ask that general question.
    Col. Gerber. Could I take a stab at this? You ask some very 
good questions that we ask ourselves: Why all our eggs in one 
basket? And we are working to resolve that.
    I think there is a little interesting history here that 
when you go back to the vaccine industry here in the United 
States, back to the 1960's and 1970's, when there were 60 or 70 
vaccine manufacturer plants in America. After some of the early 
polio vaccine, even the threat of a catastrophic lawsuit caused 
most of these vaccine manufacturers to close.
    In fact, it is commonly known today that there are four, or 
only four, principal, major vaccine manufacturers, probably a 
dozen total. There is, again, the mere threat of a lawsuit is 
enough to cause vaccine manufacturers not even to get into that 
business. So----
    Ms. Schakowsky. So we have immunized them against that. We 
have given them--they aren't liable for mistakes, according to 
our contract, are they?
    Col. Gerber. If you are talking about the indemnification 
issue, you know, in 1976 we started with the swine flu, when 
the national swine flu vaccine, to indemnify that vaccine. But 
the fact of the matter, most vaccines under the National 
Childhood Vaccination Act are covered by Federal 
indemnification. So it is not an uncommon practice.
    Mr. Shays. But the answer was yes.
    Col. Gerber. Affirmative.
    Col. Gerber. So that's just a little history. There has 
been no money in making anthrax in America, from the 1970's to 
the 19--to the modern anthrax vaccine program. BioPort, I 
understand, sold about 6,000 to 7,000 doses annually to 
veterinarians, laboratory workers, so on, and so forth. So 
there was really no need to have an additional vaccine plant.
    Mr. Shays. Let me jump in if I could on this one and then I 
will give you back the floor.
    Ms. Schakowsky. OK.
    Mr. Shays. When, and this relates to the question of sole 
source. When did DOD begin work on a pure anthrax vaccine?
    Col. Gerber. On a pure?
    Gen. Claypool. I don't when they began to work on it, but 
there is ongoing work that sometime back in the early 1990's, 
at least probably 1993 or 1994, I'm guessing, is when the work 
began.
    Mr. Shays. And when did you discontinue it?
    Gen. Claypool. It hasn't been discontinued. It is still 
ongoing. I think what you are talking about is the recombinant 
PA vaccine.
    Mr. Shays. General, could we be clearer on whether your 
definition of ongoing means that it hasn't been discontinued 
but it is going no where. Is this, is this, are we under active 
pursuit of a pure vaccine.
    Gen. Claypool. Yes. Let me add. I would like to address 
that. I appreciate the opportunity to do that. Back in 1994, in 
about that time period, at that point, when we did not have an 
AVIP program to immunize the total force and we did have the 
current FDA-established vaccine and we didn't have the program 
we have in place and we didn't have the ability to have the 
total force immunized, we had an FDA fully licensed vaccine.
    And so at that point, as you know Congress requires us to 
have fiscal responsibility for our programs, there was dialog 
and discussions, and at that time the best decision was made, 
since we had a fully licensed vaccine by the FDA, it may not 
make the most sense at that point to go ahead and continue with 
the development of a new vaccine, given all the other kinds of 
requirements that we have.
    As you know, things have changed. We now have a total force 
immunization process, and so what we are doing is we are 
looking at ways to take this vaccine, and, if we can, go ahead 
and----
    Mr. Shays. OK. So the answer really is, that we don't have 
an ongoing program for a pure vaccine right now. We 
discontinued----
    Gen. Claypool. No, sir, that is not correct.
    Mr. Shays. OK, we are going to pin this one down because 
this is really important. And let me just tell you where it 
leads me. We were Camar and Great Britain, where they were 
surprised, I think it is fair to say, that the United States 
made a determination to take an old vaccine with impurities 
under old technology that would probably not even get licensed 
today under FDA, and they were surprised that we sought to use 
this old vaccine when it was used for a few hundred a year and 
then ratcheted up to millions.
    And the negative, obviously would be, by developing a pure 
vaccine, it would take time. The positive would be that it 
would be a pure vaccine and you wouldn't have as many adverse 
reactions.
    And then this really gets to the point that Ms. Schakowsky 
is raising. It is my understanding that the pure vaccine does 
not have to be isolated, that it can be made in a plant where 
other vaccines can be made. And, therefore, you are more likely 
to have other players in this process. You wouldn't have to 
have just this sole--a facility just solely devoted to this.
    So that is why I am going down this route. And what I think 
is on the table, honestly, and if I am wrong then we will let 
the record correct it, but it is important we be really 
accurate here. My understanding was, the DOD was pursuing a 
pure vaccine and made a determination that we need to act now, 
and the only thing we had on the table right now was this older 
vaccine.
    So we made a decision that we would go with that. And it is 
my understanding that we are treading water right now in the 
development of a new vaccine. Treading water to me is basically 
going nowhere. And that is my interpretation, and if I am 
wrong, I want you to correct it.
    Gen. Claypool. On Friday, this coming Friday, Mr. Dave 
Oliver, who had the opportunity to appear before your committee 
recently, has directed me to go ahead and convene a group of 
individuals that will help look at the question about the 
feasibility of bringing from farm to market, or bringing to 
production, this new capability. So I am having a task force 
that includes members from MR----
    Mr. Shays. That's fair. That's fair. But that is different 
than what you said, it seems to me. That is saying that you are 
considering resurrecting this.
    Gen. Claypool. Well, the research--excuse me, sir--the 
research has been going on. I don't know the details. It hasn't 
received a lot of funding, and it hasn't received a lot of 
priority on the list of priorities. But it hasn't been stopped, 
it hasn't been stopped.
    Mr. Shays. OK.
    Now this testimony is from when?
    I would love GAO to jump in on this because I am looking on 
page 4, and you said: The vaccine was tested on animals, but 
clinical trials were not conducted in humans. DOD currently 
considers such a vaccine an unfunded requirement.
    Gen. Claypool. Can we take that for the record and come 
back with specific numbers. I am going to get those.
    Mr. Shays. Yes, I would like--we can get specific numbers, 
but I would like to have a sense of where we are at.
    Gen. Claypool. I mean, me personally, I can tell you that I 
am, you know, because of the--I truly believe that in the 
environment in which the decision was made, when it was made, 
it was made with the best available information at that point. 
At this time, given the fact that Representative Schakowsky 
identified the fact that we have all of our eggs in one basket, 
not only with one producer but with one facility. And for 
national security concerns, many of us have wondered whether or 
not we need to have another facility just to be able to protect 
our source.
    Mr. Shays. And that part is a valid concern.
    Gen. Claypool. So, what I am saying is, is that I think the 
equation has changed. And because of that, I think it is 
important to look to see whether we can take this new vaccine, 
kick start it, jump start the basic research that goes to the 
tech base, that gets the production. And this is what we are 
trying to get at.
    Mr. Shays. OK. I understand that, General. I am just--kick 
start means it wasn't started. And I just don't want us to 
quibble over terms. Whatever your understanding of the term and 
whatever my understanding is, in the end we have to have one 
sense of it. And I am not trying to put words in your mouth, 
but my sense is that we have a dormant program, and you want to 
kick start it.
    And if my word dormant--if you want to elaborate on that, 
but let me first have GAO jump in because they were the ones 
who kind of introduced that concern. And then let me give you 
some time to think about what you want to say about it.
    Mr. Chan.
    Mr. Chan. Let me try to answer this question. Give you a 
little bit of perspective here. Since the alternative issue has 
been raised about it. And then I certainly will ask Dr. Sharma 
to supplement it.
    The way I understand it is that as far back as----
    Mr. Shays. Talk into this mic here. OK? Turn it.
    Mr. Chan. Which way? This one? OK.
    Mr. Shays. The bigger mic will pick it up, but the 
amplification is in this mic here. OK? Thank you.
    Mr. Chan. The way I understand it, as far back as 1988, the 
Department of Defense with health affairs had decided that they 
needed to pursue production of an anthrax vaccine, and at that 
time, clearly, MBPI was the only producer. And they were the 
ones that produced the vaccine for the Gulf war soldiers at the 
time.
    In 1991, around September of that time, they decided to 
examine the possibility of having a second source to produce 
the vaccine, using the same manufacturing process as well as 
the same formula.
    Mr. Shays. The old technology.
    Mr. Chan. Yes, and that is with NIH and PRI. That is how I 
understand it. But by 1993, they decided that they should not 
pursue this course of action even though the building in Fort 
Detrick had been prepared to supposedly produce such a vaccine.
    Mr. Shays. You're not talking about creating a new vaccine.
    Mr. Chan. No. It is the same thing. I am just trying to 
give a perspective.
    Mr. Shays. OK.
    Mr. Chan. Meanwhile, I think as late as 1980's, everybody 
had given some thoughts about it: This may not be the vaccine 
to go in the long term and experiments had been done. As we 
stated in our testimony that research had been done with a 
recombinant PA vaccine, which is pure and clearly would not 
have, possibly, impurities and have a much better control and 
so on.
    Mr. Shays. Let me interrupt you a second.
    Mr. Chan. Excuse me.
    Mr. Shays. Excuse me, I am interrupting you.
    The advantage of a pure vaccine is you will have less 
adverse reaction, one, and two, my understanding is that you 
would be able to produce it in a plant that wasn't totally 
dedicated just to this vaccine.
    Mr. Chan. Exactly, the intent is to have a vaccine that is 
non-spore forming so that in fact it would be safe to produce 
it without dedicated building for that purpose.
    OK. And as I understand it, and now may I quote General 
Blank, who told me that as of 3 or 4 years ago, they 
discontinued this effort to continue with, you know--so that is 
why we said there is no further clinical trials being done on 
this particular approach.
    So our understanding recently is that HHS is thinking about 
pursuing this.
    Mr. Shays. OK. But that is what is on the table, and then 
tell us where you think that is accurate and where you think it 
is not.
    Gen. Claypool. Yes, sir.
    Adm. Cowan. I will make one quick comment. I think we need 
to go back and find out exactly what is going on and bring it 
back to you. I do know there is an $18,000 bonus of money that 
has been given by the Joint Program Office for research in 
animal and assay validation studies. Those are ongoing now.
    It is likely, upon termination of that, at this point in 
time, there are truly no more funds available for research 
going beyond there. That should be resolved or get resolved at 
this upcoming meeting that General Claypool said.
    But we will get the accurate information back to you.
    Mr. Shays. Well, well--yes, Dr. Sharma.
    Mr. Sharma. Let me just sort of give you a little detail. 
In 1995, that was the last year funding was provided for the 
recombinant vaccine. At that time----
    Mr. Shays. And the combinant vaccine is the new vaccine?
    Mr. Sharma. Right. And at that time----
    Mr. Shays. Recombinant, I'm sorry.
    Mr. Sharma. Recombinant vaccine. All the basic R&D work was 
done and they were ready to go ahead for clinical trials. But 
since the funding was stopped and it was considered to be not, 
you know, a priority, the researchers stopped there.
    Now, we had also spoken to the commercial manufacturers, 
because this was one of the issues that, you know, DOD was 
dealing with. And we wanted to know two things: their, you 
know, comments and reactions about the current vaccine or their 
assessment, and their willingness to join in the partnership 
with the Department of Defense or what their concerns were.
    It is true indeed that the current vaccine requires the 
dedicated facility, but Merck and Lederle and American Home 
Products told us that if the Department of Defense would 
consider a recombinant vaccine, that they would consider 
production. One of the major difficulties is because they don't 
buy----
    Mr. Shays. Let me just--we are getting off a little. I 
mean, what's on the table, I just want to nail down, is what I 
understand is--and you have helped answer, Dr. Sharma--but I 
think we are getting off a little here. The bottom line is we 
have the older technology in use, and that is the policy to use 
it. And we have a contract with a producer, the sole source.
    And it is my understanding, based on the testimony of the 
GAO, that this is--the program to go to the recombinant anthrax 
vaccine is really basically on hold except, Admiral, for 
$18,000 continuing research, which in my judgment is 
practically insignificant to almost irrelevant but important 
you mention it, just so it is on the record.
    And that, General, whether it is a glimmer in your eye or 
not, it doesn't make it an ongoing program. And so I think what 
is on the table is that we aren't able, we aren't actively 
pursuing that program as of now.
    We may, and we probably should.
    Col. Engler. Sir?
    Gen. Claypool. Well I consider----
    Mr. Shays. Now let me just say something. Before we all 
answer. The deeply--Admiral, I am sorry, General, I am sorry to 
interrupt you--but I just want to say to you that with no 
disrespect, we will keep going down this road if you want to, 
and I am happy to. But I am looking at the testimony today, and 
it seems pretty clear.
    I don't want to suggest you shouldn't go further if you are 
comfortable, but----
    Col. Engler. Sir, I would just like to add for the record 
that the assumption that a recombinant DNA vaccine will have 
fewer side-effect rates in terms of local reaction or systemic 
flu-like symptoms is not necessarily true. The new recombinant 
DNA Lyme vaccine has a very high rate of both local-reaction 
side effect and systemic side effects. And there is a concern 
in regards to perhaps some people being at risk for auto-immune 
disease with that vaccine.
    And we have, as an old vaccine person for many years, I can 
tell you some of the, ``newer and better recombinant vaccines'' 
have actually had higher local-reaction rates because of some 
of the other elements in--the concept that they are totally 
pure is not technically correct, sir.
    Mr. Shays. OK. I don't want to--I realize and I think it is 
important to be technically correct, but as a general rule, is 
it not true that a newer vaccine is more likely to have 
benefits that will not have the side effects?
    Adm. Cowan. Sir, I think we all agree that we should do 
this. I have--perhaps this can bring this to closure. Recently 
the National--this is one of the responses to the questions 
that you had asked in preparation for this. Recently NI--the 
National Institute of Allergy and Infectious Disease formed a 
working group on anthrax vaccines. NIH, FDA, USAMRIID were all 
there. Two meetings were held. The latest on February 19th. An 
NOU is being developed to develop this new vaccine. It is 
estimated that completion of phase one and phase two studies 
and a surrogate model for proof of efficacy could lead to 
licensure within 8 years.
    So there is a current program. There is interagency 
development under way. We are not going to have all the 
information here, and so we will take the question. But it is 
under way, sir.
    And we all agree we should do that.
    Mr. Shays. General, did you have anything you wanted to 
say. Do you have anything you want to add to this.
    Gen. Claypool. No, sir.
    Mr. Shays. I interrupted you, and I apologize for not 
letting you finish. Is there anything that you wanted to add to 
this.
    Gen. Claypool. No. I mean. I would repeat what Admiral 
Cowan has said. I mean, I think that I consider this a live 
program in the sense that we have been doing some things. Maybe 
we could do more; we intend to do more. It isn't a foregone 
conclusion that we will be able to come up with a product, even 
in 5 to 8 years.
    In the meantime, the anthrax vaccine that we have, 
venerable though it is, is a safe and effective vaccine.
    Mr. Shays. Just to make a point, this is an 8-year program, 
but had we started in real aggressively it would be 3 years to 
go, as my counsel has just whispered in my ear. And that is why 
he is next to my ear.
    Mr. Shays. So. All right.
    Mr. Chan. Can I add a couple points here, somehow.
    Mr. Shays. Sure.
    Mr. Chan. I think it is important. When we talk about the 
disadvantages of the current vaccine, one clearly was the 
production problem because of the spore form, and that limits 
you in terms of getting greater participation for competitive 
production of that vaccine.
    It is the second major problem, which I wish, you know, 
that we should think about, is the fact that it is often used--
the reason why we cannot have a vaccine, IND-approved and all 
that, it's because of the fact that we need human clinical 
trials. And we can't do that.
    And the advantage, hopefully, with a new vaccine is that 
somehow you can, and as Admiral Cowan said, find a surrogate by 
which you can correlate that fact that using animal study to 
show that, in fact, it would give you the efficacy against 
humans, thereby bypassing the human medical trials.
    I think that is the major advantage of something new, if 
that is doable. And they are looking into that, and there is 
some science behind it, how it can be done and so on. And 
certainly I think it is worthy of looking into because I think 
that is the other major barrier for developing a new vaccines.
    Mr. Shays. Dr. Sharma.
    Mr. Sharma. I would just like to add, I think one of the 
difficulties, we are saying things here for which I am not sure 
we have complete evidence about its efficacy. Yes, it is true--
--
    Mr. Shays. Sir, I am going to interrupt you a second.
    [Chairman consults Ms. Schakowsky.]
    Mr. Shays. Only one vote? Two votes?
    I am sorry. Hold on 1 second.
    [Consultation continues with counsel.]
    Mr. Shays. I am sorry, we are going to be asking you to 
come back. I think that we need to nail these down. I know you 
all have been here a long time, but we are going to have two 
votes. We will continue for a few more minutes, but I can't let 
one go and then come back, because we still have two votes. So 
I apologize for that.
    I am sorry, why don't you continue.
    Mr. Sharma. I think one of the problems with this vaccine 
is that, you know, as Mr. Chan mentioned about the lack of 
correlates, and when this vaccine was licensed antibody levels 
were considered to be a marker, but subsequently we have found 
that there is no relationship between antibodies level and 
protection. And that raises this whole issue about the number 
of the shots itself.
    I mean, the whole premise of number of shots is that if you 
reach certain level of antibodies your body has, then it will 
protect you. So for that reason, if you can attain, you know, a 
certain antibodies level with two shots, you as much protected 
as with six shots.
    And I think I have to really recognize Dr. Engler, who is 
in my view an excellent clinician and researcher and from whom 
I have learned quite a bit about the relationship between 
antibodies and their implications.
    With the recombinant vaccine, in addition to developing 
surrogate markers for protection for which whereby we could 
certainly know for sure that the vaccine will work or not, it 
would also require fewer doses which certainly has, in the 
current vaccine, a clear indication that the more shots you 
give, and logically you would expect more reactions. So if you 
have fewer shots, and the researcher that we have spoken to at 
USAMRIID and in Camar in England, they certainly seem to 
believe that you could easily reduce the dosage to two, or at 
the most three. And that is quite a bit of improvement over the 
current vaccine.
    Mr. Shays. OK. Let me--we have about 8 more minutes. Do you 
want to take about 5 minutes now and then come back or do you 
want to just----
    Ms. Schakowsky. Well, unless you want to follow this----
    Mr. Shays. Yes, I am going to be asking you to come back. 
And we are going to promise you that when we come back it will 
only be 30 minutes, at the most. So you can judge how much time 
you have left.
    We have one vote, and then we have another. As soon as that 
other vote is over, we will come back. And we have a few more 
minutes if you want to just ask a few.
    Ms. Schakowsky. I did want to followup on something that 
was brought up by the other panel, and I am not sure who the 
appropriate person would be to answer: the issue of the concept 
of waiver, and if anybody is allowed to have one, under what 
circumstances, do they exist. What's the policy?
    Col. Gerber. If I could take that, ma'am. We refer to 
waivers and deferrals, as you had asked us in your question, 
Congressman Shays, we actually refer to those as exemptions. In 
the DOD we have permanent and temporary exemptions, your terms 
for waivers and deferrals.
    In the DOD system, we have 11, I am sorry, 12 categories of 
permanent and temporary exemptions: 5 categories of medical 
exemptions and 7 categories of administrative exemptions. We 
are presently, all services inputting those permanent and 
temporary exemptions into the Defense Enrollment Eligibility 
Requirements, the DEER system.
    The Army was the first to input those. The Air Force is 
inputting them now. And after the Air Force finishes, the Navy 
is the third scheduled in line to input their medical and 
administrative exemptions.
    Let me just speak for the Army. That was the first in line 
or the first scheduled to dump their exemptions into the 
system. The Army, for example, records 5,779 exemptions in the 
system; 92 percent of those, 5,700 exemptions, are for 
administrative reasons. For example, a soldier has died. We 
want to take him out of the system so he doesn't count against 
compliance.
    Ms. Schakowsky. That makes sense. [Laughter.]
    Col. Gerber. The majority of those--well, the vast majority 
of those are, for example, permanent changes of station: A 
sergeant leaves my unit; while he is inbound to the next unit, 
I want him to come off of my rolls so I am not beaten up for 
non-compliance.
    And then we have 8 percent of the remaining 5,700 
exemptions that are there for medical reasons; 79 percent of 
those medical exemption categories are for a medical temporary 
pregnancy hospitalization or convalescent leave.
    So, we are getting a very good handle on all the 
exemptions, both medical and administrative.
    Ms. Schakowsky. So, if someone exhibits some kind of an 
allergic reaction or serious adverse reaction, are they ever 
eligible for an exemption?
    Col. Gerber. Absolutely. I am going to ask Dr. Engler to 
expound on the medical aspect, but it is very common in our 
system when our soldier, sailor, airman, Marine comes in and 
requires some sort of exemption. For example, he has had a heat 
injury or he has had a cold injury, we frequently write 
permanent and temporary profiles to limit their duty for 
temporary or permanent periods of time.
    It is a very common experience, and I will ask Dr. Engler 
to simply comment on----
    Ms. Schakowsky. Well, let me just--then Captain Piel could 
get, might be eligible or would be eligible for an exemption. 
Couldn't fly in those particular areas but would--could you 
explain this, it further?
    Col. Engler. Yes. Anyone to any vaccine, travel vaccines 
and other vaccines that may be indicated or required for 
deployment, if there is a serious and persistent adverse 
reaction, and the majority of the adverse reactions that we 
see, we treat, and we continue the immunization with certain 
interventions or special approaches. So in that case, there is 
no need for a permanent medical exemption.
    Really relatively rarely, if--and so none of these are 
filed until the work-up is completed and the treatment is done. 
And I think there may be some confusion in that initially a 
temporary exemption or temporary delay until the situation is 
clarified. And if then it is deemed that the benefit risk 
ration does not justify continued immunization, then there 
should be a submission of a medical exemption from that 
vaccine.
    Mr. Shays. We have 4\1/2\ minutes until the time is out. 
And they will probably leave the machine open a speck longer. 
As soon as the next vote, we will vote, and we will come back.
    And we will get you out in 30 minutes, even if we want to 
go further.
    [Recess.]
    Mr. Shays. I call this hearing to order again, and we are 
going to get you out very quickly. Let me start with you, 
Colonel Engler. And if you would tell me how many patients have 
you seen at Walter Reed--this is for Colonel Engler--how many 
patients have you seen at Walter Reed who present symptoms that 
may be associated with the anthrax vaccine?
    Col. Engler. In terms of referrals for specific adverse 
reactions or prolonged?
    Mr. Shays. Yes.
    Col. Engler. At this point, from all over, and we have a 
wide referral base, we are--I don't have the exact number--but 
it is in excess of 40.
    Mr. Shays. OK. How many have been sent from Dover Air Force 
Base?
    Col. Engler. At this point, my department has, I believe, 
had six of those patients. And there are scheduled right now, 
the rest of them to come down, not just to see my department 
but other departments based on their symptoms.
    Mr. Shays. And the rest constitute about how many?
    Col. Engler. The 40 that I mentioned to you are independent 
of Dover.
    Mr. Shays. All right. And then six----
    Col. Engler. Then six from Dover to date.
    Mr. Shays. And are you expecting more?
    Col. Engler. Yes.
    Mr. Shays. How many more?
    Col. Engler. The plan that I was informed because--I would 
be happy to get specifics back to you cause I have been out due 
to the death of my mother--but the plan is that all of them 
will come to Walter Reed. If they have symptoms referrable to 
neurology or endocrinology they may not come to my department. 
So there is a centralized plan for Walter Reed to respond to 
anyone who has a problem.
    Mr. Shays. I am very sorry to hear about your mother. Is 
this something very recent?
    Col. Engler. Yes.
    Mr. Shays. It's is good that you are willing to be here 
under those circumstances.
    I just would like to ask you, is the number closer to 30 
from Dover, because that is the number being bandied about?
    Col. Engler. Again, I have been told that the spreadsheet 
that is being maintained has 31, but, again, it is plus or 
minus, please----
    Mr. Shays. I know. Is there any commonality of symptoms in 
the patients you are seeing?
    Col. Engler. No. There are maybe two patients that have 
overlapping symptoms, you know, two here, two there, but for 
the most part, they are distinct. What frequently, if you take 
the whole group, not focusing on Dover alone, we see an awful 
lot of the more severe large locals who have had flu-like 
symptoms that may have persisted for a week, and the question 
is, continuance or not.
    Mr. Shays. Are the symptoms, any of them related to the 
same kind of symptoms we see in Gulf war illnesses.
    Col. Engler. There are a few patients that I am aware of in 
detail that have overlapping symptomatology to Chronic Fatigue 
Syndrome and Gulf war illness-like symptoms.
    As you know, the symptomatology with Gulf war is somewhat 
heterogeneous in that there isn't one single pattern of 
symptoms.
    Mr. Shays. Let me just yield to the counsel.
    The Counsel. Any commonality in terms of ears or, you know, 
audic nerves? We heard about ear infection before. There is a 
lot of reports about tinnitus and ear-ringing.
    Col. Engler. Right. Ringing in the ears. In the spread 
sheet that we are compiling on those folks that we are seeing, 
I have a total of four patients who, as part of their symptoms, 
have had tinnitus. I would say that at least two of them are 
still being tested as to whether they have had some damage to 
their hearing just from the noise exposure, you know, 
occupationally that they have had. So that needs to be 
clarified.
    But the patients have believed that their symptoms worsened 
with a repeated dose of anthrax.
    Mr. Shays. Thank you. Doctor, General Claypool, how many 
immunologists does DOD employ or retain as consultants?
    Gen. Claypool. I would have to check the records. I don't 
know.
    Mr. Shays. OK. That would be a number we would like to have 
a sense of. When we dealt with the Gulf war illnesses, we found 
that illnesses related to chemical exposure, expertise in that 
area was rather slim. And I would want the same for the 
allergists. How many you would employ as well.
    Gen. Claypool. I will ask you a specific question. As 
immunologists, you mean--allergy and immunology is usually a 
conjoined or one flavor. So, we will come up with some numbers.
    Mr. Shays. I think you get the sense of the areas that we 
would like. And we would like to just know if there is 
appropriate expertise or whether the military has the 
appropriate expertise in these areas and the numbers.
    Sorry.
    Col. Engler. I was just going to comment that I think we 
need to get to the numbers together cause they are in the 
research division, there are research immunologists who 
specialize in vaccine research. I am not privy to the exact 
numbers. And there are clinical immunologists who manage 
clinics.
    Mr. Shays. The logic to it is, if we are going to have 2 
million-plus, we are going to have some people who are going to 
legitimately have symptoms and some severe reactions. And do we 
have the expertise to cope with that. That is the basis for the 
question. And we will leave that on the table that you will get 
back to us on that.
    Let me just as four more questions, unless there is a 
followup. Let me--Ms. Ellenberg, if you would, you have said, 
according to FDA, passive surveillance systems are essential to 
the discovery of potential rare adverse consequences of medical 
products that may not become evident until many thousands or 
millions of people have been exposed to them. That is from your 
statement.
    And, is the FDA satisfied the DOD's surveillance efforts 
using VAERS is being implemented consistently and thoroughly 
enough to capture, ``signal events or unexpected adverse 
reaction trends?''
    Ms. Ellenberg. We don't have a way of monitoring exactly 
how this is being implemented. The plans that have been shared 
with us in terms of the reporting, the basis for reporting, 
should be able to get us reasonable numbers of what we would 
consider the serious events, if in fact all such events are 
reported. And we have been told that the criteria that were 
originally put forward are being expanded to include 
significant medical events.
    Mr. Shays. But you do have some concern about the fact that 
this data is passive, it's not----
    Ms. Ellenberg. I wouldn't use this kind of a system to 
give, to come up with precise estimates of rates of adverse 
events. You really need, as has been discussed previously, a 
more active, more effort, a formal study to be able to produce 
those kinds of estimates.
    Mr. Shays. Just as it relates, and I know that Ms. 
Schakowsky had asked the question, particularly as they relate 
to women, a number of them, but would you accept the VAERS data 
that says that women have twice the negative reaction that men 
do or----
    Ms. Ellenberg. Well, we can't make those kinds of estimates 
right now from the VAERS data. We have a relatively small 
number of reports. The actual--in our reporting system, there 
are more reports for men than for women. We don't know what the 
balance is in terms of who got the vaccine. So we really can't 
make those estimates from VAERS data.
    Mr. Shays. OK. I am sorry. Dr. Engler.
    Col. Engler. I just thought it might be helpful to the 
committee that the VAERS reports can be duplicative so that the 
numbers--you know, there could be two or three for the same 
patient, or if a person has a large local with mild flu 
symptoms for dose one, two, and three, those are three VAERS 
reports. So the frequency--it is not a system that will give 
you the data for the side-effect rates that we put in a vaccine 
information sheet or educate the patient about what to expect.
    That is done with solicited surveys.
    Ms. Ellenberg. But actually, we do search for duplicates. 
The numbers that we are giving you, 215, were done after 
duplicate reports were taken out.
    Mr. Shays. The challenge is that the VAERS gets attacked 
from both sides, but the DOD, you know, uses it as viable 
information. I mean, this is documents that you have. And so, 
it is just a little unsettling to me that we would base much of 
anything on it, frankly.
    Col. Gerber. Sir, could I just add that the chart that you 
see depicted comes out of our office and what we are reporting 
is the rate of reporting. We are not using that chart to depict 
that that is the number of adverse reactions or events. It is 
the rate of VAERS reports submitted, the VAERS form dash one.
    Mr. Shays. Well, you basically, in the chart, say 65 
adverse reactions of 890,888 cases of vaccinations given, 0.007 
percent. I mean, that is given to make people feel comfortable. 
And so, I think it is being used differently than you think it 
is.
    This is a PR document in favor of the vaccine.
    Dr. Braun, is there anything that you want to say. I find 
that people who don't participate sometimes have very cogent 
observations cause they have been listening instead of talking. 
[Laughter.]
    No reflection on you.
    Dr. Braun. Not at this time. Thank you for the opportunity.
    Mr. Shays. I am going to assume that you are brilliant. 
[Laughter.]
    Ms. Ellenberg. That is why I hired him.
    Mr. Shays. There is this wonderful picture of Attorney 
General Mitchell--this is off the record--when he was working 
with President Nixon, and he was described as the person who 
had created the new Nixon. And he was described as brilliant. 
And he never said anything. You just saw him sit in the biggest 
chair at the White House. And then one day we got to see him 
speak at Watergate, and we all had a different feeling. 
[Laughter.]
    OK, you are on.
    Why did I say that? [Laughter.]
    I'm counting on you, boss.
    Ms. Schakowsky. A couple of things that I would like given 
to me, one is, at an earlier hearing with different witnesses, 
I had asked for a list of the producers of vaccines that also 
get the same kind of indemnification. And maybe it is in the 
process to get to me. But I haven't gotten it yet. And the 
other is, I would like, Colonel Gerber, a copy of the waiver 
policy, and also you gave some statistics on who--not waiver, 
exemption policy. And I would like to see that and also some of 
the numbers associated with that.
    Dr. Sharma, you had your hand up and I didn't get to hear 
what you had to say in regard to the issue of the differential 
between men and women in their effect. I wondered if you had 
some comments on that, on the gender issue?
    Mr. Sharma. Yes, I think this is significant because if you 
take a look at the percentages, we see two things. Overall 
reaction rate in both men and women is in these active systems 
significantly higher than what we had assumed it to be to date, 
and second, these findings about differences in genders have 
very specific implications about the dosing or over-dosing in 
women. And I think I would like to--I mean, there is nobody I 
know in this panel, perhaps there are, but at least I know Dr. 
Engler has tremendous expertise and we have talked to, and 
maybe she would like to comment on that. And she--I think it is 
more appropriate at this point.
    Ms. Schakowsky. Thank you.
    Col. Engler. I think the challenges of making a vaccination 
program like anthrax better as we learn and the science and 
immunology of female immune responses versus male is still 
somewhat in the growing phase. But we already know that inter-
muscularly the anthrax vaccine, a large local reactions, are 
radically reduced. And the preliminary data, as far as I 
understand, was presented in December 1998 to the FDA and they 
just asked for larger numbers to allow us to change the route. 
And that also helped women in terms of the large local 
reactions.
    And then, the other issue is that we would like to address 
that fact that in the female population are probably going to 
be more what we call hyper-responders. And in other vaccine 
models we know that hyper-responders do not need the full 
series. And in many vaccine models over time, tetanus was an 
example, many of you may remember we used to get a booster 
every 3 to 5 years, now we get it every 10 because it was 
learned that it wasn't necessary because there was such a high 
rate of hyper-response as you continue.
    And I think we are learning the same lessons with anthrax 
and that the program will evolve in that knowledge-base to make 
it better.
    Ms. Schakowsky. I think it is so important that we do 
carefully examine this data because it is only in recent 
history that we have even looked at the different impacts on 
women in clinical trials. For years, only men were observed. 
And so I think it so important that we don't have a one size 
fits all when it comes to gender and the application of this 
vaccine.
    Gen. Claypool. And I believe in the license applications 
too--excuse me--but I don't think that women were part of the 
study when the initial license request was submitted. So that 
is a valid thing that we are pursuing.
    Ms. Ellenberg. I actually--because we don't have the data 
on gender from the original study, nobody knows for sure, but 
there are suggestions in the data that women were in fact 
included. But I would have no idea what the ration was.
    These were done in millworkers, and there is no reason to 
think that there wouldn't have been women.
    Ms. Schakowsky. I am trying to remember what my final--oh, 
I know what it was. OK, I got it.
    I don't know what you call it again, that information sheet 
that is included with any vaccine.
    Col. Gerber. Product insert.
    Ms. Schakowsky. The product insert, were you saying--was it 
Mr. Chan or Dr. Sharma--that it was based on a different 
formulation? Is that legal? Are we allowed to do that, to put 
information about a different drug in, you know?
    Mr. Sharma. I think I am not a lawyer and nor is Mr. Chan, 
but perhaps the FDA could comment on that. However, to be fair, 
I think there was an assumption made that these are two very 
similar vaccines. However, there is a difference between look-
alike and having the same gene. They are not identical, and we 
do know, for example, there are some differences, some of them. 
Certainly there is some suggestion from the clinical literature 
that they are associated with higher reactogenicity levels.
    One of them is that this vaccine has higher PA content, and 
there is some suggestion from the different vaccines using 
different PA content level that higher content levels are 
associated with higher reactogenicity, for example.
    Second, this vaccine uses aluminum hydroxides, and there is 
some suggestion that similar vaccines, other vaccines, that use 
aluminum hydroxides have higher reactogenicity. I think these 
are important differences which I am not sure, and again we are 
going back to the history, to what extent they were looked or 
not looked. We have, you know, documentation of the IND that 
was submitted and any written documentation that existed, which 
is not much compared to the current standard. So it is really 
hard to go back and say why they made that assumption, but it 
is very clear they made an assumption, and everything that we 
know about what is mentioned there is about from the other 
vaccine, which was similar.
    Ms. Schakowsky. It just seems to me, in terms of confidence 
in the entire program, that it is really important that 
accurate information be given, that there is good access to 
information, that we monitor accurately and fully inform, and 
that we process it well. And in that regard, I feel the 
hearings that I have been at that I don't have that sense of 
confidence that really any of those things happened.
    Col. Engler. I would just like to add one comment to what 
you just said that I think risk communication and communicating 
with patients at a level that they can understand and that is 
meaningful for what they experience following any therapy is a 
continuing challenge for the health-care system in and outside 
of the military. The CDC has for the standard vaccines, not the 
travel vaccines, a whole staff dedicated to translating what we 
call vaccine information sheets cause the package inserts 
aren't real helpful to patients.
    And we are in the process, actually, right now of having a 
draft document that is being reworked by the CDC to have the 
same kind of equivalent information as we give to parents of 
children who are coming for their polio or DPT that is a more 
balanced reflection of risk communication. And I think we all 
here recognize that there is a need for improvement in risk 
communication.
    And I think, like with the Lyme vaccine, there is no VIS 
yes, vaccine information sheet. So we are challenged in the 
clinical arena to make our own. And I personally think that 
before a vaccine is licensed, not just a package insert but a 
VIS should be developed and marketed with it because right now 
the clinicians are left a little bit to hang out to dry.
    Mr. Sharma. I think I would like to have a comment to 
follow Dr. Engler. I think she mentioned about the management 
strategies that are available for other vaccines, and I think 
DOD has an opportunity to develop such strategies, especially 
as they pertain to women, especially as they pertain to people 
who are hyper-responders. And I think we could really, you 
know, learn something about this vaccine as it, you know, the 
events are taking place.
    But without those models, it is going to be very difficult 
to know what is happening to people and something that we have 
learned, I mean, people call us. Immediately after we started 
the study we were getting about 100 calls a week between Mr. 
Chan and myself. And these were calling from public telephones 
because they were afraid, they didn't want to be identified 
talking to us.
    They see people there left and right are getting sick. Now, 
it may be, you know, whatever, I am not questioning whether 
those events were associated with vaccines or not, but they 
want to be heard, they want to be managed, and such strategies 
would certainly help gaining confidence of these individuals.
    And DOD should consider using or developing models for 
anthrax as they exist for other vaccines.
    Mr. Shays. I think we can conclude here by just two 
questions, and I would like to make an observation, and you 
might as well. But the first question would be, on what basis, 
and this would be to you, General Claypool, and others respond, 
on what basis does the anthrax vaccine immunization program can 
deploy troops or protect them from anthrax attack after two or 
three shots when the FDA-approved regimen calls for six.
    Gen. Claypool. We do believe that there is at least 
evidence to suggest that there is some immunologic protection 
afforded after two or three shots, but the issue is, is that 
would we wait until they are fully immunized with six shots 
before we deploy them. No.
    We can't wait until, indeed, you know, a full force totally 
immunized back within the continental United States before we 
send them to theaters where there are.
    So, we understand that they are not fully protected, but we 
have started on our road for total force immunization, and that 
speaks to the issue as to why the whole force has to be 
immunized because of the fact that we don't have a short lead 
time. We need a long time to get the force immunized. So that 
is why we are doing it.
    Mr. Shays. Does Dr. Engler--excuse me, not Dr. Engler--Dr. 
Ellenberg, if you would--I used to have a girlfriend named 
Ellen, that is what is confusing me. [Laughter.]
    Dr. Ellenberg, if you----
    Ms. Schakowsky. Too much information. [Laughter.]
    Mr. Shays. And that can be off the record too. [Laughter.]
    Mr. Shays. It was legitimate. It was before--many years 
ago. [Laughter.]
    Dr. Ellenberg, would you confirm that there is indication 
that two or three shots is going to provide protection?
    Ms. Ellenberg. I don't have the numbers from that study in 
front of me. The vast number of people who--I mean, all the 
numbers were relatively small--but the big majority of people 
who did get anthrax in that study were people who did not get 
any vaccinations. There were a few who were partially 
vaccinated who also got anthrax, and none with the full 
vaccination.
    Now, I don't have the numbers in front of me to remember 
there were in each group, that is, how many got the full 
series, how many got partial. So I can't really--I would have 
to check that.
    Gen. Claypool. I didn't mean to imply that I think they are 
fully immunized. In fact, you know, we deploy people after they 
have one shot if they are going to a theater to start, so----
    Mr. Shays. I know that. I know that.
    Adm. Cowan. As a matter of fact, if I could share--well 
there is some evidence, going back to the Brachman study, that 
there is at least partial immunization. It is not our goal, and 
we feel that we are running somewhat of risk, and we just don't 
like doing this. But it is an interim measure that we have 
taken as we go to the total force. When we get to the end of 
the program, people will come in as a condition of employment, 
and then we won't have to do things like this.
    Mr. Shays. Yes, I hear you. What adverse reaction rate 
would be too high? There must be some level in which we say, it 
just isn't worth it.
    Do we have any documents or memos or anything that have 
tried to wrestle with this problem?
    Gen. Claypool. I think in part, it would have to be on what 
kind of an adverse reaction rate it would be and how long it 
would last, for instance, if indeed we found X percent had 
developed a significant neurologic problem that wound up in 
paralysis, of course, that would obviously be the case.
    I don't mean to be vague. We don't really have an answer.
    Mr. Shays. That's fair. I think of Captain Piel, and she 
wants to fly. And one of the things I hope is that we all can 
find a way to get her healthy again so she can fly.
    And, she is a casualty cause she can't--she can still 
serve, but she can't serve the way she was trained.
    Let me ask if any of you would like to just make a closing 
statement or just an observation or something that you think 
would contribute to the hearing or you just think you would 
like to put on the record.
    We will start with you, Mr. Chan.
    Mr. Chan. Well, I think as you said, this is the third or 
fourth hearing you have on this subject.
    Mr. Shays. Fourth.
    Mr. Chan. Fourth, I'm sorry.
    I would like to make one observation. It seems to me that 
if there is a way for us to all agree with the data, the 
information that is being given out, being transmitted, being 
told to the soldiers are in fact of consistent and reliable 
nature. That, you know, to implement this program, I think 
partly requires a lot of effort in terms of outreach and people 
who can speak to the soldiers because, as Dr. Sharma said, we 
have been partially the receiving end of a lot of phone calls. 
And we understand a few of their pains.
    And we cannot advise them anything further than go to the 
VAERS system and report, and if they don't want to, we couldn't 
force them. And as a result, I think, you know, the discussion 
around the new vaccine needs to be clarified, if that is 
important or not. The discussion about how do we get to where 
we are in terms of the early Brachman study using a different 
formulation basically showing cutaneous anthrax as the vaccine 
for that particular disease, and then applying it to inhalation 
anthrax, which is currently what we believe to be a threat, we 
are using a different formulation, using different strains.
    The idea of the fact that the current vaccine may not be as 
efficacious against other strains in animal studies. The fact 
that there are potentially concerns about reactions and 
reactivities, and the differences among sexes, and all those 
things.
    It seems to me that we clarify a lot of things, because 
this is really not a question of policy, what's important, but 
rather, how would you implement this program in such a way that 
in fact would not affect the readiness of our forces. And that 
is where, you know, I think it is a greater concern than the 
issue of the details.
    Mr. Shays. OK. Thank you. Dr. Sharma.
    Mr. Sharma. No. I will pass.
    Mr. Shays. General Claypool.
    Gen. Claypool. I do have a couple of comments I would just 
like to make for the record, for that terminology. First has to 
do with what we were discussing about vaccine immunization 
indemnification. And, as I understand it and I am not an 
attorney, of course, but as I understand it, the language that 
is very commonly used in such indemnification talks about an 
unusually hazardous risk.
    Mr. Shays. Yes.
    Gen. Claypool. That unusually hazardous risk should be 
construed that it is a risk because of medical consequences of 
the vaccine. It is because of the financial risk to the 
company, for whom the government is providing indemnification. 
And it is done, I think, in sisterhood or partnership with the 
National Childhood Vaccination Injury Act that led to----
    Mr. Shays. So, in fairness to the military, the terminology 
is more the legalistic term that is somewhat of a boilerplate. 
That is your point?
    Gen. Claypool. I believe the ``unusually hazardous risk,'' 
as I say, is not from the vaccine, per se, but toward the 
financial risk.
    Mr. Shays. OK.
    Gen. Claypool. That's the intent behind it. So, when the 
Secretary of the Army talks about that, he is not talking about 
the unusual risk from the vaccine.
    Mr. Shays. OK. Fair enough.
    Gen. Claypool. And No. 2 is, just to make an observation, 
and that is, and we have talked about this, but it certainly is 
important to evaluate all these individuals that are here and 
the ones that are in Dover and the ones that are coming into 
the Walter Reed clinic, but we ought not assume that there is, 
necessarily, a cause and effect.
    These individuals are ill and they need to have their 
medical conditions rendered, but the fact that it occurred 
temporally with relationship of the vaccine doesn't necessarily 
make it a fact that it is due to the vaccine.
    Mr. Shays. I think that is true, but, you know, if in doubt 
you err on their side.
    Gen. Claypool. Well, the thing we want to do is get them 
well again and get them back in the cockpit. That is what we 
want to do.
    The third is, you asked us to provide a list of 
immunologists, and we are certainly happy to do that. I just 
wanted to hope that you don't assume that--because it will be a 
low number. Dr. Engler told me that within the Army I think 
there are like roughly on the order of magnitude of 20 or so 
immunologists.
    You don't need immunologists to take care of people like 
this. You need immunologists to help direct research and look 
at laboratory studies and that sort of thing. So, the important 
thing, I think, is that we have the right specialty and the 
right mix and the right mechanisms to take care of individuals 
who are ill. And that will include immunologists, and we will 
provide that number for you.
    The last thing is I think--not last thing, one more thing--
is that there is ongoing research, and we can get, if you want, 
numbers and specificity, but there is ongoing research on two 
accounts that we talked about. No. 1 is the characterization of 
the current vaccine, from the standpoint of the antigen that is 
there, the protective antigen, the concentration, as well as 
the other antigens that are part of it. So we are looking at, 
this is the current vaccine.
    And second, there is also ongoing characterization of a 
surrogate animal model. That is how we are going to have to do 
business in the future anyway with the FDA. We are going to 
have to do it with surrogate models. That research is under way 
and ongoing.
    Mr. Shays. Let me just say, as a courtesy to people when 
they close, I like not to generally jump in, but on this one I 
just want to say, I know the military, when they put their mind 
to it. So on this level here, I think we are pretty much in a 
kind of a treading water position, and I think you all need to 
determine where you are going to go.
    But I don't have any comfort level that we are pursuing a 
new vaccine and that this is on a fast track. I don't even 
think it is on a slow track.
    That's with all due respect, but your point is, it's there 
to be considered and to be pursued and some element of progress 
is being made.
    Can we agree on that?
    Gen. Claypool. Yes. I was trying to address more 
specifically the GAO's talk about looking at surrogate models. 
We are doing that. We are working on it.
    And last, I really do appreciate, sir, the opportunity to 
come before you. I am very, I am very much committed to this 
program. I really do believe that the risk is real and that we 
have a safe and effective vaccine when----
    Mr. Shays. Just to clarify for the record: the risk of an 
enemy using anthrax.
    Gen. Claypool. Yes. And I think that the product that we 
have has a profile of adverse events that is comparable to 
other vaccines. We are continuing to look for this, for anymore 
severe reactions, but I think it is the right program for the 
country at this time.
    Mr. Shays. Thank you.
    Adm. Cowan. Sir, I am also grateful for the opportunity to 
be here and speak. The only job I have ever held in my entire 
adult life has been a Navy doctor, taking care of sailors and 
Marines, and now being responsible for the other services too.
    I am particularly grateful, and I feel obligated to comment 
about the first panel, not only for their courage to stand up, 
but my dismay that they had to have that courage, my dismay 
that the leadership somehow stiff-arms people and that the 
medical department pushes them away or makes access to care 
difficult.
    And, frankly, that just, I find that, I don't know, equal 
parts, saddening and infuriating. And one of the major messages 
that I go back with is my eyes opened up at our continuing 
problem of getting our people in to do the right things for 
them.
    So I thank you very much for that, sir.
    Mr. Shays. Thank you. Thank you for those comments.
    Yes, sir, Colonel Gerber.
    Col. Gerber. Sir, I was also struck, impressed with your 
opening premise that we are all interested in the safety and 
welfare of our service members, and I think you can assume--I 
mean, that is job No. 1, that is what we do for a living. I 
have been associated with the anthrax vaccine immunization 
program everyday for the past 20 months. And the easiest part 
of my job is accepting the national intelligence estimates that 
are validated every year by the five war-fighting CINC's that 
readily, beyond any reasonable doubt, depict an array of 
anthrax weaponized threat arrayed against our servicemen.
    The second part of my job is my overwhelming belief in the 
safety and efficacy of an FDA-certified vaccine that we know is 
safe, it's effective, just as safe, and as reactogenic as many 
of the national vaccines that we employ.
    So, thank you very much for this opportunity.
    Mr. Shays. Thank you very much. Colonel Engler.
    Col. Engler. I also would like to thank the committee for 
the opportunity to participate, and for me, at least, a unique 
experience. I would like to also, for the record, state that I 
think the anthrax program and the lessons learned as we evolve 
it are very important lessons that may someday have value added 
for the taxpayers' money expended in a future flu pandemic.
    As the ex-officio member to the National Vaccine Advisory 
Committee, I think there is a serious concern of how do you 
deliver a vaccine rapidly and effectively to millions of people 
to save lives. And a flu pandemic in the future, where in 
months we can see millions of people die, is an awesome 
thought. And how we, as a military, will play in that, some of 
the lessons learned from this program may add value to that 
experience.
    Mr. Shays. Thank you. Ms. Ellenberg, doctor.
    Ms. Ellenberg. I would just like to say that we have made, 
and will continue to make, the review of the VAERS reports on 
anthrax a high priority. And we expect and are happy to 
continue working with the DOD to enhance the effectiveness of 
the reporting programs.
    Mr. Shays. Thank you. Dr. Braun, would you like to make a 
comment.
    Dr. Braun. Thank you for the opportunity. I have no comment 
to make right now.
    Mr. Shays. Well, it has been a very helpful hearing. This 
committee wants to weigh in on the right side, and we, I think, 
we have some sense of where we want to move, but it is a 
gigantic issue. The threat, the terrorist threat is real, the 
threat that our adversaries may use chemical or biological or 
even nuclear weapons to work their will is very real. Terrorist 
threats are extraordinarily real. So, this is a big deal.
    Thank you very much.
    And, my colleague, any comments you would like to make.
    Ms. Schakowsky. Let me just say, for my part, in closing 
that in our understandable zeal to protect our service men and 
women from the threat of anthrax and ultimately to protect all 
Americans, therefore, what I don't want to see happen is that 
we are willing to sacrifice good science, good medicine, good 
production methods, and, ultimately, the good treatment of 
those individuals who truly want to serve their country.
    Mr. Shays. We will conclude by thanking the majority and 
minority staff for their good work, as always, and 
particularly, on bended knee, to thank our court reporter, Ron 
Claxton, who is, who I am at his mercy. [Laughter.]
    We will now adjourn. [Laughter.]
    [Whereupon, at 3:07 p.m., the subcommittee was adjourned.]

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