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




                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION


                         OCTOBER 3 AND 11, 2000


                           Serial No. 106-249


       Printed for the use of the Committee on Government Reform

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

73-979                     WASHINGTON : 2001

 For sale by the Superintendent of Documents, U.S. Government Printing 
Internet: bookstore.gpo.gov  Phone: (202) 512-1800  Fax: (202) 512-2250
               Mail: Stop SSOP, Washington, DC 20402-0001


                     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
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
    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-HAGE, Idaho              (Independent)

                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
                     James C. Wilson, Chief Counsel
                        Robert A. Briggs, Clerk
                 Phil Schiliro, Minority Staff Director

                            C O N T E N T S

Hearing held on:
    October 3, 2000..............................................     1
    October 11, 2000.............................................   293
Statement of:
    Chan, Kwai-Cheung, General Accounting Office; and Major 
      General Randall L. West, USMC, Senior Advisor to the Deputy 
      Secretary for Chemical and Biological Protection, 
      accompanied by Major General P.A. Weaver, Jr., ANG, 
      Director, Air National Guard...............................   420
    Cragin, Charles, Principal Deputy Assistant Secretary of 
      Defense for Reserve Affairs, U.S. Department of Defense, 
      accompanied by Dr. J. Jarrett Clinton, Acting Assistant 
      Secretary of Defense for Health Affairs; Dr. Anna Johnson-
      Winegar, Deputy Assistant to the Secretary of Defense for 
      Chemical and Biological Defense; Major General Randy L. 
      West, Senior Advisor to the Deputy Secretary of Defense for 
      Chemical and Biological Protection; Colonel Arthur 
      Friedlander, science advisor for the U.S. Army Medical 
      Research Institute of Infectious Diseases; and Mark 
      Elengold, Food and Drug Administration.....................   125
    Heemstra, Tom, Lexington, KY; Dan Marohn, Plymouth, IN; Pat 
      Ross, Battle Creek, MI; and R. Stephen Porter, Virtual Drug 
      Development, Inc., Brentwood, TN...........................   297
    Irelan, Major Jon, U.S. Army, Forest Grove, OR; Nancy Rugo, 
      Spokane, WA; Barbara Dunn, Ionia, MI; Kevin Edwards, San 
      Antonio, TX; Toney Edwards, Fayetteville, NC; Senior Airman 
      Thomas J. Colosimo, Andrews Air Force Base, Maryland; 
      Joseph Jones, Oklahoma City, OK; David Ponder, Okinawa, 
      Japan; John J. Michels, Jr., McGuire Woods, LLC, McLean, 
      VA; and Dr. Alexandrer M. Walker, professor of 
      epidemiology, Harvard School of Public Health..............    29
    Metcalf, Hon. Jack, a Representative in Congress from the 
      State of Washington........................................    23
Letters, statements, etc., submitted for the record by:
    Burton, Hon. Dan, a Representative in Congress from the State 
      of Illinois, prepared statement of.........................    12
    Chan, Kwai-Cheung, General Accounting Office, prepared 
      statement of...............................................   424
    Chenoweth-Hage, Hon. Helen, a Representative in Congress from 
      the State of Idaho, prepared statement of..................   508
    Colosimo, Senior Airman Thomas J., Andrews Air Force Base, 
      Maryland, prepared statement of............................    60
    Cragin, Charles, Principal Deputy Assistant Secretary of 
      Defense for Reserve Affairs, U.S. Department of Defense, 
      prepared statement of......................................   129
    Cummings, Hon. Elijah E., a Representative in Congress from 
      the State of Maryland, prepared statement of...............    20
    Dunn, Barbara, Ionia, MI, prepared statement of..............    48
    Edwards, Toney and Kevin, Fayetteville, NC, prepared 
      statement of...............................................    53
    Elengold, Mark, Food and Drug Administration, prepared 
      statement of...............................................   146
    Heemstra, Tom, Lexington, KY, prepared statement of..........   301
    Hutchinson, Hon. Tim, a U.S. Senator in Congress from the 
      State of Arkansas, prepared statement of...................   173
    Irelan, Major Jon, U.S. Army, Forest Grove, OR, prepared 
      statement of...............................................    31
    Jones, Joseph, Oklahoma City, OK, prepared statement of......    72
    Marohn, Dan, Plymouth, IN, prepared statement of.............   318
    Metcalf, Hon. Jack, a Representative in Congress from the 
      State of Washington, prepared statement of.................    26
    Michels, John J., Jr., McGuire Woods, LLC, McLean, VA, 
      prepared statement of......................................    89
    Ponder, David, Okinawa, Japan, prepared statement of.........    79
    Porter, R. Stephen, Virtual Drug Development, Inc., 
      Brentwood, TN, prepared statement of.......................   336
    Ross, Pat, Battle Creek, MI, prepared statement of...........   325
    Rugo, Nancy, Spokane, WA, prepared statement of..............    41
    Shays, Hon. Christopher, a Representative in Congress from 
      the State of Connecticut:
        Letter dated November 3, 1999............................   408
        Prepared statement of....................................     4
    Walker, Dr. Alexandrer M., professor of epidemiology, Harvard 
      School of Public Health, prepared statement of.............   105
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statement of.................     9
    West, Major General Randall L., USMC, Senior Advisor to the 
      Deputy Secretary for Chemical and Biological Protection, 
      and Major General P.A. Weaver, Jr., ANG, Director, Air 
      National Guard, prepared statement of......................   447



                        TUESDAY, OCTOBER 3, 2000

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 11 a.m., in room 
2154, Rayburn House Office Building, Hon. Dan Burton (chairman 
of the committee) presiding.
    Members present: Representatives Burton, Morella, Shays, 
Horn, Hutchinson, Jones, Waxman, Maloney, Norton, Cummings, 
Kucinich, and Schakowsky.
    Staff present: Kevin Binger, staff director; David A. Kass, 
deputy counsel and parliamentarian; Sean Spicer, director of 
communications; S. Elizabeth Clay, professional staff member; 
Gil Macklin, professional staff member and congressional 
investigator; Robert A. Briggs, clerk; Michael Canty and Toni 
Lightle, legislative assistants; Josie Duckett, deputy 
communications director; Scott Fagan, staff assistant; Leneal 
Scott, computer systems manager; John Sare, staff assistant; 
Maria Tamburri, assistant to chief counsel; Corinne Zaccagnini, 
systems administrator; Phil Schiliro, minority staff director; 
Sarah Despres and David Rapallo, minority counsels; Ellen 
Rayner, minority chief clerk; and Earley Green, minority 
assistant clerk.
    Mr. Shays [presiding]. Good morning. A quorum being 
present, the Committee on Government Reform will come to order. 
The hearing will come to order.
    I will begin by asking unanimous consent that all Members' 
and witnesses' written opening statements be included in the 
record. And without objection, so ordered. I ask further 
unanimous consent that all articles, exhibits and extraneous or 
tabular material referred to be included in the record. And 
without objection, so ordered.
    The vulnerability of the Department of Defense Anthrax 
Vaccine Immunization Program [AVIP], to supply shortages, was 
one of the major reasons the Government Reform Committee 
recommended suspending the program 7 months ago. We saw then 
what DOD only now has been forced to concede, the program is 
too broad, an undertaking built on too narrow a foundation.
    The decision to scale back the AVIP addresses the reality 
of the current shortage, but fails to confront the fundamental 
flaw on the program: use of an antiquated medical technology to 
counter a decidedly modern threat. No program based on the old 
vaccine can be sustained. The current producer, the BioPort 
Corp., has been unable to qualify for a license to make more 
    Their facility is virtually Government-owned already, so 
there is no reason to believe another Government-owned, 
contractor operated, GO-CO enterprise, would have any greater 
success attempting to use the same elaborate, highly regulated, 
manufacturing process. Why? Because neither BioPort nor DOD is 
ready to admit the significance of the key FDA inspectional 
finding first stated in February 1998, and repeated in November 
1999: the anthrax vaccine production process is not validated.
    That means BioPort lacks data to support the way they 
conduct key steps in the production process. That in turn means 
BioPort cannot prove the process is ever the same twice in a 
row or the vaccine is the same from lot to lot. Validating the 
anthrax vaccine production process will not be quick and it 
will not be cheap. When DOD spokesmen blithely describe the 
company's efforts to work down the list of 30 FDA inspectional 
findings, they make it sound like a car repair checklist.
    DOD seems to believe all BioPort needs to do is tighten a 
few screws, plug a few leaks, fill out some pesky paperwork and 
the FDA will be satisfied. In fact, validating a 1950's era 
vaccine process against current biologic manufacturing 
standards is more like trying to get an Edsel through modern 
auto safety and emissions testing. To pass muster will require 
bending the rules or the expenditure of extraordinary amounts 
of money, money that could be better applied toward the 
approval of an improved vaccine.
    Without an insured supply of modern anthrax vaccine in 
hand, continuing to order soldiers, sailors, airmen and marines 
to start a course of shots they may never finish constitutes in 
my judgment military malfeasance and medical malpractice. 
Despite earlier promises to adhere to the FDA approved regimen 
of 6 shots over 18 months, DOD now admits the shortage means 
many service members will not be kept on the regime shown to 
protect humans against anthrax. According to DOD, shots can be 
delayed up to 2 years before the series has to be restarted.
    Now that the program has been reduced to a more reasonable 
size, what will be the fate of those who are punished for 
resisting an order that no longer stands? They didn't get a 2-
year reprieve. Because DOD placed more faith in BioPort's 
faulty production estimates than in the intelligence and 
integrity of those with legitimate questions about the program, 
hundreds of dedicated, loyal Americans have had their health 
damaged or their military careers ruined.
    Don't they deserve the same deference, even forgiveness, 
DOD seems so willing to extend to BioPort? No one should doubt 
the threat is real, as real as the threat of radiological 
weapons and the threat posed by a myriad of easily obtainable 
chemical compounds which we have no medical pretreatments. No 
one should doubt the good intentions motivating this response 
to the anthrax threat.
    But I have come to doubt the judgment, the foresight and 
the competence of those who chose the wrong approach, persisted 
in pursuing that approach well after it had become obviously 
unsustainable, and now can't seem to admit their mistakes and 
move on.
    In the early 1990's, DOD faced a fork in the road to 
effective force protection and picked the wrong path. Had DOD 
followed its own assessments of the inadequacies of the current 
vaccine, they could have focused on obtaining FDA approval of 
the modern, improved anthrax inoculation needed to meet the 
real military threat. Instead, they have wasted precious time 
and money acquiring little more than a false sense of security 
U.S. troops will be protected against biological warfare.
    That time and money should have been spent on modern 
medical counter-measures and improved protective gear, suits 
and masks effective against all chemical and biological CB 
    When confronted over weak CB defenses, including a flawed 
anthrax vaccine program, some DOD officials retreat to the 
indefensible position, something is better than nothing. But 
that false choice glorifies mediocrity as an acceptable force 
protection standard. U.S. forces deserve the best protection 
against a growing array of chemical and biological threats. 
They should not have to risk their lives relying on defective 
equipment and antiquated vaccines that run out.
    We will hear testimony today from many who are involved in 
and affected by the anthrax vaccine program. Their experience 
and perspective should help the committee better understand 
where the AVIP has gone wrong, and where the program needs to 
go. We welcome their testimony.
    [The prepared statement of Hon. Christopher Shays follows:]

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    Mr. Shays. At this time, I thank my colleague, Mr. Waxman, 
for allowing us to begin without his presence, and would now 
recognize him.
    Mr. Waxman. Thank you very much, Mr. Chairman.
    When this committee took up consideration of the anthrax 
vaccine report by the National Security Subcommittee last 
March, I stated that I had several concerns about the Defense 
Department's program. For that reason, I agreed with many of 
the report's findings.
    I agreed, for example, that the anthrax program was 
vulnerable to supply shortages and price increase. I also 
agreed that a reduced shot series potentially could bring down 
the number of adverse events experienced by service members. 
And I agreed with proposals to conduct further study on the 
safety of the vaccine.
    I'm pleased to see that the Department of Defense has begun 
to implement several of these recommendations, such as 
investigating a reduced shot regimen and soliciting bids for 
second source contracts. I note, too, that the Institute of 
Medicine is today convening a conference to assess the safety 
of the vaccine.
    I also said in March that I am not a medical doctor or an 
intelligence expert. For that reason, I deferred to FDA's 
assessment of the vaccine's safety and the Defense Department's 
conclusion about the need to vaccinate members of the armed 
services. And this remains my view.
    At today's hearing, we will hear from several service 
members who have served this country honorably and their family 
members who are understandably concerned about the health of 
their sons and daughters, husbands and wives. Some of these 
cases are heartbreaking.
    Senior Airman Thomas Colosimo, for example, developed 
multiple cysts on his skull, suffers from repeated blackouts 
and has been unable to work, travel or do anything 
unaccompanied since he developed his condition. And Sergeant 
Kevin Edwards was forced to have a tracheotomy in a helicopter 
on his way to a hospital in Korea. He has suffered from a 
terrible skin condition, has lost part of his eyesight, and has 
even had his tear ducts removed. My heart goes out to these 
brave individuals. We should be committed to their proper 
treatment and care and we should honor their service to our 
    Finding what caused these terrible illnesses and injuries 
can be difficult. As epidemiologists explain, it is often hard 
to establish a link between a vaccination and an illness that 
subsequently develops. Statistically, many health problems 
occur in the general population at or near points in time when 
individuals receive injections.
    It is important, therefore, that we actively gather as much 
information as possible. We must examine all relevant medical 
data about the origin and development of conditions in specific 
cases. We can also compare the prevalence of these conditions 
among vaccinated populations against those among unvaccinated 
    A positive step occurred in July 1998, when DOD proposed a 
program to evaluate, on an individual basis, adverse event 
reports for the anthrax vaccine. In response, the Department of 
Health and Human Services convened a group of non-governmental 
medical experts as the Anthrax Vaccine Expert Committee [AVEC]. 
AVEC is unique in that it provides an independent expert 
assessment of adverse events reported for the anthrax vaccine. 
And as I understand it, the AVEC has been evaluating cases 
involving some of the service members here today.
    AVEC was not invited to testify about its findings which 
could have shed more light on this issue. But the expert 
committee has prepared a description of their origin, function 
and findings to date. And I would ask unanimous consent to 
include their summary in the record.
    Mr. Shays. Without objection, so ordered.
    Mr. Waxman. In closing, I'd like to thank the chairman for 
agreeing to the minority request to invite Dr. Alec Walker, an 
esteemed epidemiologist from the Harvard School of Public 
Health. Perhaps Dr. Walker can provide some additional context 
for this issue.
    Thank you very much, Mr. Chairman, for convening this 
hearing and giving our witness an opportunity to make a 
    [The prepared statement of Hon. Henry A. Waxman follows:]

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    Mr. Shays. Thank you very much, Mr. Waxman.
    At this time we would recognize Mr. Horn and then I will 
give up the Chair to the chairman. Mr. Horn, you have the 
floor. Mr. Horn, do you have an statement?
    Mr. Horn. No.
    Mr. Shays. I recognize at this time the chairman of the 
Committee, Mr. Burton.
    Mr. Burton. Mr. Chairman, let me just say that I'm going to 
have to run in and out, because we have some important business 
with the other committee. So I will stay here and hope you'll 
retain the Chair while I travel back and forth for a while.
    [The prepared statement of Hon. Dan Burton follows:]

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    Mr. Shays. Thank you. It's good to have you back.
    At this time, Mr. Cummings.
    Mr. Cummings. Mr. Chairman, I just wanted to thank you for 
holding this hearing. I will submit my statement for the 
    [The prepared statement of Hon. Elijah E. Cummings 




    Mr. Shays. Thank you, Mr. Cummings.
    Mr. Hutchinson.
    Mr. Hutchinson. Thank you, Mr. Chairman.
    I just want to express my appreciation for this hearing. I 
actually came here for a couple of reasons, one, to hear my 
good colleague, Mr. Metcalf, but also to hear my brother, 
Senator Hutchinson. And I understand that he has been called to 
a conference meeting and may be unable to be here. But I did 
want to make sure that his statement was submitted in the 
record and made a part of it. And he really has a great 
interest in looking at the Government-owned, contractor 
operated vaccine production facility and is working to 
accomplish that or look into that from the Senate side.
    I hope that that will be a tangential aspect of this 
hearing as well. So with that, Mr. Chairman, I yield back.
    Mr. Shays. Thank you.
    At this time, Ms. Schakowsky.
    Ms. Schakowsky. Yes, thank you, Mr. Chairman.
    I don't have a statement, but let me just say a few words 
of thanks to you for holding this hearing, and also to Mr. 
Metcalf for his leadership on this issue. I was happy to 
support and sign on to the letter that you sent to the 
Department of Defense on squalene. And I also appreciate your 
support in asking for a GAO report on gender differences in our 
vaccination program and hope that maybe we can get some answers 
on the status of that issue. So I just want to thank you.
    Mr. Shays. Thank you very much.
    We would ask at this time for unanimous consent that Mr. 
Jones be allowed to participate in our hearing, both to hear 
the witnesses, to ask questions. And also I understand that you 
will be introducing one of the witnesses. So would you like to 
be recognized now or then?
    Mr. Jones. Mr. Chairman, I'll be glad to--the witness that 
I was asked to introduce will be in the second panel.
    Mr. Shays. But if you'd like to make a statement, you're 
more than welcome.
    Mr. Jones. I just thank you very much for letting me join 
this committee as this, I think, is one of the most, when I 
think about the number of men and women who have left the 
military over this issue, I think this is extremely important 
to the national security of this Nation. Thank you.
    Mr. Shays. Thank you. And I, too, want to thank the 
chairman for conducting this hearing, and establishing it. And 
I'm happy to participate in it.
    Mr. Metcalf, my understanding is you are going to make a 
statement and not respond to questions. We won't swear you in 
for that reason, and then we'll be swearing in our witnesses 
that follow. You have the floor.


    Mr. Metcalf. Thank you, Mr. Chairman, for this opportunity. 
I share the gratitude of many veterans and military personnel 
across this Nation for your determined insistence that our men 
and women in uniform be provided with the best in force 
    When I began my investigation in 1997, I did so for the 
veterans and their families who had heard that antibodies to 
squalene had been discovered in the blood of some sick Gulf war 
era veterans. I was assured at the time by many that there was 
nothing to these allegations. But it seemed prudent to me to 
have the General Accounting Office take a look.
    Today, due to a stunning lack of cooperation, we find 
ourselves with only more questions and only few answers. We 
must get to the truth.
    For that reason, I have issued a report culminating a 3-
year investigation into the conduct of the Department of 
Defense with regard to the possibility that squalene, a 
substance in vaccine adjuvant formulations not approved by the 
FDA, was used in inoculations given to Gulf war era service 
    According to the General Accounting Office, scientists have 
expressed safety concerns regarding the use of novel adjuvant 
formulations in vaccines, including squalene. The report 
reveals that the FDA has found trace amounts of squalene in the 
anthrax vaccine. The amount recorded could, and I quote from 
the report, ``boost immune response,'' according to immunology 
professor Dr. Dorothy Lewis of Baylor University.
    Mr. Chairman I was shocked to learn this week that an FDA 
spokesperson had dismissed their own findings by declaring that 
the levels found are inconsequential, that they are naturally 
occurring and that one would expect to find these levels in any 
biological vaccine. We've been told for 3 years there is no 
squalene in anthrax vaccine. Then suddenly we're told, oh, yes, 
there is, but it's no big deal, it's everywhere. The questions 
must be asked: have they indeed tested all vaccines for the 
presence of squalene? If so, at what levels has squalene been 
    Does that mean the FDA would expect to find squalene in 
childhood vaccines? If detected, could levels harm a 3-month 
    For years we've been told by the Department of Defense, as 
the FDA sat by in silent complicity, that they had tested for 
the presence of squalene and that the anthrax vaccine was found 
to contain no squalene. Indeed, they have stated repeatedly, 
the FDA verified that none of the vaccines used during the Gulf 
war contained squalene as an adjuvant.
    Since the FDA's own findings call this statement into 
serious question, I am calling on you, Mr. Chairman, to 
initiate an immediate GAO investigation that must ask one vital 
question: how did squalene get into the anthrax vaccine tested 
by the FDA?
    Scientists who have reviewed my staff's findings agree that 
this question must be answered. My report states that an 
aggressive investigation must be undertaken to determine the 
source of the squalene and the potential health consequences to 
those who have been vaccinated, both during and after the Gulf 
war. It again calls for an immediate halt to the current 
anthrax vaccination immunization program until this issue and 
the other problems so clearly defined by this committee have 
been resolved.
    My report also documents at length DOD stonewalling 
attempts to resolve the squalene issue, which led General 
Accounting Office investigators to document their concerns 
questioning a pattern of deception, a pattern of deception. The 
GAO stated that the Department of Defense denied conducting 
extensive squalene testing before the Gulf war, then admitted 
it after being confronted with the public record.
    The GAO revealed that some Department of Defense officials 
deliberating deployment of the anthrax vaccine expressed, ``a 
willingness to jump out and use everything,'' in discussing 
experimental vaccines containing adjuvants not approved by the 
    General Accounting Office also found that Peter Collis, the 
Department of Defense official who headed vaccine efforts, 
refused to cooperate with them. The report states that the 
Department of Defense has refused to act in good faith upon the 
General Accounting Office recommendations to replicate the 
findings of a test developed by renowned virologist Dr. Robert 
Garry of Tulane University. Although Department of Defense 
admitted that they could easily do so. The work of the Tulane 
researchers has been peer reviewed in a scientific publication 
of high standing.
    Finally, my report states that Congress should take 
immediate action to review the findings of the General 
Accounting Office and the Armed Services Epidemiological Board, 
and provide independent oversight for the immediate 
implementation of their recommendations. The board recently 
called on the Department of Defense to engage in close 
cooperation with Tulane researchers, mirroring the General 
Accounting Office recommendations from March 1999.
    How tragic that we have lost nearly 2 years because the 
Department of Defense insisted on having their adjuvant expert, 
who lied to the GAO about his role during the Gulf war, to try 
to reinvent the wheel instead of cooperating with the Tulane 
researchers as directed. They have repeatedly expressed their 
willingness to help find answers to those who are suffering 
from Gulf war illnesses.
    I ask this committee to ensure the recommendations are 
implemented by those who will guard the integrity of the 
process and get to the truth. Mr. Chairman, I once again 
commend you for your courage and leadership. As I am about the 
leave the Congress, I ask you and the committee to stay the 
course until the truth is determined and justice is done. 
Veterans, active service members and their families deployed 
around the world, are counting on you.
    Thank you so very much.
    [The prepared statement of Hon. Jack Metcalf follows:]

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    Mr. Shays. Thank you, Mr. Metcalf. You truly will be missed 
for so many issues. Obviously this is one that you're very 
focused on, but so many others. And your service has been 
    Thank you for being here.
    Mr. Metcalf. Thank you.
    Mr. Shays. We have a panel that is fairly lengthy, and I 
would invite them to come up basically in the order that we 
call them. Major John Irelan, Nancy Rugo, Barbara Dunn, Kevin 
Edwards, Toney Edwards, Senior Airman Thomas J. Colosimo, 
Joseph Jones, David Ponder, John J. Michels and Dr. Alexander 
M. Walker. Except for the last two people I have called, I 
would basically describe this panel as a panel comprised of 
potential victims of anthrax or related to people who are 
possible victims.
    Major Irelan is the first one. Is he here? Why don't you 
walk around the front. And you might as well remain standing, 
because we will be swearing you in.
    If I could now invite all of you to stand and raise your 
right hands, please.
    [Witnesses sworn.]
    Mr. Shays. Thank you. Note for the record that all our 
witnesses have responded in the affirmative. Please be seated.
    Now, it's been my practice to allow people to wander over 
the 5-minutes, but that's not going to happen with this panel. 
I think you can understand why. A very important panel, and we 
appreciate your being here. I would note that our last two 
witnesses again are, one is an attorney and one is an 
epidemiologist. It may require, Dr. Walker, I know you're a 
witness requested on behalf of the minority. Given that you may 
be responding to a number of issues, I might allow you go over 
the 5-minutes if that's necessary.
    But we'll cover the gamut and I think we'll hear some very 
important stories. So Major Irelan, you may begin.


    Major Irelan. Thank you, sir. I'll try to be concise.
    My name is Jon Irelan. I'm a regular Army officer and 
serving as an advisor to Oregon's Enhanced Infantry Brigade.
    One year ago today, while stationed in Dhahran, Saudi 
Arabia, I received my fourth anthrax vaccine. That's when my 
problems began. Until that point, I weighed 175 pounds, 5'9``, 
excellent physical condition.
    That night, I had a raging fever and my physical condition 
continued to deteriorate over the next couple of weeks. During 
that time, I lost facial hair, my testicles shrank to the size 
of a peanut; the right one, that I could find. I had rapid 
weight gain, mainly in the form of subcutaneous fat. I suffered 
mood swings, had severe groin pain and I lost muscular 
    I went from a normal workout bench press of 280 pounds to 
less than 100, and that was in the space of less than 2 weeks.
    I made it to Riyadh, to our Joint Aid station on November 
4, a flight surgeon diagnosed me as having hypogonadism, and he 
wrote a referral for me to see a urologist. I did so back in 
Dhahran at a Saudi medical facility, and he started me on 
massive doses of testosterone, after screening me for cancers. 
I soldiered on, came home for Christmas leave with my family, 
and my family physician was still concerned that they might 
have missed something. So when I returned to Saudi Arabia, I 
had some more tests conducted, still there was no other cause 
    As I got ready to leave Saudi Arabia in May, I visited with 
a new flight surgeon. He reviewed my records and he noted the 
strong link between the shot on 1 day and being ill the next. 
He also directed that I put in a VAERS report at an Air Force 
medical company, co-located on that same compound. He wrote up 
the report, I walked over and an Air Force, senior Air Force 
doctor came out and blocked the report. He scrawled across the 
back of the page that he did not think they were related, that 
I needed to see a urologist and if the urologist concurred, 
then go ahead and file the report.
    Had he asked or had he looked at my records, he would have 
seen that I had been under medical care, specialist's care, for 
over 6 months.
    So when I returned back to the States, I in-processed at 
Fort Lewis, WA. I visited a very nervous endocrinologist. He 
never asked any pertinent questions, but focused on 
discrediting first-hand observations of endocrinologists and 
flight surgeons. When I left his appointment I went to a 
urologist and the urology department had a little bit different 
spin on things. That was when the diagnosis changed from 
hypogonadism to primary testicular failure. And I was told that 
something had caused my body to attack the testosterone 
producing cells in my testicles, and that I would have to take 
testosterone, in my case, by injection, for the rest of my 
    That's really the short of it, Congressman. The final thing 
that I would like to add is that I retire next June. I've 
enjoyed every day of service. I'm very proud of it. I would 
willingly lay my life down for this country, no problem. But I 
feel that certain members of the Department of Defense have 
breached the trust between the soldiers and themselves. No one 
needs to tell us that this is a dangerous occupation. We 
understand the associated risks.
    But we do not have any protection beyond our elected 
officials. You are it. You are our last court of appeals.
    I and my fellow service members that have been sickened 
come to you for help. Please do not abandon us.
    [The prepared statement of Major Irelan follows:]

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    Mr. Shays. We will be going through everyone and then will 
be asking questions. Thank you for your extraordinary service 
to our country.
    Ms. Rugo.
    Ms. Rugo. Good morning, Mr. Chairman. My name is Nancy Rugo 
and I am the sister of Sergeant Sandra L. Larson. Today I am 
here on her behalf, as she passed away June 14, 2000, at the 
age of 32.
    During her illness, before her death, she made it clear to 
me to do whatever I can on her behalf as she said, if something 
were to happen to her, she wanted me to help other people. She 
frantically began researching the causes of her condition, and 
started to suspect vaccine connection. As her condition 
worsened, she communicated some of her discoveries with me.
    Obviously, something happened, which is why I am here 
today. And as she requested, I am not going to let this go.
    I would like to inform you about my relationship with her, 
my knowledge of her relationship with the military, and most of 
all, the events which I believe led to her death.
    Sandra and I both grew up in a military atmosphere, as our 
father was in the Army himself. In fact, she was born while my 
father was in the Vietnam war. We moved a lot, and my father 
was in the military for 19 years.
    Sandra married a military man, Martin Larson. They met in 
Tacoma, WA, near the Fort Lewis base. In December 1985 she had 
her first child, a girl, Megan Marie. Megan is 14 years old 
today, living with her father in Michigan.
    In August 1995 was when Sandra made a decision to enlist in 
the military. Her reason for enlisting was she wanted to take 
advantage of receiving a college education, preferably in the 
medical field. She did her basic training in Fort Campbell. In 
February 1997, after completing her basic training and getting 
settled, she gave birth to another girl, McKenzie Marie. Today 
I am raising McKenzie for her.
    McKenzie lived with me during her mother's tour duty in 
South Korea. And this is where I begin the events to share with 
you that have led to the last days of her life.
    It was the month of April 1998 when Sandra and her daughter 
were back in Spokane, WA with me. She was preparing for a 1-
year tour duty in Camp Stanley, South Korea. She began her 18 
month Anthrax program that September 1998 at Camp Stanley. She 
received her first four of six shots during this stay in Korea 
and all four vaccines were from Lot 17.
    In January 1999, she was granted a 2-week leave to visit me 
and her daughter in Spokane. I noticed that she did have rashes 
on her arms at that time and she was very tired. She was 
assuming she was tired because of work and just needed to catch 
up on rest.
    She also acquired numbness in her arms and was evaluated 
for what the doctors thought might be carpal tunnel syndrome. 
She never did object to the vaccines at that time, because she 
related all these things to nerves and just working hard and it 
never crossed her mind.
    In October 1999, she was relieved of her duties from South 
Korea and had new orders to relocate to Fort Riley, KS. She was 
really excited about coming home. She found a nice home, and 
they settled, her and her daughter, in Fort Riley. And they 
called often, and I found them both to be really nicely 
settled. No one would ever guess that in just 8 months from 
this date, that she would no longer be here.
    March 8, 2000, she received her sixth and final vaccine 
from Lot 31. I heard about more rashes she noticed on her arms 
and legs. She was feeling like she was being a bad mother 
because she was so tired and had no energy. She did express 
this with military personnel, feeling she was maybe working too 
    April 7, 2000, in just 4 weeks after that sixth shot, she 
was admitted into the hospital. Her blood capillaries were 
bursting, she had no platelets, she had no red or white blood 
cells and was diagnosed with aplastic anemia. Aplastic anemia 
is a rare and serious blood disease that occurs from 
unexplained failure of the bone marrow to produce blood cells.
    Her case was extreme, as her symptoms were sudden. This was 
not a gradual case of aplastic anemia. She was healthy 4 weeks 
ago, to then have no bone marrow, no platelets. It was as if 
there was something in her that was killing her immune system, 
shutting her down.
    The doctors could not find a cause, so they diagnosed her 
as idiopathic aplastic anemia. She was granted a compassionate 
leave to Fort Lewis, WA, and on April 26th, was at a point 
where her illness, where infection started to kick in. It looks 
like I really need to sum this up, so I'm going to have to pass 
on a lot of the technicalities on here.
    I would like to say that on June 2nd, the VA gave her a 130 
percent medically retired benefit for her two girls. And on 
June 14th, she passed away.
    In summary, I'd like to say, she joined the military in 
1995, transferred to South Korea in 1998. She began the 18 
months program, having four of six shots from Lot 17. While she 
was stationed in South Korea in October 1999, having completed 
her tour of duty, being transferred to Fort Riley, KS, where 
she completed her final two vaccines from Lots 44 in September 
1999 and Lot 31 in March 2000. April 7, 2000, just 4 weeks 
after being injected from her sixth shot, she was admitted into 
the hospital with a serious rare blood disease, aplastic 
anemia, which is considered an autoimmune disease.
    June 14, 2000, 12 weeks after receiving her shot, she was 
gone. And I really hope that there is an investigation in this 
squalene. Because the research that I have, if she received 
contaminated lots or squalene, there's a lot of validation to 
prove that that's what killed her.
    Thank you.
    [The prepared statement of Ms. Rugo follows:]

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    Mr. Shays. Thank you, Ms. Rugo. Thank you very much.
    Mrs. Dunn.
    Mrs. Dunn. Thank you, Mr. Chairman, members of the House 
Government Reform Committee.
    Mr. Chairman and members of the House Government Reform 
Committee, I'm appearing before you today to at least try to 
ensure that no other person or family goes through what my 
family has been through as a result of the Department of 
Defense BioPort anthrax program. My husband, Richard Dunn, 
worked for BioPort in Michigan Biologicals since 1992. Dick's 
job was to care for and monitor animals at BioPort. He was 
required to take the same vaccine given to our Nation's 
military personnel.
    Dick received 11 doses of the vaccine. The last two were 
given on April 6th and April 13th, both in his left arm. An 
autopsy performed in July suggests that the vaccine is a 
factor, according to our Ionia County medical chief examiner, 
Dr. Robert Joyce. Dr. Joyce said Dick had an inflammatory 
response to the vaccine throughout his body.
    Immediately after the results of the autopsy were 
performed, BioPort went on television and said they had no idea 
Dick ever showed symptoms. BioPort also said the worst reaction 
they've ever seen were minor headaches and localized pain.
    First of all, let me tell you, my husband Dick had more 
than a headache after his vaccine was given to him in two parts 
in April. Soon after, he started swelling, left arm, wrist and 
hands. Dick also had nausea, joint pain, and his left arm was 
quite hot to touch.
    These symptoms never went away. They were no different than 
any other reaction he had every year, except this time they 
were much worse.
    I understand that these are the same chronic symptoms our 
military personnel suffered.
    On May 11, 2000, the swelling in the left side was much 
worse, the joint pain was worse, as was his fatigue. My husband 
seemed much worse than he was the month before.
    He went to work on May 13th and called me to say he needed 
to see a doctor. My husband was put off from work that day. 
When he would see the BioPort workers compensation doctor in 
Lansing, he always stopped to see his friends in BioPort. The 
company knew of his ongoing symptoms, because they were always 
there to help us with paperwork and would make phone calls to 
see how he was doing. For that, I'm grateful. He did think of 
BioPort as his family.
    However, when Dick returned to work, he was still swollen, 
very tired, but was given a release to go ahead and go back to 
work. He still suffered the joint pain.
    Dick died July 7, 2000. That's changed my life and the life 
of my children forever. This is fact, not fiction. Dick 
believed in this program, but also wanted it to be a safe 
    I know that BioPort has had a lot of legal troubles, and 
that you, the Government, have been investigating the company 
for safety reasons. Only recently did I learn, late in August, 
BioPort had to recall three products, including the anthrax 
vaccine, because the wrong expiration date was on the labels.
    I don't know what lot or batch of vaccine the company gave 
my husband. But I do know that a lot of other Americans have 
been made sick by this vaccine. That's why I'm here today. 
Nothing can be done to bring my husband back. But I ask this 
committee to please rethink this program and make it a safe 
    I hope some day that if any of you need to take this 
vaccine you have the option of whether to take it or not, and 
if your option is no, that you have no repercussions from it.
    [The prepared statement of Mrs. Dunn follows:]

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    Mr. Shays. Mrs. Dunn, thank you. There are many of us who 
feel that this needs to be a voluntary program and that there 
should be no repercussions.
    Now, it's my understanding, Specialist Edwards, that you 
are here to answer questions. I know you had an operation on 
your eyes. And so, I believe that your father, Mr. Edwards, 
will be reading the statement, is that correct?
    Mr. Kevin Edwards. Yes, sir.
    Mr. Toney Edwards. Mr. Chairman, members of the committee, 
good afternoon. My name is Toney Edwards, and I'd like to say, 
it is indeed a pleasure for me to appear before me today, 
except for the nature of my testimony. I do, however, very much 
appreciate the chance to tell my story of multiple medical 
tragedies in my family.
    I have with me today my son, Kevin Edwards, who is 
currently on active duty and is now assigned to the Medical 
Hold Co. at Fort Sam Houston, TX, where he has been assigned 
since November 1998. I hope that the information I will present 
to you today will help this committee in making recommendations 
or decisions concerning the safety and future use of the 
anthrax vaccine.
    Before I begin, I would like to give a little information 
about myself. I'm retired from the U.S. Army. I served 
approximately 15 years in the 82nd Airborne Division. I served 
with the 101st Airborne Division in Vietnam. I served in the 
Berlin Brigade, and I served as a drill instructor at Fort 
Jackson, SC.
    During my tour with the 101st Airborne Division in Vietnam, 
I was exposed to the herbicide known as Agent Orange, which was 
used to kill the vegetation in the jungles of Vietnam so that 
we could have a better opportunity to seek out and destroy the 
enemy. It was not until later that I learned that the herbicide 
that I observed being sprayed from military aircraft would 
ultimately cause the death of many American soldiers, including 
    I now have prostate cancer as a result of exposure to Agent 
Orange in Vietnam. I served my country in Vietnam and my life 
will be cut short as a result of exposure to this toxic 
chemical, which I was led to believe was harmless and only used 
to kill vegetation.
    My son, Kevin, joined the U.S. Army in August 1994. And 
after spending some time at Fort Bragg, he was assigned to the 
Republic of Korea. It is my understanding that the Army's 
policy that those serving in Korea were required to take a 
series of anthrax shots. Without objection, without disobeying 
any orders from his superiors, my son took his first shot, lot 
No. FAV017, on September 10, 1998, his second shot on September 
24, 1998, lot FAV017, and his third shot on October 8, FAV017, 
in 1998.
    On or about November 15, 1998, my son started having 
headaches and flu-like symptoms and went on sick call at the 
troop medical center. He was evaluated and given some Actifed 
and returned to his barracks and again, on November 16, 1998, 
Kevin again went back to sick call, because his condition had 
not improved.
    He was again examined and was given Motrin and instructed 
to go back to his barracks. On or about November 17th or 18th, 
he went back on sick call, because the blisters had begun to 
form around his mouth, face, neck and back. He was again 
treated and returned to the barracks. Records show that at some 
point between November 15th and November 18th, he was treated 
for a possible adverse reaction. However, the records do not 
specify what medical personnel suspected caused the adverse 
    On November 19, 1998, Kevin again returned to sick call and 
subsequently was air evacuated from his station at Camp Carroll 
to the 121st General Hospital in Seoul, Korea. Some time during 
the evacuation period, my son lost consciousness, and when he 
awoke, he had been given a tracheotomy, which was necessary 
just to save his life.
    My wife and I were notified of Kevin's illness on or about 
November 20, 1998, and when the decision was finally made to 
fly Kevin to Texas, we flew to Texas to be with him. Kevin was 
air-evaced to Brooke Army Medical Center on November 25, 1998. 
We arrived at Brooke Army Medical on November 25th, just short 
of midnight, and were allowed to see our son the same night.
    My daughter, who was already stationed in Texas, arrived at 
Brooke Army Medical Center before we did. She met us in the 
hallway and told us to be prepared for an ugly sight. When I 
first saw my son, I went into a state of shock. I could not 
believe the condition that he was in. My first thoughts 
reminded me of my experiences in Vietnam in which I witnessed 
members of my unit as they were hit by napalm fired from United 
States aircraft.
    Since my son was not involved in any kind of accident 
involving a vehicle or some type of explosion, I did not expect 
to see the kind of illness I witnessed when I first saw him. It 
was hard for me to understand how he could possibly have this 
type of illness or injury that we witnessed.
    After a quick evaluation of his condition, I quickly 
realized, however, that whatever caused this illness, that my 
son was very ill and appeared to have a very slim chance of 
survival. Once we were satisfied that Kevin was out of danger, 
we returned to Fayetteville and waited for additional 
information from Brooke Army Medical Center. We arrived back in 
Fayetteville thinking that we would be kept informed of Kevin's 
    On April 17, 1999, I mailed a certified letter to the 
commanding officer at Brooke Army Medical Center, Brigadier 
General Ogden deWhitt, and asked him if he or a member of his 
staff would provide me with an update on Kevin's condition. 
Brigadier General deWhitt did not respond to my letter until 
October 20, 1999, after I contacted North Carolina Congressman 
Walter Jones for assistance. And in a letter dated October 20, 
1999, Brigadier General deWhitt stated that Kevin's primary 
diagnosis was staphylococcal scalded skin syndrome [SSS], but 
that Steven Johnson's Syndrome could not be ruled out.
    Brigadier General deWhitt also stated that Kevin should 
remain at Fort Sam Houston so that his condition could be 
monitored by the experts at the Army's sold Institute of 
Surgical Research located at Fort Sam Houston. However, even 
though the experts at Fort Sam knew of my son's deteriorating 
eyesight, nothing was done to help him until January 2000, 
which was 14 months after his hospitalization.
    In a memorandum dated November 24, 1999, to Brigadier 
General deWhitt from Colonel Benjamin Chacko, of the 
ophthalmology services at Fort Sam, Colonel Chacko states, ``He 
was sent to the burn ward in November 1999 with acute Steven 
Johnson's Syndrome, or TENS. His mucus membrane, including his 
conjunctiva and cornea were acutely affected.'' Again, in the 
same memoranda, Colonel Chacko states, ``his visual acuity was 
20/70 od and 20/40 os. He does have severe photophobia from his 
chronic keratopathy. Unfortunately, there is no cure to reverse 
these cicatricial changes.''
    Even though Kevin's sight continued to get worse from 
November 1998 through 1999, the experts did not have him seen 
by a specialist until January 20, 2000. At this time, Brooke 
Army Medical Center hosted a visiting professor from the 
University of Florida, Dr. Scheffer Tsang. After examining 
Kevin, Dr. Tsang made a recommendation that could correct and 
save some of his vision. I was present when Dr. Tsang evaluated 
Kevin, and he stated that Kevin's sight would not have gotten 
to that point if the recommended surgical procedure had taken 
place earlier.
    I'm convinced that my son's illness was caused by the 
anthrax vaccine. I'm also convinced that my son's case is one 
of the so-called confirmed cases. This being the case, I ask 
all members of this committee to take a close look at the 
evidence that has been presented to you today, in the past, and 
any that may be presented to you in the future. I urge you to 
make a recommendation, and I make a bold recommendation that 
this vaccine be discontinued.
    Thank you very much.
    [The prepared statement of Mr. Toney Edwards and Mr. Kevin 
Edwards follows:]





    Mr. Burton [presiding]. Thank you, Mr. Edwards.
    Is it Sergeant Colosimo? Airman. I was in the Army.
    Mr. Colosimo. Mr. Chairman and members of the Committee, I 
thank you for allowing me the opportunity to speak to you 
today. My name is Thomas J. Colosimo, and I'm a Senior Airman 
in the U.S. Air Force.
    Please note that any opinions I express are my own and in 
no way reflect the opinions of the U.S. Air Force.
    After I received my first, second and third anthrax shots, 
I immediately felt pain at the injectionsite. I also had a 
total of nine cysts that gradually multiplied and increased in 
size on my scalp. The largest one being the size of a half 
dollar, and one at the corner of my right eye. The pain got so 
bad that I went to the base hospital and had the cysts 
surgically removed.
    After each shot, I felt disoriented. I also felt as if a 
cold were coming on, with headaches, coughing, fatigue and 
lightheadedness. These symptoms lasted for a few days.
    When I received my fourth anthrax shot, the pain at the 
injectionsite was unbearable. The following day I was sick like 
the previous three shots. I also started developing a terrible 
cough that would cause me to gag when I was done. It continued 
until December when I deployed to Al Jaber, Kuwait, and my 
condition worsened.
    Once there, I started to lose weight rapidly. I lost a 
total of 50 pounds within the next 3 months. My energy was 
declining at a rapid pace. The lightheadedness increased to the 
point of feeling like I was going to pass out. I had night 
sweats, chills, ear ringing, tremors and severe fatigue. I went 
to the hospital and spoke with a doctor who sent me to Camp 
Doha, an Army base nearby, for tests. The results came back 
normal, and my concerns were dismissed.
    I finished the deployment and returned to Hill Air Force 
Base. I went to the base hospital, disclosed my health 
concerns, which included increased episodes of vertigo, short 
term memory loss, shortness of breath, mood swings, confusion, 
tunnel vision and fatigue. I saw the same doctor that I had 
seen in Kuwait and suggested that my symptoms were anthrax 
related. He again minimized my concerns.
    My condition continued to worsen, and I started to 
experience staring spells. I was also getting severe abdominal 
pains when going to the bathroom, and shin pains that lasted 
for days for no apparent reason. My ability to concentrate was 
declining, and forgetfulness was increasing. Memory loss with 
dizziness was now constant.
    The evaluation by several specialists was to no avail. The 
dizziness was soon followed by daily drop attacks, during which 
I would collapse wherever I was and which later led to full 
loss of consciousness. At first, the loss of consciousness only 
lasted for a few minutes, but as time went on, increased in 
duration from 30 to 45 minutes, resulting in the inability to 
speak for about 20 minutes. Several of these episodes included 
respiratory arrest.
    An overwhelming feeling of tiredness occurred prior to 
these incidents. It was at this time the doctors placed me on 
an indefinite convalescent leave, and a profile stating no 
driving or being alone. Because the Air Force tried to convince 
me my symptoms were psychosomatic and not life threatening, I 
had to seek congressional help to seek the medical care I 
needed. Only with the strong influence and intervention from 
Representative Peterson and my wife's and mother's involvement 
did Hill Air Force Base decide to send me to Walter Reed.
    Mr. Burton. If you're having trouble breathing, would you 
like to take a brief break? Are you all right?
    Mr. Colosimo. I'm all right, sir.
    After 35 days of numerous and extensive tests, Walter Reed 
diagnosed me with neurocardiogenic syncope, chronic fatigue 
syndrome, obstructed sleep apnea, anxiety disorder, and 
situational stress. None of these symptoms predated my first 
anthrax vaccine.
    In fact, I have my narrative summary and patient discharge 
instruction sheet dated May 13, 2000, my mission diagnosis, 
anthrax intoxication. I also have a document from the DOD 
clinical consultant from the anthrax program and advisor to the 
office of Major General West that my mission to Walter Reed on 
May 10, 2000 was anthrax related. I have these documents in my 
possession today.
    Walter Reed released me back to Hill Air Force Base and I 
ended up having no one accept the responsibility for monitoring 
my illness and medication regimen, because the medical 
technicians didn't understand my condition and seemed afraid of 
the congressional advocacy that was involved.
    Because of this lack of medical attention, my condition 
worsened again and I started to develop new systems. I was also 
left with the responsibility of adjusting my own medication.
    Hill Air Force Base then requested a medical review board. 
The board decided I was fit for duty and I was to return to 
work, even though I had been told not to drive or to be alone. 
My profile stated history of syncope, no prolonged standing, 
climbing, operation of heavy machinery or work with hazardous 
material, no excessively long shifts or overnight work, no 
strenuous training or physical fitness requirements, no work on 
flight line or uncontrolled climate, no deployments, no 
Government or personal driving. Fit for duty.
    At this time, my vision started to fade in and out as with 
tunnel vision, causing me to fall down stairs and run into 
walls. I also started to become overly sensitive to household 
chemicals that never bothered me before, causing me to have 
episodes of delirium. Because of my increased sensitivity to 
chemicals and sleep deprivation, I would become delirious, 
stumble, have slurred speech, my thought process would become 
unclear, and forgetfulness would be constant. This state of 
delirium could last for a few minutes to a few days, and I 
would not remember a thing.
    Once again, with the strong and persistent intervention of 
Representative Peterson and Senator Hatch, and my wife's and 
mother's involvement, Hill Air Force Base reluctantly returned 
me to Walter Reed Army Medical Center. I was given less than 1 
day's notice and was told I was not allowed to return to the 
base. It took the Air Force a total of 10 weeks and my falling 
over 50 times to be returned for treatment.
    Since mid-March, I have had over 200 falls. I believe the 
Air Force is taking a retaliatory posture with me for the 
congressional advocacy my family sought for my medical care. 
But with encouragement of my wife, I am convinced I needed to 
come forward and tell you my story anyway.
    I know of numerous individuals who are sick from the 
anthrax vaccine. They are afraid to come forward for fear of 
repetition of the same treatment or lack of that I have 
sustained. It sickens me that the military leaders have 
instilled this much fear. I must stand up for what I believe is 
morally and ethically right. It is for them and others who will 
soon be sick from this vaccine that I testify before you today.
    You leave here whole and intact tonight. I do not. Nor do 
the other sick victims I represent. Many have symptoms that are 
far worse than mine, but cannot speak. Many are paralyzed 
because of fear. Even sadder, many have physical conditions 
which have been misdiagnosed or under-treated because the 
optimal method of treatment has been to keep us all separate. 
What is profoundly disturbing is that wherever two or three 
sick military gather, anthrax is in the midst of them.
    We love this Nation and are proud to serve you all. Neither 
I nor they bear any shame. Shame rests upon a system allowed to 
become so evil that it's abandoning its own. All it takes is 
for good people to do nothing. Today is the day a line needs to 
be drawn, not upon the sand, but upon your soul. You need to 
say, no more, please stop this insanity.
    I want to be among the last sick to testify before you. I 
was called upon here today to be a token sick person. This is a 
false perception. In this regard, I am not a singular 
individual. I am the many who have not lost only their health, 
but their hope in America.
    If I was to imagine an opportunity to testify before 
Congress in my lifetime, I would certainly prefer it to be on 
another matter and other circumstances. It has been an honor 
and a privilege to testify before you anyway, only because I 
represent thousands and thousands of good people in the 
military, your spouses, neighbors, friends, sons, and daughters 
who want to tell you the same thing I am saying to you today, 
please stop this insanity.
    [The prepared statement of Mr. Colosimo follows:]

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    Mr. Burton. Thank you, Airman Colosimo.
    Let me just say that we've sent this message out to the 
military before, and I see a lot of people here who are 
probably from the Pentagon. If there is any undue command 
influence being exerted in order to intimidate any military 
personnel, there will be very strong congressional action by 
this committee, and by the entire Congress. You know, I've been 
getting a lot of stories, we're going to go to Mr. Jones in 
just a minute, but I've been receiving a lot of stories from 
people who say they feel intimidated and they will not talk 
about these problems they're having.
    That is unacceptable. I know the military code of conduct. 
I was in the Army myself. But if something's being done that's 
wrong, and they're being intimidated to the degree they will 
not come forward and tell the American people and this Congress 
the truth, then by golly, that can't be tolerated. And so I 
want that message to go out to everybody. And to those who are 
afraid to testify and don't want their names used because of 
the possible repercussions, let me just say that we will keep 
their names confidential. We've received over 200 responses to 
our Web site already from people who have asked us to keep 
their names quiet, and I'm sure there's thousands more who 
would like to respond but they're afraid.
    But if they respond to us, unless they want us to have them 
before the committee and have their name used, we will not use 
it. We're trying to get as much information as possible, so we 
can come to a logical conclusion and bring this problem to an 
    Mr. Jones.
    Mr. Jones. Mr. Chairman, committee, good morning. My name 
is Joseph Jones, and I served in the military for 3 years, 6 
months and 12 days. All I ever wanted to do was be a soldier. 
This was until I had the anthrax vaccine.
    On a training mission in Kuwait, I was told that I might 
have to take an anthrax vaccine, just in case war broke out. I 
said OK. I had nothing else to say, I was in the military. The 
acting sergeant major of the company said that we all had to 
take the shot. If we refused, we would get a field grade 
article 15 and the MPs would still hold us down and give us the 
shot. So you see, either way, we were getting the shot.
    I was a good soldier, I did what I was told without 
question. But if I knew then what I knew now, I would have 
refused the shot and taken the article 15 along with the 
consequences for that decision. The consequences I have 
suffered instead for taking the vaccine have been horrific.
    My first three shots resulted in severe headaches, joint 
pains, chills and fever, vomiting, diarrhea, and weight loss 
and worsened with each shot. At first, I refused to believe 
that the anthrax vaccine had anything to do with how I was 
feeling. Surely, the military would not give me anything that 
would make me anywhere near this sick.
    Within 6 hours after I received my fourth shot, I was sent 
to the hospital by an ambulance because I had a violent seizure 
and passed out. I was never admitted to the hospital then or 
after for observation of the 70 seizures and many separate 
blackouts which followed. Several times I lost my memory and 
forgot who my wife was.
    I would not wish this on anyone. There have been times I 
got lost simply because I forgot where I am.
    I did not even think about the anthrax vaccine being 
related to my condition until I read the package insert a few 
days after the fourth shot. This statement is from the insert 
itself, that I'll hold up. ``Systemic reactions which occur in 
fewer than 0.02 percent of recipients have been characterized 
by malaise and lassitude. Chills and fever have been reported 
in only a few cases. In such instances, immunizations should be 
    Every doctor I knew and saw, I had become ill after each 
shot, and never once did they discontinue the shot. For this 
reason, I am ill.
    I avoided the fifth and sixth shot because of my reactions 
to the fourth shot. Fortunately, no one insisted I take any 
more. No doctor reported my reactions. I had to report them to 
the FDA myself.
    A few months later, I went on medical leave for nearly a 
year. During that leave, I was either at home in bed or being 
transported by ambulance or by my wife to the hospital. My 
seven doctors ordered test after test, but diagnosed nothing.
    Today I can no longer function as a productive person in 
society. I cannot run or do anything that over-exerts my body. 
It weakens me too much, and it will cause me to have seizures 
or blackouts.
    I'm 24 years old, and like many other young men, I like 
football and basketball and other sports. But I can't play 
anywhere like I used to. I don't like the word can't, but I had 
to get used to using it.
    I can only have a job that allows me to set my own hours, 
because I am sick three times or more a week. I have difficulty 
getting insurance benefits, because I have to purchase 
insurance that will take pre-existing injuries, a very 
expensive option. The military has allotted me only 30 percent 
medical benefits and 30 percent of my pay. Now, ask yourself, 
can you live on $554 a month and survive on 30 percent of your 
medical benefits?
    The promise the military made me that the VA would take 
care of me is a joke. It took a year for me just to receive the 
VA card. And getting employment takes an act of Congress.
    I enjoyed my time in the Army immensely. If I was not sick 
and I had a choice to reenlist, I would serve my country again 
in a heartbeat. But now as I know many others who are sick, I 
would have to rethink that long and hard about joining an 
organization again that neglects its people.
    I can understand why all the soldiers do not want to take 
the anthrax vaccine. Why would they, if they know they are 
going to get the same medical treatment that I and all the 
other soldiers have received. There has been no treatment or 
admission of problems, just unknown causes of whatever illness 
the military lists on our medical records.
    I believe the military is responsible for my illness 
because of their carelessness and lack of responsibility in 
taking care of soldiers, and perhaps the belief that no one 
would read the vaccine package insert. I'm afraid that this 
illness will not go away. I'm afraid that the U.S. Government 
will not acknowledge that I and the other soldiers are sick 
from the anthrax vaccine.
    Last week, we all learned that the FDA found an illegal 
substance called squalene in the vaccine. The only two lot 
numbers I got, FAV020 and 30, were both found to contain 
squalene. Now, I wonder what else holds for my health in the 
    I ask you to help me and all the other soldiers who are 
sick from this vaccine. Thank you for the time and opportunity.
    [The prepared statement of Mr. Jones follows:]

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    Mr. Burton. Thank you, Mr. Jones.
    Mr. Ponder.
    Mr. Ponder. Mr. Chairman and members of the committee, I am 
thankful for the committee's time and concern regarding the DOD 
mandatory anthrax vaccination immunization program. I hope that 
I can provide some insight and understanding to the committee 
as to how this program has affected me personally and how this 
program is being carried out in the real world.
    My views here and my testimony are my own and not meant to 
be taken as those of the Navy.
    I have been in the Navy for a little over 3 years as a part 
of the Seabees, which is the construction force of the Navy. I 
have a wife of 2 years and a son that just turned 1 year old. I 
am now deployed to Camp Shields, Okinawa, Japan and have been 
there for almost 7 months.
    I am a part of Naval Mobile Construction Battalion 74. We 
are home ported in Gulfport, MS. As a part of a routine 
deployment to Okinawa, I was scheduled to go to Pohang, South 
Korea, as a part of a detachment. I was required to take the 
anthrax vaccine and I refused it. I would like to explain why 
and what happened to me as a result.
    First I would like to say that I refused the shot after a 
lot of soul searching, serious thought and inquiry. It was not 
a snap decision. I am not, as some people have suggested, the 
pawn of others who for their own reasons, want to stop this 
program. Quite simply, I was fearful of taking the shot, and 
nothing I have heard since I first began has reassured me or 
made me question my decision.
    In fact, everything I have learned only makes me more 
thankful that I did not take this shot. I would like to explain 
my reasoning for this.
    Prior to this, there had already been rumblings about the 
program and the shot. I had heard and read about people who 
refused to take it, and I had also read and heard about some of 
the adverse reactions people had had to the shots. I had heard 
about a study that showed the presence of squalene antibodies, 
and the large number of Gulf war veterans who showed signs of 
Gulf war illness.
    During the Gulf war, the DOD had given a number of drugs 
and vaccines to troops and was testing an experimental anthrax 
vaccine that contained squalene, a kind of booster for the 
immune system on cattle. All of this made me very nervous, and 
I had also read reports of veterans passing illnesses on to 
their families.
    My wife had just had our son in September 1999, and I was 
scared. Regardless of the source and information, I had some 
serious questions about the vaccine as my time to take it 
    After I refused the vaccine, I was told that I would be 
given Captain's Mast, which under the Uniform Code of Military 
Justice, I had the right to refuse in favor of a court-martial. 
I didn't particularly want this, but I knew that I was never 
going to take the shot, so I refused Captain's Mast in early 
February, with my unit scheduled to deploy in March to Okinawa.
    There were two other people that refused the shot at the 
same time with me. They elected to take their punishment at 
Captain's Mast. Punishment for them was 45 days restriction and 
extra duty, reduction in rate one pay grade and a half month's 
pay taken away for 2 months.
    The vaccine, as I was told, was a prerequisite to 
deployment. Despite this, after I refused Mast, I was told that 
I was going to be going to Okinawa to be court martialed. 
Something about this didn't seem quite right, so I hired a 
civilian attorney to represent me, a considerable expense for 
someone drawing E-4 pay with a wife and a son. There had been 
two people in our battalion who, about a week earlier, had gone 
to Captain's Mast on drug charges. They refused mast as well 
and went to court-martial. They were both kept in Mississippi 
for their trials.
    Now, as my unit prepares to come home, I am told that I 
will remain in Okinawa for my court-martial, which has been 
stayed by the Navy and Marine Corps Court of Criminal Appeals. 
They have agreed to hear my case and my appeal of the judge's 
ruling that the order to take the shot was lawful.
    My being left behind is not a new tactic. A Marine in 
Okinawa who also refused the shot was left behind by his unit 
as well, even though no stay has been issued in his case. It is 
a way for the Navy Marine Corps to get us to give in and take 
our punishment without a fight. We are left thousands of miles 
from our home without any support, even from our own units, 
while the witnesses and other members of the court come home.
    Despite this, I will never take the shot. I might 
eventually do whatever the Navy wants to get home, because I 
have already been away from my family for more than 6 months. 
My son recently had his first birthday, but I will not take the 
shot. I do not believe the order is lawful and I do not believe 
the vaccine is safe. This Congress passed a law in 1999, after 
the hard learned lessons of the Gulf war and the use of 
experimental investigational drugs on troops. That law, 10 
U.S.C. 1107, prevents the use of investigational drugs or drugs 
unapproved for their applied use to be given without a service 
member's informed consent.
    I can assure you that no one has ever asked for, and I have 
never given, my consent to take this vaccine. What is 
particularly amazing to me is that the DOD knows that the drug 
is investigational, but it continues to prosecute people like 
    In 1996, the predecessor of BioPort filed an 
investigational new drug application with the FDA. That 
application was for the anthrax vaccine to be used against an 
aerosolized challenge and the DOD joined in that application. 
The application is still pending and has never been withdrawn.
    I have learned that there have never been any long terms 
studies on the effects of this anthrax vaccine. I learned that 
the company that makes the vaccine still, to this day, cannot 
get FDA approval because of problems with its production 
facility, including serious quality control violations that 
raise questions about what exactly is in these lots of vaccine.
    I do not have to detail all the problems to this committee. 
One only has to pick up the paper, it seems, and at least once 
a month there is some new revelation about the company, the 
program or the vaccine that would scare me if I had taken the 
    The lessons of the Gulf war will be repeated and years from 
now, we will have people complaining of illnesses and the DOD 
will not have answers. This is because the DOD will not admit 
what is so blatantly obvious to those of us staring down the 
barrel and who are more concerned about our health than our 
    The program was and is a bad idea, no matter how well 
    I would like to add a final footnote to my testimony. I was 
offered, through my attorney, one chance to return home if I 
agreed to plead guilty for disobeying a lesser order at a 
lesser forum and accept my punishment. Unless I agree to that, 
I will, according to my command, be staying in Okinawa for who 
knows how long. My only regret in all this is the price that my 
wife and son have had to pay for my decision.
    I want to close by thanking my wife and family for their 
support through this. Thank you.
    [The prepared statement of Mr. Ponder follows:]

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    Mr. Burton. We'd like to have your complete testimony. Do 
we have copies of that? OK. And if we could get the information 
on the others that were stationed with you down in Louisiana 
that were going to be court-martialed for drug charges that 
were kept there when you went to Okinawa, I'd like to have 
their names, if you have it, so we can followup on that and 
find out why they were treated differently than you.
    Mr. Ponder. Yes, sir.
    Mr. Burton. Thank you.
    Mr. Michels.
    Mr. Michels. Thank you, Mr. Chairman, distinguished members 
of the committee, and your staffs. My name is John Michels, Jr. 
I am a former active duty Air Force officer, 14\1/2\ years on 
active duty, with 9 years following on reserve duty. I spent 
time as both a flying officer and a judge advocate while on 
active duty, and I am currently a reserve Lieutenant Colonel 
and a judge advocate.
    I'd like to emphasize again, the committee has a more 
complete biography in my written statement that I filed with 
you. I'd like to emphasize again that I am here in my capacity 
as a private citizen, and not in my capacity as a reserve 
Lieutenant Colonel or a judge advocate.
    Let me make my points directly and initially. The 
inoculation program as it is currently being administered, that 
is, with members of the armed forces being forced to submit to 
vaccinations without first obtaining their informed consent, 
violates both a Federal statute and a Presidential Executive 
order. I believe that the orders to take the shots are 
therefore illegal, the discipline that has been handed out to 
individuals who refuse to take the shots invalid.
    I might add that I worked with Petty Officer Ponder's 
defense counsel in preparing the defense that was ultimately, 
we hope, successful, and ultimately will be successful before 
the Navy Court of Criminal Appeals. I believe that the orders 
to take the shots are invalid, because the anthrax vaccine 
absorb, as it is currently being used by the Department of 
Defense, is an investigational new drug.
    My assessment of the vaccine status as an investigational 
new drug [IND], is based on my review of the manufacturer's IND 
application in September 1996, which specifically sought IND 
status for the vaccine for use for inhalation or aerosol 
anthrax. My opinion on the IND status of the vaccine is also 
based on the Department of Defense's recent admission that it 
will not follow the labeling requirements for the vaccine, 
which means that the vaccine is not only being used for a 
different purpose for which it was originally licensed, but in 
a completely different way as well.
    And finally, I based my opinion on the recent report that I 
reviewed late last week indicating that squalene has apparently 
been found in anthrax vaccine lots, and that squalene 
antibodies are apparently showing up in some vaccine 
recipients. I might add, this raises a separate issue under the 
FDA regulations concerning the production and distribution of 
an adulterated product, but I don't intend to talk about that 
today, and it's not in my written statement. I'd be happy to 
prepare additional information for the committee if it desires.
    Mr. Burton. We would appreciate that.
    Mr. Michels. OK.
    Although the Department of Defense has relied heavily on 
two letters from FDA officials, and I expect you'll see those 
today when these folks testify, indicating that the use of the 
vaccine against the aerosol version of anthrax is not, 
``inconsistent,'' with the labeling requirements from a legal 
perspective, the reliance on those letters is completely 
misplaced. That is because those letters were not issued as 
formal FDA opinion letters and because regardless of the 
contents of the letters, the IND application clearly indicates 
that the manufacturer believed, in 1996, and again, that 
application has never been modified or withdrawn, that the 
product itself, in the opinion of the manufacturer, is not 
licensed for its current use.
    In addition, a Supreme Court decision this spring indicates 
that the letters such as those relied upon by the Department of 
Defense are entitled to no deference whatsoever by the courts 
other than to the extent that they are logically persuasive.
    The anthrax vaccination program first came to my attention 
when it was originally announced in late 1997. At that point, I 
wondered how long it was going to be before I had to have my 
shots. I discounted for the most part claims that the vaccine 
was unsafe, that the program producing the vaccine was 
mismanaged and unsanitary, that there were substantial 
misleading statements in the record from various DOD officials 
about who would approve the vaccine and how it was approved, 
the medical review of the overall program and the certification 
of the supplier.
    Late in 1999, I was contacted by a colleague, Reserve Major 
Bruce Smith out of Raleigh, NC, to assist in the defense of an 
Air Force major, Sonnie Bates. Major Bates is at Dover Air 
Force Base. He's a pilot who refused to take the anthrax shot. 
I'm going to summarize here quickly, I don't want to take too 
much time, and you've got at least one more witness.
    The bottom line is this. In 1995, the Army and the 
manufacturer of that anthrax vaccine decided that they need to 
seek a modification of the anthrax vaccination license. They 
went after that by filing an IND application. The committee has 
a copy of the application, it was submitted with the documents 
I turned in. That application specifically says, ``we are 
looking to modify the license to get an indication against 
inhalation anthrax and a changed vaccination schedule,'' the 
exact modifications that have been made to the drug at this 
    Once that application is filed, the drug goes into 
investigational status under FDA regulations. And it stays 
there until either the investigational process is completed or 
the investigational application is withdrawn. The statutes that 
it violates are 10 U.S.C. 1107, and the Executive order issued 
by President Clinton last fall is Executive Order 13139. Both 
of those say that you cannot give investigational new drugs to 
armed forces service members without their informed consent, 
unless you are willing to certify to the President and get a 
declaration that the process or the informed consent process is 
infeasible or that there is an issue of national security 
    There is a way to get around the informed consent 
requirement. The Department of Defense is well aware of it. 
Nobody has taken that option.
    I want to echo something that Congressman Jones said 
earlier, then I'm going to wrap up. The effect of this program 
on the trust and morale of both the active duty, the Reserve 
and the Guard forces is dramatic. I'm queried on it constantly. 
There's going to be a conference of Reserve judge advocates out 
in Denver this weekend. I have already been requested to 
provide copies of the memorandum I prepared in an effort to 
elevate this issue. Because there are a lot of folks out there 
that simply have lost faith, they are concerned that their 
commanders and the people who supervise those commanders are 
breaking the faith that they have with their soldiers.
    And that's, I think, the real tragedy of this entire 
program. Thank you, sir.
    [The prepared statement of Mr. Michels follows:]

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    Mr. Burton. We're well aware of the morale problem with a 
lot of National Guard units and Reserve units, as well as the 
active duty. We're working on that as well. We'd like to have 
any information that you might have, if you could send it to us 
after you have your meeting out there, where was it, Colorado?
    Mr. Michels. I'll be happy to provide that to you, sir.
    Mr. Burton. And those citations that you gave us, I don't 
know if we have those, but if we don't, I'd like to have those 
so we can followup on those as well.
    Mr. Michels. Thank you, Mr. Chairman. They're in my written 
    Mr. Burton. OK, thank you.
    Dr. Walker. Mr. Chairman, members, ladies and gentlemen, I 
feel privileged to address you.
    The Soviet dictator, Josef Stalin, said, ``A single death 
is a tragedy, a million deaths are a statistic.'' I am deeply 
concerned that Stalin's twisted insight has infected the debate 
on vaccine safety.
    My name is Alec Walker. I study the safety of drugs, 
vaccines and medical devices. I am a professor of epidemiology 
at the Harvard School of Public Health. I am also senior vice 
president for epidemiology at Ingenix Pharmaceutical Services. 
I hold doctoral degrees in medicine and public health.
    Mr. Burton. Excuse me, Doctor, let me interrupt you. I want 
to hear all of your testimony, because I'm very interested in 
it. We will have to recess until Mr. Shays gets back. I'll get 
back just as quick as I can, because we have a vote on the 
floor. But we'll be right back.
    So we'll stand in recess until the fall of the gavel.
    Mr. Burton. Dr. Walker, if you would, once everyone regains 
their seats, if you would start over. I don't think you were 
too far into your statement. I want to make sure we get all of 
it. Sorry we had to rush to the floor, but Congressman Shays 
will tell you that you have to get down there and vote, 
otherwise they'll throw you out of office.
    Dr. Walker.
    Dr. Walker. Mr. Chairman, members, ladies and gentleman, I 
feel privileged to address you.
    The Soviet dictator, Josef Stalin, said, ``A single death 
is a tragedy, a million deaths are a statistic.'' I am deeply 
concerned that Stalin's twisted insight has infected the debate 
on vaccine safety.
    My name is Alec Walker. I study the safety of drugs, 
vaccines and medical devices. I am a professor of epidemiology 
at the Harvard School of Public Health. I am also senior vice 
president for epidemiology at Ingenix Pharmaceutical Services. 
I hold doctoral degrees in medicine and public health. I've 
published widely and I serve on scientific advisory and 
editorial boards. I've been a consultant to the World Health 
Organization, national governments, and most large 
manufacturers of drugs and vaccines.
    I would like to talk about the value of doing population 
level thinking when we talk about vaccine safety and efficacy. 
Clinical scientists establish cause and effect by looking at 
groups of people. Imagine that we vaccinate 100 people who are 
facing a smallpox epidemic that would be expected to kill a 
third of them. Suppose that all of them live. We suspect the 
vaccine has caused the good outcome.
    Whenever we give the vaccine, all live. Whenever we fail to 
give it, many die. We can say that the vaccine prevents death, 
and this is an example of statistical reasoning.
    Knowledge that comes from groups is the cornerstone of 
clinical science. It has some important consequences. First of 
all, we cannot say for any one of the vaccinated people whether 
the vaccine saved them. After all, most would have survived 
anyway. This means that we can know a medical fact can be true 
for groups of people, and at the same time, not know whether it 
is true for individuals in the group.
    The second lesson is that we need scientific methods that 
talk about whole populations. These are clinical trials, which 
are experimental studies in man, and epidemiology, which learns 
from careful observation alone. A scientific study compares a 
group, such as those who were vaccinated, to a control group of 
people who were not vaccinated. Using the experience of 
unvaccinated people helps researchers answer an otherwise 
impossible question: what would have happened to the vaccinated 
people if they had not received the vaccine?
    We learn about unvaccinated people in general from the 
control group, and about vaccinees in general from the 
vaccinated group. We learn about the vaccine by comparing the 
vaccinated to the unvaccinated groups. This knowledge, which is 
vital to protecting public health, is not possible if we only 
compare single individuals.
    Scientifically useful groups are defined by an exposure 
such as a vaccination. The outcomes, good and bad, are 
enumerated and compared. The rules of evidence in science 
require these kinds of population comparisons.
    By contrast, a group of injured people cannot really tell 
you about the science behind their injuries. If we know already 
about a vaccine effect, we can examine an individual to see 
whether his is a case of vaccine injury. From unusual cases, we 
can get ideas of what might be studied. However, we cannot 
usually come to conclusions based on isolated accounts.
    Many people in this room have legal training. You are 
familiar with formal rules of evidence. You also know about the 
uncertainty of judgments on an individual level. As you 
consider the problem of vaccine effects, I would ask you to 
hold tightly to the idea that there are rules of evidence in 
science, just as in law. In the matter of vaccines, one of the 
fundamental rules is reliance on a large enough sample, 
individual cases just do not provide enough information.
    Science does not typically draw a conclusion from one man's 
story, or even groups of stories. For good reasons that are not 
science, the human sensibility is deeply affected by individual 
stories. But when it comes to making decisions about what will 
best protect the most people with the most efficient use of 
resources, the 6 million are more important than the 1.
    We are grateful that there have been no enemy attacks that 
spread weaponized anthrax. These would have let us test the 
efficacy of anthrax vaccine against the pathogen for which it 
was created. Your deliberations on anthrax vaccine will be 
complicated, thank God, by the lack of real world experience. 
Against that backdrop, it will be impossible to weigh risk 
against benefit.
    Let me implore you, nonetheless, to look for risks in a 
quantitative fashion. Numbers and comparison do not make a good 
story. But they are your only defense against decisionmaking 
based more on the emotional circumstances of the few rather 
than the public health needs of the many.
    Thank you for your attention. I'll be happy to take any 
    [The prepared statement of Dr. Walker follows:]

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    Mr. Burton. Let me start with you, Dr. Walker. Then I'll 
yield to my colleague.
    How many strains of anthrax are there?
    Dr. Walker. Sir, I'm not here as an expert on anthrax. I'm 
here as an expert----
    Mr. Burton. Well----
    Dr. Walker [continuing]. Excuse me--on the methods of how 
one establishes causal relations.
    Mr. Burton. OK, let me ask you a couple of questions. 
According to my staff, there's at least 27 strains of anthrax, 
and you're here as an expert witness. How many strains of 
anthrax will this vaccination, if it is workable, if it does 
work, will protect the American troops, will it protect them 
against all of them, one of them or how many?
    Dr. Walker. Sir, I can't tell you that.
    Mr. Burton. You don't have the answer.
    Let me ask you, how many controlled studies have been done 
on the anthrax vaccine?
    Dr. Walker. I'm aware that there have been a number of 
studies in which there have been followup of safety issues. I 
have not reviewed those in detail, but I'm aware of them.
    Chairman Burton, let me remind you, I'm not here as a 
defender of the vaccine. I'm here to address methods of 
    Mr. Burton. You work for a pharmaceutical company as a vice 
president, do you not?
    Dr. Walker. No, it's not a pharmaceutical company. It's a 
research arm of a, of United Health Group, which is an HMO 
    Mr. Burton. Oh, it's an HMO company. I see. Is Harvard 
receiving any DOD funds for vaccine or biological warfare 
research, do you know?
    Dr. Walker. Sir, I don't know.
    Mr. Burton. Mr. Ponder, do you know the names of the other 
two people who were going to be court-martialed--excuse me, 
Captain, did you have something you wanted to say?
    Captain Sanes. Sir, I apologize, I'm Petty Officer Ponder's 
attorney. My apologies.
    Mr. Burton. Do you have the names of those two other people 
that were to be court-martialed on the drug charges that were 
not sent to Okinawa?
    Mr. Ponder. I do not have them with me right now, sir, but 
Captain Sanes does. He has them, he knows them.
    Mr. Burton. We'd like to have those, their rank, their 
serial numbers and where we could get hold of them.
    Mr. Ponder. Yes, sir.
    Mr. Burton. Mr. Ponder, how many medications are you now 
being given by the military?
    Mr. Ponder. None right now, sir.
    Mr. Burton. Let me yield to Mr. Shays, I'll come back to my 
    Mr. Shays. Dr. Walker, let me ask you this question first, 
and say to you that you provide a valuable source for us. 
Because we have heard from a number of witnesses and it's very 
moving. What I want to thank you for is that you basically are 
giving us the argument that we do need to address. And I think 
it takes frankly some courage to do it, in light of the fact 
that you are appearing at the same table.
    But I do want to say to you, these are not isolated 
stories. These are countless stories. I'd like to know if any 
of their stories would be the basis for your statement, if we 
know already about a vaccine effect, we can examine an 
individual to see whether his is a case of vaccine injury. From 
an unusual case, we can get ideas of what might be studied. 
However, we cannot easily come to a conclusion based on these 
isolated accounts.
    So you've seen, heard some cases. In the process, have you 
had a sense that some of these cases could be studied?
    Dr. Walker. There are two pieces to this. One is deciding, 
in the case of an individual, whether or not some injury that 
he suffered is the result of the vaccine. That presupposes that 
you know about, the scientific question is, does the vaccine at 
least sometimes cause these injuries.
    What you do in that case is to match up the symptoms, the 
presentation of the disease and the timing, with what you've 
established in the past. From Mr. Jones' testimony, it sounded 
that at least his immediate symptoms were indeed related to the 
vaccine, but I obviously haven't reviewed his records. The 
second piece that you can get from individual experience is a 
way of defining, what is it exactly that I'm looking at. 
Statistics are not very helpful if they don't count what you're 
trying to count.
    And sometimes, particularly with drug adverse effects and 
vaccine adverse effects, you have surprises. And you realize 
that your old way of counting things didn't work. And so you 
use an individual case to define what the disease entity is 
you're trying to study, and then you go back to the large 
population groups to say, well, does this happen more 
frequently among the vaccinees than the non-vaccinees.
    I think that each of the medical stories we've heard today 
could potentially serve as the basis for that kind of exercise. 
You say, all right, we have a case of primary testicular 
failure. Well, we wouldn't have thought to look at that, had we 
not had this brought to our attention. But now we can look at 
it, and see, does that occur more frequently in vaccinees than 
non-vaccinees. And this is how you proceed.
    Mr. Shays. So the answer would be yes?
    Dr. Walker. The answer would be yes.
    Mr. Shays. When I hear some of these stories, of course, 
we've had, our subcommittee on Government Reform has had 
countless hearings on anthrax. So the thing that I'm aware of 
that you're not aware of is the extraordinary arrogance of the 
military. And so you are not necessarily defending the program 
or opposing it, correct?
    Dr. Walker. That's correct.
    Mr. Shays. You're just trying to give us some guidance that 
we have to look at a larger picture. And so I think what you're 
saying is, if it can be demonstrated, and I think implicit in 
your statement is, that in the process of saving many, some may 
or will get hurt.
    Dr. Walker. That's always been the decision around 
    Mr. Shays. So it is a given that some people, and it just 
so happens that through modern technology, all the people that 
seem to be hurt by this are coming to us. But I just want to 
say for the record, there are hundreds and hundreds.
    I also want to say for the record, since you're not 
necessarily aware of it, that we have had military personnel 
who have said to us that there are no adverse effects and you 
acknowledge that there will be adverse effects, and that they 
could be serious. Because that is always the impact of 
something on such a large scale.
    But they have, under oath, said there are no adverse 
effects. They have also said to us that no one has been forced 
out of the military, no one has been court-martialed. It just 
boggles the mind. And I think you also heard Mr. Ponder explain 
something that is, maybe it would happen in the Soviet Union 
under Stalin, where they isolate the individual from his 
family, his support group. No one denies Mr. Ponder is sick, 
the question is, should he still be allowed to do it, and is 
there a connection and the military will insist.
    Basically, what they're basically doing, in my judgment, is 
saying that no one gets sick from this. Some could view your 
testimony as unfriendly to the cause of wanting us to address 
this. But even if we can't get the military to stop their 
absurd requirement that this be mandatory, force-wide, even 
though we can't get them to stop that they don't follow the 
protocol of six shots, and now have arbitrarily decided, even 
though they have made a determination, though they requested 
that this be an investigative drug, they still have a letter 
from the FDA saying you could still do this, even though the 
testing wasn't proper. Even though all those things have 
    They still denied individual servicemen the care they need. 
And you have supported the fact, by your testimony, in my 
judgment, that there are going to be some people who are sick, 
which is, just like an on bended knee requirement, that they 
find those people and help them. And they deny that there's 
even those people that exist.
    So I'm just trying to say to you that that's the 
frustration we have. Mr. Ponder has basically been isolated 
from his family, his friends and his legal counsel. And they 
are basically, in my judgment, if his testimony under oath is 
to be believed, requiring him to plead guilty and then he can 
come home.
    So you're not in any way speaking in favor of what I've 
spoken to, you're just speaking in favor of, and I want to be 
clear, that when you require a large group to be part of a 
program, that the benefits clearly may outweigh the costs, but 
there will be some costs, and they just happen to, some of them 
may just happen to be before us. Do you want to qualify 
anything I've said?
    Dr. Walker. There will always be costs. I think we see this 
in every form of medical treatment. That even the safest ones 
that there are, there are costs. And it's always a judgment as 
to what the best thing is to do for the individual in front of 
    With vaccines, unlike, say, antibiotics, the question is 
much more difficult, because the benefits are in a sense 
theoretical, as if this person is never exposed to attack, that 
he's not going to derive any benefit from the vaccine. And so 
the individuals that you see who have had an adverse effect, in 
that instance is being laid against no benefit, just a 
theoretical benefit that the person had. And that's very 
    Mr. Shays. Mr. Chairman, could I just have another 5 
minutes and then I could finish? Would that be all right? Thank 
    What would you say to someone, if we know that some will 
have an adverse effect, it could be tiny, but there was some. 
And you have people who have said, when I took the first shot, 
I had an adverse effect. I took the second, and you've heard 
some of the stories here. And by the third time, and maybe it's 
coincidence, but I was sick the first time, sick the second and 
sick the third, and I really haven't been sick in between, but 
maybe I--whatever. You get the gist of my point.
    Don't you think there should be some kind of presumption 
that maybe this person might be that one isolated very small 
person, statistical individual, that maybe should now have some 
ability to say now? I mean, we're not talking military 
ordering. They get court-martialed if they don't take it. But 
medically speaking, wouldn't that be logical?
    Dr. Walker. I can obviously only speak from the point of 
view of civilian medicine. I don't know the military.
    It's, in the general society, I think it's a bad practice 
to compel vaccination. People may make mistakes, but I think 
it's just a violation of fundamental liberties. And it also 
provides the groundwork for a lot of fear. And there are, you 
can have this funny mixture of real things and things that 
aren't imagined, but they are unconnected, suddenly take on a 
different flavor when the vaccination itself is compelled.
    So your question presupposed that the fever and headache 
actually was a marker of somebody who would go on to have 
seizures and blackouts and so forth afterwards. I don't know if 
that connection is true. But that's what you look at. You look 
at people who have had a particular adverse effect and then you 
look back at their experience with the vaccination, and compare 
it to people who didn't have the effect.
    Mr. Shays. So the bottom line is, though, in a six series, 
in having six shots, when we start to see adverse effects 
continue to grow, from a medical standpoint, it would not be 
unreasonable to say, maybe this is someone who we shouldn't 
continue requiring to take the vaccine?
    Dr. Walker. In fact, that was commonly what we did with the 
old pertussis vaccine, that there were children who had had 
fevers and so forth, they reacted poorly. And they typically 
got half doses or withheld doses. Nobody knows really whether 
that affected the safety of the vaccine, but it was common 
    Mr. Shays. I have to tell you, in the entire time we have 
had a witness, first off, you have been extraordinarily candid 
on both sides of this issue, you have said to me the most 
powerful thing that I've heard from a professional. You have 
said that in the private side, this would be bad practice, to 
require someone to take a vaccine that they didn't want to 
take. And you said it would be a violation of fundamental 
    And I just thank you for saying that. Because that's the 
fact. As well as all the other things you admit. Thank you very 
    Mr. Burton. Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    I want to take a moment to thank all of our witnesses for 
your testimony today. I know it has been quite difficult at 
    Major Irelan, as I listened to your testimony, I kind of 
got the impression that, well, let me not talk about my 
impression. Were you satisfied with the military's reaction to 
your efforts to, No. 1, be diagnosed, and No. 2, receive proper 
    Major Irelan. Congressman, I was trusting. Originally I 
went back out to Arabia, and I was treated for the symptoms. 
The Saudi endocrinologist had no idea of what else to look for.
    When I got back to the States, I was pretty philosophical 
about the whole thing, even after having that report blocked by 
the flight surgeon. And I wrote to my Tennessee Senator, just 
kind of let him know what's going on. After my experiences up 
at Madigan Army Medical Center, I got angry, and that's when I 
started researching around. And when I read the record, I was 
pretty upset.
    No, I was not satisfied with the care from the 
endocrinology side. I was from the standpoint of the urologist, 
who was brave enough to treat me as a patient and set the 
politics aside.
    Mr. Cummings. How are you doing now?
    Major Irelan. I'm hanging in there, sir.
    Mr. Cummings. I didn't get a chance to hear all the 
testimony, because I was at another hearing. But the thing that 
you said that I guess really touched me was when you said that 
you were willing to die for your country. Even with all of 
    So it must tear at you to be willing to die for this 
country, but at the same time, feel that you weren't treated 
right. I mean, I'm just curious.
    Major Irelan. Sir, I'm a grunt. I'm a ground pounder, I 
don't know much about medicine. The whole time, I've walked up 
to doctors and said, here I am, you tell me. There is trust. I 
have to trust my leaders and particularly the medical folks for 
my care and those of my men.
    When a guy shakes and stutters and is concerned about the 
politics of the entire issue versus looking at me as a patient, 
that is frightening. It is very unsettling.
    Mr. Cummings. How do you address a soldier who comes under 
you and says, look, major, they want me to take this vaccine 
and I heard about your situation, and as much as I love my 
country, I want to be alive to fight for it, I mean, what do 
you say to somebody like that?
    Major Irelan. Acquaint yourself with the facts. I was 
ignorant of them until it was actually too late. Went to Mr. 
Burton's site and started reading the testimony, pored through 
120 pages of it, and it sickened me.
    A soldier obviously has to make his own value judgment of 
whether or not that's an order that he could follow. As for 
myself, given the facts that I have found from testimony, and 
matter of fact, from this committee, I would not have taken the 
shots had I known then what I know today.
    Mr. Cummings. You're very fortunate, and I want to applaud 
the chairman for having that on his site. You're very fortunate 
to have gotten that information. What would you have us do as 
far as information is concerned, and trying to get out the 
information that you had access to? Or would you have any 
    Major Irelan. Sir, one recommendation would be to provide, 
or make sure that information is available to military medical 
resource tables, just like the Department of Defense's little 
pamphlet, What Every Service Member or Family Member Needs to 
Know About the Anthrax Vaccine. So there is a counterpoint, 
soldiers need to have that access.
    It was my father-in-law that actually suggested that I go 
to the site. I was completely unaware of the issue at hand.
    Mr. Cummings. Just one last question, Mr. Chairman. Dr. 
Walker, and you may have answered this already, every time I go 
to the doctor, they always ask you your history. They want to 
know what your father suffered from, your mother, you know, 
heart disease, whatever. And I'm just wondering, for somebody 
like Major Irelan, based on what you know, say his son were to 
take this vaccine. Would you, based upon, I know you don't have 
all the answers, but if they asked you these questions about 
regular, routine kinds of things, and reactions, they even ask 
you about reactions to antibiotics, would you expect, I mean, 
that his son might go through similar types of reactions?
    Dr. Walker. You take a family history, in this case, to get 
at genetics. In other words, is there something about the way 
this person's built, that they inherited, that made them 
susceptible to a particular disease or a particular adverse 
event. I'm not aware of research indicating that there's a real 
familial tendency for these kinds of reactions, but surely some 
of them must be genetically based.
    I couldn't tell a son, you would be in a situation, the 
problem here is that there's a risk rather than a fact. You 
don't even know really the level of the risk. And in the case 
of the vaccine, you're weighing it against, what's the risk 
that this person's going to be exposed to aerosolized anthrax. 
And you certainly want to know it. I don't think you could give 
him just a clear yes, no, without knowing more facts.
    Mr. Cummings. It just seems to me that so many people don't 
seem to have a problem, then you have the ones that do. And it 
seems to me, and I'm not a doctor, but it seems kind of logical 
that if he has it, I mean, if my son, if I had gone through 
what he went through and my son went into the military, I tell 
you, I would be very reluctant to see him go through the same 
thing I went through.
    Dr. Walker. I can understand your reluctance. But surely 
you would think about what risks there were in not taking the 
vaccine as well. And that's what you have to lay against it.
    Mr. Burton. Thank you, Mr. Cummings.
    Dr. Walker, do you believe that the Institute of Medicine 
is a reliable barometer of whether or not a vaccination is good 
or bad or if there's been enough research?
    Dr. Walker. It's a human process, but it's one that the 
Institute of Medicine deliberations certainly give you the best 
mainstream thinking in a area.
    Mr. Burton. Well, the Institute of Medicine has stated that 
there is a lack of research to show the anthrax vaccine is safe 
and effective for inhalation exposure. And so, you know, that's 
one of the leading institutions, I guess, as far as advice is 
concerned and information is concerned. Do you accept that kind 
of evaluation from them?
    Dr. Walker. It could hardly have been proved safe for 
inhalation exposure. Because you're not going to do those big, 
large scale, battlefield style tests. So it can't be proved 
safe for inhalation exposure.
    Mr. Burton. So there's not been any real strong studies or 
research? Because they couldn't do it unless they used humans 
as guinea pigs?
    Dr. Walker. That's exactly the problem.
    Mr. Burton. OK. Let me go to, there was a press release 
that came out from BioPort. This is one of the things that's 
troubling. BioPort put this press release out, and it said that 
they were saddened by the death of Dick Dunn. And they said 
that Dr. Stephen Coley, the pathologist who conducted the 
autopsy, called into question the link between the vaccine and 
his death. Called into question.
    And yet if you look at the chief county medical examiner, 
Dr. Robert Joyce, he said he had an inflammatory response to 
the vaccine throughout his body. And this is the kind of 
parsing of words that really bothers me. The county examiner 
says that there was an inflammatory response to the vaccine 
throughout his body. And this press release says the vaccine 
cannot definitely be linked, cannot definitely be linked.
    But the boss of this fellow, his boss, says that it was 
caused, there was an inflammatory response to the vaccine 
throughout his body.
    Let me just ask you a question, Mrs. Dunn, and I know this 
is a very, very difficult time for you. We appreciate your 
being here, and we're sorry that you have to go through this 
after the tragedy you just experienced.
    Did you or your husband ever hear of any other BioPort 
employees that had any trouble with these vaccines from taking 
them? Any reactions? Do you know of any?
    Mrs. Dunn. Yes.
    Mr. Burton. Can you elaborate just a little bit?
    Mrs. Dunn. The swelling, the joint pain.
    Mr. Burton. How many others do you know of that had that?
    Mrs. Dunn. I don't know, sir.
    Mr. Burton. But he did mention there were others that had 
that reaction to it?
    Mrs. Dunn. Yes.
    Mr. Burton. Were the reactions pretty much restricted to 
swelling and joint pain, or was there anything more severe than 
    Mrs. Dunn. My husband didn't talk a lot about BioPort. The 
most he talked was in the last week that he was alive.
    Mr. Burton. Is there anything else you'd like to share with 
us about what he said that last week?
    Mrs. Dunn. No, not at this time.
    Mr. Burton. OK. Major, do you know of anyone else with a 
similar reaction to what you experienced?
    Major Irelan. Possibly from Dr. Nass, she has mentioned a 
number of folks, Dr. Meryl Nass.
    Mr. Burton. She would have that information, but she 
probably wouldn't be able to divulge it without the permission 
of the patient, I suppose.
    Major Irelan. Possibly, sir.
    Mr. Burton. But there were other cases that she dealt with?
    Major Irelan. Yes, sir.
    Mr. Burton. Do you know of any others besides that?
    Major Irelan. No, sir. I was in a three man detachment in 
Saudi Arabia, and I'm in an isolated location now.
    Mr. Burton. You're in an isolated location now?
    Major Irelan. I'm part of a little bitty team that advises 
the National Guard. So I'm not around the major military 
population centers.
    Mr. Burton. Is that by design? So that you won't be 
inflaming the situation?
    Major Irelan. No, sir, it has nothing to do with the 
military trying to keep me away from everybody. It's simply my 
retirement assignment.
    Mr. Burton. OK. Ms. Rugo, what has DOD done to help with 
the adverse event evaluation?
    Ms. Rugo. The Department of Defense?
    Mr. Burton. Yes. Have they done anything to help with the 
adverse reaction that your sister had?
    Ms. Rugo. I don't believe so.
    Mr. Burton. They haven't talked to you about any of that, 
or the family?
    Ms. Rugo. They have not.
    Mr. Burton. Have you heard of any other anthrax related 
    Ms. Rugo. Yes, I have. Just from doing Internet research 
and finding other Web pages. And I did find a data base of a 
couple of other deaths. I don't know if it's accurate, but I do 
know that I have found some.
    Mr. Burton. If I might proceed just a little bit longer 
here, with the consent of my colleagues.
    Mr. Colosimo, I see here this U.S. Air Force active duty 
Walter Reed medical sheet. And it says that the diagnosis that 
you had was anthrax intoxication, is that correct?
    Mr. Colosimo. Yes, sir.
    Mr. Burton. Did they elaborate when they told you that you 
had anthrax intoxication?
    Mr. Colosimo. No. In fact, I didn't recognize that until 
later. I found out much later.
    Mr. Burton. Did the doctors say anything to you out at 
Walter Reed, saying, you know, this could be anthrax related, 
or what did they tell you?
    Mr. Colosimo. They told me my first three shots were most 
likely anthrax related. They told me my fourth shot was maybe 
something I was exposed to in Kuwait, or it could be related to 
the anthrax. But they were uncertain. They gave me a 1-year 
waiver from the anthrax shot.
    But the other document I provided you was one from the 
chief of allergy. And she stated that my symptoms were anthrax 
    Mr. Burton. Mr. Edwards, are you aware of anyone else who 
had reactions to the anthrax vaccine?
    Mr. Kevin Edwards. There was another soldier in the medical 
holding unit who also had blisters in his mouth after receiving 
his shots. And I have not seen him in about 4 months. But he 
expressed to me that his reaction was from the vaccine and he 
also had ocular involvement as well.
    Mr. Burton. His eyes were affected?
    Mr. Kevin Edwards. Yes, sir.
    Mr. Burton. Do you remember the fellow's name.
    Mr. Kevin Edwards. I have it written down.
    Mr. Burton. We would like to have that, so we can pursue it 
to see how he's doing.
    Are you concerned that minorities are more severely 
affected by this vaccine than other nationalities or other 
    Mr. Kevin Edwards. It was a question that came into my 
mind, because he was Hispanic. And I had heard of other cases 
of people that had had reactions, and most of them were 
minorities as well. They had not been confirmed, so I don't 
know for sure if they were from the vaccine. But that was a 
concern of ours.
    Mr. Burton. What did the military do with your clothing 
after you had this?
    Mr. Kevin Edwards. When I was med-evaced, my personal 
belongings were placed in plastic bags and quarantined. No one 
knew what I had, what to do with me, really. So all my personal 
belongings were just placed in a plastic bag, and that's how I 
received them.
    Mr. Burton. You got them back that way?
    Mr. Kevin Edwards. Yes, sir.
    Mr. Burton. Before you got the vaccinations, were you given 
any information about possible reactions or any side effects?
    Mr. Kevin Edwards. No, sir.
    Mr. Burton. They just said you had to take it?
    Mr. Kevin Edwards. Yes, sir.
    Mr. Burton. And how many times did you go to the clinic 
before you saw a medical doctor?
    Mr. Kevin Edwards. I never saw a medical doctor until I was 
med-evaced from Camp Carroll to 121 hospital.
    Mr. Burton. And how long a period was that from the time 
you first started experiencing these problems?
    Mr. Kevin Edwards. About 5 days. I think I went to the TMC 
approximately four or five times.
    Mr. Burton. Mr. Edwards, is the military, and you're the 
father, is the military providing adequate care for your son 
now, do you think?
    Mr. Toney Edwards. At the present time, they are providing 
care. Obviously he has lost so much of his sight at this point, 
I'm not sure if it's adequate. I have not, military personnel 
at Brooke Army Medical Center have not kept me informed of 
anything in terms of his condition.
    Mr. Burton. But they did say, didn't they, if they had 
gotten to him sooner, they could have saved his eyesight, or 
made it a lot better?
    Mr. Toney Edwards. Right. That was when they first got the 
doctor from the University of Florida to come up. By the time 
they got the doctor from Florida, my son had lost 1 year of his 
deterioration of his eyesight, before he actually got before an 
    So I would think that in response to that question that 
they did not respond as fast as they could have. Perhaps they 
didn't have the knowledge of what to do. And based on the fact 
that they said they had to wait on an expert, apparently this 
is what they did.
    However, when I requested that my son be transferred to 
Fort Bragg Medical Center, General deWhitt convinced me that he 
had all the experts, and that they were going to take care of 
him. But he sat there for 1 year, and his eyes stayed infected. 
And he lost his sight over a year period of time before they 
got a doctor from the University of Florida to recommend some 
kind of procedure that would slow down on the loss of sight.
    Mr. Burton. I'm going to yield to Mr. Horn, but let me just 
say that this general who had no particular medical training 
said that they had experts there who could take care of your 
son's eyesight and didn't send him where he could get care.
    Mr. Toney Edwards. What he was responding to was when I 
wrote him a letter asking him to update me on my son's 
condition. He responded to the letter after Congressman Jones 
got involved and said that he felt that Kevin needed to stay 
there at Brooke Army Medical Center where all the experts were. 
Well, that made me believe that he had all the experts that he 
    But when it came to treating my son, he didn't have it.
    Mr. Burton. Mr. Horn. Mr. Jones, Mr. Horn has to leave, so 
we'll get to you as soon as he's through.
    Mr. Horn. Thank you, Mr. Chairman. I appreciate all the 
things that you've told our committee. I just want to ask you a 
few more, just put your hand up. Did the Food and Drug 
Administration [FDA], ever contact you, those that were 
contacted? Now, that's Mrs. Dunn, anyone else ever contacted by 
the Food and Drug Administration?
    So only one of you out of this panel have been contacted by 
and examined and surveyed, you, Mrs. Dunn. So that sort of 
disturbs us, to say the least.
    Are you all on medication monthly? How many are on 
    Of those on medication, what's the average amount you have 
to pay in a month? What about it, Major Irelan?
    Major Irelan. It would come out to $40, right now, a month. 
Once I leave the military.
    Mr. Horn. Who's next?
    Mr. Kevin Edwards. I'm not exactly sure how much it would 
cost, since I get all my medication through the military.
    Mr. Horn. So they're not charging you for that?
    Mr. Kevin Edwards. No, sir. I do have to buy these drops, 
sometimes, though. Because our pharmacy does not carry them on 
their formulary. So from time to time, I'll have to buy them 
myself, and they are pretty costly, between $9 and $11 for a 
box of 30. And I go through a box of these per day.
    Mr. Horn. Do you know what that costs, at all?
    Mr. Kevin Edwards. For the one box of 30?
    Mr. Horn. Right.
    Mr. Kevin Edwards. Anywhere between $9 and $11, depending 
on where you get it.
    Mr. Horn. Who's next on medication? Mr. Edwards. Mr. 
    Mr. Colosimo. I'm active duty.
    Mr. Horn. So you're OK on covering your costs.
    Mr. Johnson.
    Mr. Johnson. I'm actually out of the military now. 
Fortunately, I was able to salvage some of my extra pills that 
I, when I left the military. On average, each pill that I have, 
Fioronal, costs $37.50, each pill.
    Mr. Horn. $37 for each pill?
    Mr. Johnson. Yes.
    Mr. Horn. What is the medication?
    Mr. Johnson. It's Fioronal, and it's for headaches. It's 
for migraine headaches. It's laced with a slight bit of cocaine 
and I don't know what else.
    Mr. Horn. Are you on disability?
    Mr. Johnson. I am on 30 percent disability.
    Mr. Horn. Does that cover your medications?
    Mr. Johnson. At this time, I am not purchasing extra 
medications, because I have extras. But when I do, it will 
cover 30 percent of it, not 100 percent.
    Mr. Horn. Mr. Jones, medication, how much does it cost you 
    Mr. Jones. I'm not on medication, sir.
    Mr. Horn. You're still in the service?
    Mr. Jones. Yes, sir.
    Mr. Horn. Mr. Ponder.
    Mr. Burton. Mr. Horn, Mr. Ponder was in Okinawa. He was 
brought back here because he wouldn't take the shot and he's 
under possible court-martial for that purpose, that reason.
    Mr. Horn. Well, I think one of our witnesses, maybe Dr. 
Walker, has said we've got the freedom of privacy and the 
freedom of person under the constitution. I can't see if you 
don't want to take it why they should be penalizing you in any 
    Mr. Michels, any medications?
    Mr. Michels. No.
    Mr. Horn. Dr. Walker, you are not injured in this thing, 
but I take it you did make the statement to Mr. Shays that one 
shouldn't really be forced to take any medicine.
    Dr. Walker. I did qualify that, that was speaking of 
civilian practice. I don't have any knowledge of military 
practice. But in the civilian environment, it would be a 
    Mr. Horn. Mr. Colosimo, while you were at Walter Reed, were 
you seeing other individuals that were ill from anthrax?
    Mr. Colosimo. I've seen, I don't know if it's just anthrax, 
I've seen individuals that were ill from the Gulf War Syndrome, 
who took the anthrax shot. And there were some that had the 
same diagnosis that I had.
    Mr. Horn. And so they would be what? Given by the military, 
or would they have to go out and buy it themselves?
    Mr. Colosimo. They'd have to purchase it themselves.
    Mr. Horn. Do you know what that would be?
    Mr. Colosimo. No, I don't, sir.
    Mr. Horn. Well, thank you, you've all given us great 
testimony. And I regret, Mr. Chairman, I have to be in my 
office for the chairman of the FCC, and we've got a hearing 
with it coming up.
    Mr. Burton. OK, Mr. Horn, we appreciate you.
    Mr. Jones. Mr. Chairman, I want to thank you. As you know, 
I'm not a member of your committee, so I thank you and each 
member of this committee for giving me a little bit of time. I 
do serve on the Armed Services Committee. And I sit here today, 
I don't know if I've been to, counting Armed Services and your 
committee, 10, 8, 9, 10 hearings. And there are two words that 
come to my mind. And the two words are tragedy and politics.
    I think that's what's driving this issue, quite frankly. I 
look at these men here today, and ladies who have lost loved 
ones. And I think about the men and women I've seen, both in 
the full committees and in my office. Most of you know I have 
three bases in my district, Seymour Johnson Air Force Base, 
Camp LeJeune Marine, down in Jacksonville and also Cherry Point 
Marine Air Station. And I think about the fact that men and 
women who love this Nation, who are in uniform willing to die 
today for our country, that what a tragedy it is that we have 
had men and women to be court-martialed or driven out of the 
military or become ill, as you. And possibly this vaccine has 
led to a death, I can't say yes or no, I don't know, I'm not an 
    Then I think about Mr. Edwards who was trying to find out 
about his son who was seriously ill, near death. And he had to 
call a Congressman from another district, and the reason for 
that is because I had been somewhat out front and involved in 
this issue.
    The fact was that it took him almost 1 year to get someone 
who knew his son's medical situation to communicate with Mr. 
Edwards and his family to say what their concerns were about 
what might have caused his illness. Then I think about the fact 
that the taxpayers of this country are propping up a company 
named BioPort that cannot even produce the drug. FDA to this 
point has not even authorized BioPort to produce this drug. 
That's just an ongoing saga to the tune of about $50 million 
and more that it's costing the American taxpayers.
    That's the politics of it. I don't know why DOD will not 
admit that we've got a problem and why Secretary Cohen will not 
ask for a moratorium for a period of time until we as a 
Congress and they as the Department of Defense can go through 
this and find out exactly where we are, and is this shot safe, 
can you say to those in uniform, that yes, it's safe, so those 
in uniform will not feel like they are guinea pigs.
    And to Mr. Ponder, I think it's a tragedy that you or 
anyone else in uniform would be forced to go to court to say 
that you are not going to take this shot. Here we have the 
State Department, whose men and women overseas are on the 
forefront of a possible terrorist attack and Mr. Chairman, you 
know this, and Mr. Cummings knows this also, because you've had 
that hearing in this committee, their people, it is voluntary 
whether they want to take it or not.
    And if anything, that gives me great trouble as a Member of 
Congress, quite frankly. Because what I think BioPort saw and 
the Department of Defense, and I've asked for an inspector 
general's investigation, quite frankly, it's a year old so far, 
and within a month or so, they're ready to bring it to a 
    But my concern is the fact that all of a sudden, a decision 
was made by the Department of Defense, they did not do an 
adequate job, in my opinion, of informing and educating these 
men and women in uniform as to the safety of this shot, the 
necessity of this shot. All of a sudden, it was just mandated 
by the Secretary of Defense that you will take six shots.
    And Mr. Chairman, I think, and Mr. Cummings, I think that 
is the tragedy of this, quite frankly. Because we as a Nation 
cannot afford to lose men and women in uniform that want to 
serve this Nation and to die for this Nation over a vaccine. 
I've heard a gentleman I have great respect for that is a 
Marine to say that losing one in uniform over this issue is a 
tragedy. And I think it is.
    And I just want to thank you and this committee for giving 
me the opportunity to be here. I think quite frankly, that the 
plus of all this, if there is a plus, is as long as BioPort 
cannot produce the product, they're running low on inventory. 
And the best thing to happen to the military, in my opinion, 
would be that they would not get FDA approval and run out of 
inventory, then no one would have to take the shot.
    But to sit here and see, as I have for 9 or 10 hearings, to 
see men and women in uniform, America's present and America's 
future, that are saying that they will either leave the 
military or they are willing to accept court order within the 
military and leave under circumstances that they do not desire.
    Major Irelan, you said a statement in answer to Mr. 
Cummings, yes, there is a lot of politics in this whole issue. 
And to the ladies who have lost loved ones, to Mr. Edwards, 
whose son, I saw all those photographs of your son when you 
came to Goldsboro to a town meeting. And Mr. Chairman and 
members of this committee, there are a lot of people in uniform 
that are very, very concerned about what the ramifications of 
this shot might be as it relates to their future.
    So I want to thank you. I don't really have questions. I 
just sat here a while ago listening to everybody. And I just 
thought, how sad and how tragic it is that we as a Nation, as 
you said, Major Irelan, your men, and every man and woman in 
uniform, looks to this Congress to be their protector when 
there are questions like this.
    And quite frankly, I think we as a Congress should demand 
that the Secretary of Defense put a moratorium on this whole 
issue until a lot of questions that right now are unanswered 
can be answered.
    Mr. Chairman, I thank you for giving me this time.
    Mr. Burton. Thank you, Representative Jones.
    Representative Norton or Representative Cummings.
    Mr. Cummings. Just a few more questions, Mr. Chairman.
    Mr. Michels, I think you referenced a letter from the FDA, 
did you get a letter from the FDA?
    Mr. Michels. Are you referring to the memorandum from Dr. 
Karen Goldenthal?
    Mr. Cummings. Yes.
    Mr. Michels. In 1997?
    Mr. Cummings. Yes.
    Mr. Michels. I did reference it in my written testimony, 
    Mr. Cummings. OK. And can you tell us?
    Mr. Michels. I can read it to you.
    Mr. Cummings. If it's not too long.
    Mr. Michels. No, it's very short. It appears to be an 
electronic message transmission, it's an inter-office 
memorandum dated February 18, 1997 from Dr. Karen Goldenthal to 
Ms. Mary Pendergrast regarding a telephone call from Admiral 
Martin about the anthrax vaccine. This communication back and 
forth between these folks was part of the Department of 
Defense's initial efforts to try to get some kind of 
authorization from the Food and Drug Administration to go ahead 
and push forward with a mass vaccination effort even though the 
drug was in investigational status as a result of the 
    Essentially what DOD was doing was trying to get several 
people at FDA, one of them Dr. Goldenthal, Dr. Michael Freedman 
was another one, to give them the OK to say, or to use the 
vaccine against inhalation anthrax, even though the package and 
the labeling and the licensing did not specifically say that it 
was all right to use it as a preventative for aerosolized 
    The upshot, or the import, if you will, of Dr. Goldenthal's 
message to Ms. Pendergrast concerning Admiral Martin's request 
for validation is that she said two things. The first thing she 
said was that she interpreted the vaccine labeling to say that 
it would be permissive to prevent pulmonary or inhalation 
anthrax. That was the first thing she said.
    The second thing she said, and the reason I cited the 
memorandum, is that she then goes on to say, however, if the 
military is interested in using a vaccination time schedule 
different from the currently licensed schedule for a mass 
vaccination effort, which, Congressman, is exactly what's 
happening now, then informed consent would be appropriate.
    In other words, if the military deviates from the labeling 
requirements for a vaccination schedule that is a six shot 
schedule, every 2 weeks for the first three shots, up to 6 
weeks, and then boosters at, I believe it's 6 months, 12 months 
and 18 months. If they deviate from that six shot regimen, the 
drug is investigational and they have to get informed consent.
    Now, DOD has already announced that they are deviating from 
the schedule. They are not going to require people to restart 
their shots if they are in hiatus for up to 2 years. So that 
sequence is going to be broken.
    I guess the question I would be asking the folks who are 
going to come on the panel after me is, what gives you, what's 
changed about Dr. Goldenthal's opinion that you don't have to 
ask for informed consent from the service members now?
    Mr. Cummings. Are you defending Mr. Ponder, are you his 
    Mr. Michels. I am not Mr. Ponder's attorney. I have acted 
in concert with Mr. Ponder's defense attorney. Basically what I 
did was send him my memorandum and support materials indicating 
that I believed the drug was investigational, and that would be 
a defense to a charge of failure to disobey a lawful order.
    Mr. Cummings. And I would take it--are you a lawyer?
    Mr. Michels. Well, that's actually a matter of opinion, but 
I've passed the bar, yes, sir. [Laughter.]
    Mr. Cummings. I was just wondering, I would take it that 
when one were to present a case like this, I'm an attorney 
also, and you have this kind of evidence, things that we've 
heard here today, it just seems like you'd almost have to, I 
mean, it would be logical, if you could get it into evidence, 
to present some of this, is that right?
    Mr. Michels. That's correct, Congressman. And let me just 
say, Petty Officer Ponder's case, along with, I believe, it's 
three others, are up on appeal before the Navy and Marine Corps 
Court of Criminal Appeal. Those cases are going to be argued up 
there on this issue, among others. And we're hopeful that we're 
going to be able to succeed there.
    I'll tell you quite frankly, my law firm is taking this as 
a pro bono effort, this is something I'm trying to do in my 
spare time. I mean, I'm moving toward setting up a declaratory 
judgment action, because there are about 300 or 400 people who 
have taken hits on this program, who have been forced out of 
the service, who I think were wrongfully separated.
    Mr. Cummings. Let me say this, Mr. Chairman. I want to, you 
know, I had to almost echo the words of Congressman Jones, it's 
so interesting that when people, so often, when people fall 
into situations where they're either harmed substantially or 
they die, sometimes it seems as if we have a tendency to sort 
of separate them and say, oh, too bad and life kind of goes on.
    And the sad part about it is that people are left to 
suffer, and suffer greatly. When Mrs. Dunn was speaking, I 
watched the reactions of some of our armed services folks 
sitting there at the desk. And when she talked about the death 
of, your husband was it?
    Mrs. Dunn. Yes.
    Mr. Cummings. I heard Major Irelan talk about how it's 
quite possible that his death will maybe be in some way related 
to this, and then I heard Mr. Edward talk about his son. I 
mean, we're dealing with some very serious issues.
    And I just hope, so often what happens is, we've heard 
these cases, Mr. Chairman, how many, many years later we 
finally do the right thing and then somebody, first of all, 
it's almost impossible to even get an apology. But then so many 
people have died, so many children are left without their 
mothers and fathers, so many loved ones don't get a chance to 
celebrate Christmas and Easter with those people. So we have 
suffered over all of those years.
    And I'm just saying, this testimony has been so compelling. 
I can assure you, we're going to do all we can we can't bring 
anybody back to life. I wish we could. When I think about the 
people, the good men and women like you all who are willing, 
like Major Irelan said, to lay your lives down, I mean, that's 
a hell of a statement. I'm willing to die for this country.
    The least we can do is try to straighten out this mess. And 
it is a mess. I don't care how you look at it, it's a mess.
    The other thing I think we have to look at, though, at the 
same time, is, and I'm sure the military will talk about this, 
and Dr. Walker referred to it, whenever we're dealing with 
these kinds of issues, I think we have to, there apparently 
must be some balancing that goes on. What is the threat? How 
likely is it that this threat is going to be put upon our 
military folks?
    So we've got a lot of questions we have to answer and a lot 
of things we have to address. But I can tell you one thing. 
Your lives are precious to us. Your lives are precious. And we 
want you to live the very best life that you can.
    I've often said that we have one life to live, and this is 
no dress rehearsal. And this so happens to be that life. So 
hopefully, Mr. Chairman, we can work together in a bipartisan 
way. And I know Mr. Jones talked about politics. But the fact 
is, this is a bipartisan effort that I hope we can do something 
about. And I want to thank you.
    Mr. Burton. Thank you, Mr. Cummings.
    We have some votes on the floor and I won't keep this panel 
any longer. Let me just tell those of you who are on the panel 
that we will continue to work to try to find as many answers as 
possible, and we'll try to do what we can to make sure that 
every member of the military is well informed about vaccines 
that they have to take, like the one we're talking about. And 
we're going to try to get this changed to where it's a 
voluntary effort, or voluntary vaccine.
    I know the military has not responded in the affirmative to 
this, but we're going to keep having these hearings until we 
force the issue. And those from the military who are on the 
next panel should be aware of that. And I'd like to also say, 
anybody that you know, and you will be running across other 
people who probably have similar problems, be sure to tell them 
to contact us. We'll keep their confidence. We have a Web site, 
and we want to make sure we have as much information as 
possible from every member of the military, male or female, 
that has had an adverse reaction to the anthrax vaccine.
    With that, our hearts go out to those of you who suffered 
the loss of loved ones or who are suffering now from the 
effects of the vaccine. And we really thank you for being here.
    I'd just like to see, which one of you is getting the eye 
drops? You're paying $11 a day? Those expenses that you're 
incurring as a result of your injury that are not being picked 
up by the military or the Government of the United States, you 
let me know what they are. Because I'll write a letter to the 
Defense Department and try to make sure that you're compensated 
for that. You shouldn't have to pay for that, because it wasn't 
your fault.
    And with that, we stand in recess. We'll be back here in 
about 10 minutes.
    Mr. Burton. We will call the next panel. Other members will 
be back shortly.
    [Witnesses sworn.]
    Mr. Burton. Be seated.
    I understand there are two opening statements that you 
wanted to make. Who will be delivering those?
    Mr. Cragin. I will, on behalf of the Department of Defense. 
I'm Charles Cragin.
    Mr. Burton. And who else?
    Mr. Elengold. I will for the Food and Drug Administration.
    Mr. Burton. All right, why don't we start with Mr. Cragin, 
and then we'll go to you next.


    Mr. Cragin. Thank you, Chairman Burton. On behalf of myself 
and my colleagues, we appreciate the opportunity to appear 
before this committee and discuss what we have learned since 
beginning the Anthrax Vaccine Immunization Program [AVIP].
    I'm accompanied today by Dr. J. Jarrett Clinton, the Acting 
Assistant Secretary of Defense for Health Affairs; Dr. Anna 
Johnson-Winegar, Deputy Assistant to the Secretary of Defense 
for Chemical and Biological Defense; Major General Randy L. 
West, Senior Advisor to the Deputy Secretary of Defense for 
Chemical and Biological Protection; Colonel Arthur Friedlander, 
Science Advisor for the U.S. Army Medical Research Institute of 
Infectious Diseases.
    And also joining us are Colonel Randolph, the Director of 
the Anthrax Vaccine Immunization Program, and Colonel Scovall 
from the Office of the Navy Judge Advocate General.
    The threat of anthrax facing our service men and women 
today continues to be a lethal threat. And Mr. Chairman, I know 
you are familiar with the history of Secretary Cohen's decision 
to vaccinate all U.S. military personnel against anthrax. So I 
will focus my remarks on our most recent actions and what we 
have learned concerning AVIP.
    Many of our military men and women stationed around the 
world go to work every day under the threat of a weaponized 
anthrax attack. Our intelligence tells us the threat to produce 
and deliver anthrax against our troops in the high threat areas 
of southwest Asia and Korea is ever present. The colorless, 
tasteless, odorless, difficult to detect anthrax is one of the 
few existing biological warfare weapons that can cause swift 
and almost certain death when an unprotected person is exposed.
    For 2\1/2\ years we have concentrated on vaccinating those 
members at greatest risk of exposure to anthrax, particularly 
those service members assigned to or deploying to southwest 
Asia and the Korean peninsula. In phase one of the program, we 
administered more than 1.9 million doses from our stockpile of 
safe and effective FDA-licensed vaccine to more than 487,000 
    Our stockpile was originally produced by the Michigan 
Department of Public Health. The State of Michigan sold the 
facility to BioPort Corp. in 1998. BioPort is currently working 
toward FDA biological license application supplemental approval 
of this new facility. While we work with the FDA toward 
achieving the approval of the site modifications, we continue 
to use vaccine from the stockpile of previously manufactured, 
certified safe and effective FDA licensed vaccine.
    The stockpile, however, is currently below the level needed 
to continue phase one. So we have refocused the scope of our 
vaccination effort. We now maintain the vaccination program 
only in the highest threat areas where service members are at 
greatest risk. Only those U.S. military personnel, emergency 
essential civilian employees and contractor personnel assigned 
or deployed on the ground in southwest Asia and Korea for 30 
days or more are receiving the vaccine. All other vaccinations 
will be deferred until we can obtain an assured supply of safe 
and effective FDA licensed vaccine.
    This is not our desired protection level. It is, simply 
put, all we can accomplish with the available supply. Once this 
assured supply is available, we will resume phase one and 
eventually proceed with the subsequent phases to accomplish the 
vaccination of the entire force. In the meantime, the rest of 
our force health protection package, including the use of field 
detectors, protective gear and antibiotics, will remain in 
    Ideally, we would have sufficient vaccine available to 
vaccinate all of our phase one service personnel according to 
the Secretary's original schedule. This is not the case, 
unfortunately, and the Department is managing the risk as 
optimally as possible, given the current circumstances.
    We have learned a great deal in the past few years about 
the program and our management of it. These lessons will help 
us better manage the program as we work toward vaccinating the 
total force in the years to come. Programmatically, the 
Department has moved toward alternative strategies for vaccine 
acquisition. We realized that while the current vaccine is the 
most effective protection available against this lethal weapon, 
we must continually explore means to improve that protection.
    Another critical lesson we have learned is how important it 
is to communicate clearly and effectively with our service 
members and their families from the beginning. We 
underestimated this task, and we shouldn't have. We are now 
using the Internet and applying communications strategies and 
tools that more effectively relay information and address the 
concerns and questions of our service men and women.
    These lessons have allowed the Department to better 
educate, protect and retain highly valuable, active duty and 
reserve component personnel. Despite our efforts to improve our 
program, however, the Department still needs FDA licensed 
vaccine to expand the AVIP and protect the total force. BioPort 
is the only supplier of the anthrax vaccine in the United 
States. Obtaining new production of FDA licensed vaccine as 
soon as possible is a high priority for the Department.
    We are committed to providing the resources necessary to 
achieve this, and have taken steps to assist BioPort in the 
submission of their biologic license application to the FDA. 
First, we provided BioPort with second party consulting and 
defense contract management oversight to enhance management 
practice and maximize performance.
    Second, we are working to reduce our reliance on BioPort as 
the only source of FDA licensed anthrax vaccine. We are seeking 
to identify a second source for manufacturing the anthrax 
vaccine that can share the product license with BioPort. We 
have received five expressions of interest thus far, and are 
analyzing them to determine the cost, schedule and technical 
feasibility of a second source.
    Third, we are restricting further payments to BioPort for 
only those items deemed allowable to comply with good 
Government and fiscal practices and congressional direction.
    Fourth, the fiscal year 2001 budget includes research funds 
to develop biological warfare vaccines, to provide protection 
against multiple biological agents. There is a research program 
to produce a multi-agent vaccine capable of stimulating 
immunity against three or more biological warfare agents, 
utilizing a common platform.
    Finally, we have asked for an independent review of the 
Department's management of vaccine acquisition to ensure that 
our efforts are credible, consistent and cost effective. We 
took these steps because our existing stocks of previously 
manufactured vaccine are not sufficient to sustain the program 
at its present pace. We are focusing our efforts on the FDA's 
approval of BioPort's renovated production suite.
    There have been many delays, some within and some beyond 
BioPort's control. Some are related to the inherently complex 
process of producing biological products. Some are the result 
of the evolving nature of current manufacturing practices 
required of a manufacturing facility producing biological 
agents. Other companies in the vaccine industry are also 
encountering these challenges. For instance, there are current 
shortages of the influenza vaccine and also snake anti-venom.
    Despite the program's slowdown, we are working with the 
commanders in chief of the high threat areas to continue to 
protect as best we can our troops at highest risk. We will 
accomplish this process consistent with FDA regulations and 
direction while maintaining our strong focus on safety and 
protection of our troops.
    To date, 13 studies have established the safety of the 
anthrax vaccine. These 13 studies include collection of both 
active and passive data from anthrax vaccine recipients. They 
also include focused and broad based studies and short and long 
term studies. Results from these studies can be seen on our Web 
site at www.anthrax.osd.mil. One of the 13 safety studies 
involves an independent civilian panel review of reports of the 
Vaccine Adverse Events Reporting System [VAERS]. After 2 years, 
in which almost 1,200 reports and medical records have been 
reviewed, the AVIP continues to report that they have 
identified no unexpected events and no disease syndromes 
associated with the anthrax vaccine.
    We continue to work hard at making this type of information 
more available to our service members and their families. We 
provide through our Web site accurate, fact-based information 
24 hours a day. Other more conventional tools include 
brochures, journal articles, other printed material, training 
video tapes, silent training aids, a toll-free hotline and e-
    All of the AVIP efforts I have discussed require resources. 
The Department has programmed $74 million between fiscal year 
1999 and fiscal year 2005 for the AVIP agency's operating 
budget. This budget increases across the years as the number of 
participating DOD personnel and the size of the program 
increases. Eventually, 2.4 million personnel will be enrolled 
and sustained once the program completes all three phases of 
implementation. The Department has funded the program with this 
in mind.
    Mr. Chairman, nearly one-fifth of our service men and women 
are benefiting from anthrax vaccine protection. That means 
nearly 500,000 more military members are protected against 
anthrax today than were protected when our Nation was last 
involved in hostilities. That is not enough, however. All who 
serve and defend our Nation deserve to be and should be 
    We are eager to resume and expand our vaccination efforts 
to include the total force as soon as an adequate supply of 
safe and effective FDA licensed vaccine becomes available. We 
will work diligently with the FDA toward achieving new 
production, as soon as it is safely practical, and to ensure 
that the newly produced vaccine remains safe, pure, sterile and 
potent throughout its shelf life.
    Our highest priority has been and will always remain to 
protect the safety and well being of the men and women who 
safeguard our country.
    Mr. Chairman, that concludes the opening remarks of the 
Department of Defense representatives.
    [The prepared statement of Mr. Cragin follows:]

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    Mr. Burton. Thank you.
    Mr. Elengold.
    Mr. Elengold. Thank you. We have a longer statement for the 
record, I'll just summarize it.
    Mr. Burton. That's fine, we'll put your whole statement in 
the record.
    Mr. Elengold. Mr. Chairman and members of the committee, I 
am Mark A. Elengold, Deputy Director for Operations, Center for 
Biologics Evaluation Research [CBER], of the Food and Drug 
Administration. I appreciate the committee's interest in the 
anthrax vaccine absorbed, and the opportunity for FDA to update 
the committee on the regulatory status of BioPort Corp. and the 
agency's experience with adverse event reports for the anthrax 
    Accompanying me is Dr. Susan Ellenberg, Director of CBER's 
Office of Biostatistics and Epidemiology. Let me assure you 
that we will continue to help assure that only safe and 
effective products are marketed and these products meet high 
standards of quality.
    There is currently only one FDA licensed facility for the 
production of anthrax vaccine. The facility was first known as 
the Michigan Department of Public Health [MDPH], subsequently 
called the Michigan Biologic Products Institute [MBPI], and is 
currently known as the BioPort Corp. FDA has inspected this 
facility on many occasions during the past decade. In 
particular, FDA conducted a surveillance inspection of MBPI in 
November 1996. Based upon the documented deviations from 
current good manufacturing practices [CGMPs], FDA issued a 
notice of intent to revoke letter to MBPI in March 1997.
    In February 1998, FDA conducted a followup inspection of 
the facility. The February 1998 inspection disclosed continuing 
significant deviations from FDA's regulations. After BioPort 
purchased the facility from MBPI in September 1998, FDA 
inspected the facility in October 1998 and still found 
deviations but also noted continuing improvement.
    In January 1998, MBPI halted production of anthrax vaccine 
sublots to begin a comprehensive renovation of the anthrax 
production facility. Although there has been a resumption of 
manufacturing by BioPort, in order to produce lots in support 
of the license application supplement for the renovated 
facility, no lots of anthrax vaccine manufactured in the 
renovated facility have been submitted to CBER for lot release.
    Due to the rules of confidentiality, FDA cannot generally 
disclose details or, or even acknowledge the existence of, a 
pending application or supplement, unless that information has 
already become public. Since press reports and information made 
public by BioPort have revealed information about anthrax 
vaccine, FDA can disclose that BioPort does have a pending 
supplement for renovation of their anthrax vaccine 
manufacturing facility. BioPort may not release product 
produced in the renovated facilities until the supplement is 
approved and each batch has received CBER lot release approval.
    In order to examine the manner in which BioPort implemented 
the renovation for the manufacturing facility, FDA conducted a 
pre-approval inspection from November 15th through November 23, 
1999. At the conclusion of the November inspection, BioPort 
received a Form FDA 483, with observations in the following 
areas: validation, failure to investigate manufacturing 
deviations, deviation report, aseptic processing, filling 
operations, standard operating procedures, stability testing 
and environmental monitoring. All observations on the Form FDA 
483 must be addressed adequately before FDA will approve the 
    In addition to inspecting vaccine manufacturers, FDA also 
monitors adverse events for vaccines and other products. For 
vaccines, this is accomplished through the Vaccine Adverse 
Event Reporting System [VAERS]. Generally, VAERS does not 
establish causality, but is essential to the discovery of 
potential rare adverse consequences of medical products that 
may not become evident until large numbers of people have been 
exposed to them.
    Since the beginning of VAERS operations in 1990 through 
September 15, 2000, 1,561 reports of adverse events associated 
with use of the anthrax vaccine have been reported to VAERS. 
FDA understands, based on information from BioPort, that from 
1990 to present, approximately 2 million doses of the vaccine 
have been distributed. Of those reports, 76 are considered 
serious events, those which are considered fatal, life-
threatening, or resulting in hospitalization or permanent 
disability. These reports are for diverse conditions, such as 
hospitalization for severe injectionsite reaction and Gullian 
Barre syndrome, widespread allergic reaction, aseptic 
meningitis and multi-focal inflammatory demyelinating disease.
    There are no clear patterns emerging at this time. The 
remaining reports describe a variety of symptoms, including 
injectionsite hypersensitivity, injectionsite edema or 
swelling, injectionsite pain, headaches, joint pain and 
itching. None of these diverse events, except for injectionsite 
reaction, can be attributed to the vaccine with a high level of 
confidence, nor can contribution of the vaccine to the event 
report be entirely ruled out. With the exception of 
injectionsite reaction, all of the adverse events noted above 
can occur in the absence of immunization.
    While the data gathered from the VAERS system can serve as 
a useful tool in identifying potential problems, the reports on 
anthrax vaccine received thus far have not raised any specific 
concerns about the safety of the vaccine. We appreciate the 
committee's interest in BioPort and the anthrax vaccine. FDA 
will continue to work with BioPort as we would with any 
manufacturer in an appropriate manner to resolve all situations 
involving pending submissions, inspectional issues and GMP 
compliance. Additionally, we will continue to monitor the 
adverse event reports that are submitted through VAERS.
    FDA continues to believe that the vaccine is safe and 
effective protection for those individuals at high risk for 
exposure to Bacillus Anthracis when used in accordance with the 
    My colleague and I will be happy to answer any questions.
    [The prepared statement of Mr. Elengold follows:]

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    Mr. Burton. Thank you. Mr. Elengold, how many strains of 
anthrax are there, do you know?
    Mr. Elengold. I could look it up in my notes, Mr. Chairman. 
But we have Dr. Friedlander, who's an expert in that. And if 
you don't mind, I'd defer to him.
    Mr. Burton. Sure. How many strains of anthrax are there?
    Colonel Friedlander. Let me say first that in my personal 
judgment as a physician and a scientist, and based upon working 
with anthrax, and having taken the vaccine myself for more than 
20 years that this vaccine is safe and effective, and it's the 
best vaccine we have available to protect against this disease.
    Mr. Burton. Thank you, Colonel, for that testimony. But 
what I'd like to know is, how many strains of anthrax are 
    Colonel Friedlander. So far as we know, anthrax is very 
uniform. Isolates appear to be essentially identical.
    Mr. Burton. We were told that there were 27 strains of 
anthrax. Is that not correct?
    Colonel Friedlander. That's not correct.
    Mr. Burton. There's only one strain of anthrax?
    Colonel Friedlander. No, there are multiple isolates and 
they're very closely related.
    Mr. Burton. Does the vaccine protect against all of them?
    Colonel Friedlander. All of them that have been tested in 
the best animal model, yes.
    Mr. Burton. And there has been extensive testing?
    Colonel Friedlander. Yes.
    Mr. Burton. Why is it the Institute of Medicine has stated 
that there is a lack of research to show the anthrax vaccine is 
safe and effective for inhalation exposure?
    Colonel Friedlander. I can't answer that without having a 
much closer look at that.
    Mr. Burton. You're not familiar with their report?
    Colonel Friedlander. I am familiar with the studies that 
we've done that have shown that it is effective in the best 
animal models.
    Mr. Burton. In the animal models?
    Colonel Friedlander. Yes.
    Mr. Burton. How many long term studies have there been in 
human beings?
    Colonel Friedlander. In terms of the studies in humans, it 
is unethical to do human challenge studies.
    Mr. Burton. So how do you know there's no problem with 
human beings? You're relying strictly on the animal studies.
    Colonel Friedlander. We have to, because of our inability 
to do such studies in humans, rely on the best animal models 
that reflect and are closest to humans.
    Mr. Burton. So there have not been any long term studies on 
human beings?
    Colonel Friedlander. Unless there was an episode or there 
were volunteer challenge studies, which would be unethical to 
    Mr. Burton. This is Dr. Arthur Friedlander, a senior 
military scientist, is here today.
    Mr. Elengold. That's the Colonel that's just been----
    Mr. Burton. Oh, I'm sorry, Dr. Friedlander, excuse me. You 
authored the only peer-reviewed efficacy study on anthrax in 
the 1999 edition of the medical textbook Vaccines. You wrote 
that the current anthrax vaccine is unsatisfactory for several 
reasons, including that there is evidence in rodents that the 
efficacy of the vaccine may be lower against some strains of 
anthrax than others. Did you write that?
    Colonel Friedlander. Those statements were made in 
reference to an idealized vaccine, a goal that we are all 
approaching. The critical, important qualities in terms of the 
vaccines are its safety and its potency. The vaccine was shown 
to be safe before licensure. And the best available vaccine is 
the one that we have.
    Mr. Burton. But you said the current anthrax vaccine, this 
was in 1999, is unsatisfactory for several reasons, including 
that there is evidence in rodents that the efficacy of the 
vaccine may be lower against some strains of anthrax than 
others. You said--I mean----
    Colonel Friedlander. I believe there is a followon 
statement in that very sentence that states that in the best 
animal model, the non-human primate, that the vaccine was 
effective against all the strains that were tested.
    Mr. Burton. But there was some question about it in the 
rodents that were tested, I guess.
    Colonel Friedlander. We believe the best animal model that 
reflects the human is the non-human primate.
    Mr. Burton. But you did have a different result when you 
dealt with rodents?
    Colonel Friedlander. We don't believe that that's the best 
model for humans.
    Mr. Burton. I hope you're right. I hope you're right. 
You've given out a lot of vaccine.
    Mr. Cragin. Chairman Burton, if I could just correct the 
record, sir. I think there may have been some confusion in your 
colloquy with Colonel Friedlander. He was talking about 
inhalation studies on humans, indicating that of course that 
would be unethical. You may have been talking about studies 
relating to reactions to the inoculation of the vaccine on 
    I just wanted to make sure that at least the record 
reflected that the colloquy may have been as a result of the 
    Mr. Burton. The study on the primates, with primates, that 
was through inhalation of the anthrax virus? OK.
    Let me ask you a question, Mr. Elengold. You said that they 
are not producing any vaccine at BioPort now because they have 
not passed all the requirements at FDA, is that correct?
    Mr. Elengold. What I said, Mr. Chairman, was they are not 
producing any products except, that in order to license a 
product, we require that a firm manufacture several lots to 
show that they can do so in GMP and consistently. They have 
manufactured some lots for that purpose, but none of them have 
been submitted for lot release.
    Mr. Burton. And they also have to be clean, pure and----
    Mr. Elengold. In order for any product to be released from 
that plant by the FDA, we have to resolve the potency test 
supplement, which is pending, we have to resolve the facility 
supplement, which is pending, and then they will have to submit 
the lots to us for individual lot release, testing, and 
ultimately lot release.
    Mr. Burton. The vaccine that's being used, or has been used 
by the military, 2 million shots, I guess, have been 
administered to 480,000 troops according to the testimony 
today, was that all manufactured before the current BioPort 
    Mr. Elengold. That was manufactured before the shutdown for 
    Mr. Burton. And how old are some of those lots?
    Mr. Elengold. Some of those lots I believe go back to about 
    Mr. Burton. So they're 5, 6 years old, some of them?
    Mr. Elengold. Yes.
    Mr. Burton. Have all those lots been tested by the FDA to 
make sure that there's no problem with them?
    Mr. Elengold. All lots, before they are released, are 
submitted, the batch records are reviewed, the testing by the 
manufacturer is reviewed and we then conduct certain tests on 
them. We do not have the capacity at the Food and Drug 
Administration to conduct the potency tests.
    Mr. Burton. How did squalene get into any of these lots?
    Mr. Elengold. We became aware of that a little over a year 
ago, after some publications and allegations. At that time, we 
conduced a second review of all the batch records and 
manufacturing at BioPort, and could not find any record of 
squalene in the plant or being used in any production.
    To check the allegations, we issued an assignment to our 
field organization to go out to the DOD depots and pick up both 
the lots that were mentioned in the Vanity Fair article, which 
were lots 20 and 30, as well as some other lots that we could 
find in those facilities. There was no reliable method for 
testing for squalene, in very, very minute quantities. The 
smallest methods we could find were in parts per million, a 
lower level than when it is used as an adjuvant. So we set 
about and developed our own test method in our laboratories, 
using our ability to set standards and obtain data on very 
minute quantities. We found, in lots 20 and 30 between 10 parts 
per billion and 20 parts per billion.
    Now, ``none'' is a changing term in science, unfortunately. 
Members of the Congress will remember the debates over the old 
Delaney amendment, which said that no part of a carcinogen 
could be in a food. And as science progressed from parts per 
hundred to parts per trillion, suddenly you were able to find 
things that were previously believed not there.
    Squalene is a naturally occurring substance that is present 
in every human body as part of the cholesterol processing 
chain. It's also present in fair amounts in things like olive 
oil. We found between 10 parts per billion and 20 parts per 
billion. As used in an adjuvant in the licensed Italian flu 
vaccine, it is used in levels that are 1 million to 2 million 
times that level. It is not unreasonable in a fermented product 
like AVA to expect some of the product in there to contain oils 
that are naturally occurring. These limits are so small that as 
I said, until we developed this test, the answer would have 
been ``none.''
    So based on the information that we looked at and found, 
and the fact that this is a naturally occurring compound in the 
human body, these extremely low levels, 1 to 2 millionths of 
which is proven to be an adjuvant, we decided was within the 
realm of both ``naturally occurring'' and ``safe.''
    In addition to that, there is much literature about the 
safety of squalene as an adjuvant and we can provide some 
papers from the literature to the committee on that.
    Mr. Burton. So there would be no adverse side effects 
because they found squalene in any of these batches?
    Mr. Elengold. As I said, at the levels of 10 and 20 and 30 
parts per billion, we do not believe that there would be any 
adverse effect, or that it is a different situation from what 
has occurred from this product from the first day it was 
    Mr. Burton. You said you believe that. Can you say 
categorically there would be no side effects from having 
    Mr. Elengold. No, sir.
    Mr. Burton. You can't say that. That was a very long 
diatribe you just went through, now you're telling me that you 
can't say categorically that it's not going to cause side 
    Mr. Elengold. As I said, Mr. Chairman, things in science 
are constantly evolving and levels of detection go down. I 
cannot categorically say that a certain test or certain data 
may become available at some point.
    Mr. Burton. Did the FDA ever tell authorities or anybody 
that there was no squalene in any of these vaccines?
    Mr. Elengold. No, sir.
    Mr. Burton. Nobody ever said that?
    Mr. Elengold. Not that I'm aware of.
    Mr. Burton. My staff expert here says that the FDA said 
that no licensed vaccine in the United States that is being 
used has squalene in it.
    Mr. Elengold. Squalene as an adjuvant, I believe was the 
entire sentence. Again, we're talking levels of 1 to 2 millions 
of something that's been found to be effective.
    Mr. Burton. Let me tell you something. I've heard these 
arguments about all kinds of vaccines. My grandson, I'm sure 
you've heard me talk about him before. He got nine shots in 1 
day and he received something like 40 some times the amount of 
mercury that is tolerable in a child in 1 day. And he's now 
    Now, I've had people say, my gosh, those microamounts of 
mercury probably wouldn't hurt. But you know, they took mercury 
off the market when it was in topical dressings, because they 
didn't want it to leach into individuals. But he's autistic, 
and they still have mercury in vaccines as well as aluminum and 
formaldehyde and other things that may cause problems.
    So when somebody says something like, you know, we don't 
believe this, I think we ought to be a little more specific. 
You just don't know if the squalene in there is causing a side 
effect, do you?
    Mr. Elengold. No, sir.
    Mr. Burton. Thank you.
    Now, let me ask you about the amount of vaccine that you 
have. You have to give these vaccines, as I understand it, over 
a period of what, about 2 years?
    Mr. Elengold. Eighteen months.
    Mr. Burton. Eighteen months. You give one shot and then you 
give it again in 30 days?
    Mr. Elengold. Two weeks.
    Mr. Burton. Two weeks. Then you give another one in?
    Mr. Elengold. Four weeks.
    Mr. Burton. That's three. Then you give another one in?
    Mr. Elengold. I have to take out my visual aide.
    Mr. Burton. In any event, you've run out of vaccine.
    Mr. Elengold. Six months, 12 months and 18 months.
    Mr. Burton. OK. Now, I've been told that the only way for 
the vaccine to be effective is for you to go through the entire 
sequence of events. And if you stop somewhere along the line, 
because you run out of vaccine, then the efficacy of the 
vaccine is very questionable.
    Now, what are you doing with all these people that have not 
received the entire regime of six vaccines? Do you start all 
over again? Any of you. Let's say you've given the three shots 
and you've run out of vaccine.
    Mr. Elengold. There is general guidance that is available 
from the Advisory Committee on Immunization Practices, which is 
general, not specific to the anthrax vaccine. So I want to 
stress that.
    Mr. Burton. I understand.
    Mr. Elengold. That in cases where it is interrupted for 
reasons beyond control, that it should be resumed at the point 
the series was stopped.
    Mr. Burton. Is that true for the anthrax vaccine?
    Mr. Cragin. Let me ask Dr. Jarrett Clinton, our Acting 
Assistant Secretary, to also elaborate on that, Mr. Chairman.
    Mr. Burton. Are you related to the President?
    Dr. Clinton. No, I'm not.
    Mr. Burton. It wouldn't make any difference, anyhow, I'm 
just curious.
    Dr. Clinton. We are following the advice of the Advisory 
Commission on Immunization Practices at CDC, as referred to by 
the FDA spokesperson. We are not deviating from the schedule, 
but we suspend the schedule when the active duty service member 
who's had the shots leaves the high risk area. We do that 
because we do not have sufficient vaccine. And as indicated in 
the opening statement, when we do have sufficient vaccine, we 
will pick up their schedule where they dropped off.
    Mr. Burton. But you don't start all over again?
    Dr. Clinton. We do not. That's on the basis of the 
recommendation from the Centers for Disease Control.
    One of the powerful things about the immune system is its 
memory. And we have studies, we don't need to go into great 
detail here, but basically, when we've had individuals who have 
only had one or two or three anthrax vaccines, as was the case 
in the Gulf war, and then follow them up a couple of years 
later and give them one or two shots, we find that 90 to 100 
percent of them respond rapidly to a 100fold increase in their 
antibodies level, because the immune system remembered that 
they are to respond again to that.
    So all of this is encouraging, that the subjective 
judgments made by the advisory committee are correct. And that 
is our plan.
    Mr. Burton. OK, I think you answered my question. You can 
pick it up where you left off. You don't have to start the 
whole series over again.
    Dr. Clinton. That's correct.
    Mr. Burton. And it will be just as effective against 
whatever strains of anthrax that we're talking about.
    Dr. Clinton. That's correct, Mr. Chairman.
    Mr. Burton. And that will be effective against all strains 
of anthrax?
    Dr. Clinton. Well, that's an interesting question. I think 
you've already heard some response on it. The anthrax disease 
works with an agent called PA. And our vaccine is an anti-PA. 
And any anthrax that has PA in it, we believe theoretically 
will work.
    Mr. Burton. You believe theoretically?
    Dr. Clinton. Well, in medicine, I can't say always or 
never. Because things are always changing. But everything we 
know, everything's that's biologically plausible in terms of 
even the genetically engineered anthrax, if they engineer to 
the point that the PA isn't there, then it's no longer anthrax, 
they've made some other kind of bug.
    Mr. Burton. OK.
    Dr. Clinton. We believe it's biologically plausible that 
it's effective.
    Mr. Burton. Thank you.
    You know, we've been told, and I have a whole host of 
questions, when my colleagues come, we'll have to let them ask 
some questions. But we've been told that there are a lot of 
biological agents that could be used in a battlefield situation 
to immobilize a potential enemy. You know, they used mustard 
gas in World War I, I believe, and they've used a lot of other 
agents. The sophistication of our potential adversaries has 
grown dramatically, i.e., Saddam Hussein and others.
    Are there other potential agents that could be used in lieu 
of anthrax in a battlefield situation?
    Major General West. Sir, I think the possibility certainly 
exists, that there are other biological agents that our 
potential adversaries either have or are trying to weaponize. 
What we know is, from our intelligence collection, is that 
there are several of them that have definitively pursued 
anthrax, and in some cases, we know they have it. In one case, 
we know that they deployed it on the battlefield, that they 
pointed it at our forces, and that their small unit commanders 
had permission to use it under certain situations.
    Fortunately, we have safe and effective protection against 
that biologic agent. We don't have safe and effective 
protection against all of them that are possibly out there. But 
this one, we do. And we truly feel we would be remiss not to 
use it.
    Mr. Burton. If you are a potential adversary of the United 
States, and you knew we had a vaccination against anthrax, 
would you go ahead and produce that kind of a weapon, or would 
you produce something else to attack our forces?
    Major General West. What we knew before we started the 
vaccine program was that they already had it, and they had it 
in great quantities. We knew that a lot of it had been 
produced. And we knew that if we didn't develop protection that 
they would be inclined to use it, if we got into a battlefield 
    So we went to the available protection that was there, that 
the people that our country depends on to say so, consider it 
safe and effective to use.
    Mr. Burton. I understand, General, but it just seems to me 
if I were an enemy of the United States and I knew that you had 
developed a vaccine, if it was effective, and of course there 
is some question about that, because it's never been fully 
tested, but I would probably opt for something else in the long 
    Major General West. I think it does keep them from using 
it, sir. There are an awful lot of civilians that will be glad 
they don't, too, because we have protection.
    Mr. Burton. Do you think we ought to immunize the entire 
civilian population with this vaccine?
    Major General West. I think when there's enough vaccine 
available that civilians that want it should be allowed to take 
it. And I personally would encourage my family members to take 
it, if it were available.
    Mr. Burton. You saw the problems with the people who were 
here today.
    Major General West. Yes, sir, I did. And I have the same 
kind of compassion for people that get sick or lose loved ones 
that you and the rest of the committee do. But when you take a 
population of half a million people and give them vaccine, some 
of them are going to go on to get sick. Eventually all of us, 
and I'm one of those half a million, are going to die. But that 
doesn't mean that everybody that gets sick or dies that that 
illness or that death was caused by the anthrax vaccine.
    In fact, sir, I think that one of the people that was here 
today that we spent the most time on, both the military 
hospital that reviewed his case, a civilian hospital that was 
called in to consult on that case, and the civilian AVEC review 
committee, determined that his illness was not related to the 
anthrax vaccine. And your staff knows that, and we saw it on 
the wall today. And there was a lot of emotion about that, as 
though anthrax vaccine caused Mr. Edwards' illness.
    Mr. Burton. You're saying Kevin Edwards was not affected by 
the vaccine?
    Major General West. I do not believe he was, sir. Neither 
do the experts at Brooke Medical facility or the experts at 
Emory University nor the civilian AVEC review committee. They 
all believe that it was non-related.
    Mr. Burton. Well, I think that's a matter of conjecture. 
Mr. Edwards and his father both feel that the onset of the 
problems he had came shortly after he had the vaccine. And 
they're convinced otherwise.
    Anyhow, we did have another person who testified today and 
we have his medical records from Walter Reed here. And it says 
that there's no question that it was anthrax intoxication that 
caused him his problem.
    Major General West. Of course, Mr. Colosimo's problem, the 
doctors do believe, was caused by the anthrax vaccine. And as 
Dr. Walker testified, occasionally that happens. It happens in 
very small numbers, and we wish it didn't happen at all.
    Mr. Burton. We had 10 people up there today.
    Major General West. Yes, sir.
    Mr. Burton. We had two ladies, one whose sister died and 
one's husband died. And we have the autopsy and the coroner's 
report. Then we had these others that had very similar 
experiences after getting the anthrax vaccine. Do you discount 
what they said?
    Major General West. What I would tell you, sir, is that of 
all the people that were here today, there is only one person 
that has a medical diagnosis that directly links it to vaccine. 
And that was only a portion of his medical problems.
    There was one other person here today that lost a loved one 
that one person said could be connected to the vaccine. There 
are other medical experts who believe it was not.
    Mr. Burton. Believe, believe, believe. But categorically, 
you can't say that they weren't caused by that. You can't say 
that about the gentleman that we had up on the screen who 
suffered dramatically as well and is losing his sight.
    But I don't want to get into a big long discussion or 
argument with you, General. I'd like to ask Mr. Cragin a couple 
of questions.
    You've been serving, I think in an acting capacity over at 
DOD what, for a couple of years now?
    Mr. Cragin. In various capacities, yes, Mr. Chairman.
    Mr. Burton. Have you ever been confirmed by the Senate? I'm 
just curious.
    Mr. Cragin. I have been confirmed by the Senate in a former 
    Mr. Burton. But not in this current one?
    Mr. Cragin. Not in the current one.
    Mr. Burton. How come you haven't appeared before them for 
    Mr. Cragin. I operate on the premise that the President 
hasn't chosen fit to nominate me.
    Mr. Burton. Oh, is that the only reason? I was just 
curious, because I hadn't heard.
    Mr. Cragin, I'm intrigued by this so-called evolution to an 
alterative acquisition strategy. What does that mean?
    Mr. Cragin. Let me ask Dr. Anna Johnson-Winegar to respond 
to that question, if you wouldn't mind, Mr. Chairman.
    Mr. Burton. Sure.
    Dr. Johnson-Winegar. Thank you, sir.
    As indicated in Mr. Cragin's statement, the Department has 
initiated some attempts to modify our acquisition strategy, 
since we admit that being in a situation where there is a 
single source for the anthrax vaccine is not the most optimal 
position for the Department.
    So the two steps that we have taken, that he indicated, are 
as follows. First, we advertised in the Commerce Business Daily 
for second sources, for other vaccine manufacturing companies, 
other biotechnology companies, other companies who may have an 
interest in getting into this business, to indicate their 
interest and willingness to become a second supplier of the 
current anthrax vaccine adsorbed.
    As he indicated, we received five positive responses. We 
are continuing to evaluate those and will pursue the time, the 
cost and the other advantages of those.
    A second step that we have taken is to initiate efforts to 
look at a Government owned-contractor operated vaccine 
production facility, as was referenced in Senator Hutchinson's 
statement, although he was not here this morning. We have begun 
the discussions and the planning and the conceptual thinking 
that would go into that, and would like to consider that as our 
long-term strategy for vaccine production.
    Mr. Burton. How long has there been an anthrax threat out 
there by a potential enemy?
    Major General West. We suspected for a number of years that 
the Soviet bloc, several members of that bloc, had anthrax 
    Mr. Burton. How far back?
    Major General West. I don't know the exact year, sir. But 
it's been several years. When we went into the Desert Storm 
conflict, we believe that Iraq already had it. We didn't know 
for certain that they had it until after the conflict was over. 
We reviewed the intelligence and documents and interviewed 
personnel, and the subsequent peace enforcement investigations 
were made.
    Mr. Burton. Well, this vaccine was licensed, what, over 30 
years ago? How come, with the possible threat of an anthrax 
attack, has it not been mandated for service people until now?
    Major General West. I can't tell you that one 
categorically, either, sir. I can tell you that as the years 
have gone by, we've become more aware of the threat. Once the 
Soviet Union dissolved and their scientists and our scientists 
sat down and talked about some of the things that they have 
made, we found out that the agent that was most lethal and had 
been made in the greatest quantities, was anthrax. And we found 
out some of the places that it had gone. And we found out that 
some of those places were our potential adversaries, and we 
wanted to give our service men and women protection.
    We don't want to make anybody sick or cause anybody to get 
deathly ill. But I also don't want to sit in front of you some 
day after we send a force in harm's way, have them run into an 
aerosolized anthrax exposure and explain to you why we had 
hundreds of thousands dead when we had protection available to 
keep them from dying.
    Mr. Burton. I was in the Army, General, and I understand 
the hierarchy in the military, the officers want to make sure 
the rank and file and people who are in combat are going to be 
protected. But because of the apparent side effects, which 
cannot be categorically denied here today, it seems to me as 
our subcommittee report requested in the findings, that every 
member of the armed services should be fully informed about the 
possible side effects and they should be able to either accept 
or reject the vaccine, because they are concerned about the 
potential side effects.
    And it seems to me that because we have never had long term 
testing, and I understand the reasons why you can't do that, 
because you haven't had long term testing, it seems to me that 
until you know more about it than you already do, that the 
members of the military ought to be made aware of the possible 
side effects, and be given some latitude in the decisionmaking 
    And to start talking about court-martialing people or 
giving them less than honorable discharges because they have 
not gone along with it, because they feel there's a threat to 
themselves or their families, and our report does indicate that 
there's some question about that, even if you don't agree with 
it, it seems to me that it's a constant drain on personnel. 
We've lost a lot of people in our reserve units, in our 
National Guard units. This issue is not going to go away.
    And as a result, the morale in many parts of the military 
is not as high as it ought to be. So I'd just like to say that 
I think the whole way you're handling this in the military 
ought to be re-evaluated. It ought to be changed. I know that 
you're recalcitrant, I know you aren't going to do what we want 
you to do, even though the Congress, this is supposed to be a 
civilian government and the Congress is supposed to have some 
say in what's going on in the military.
    But in any event, the Secretary of Defense and the 
President and everybody said, we're going to go ahead with 
this. And the bit's in the teeth, and you're going to go ahead 
with it.
    Major General West. May I respond?
    Mr. Burton. Yes, I'll let you respond. But I really think 
that the members of the military ought to have more 
information, more of a say. I know what you're going to say 
next, that you've got to have them all inoculated, because 
you're going into a combat situation, you can't have people 
half inoculated and half not, because you'll lose half your 
force, that would be a very difficult thing to control. Is that 
what you're going to say?
    Major General West. That would be part of my answer.
    Mr. Burton. I thought so.
    Major General West. It would be very, very difficult to 
take care of the half of your force that wasn't vaccinated, and 
it would keep the half that was vaccinated busy taking care of 
them when they could be fighting and winning on the 
    Mr. Burton. Seems to me the only people you'd put in a 
combat situation were those that, if you thought you had that 
kind of threat, that would have been inoculated.
    But in any event, I don't want to get into a big, long 
dissertation or argument. We have 5 minutes on the vote, and 
I've got to go back over there. And I don't want to keep you 
all day.
    Let me just say that we would like to submit to you, Mr. 
Cragin and Mr. Elengold, all of you, a series of questions. We 
would really appreciate it if you could answer those as quickly 
as possible.
    We will probably have more hearings on this, but we want to 
make sure we get as much information from you as possible, so 
that they'll be productive.
    And with that, we want to thank you very much for being 
here, and we will be submitting questions to all of you. We 
hope you will respond. You will respond, will you not?
    Mr. Cragin. We look forward to receiving them, Mr. 
    Mr. Burton. Thank you.
    With that, I ask that my opening statement and other 
documents that we want to put in the record be put in the 
record. Without objection, so ordered.
    Thank you very much. We stand adjourned.
    [Whereupon, at 3:32 p.m., the committee was adjourned, to 
reconvene at the call of the Chair.]
    [The prepared statement of Hon. Tim Hutchinson and 
additional information submitted for the hearing record 



























































































































                      WEDNESDAY, OCTOBER 11, 2000

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10 a.m., in room 
2154, Rayburn House Office Building, Hon. Dan Burton (chairman 
of the committee) presiding.
    Present: Representatives Burton, Gilman, Morella, Shays, 
Ros-Lehtinen, Horn, Souder, Terry, Chenoweth-Hage, Norton, 
Cummings, Kucinich, Tierney, and Schakowsky.
    Also present: Representatives Shimkus and Jones.
    Staff present: Kevin Binger, staff director; David A. Kass, 
deputy counsel and parliamentarian; Thomas Bowman, senior 
counsel; S. Elizabeth Clay and Gil Macklin, professional staff 
members; Robert A. Briggs, clerk; Robin Butler, office manager; 
Michael Canty and Toni Lightle, legislative assistants; Josie 
Duckett, deputy communications director; Scott Fagan and John 
Sare, staff assistants; Leneal Scott, computer systems manager; 
Corinne Zaccagnini, systems administrator; Sarah Despres and 
David Rapallo, minority counsel; Ellen Rayner, minority chief 
clerk; and Earley Green, minority assistant clerk.
    Mr. Burton. Good morning. A quorum being present, the 
Committee on Government Reform will come to order.
    I ask unanimous consent that all Members' and witnesses' 
written opening statements be included in the record.
    Without objection, so ordered.
    I ask unanimous consent that all articles, exhibits and 
extraneous or tabular material referred to be included in the 
    Without objection, so ordered.
    During last week's hearings, we heard from four men whose 
lives have been forever changed while serving in the military 
and taking the anthrax vaccine. Tom Collossimo, John Irelan, 
Kevin Edwards and Joseph Jones may never fully recover from 
their current health conditions. And yet, all except one of 
these men, who were very healthy prior to receiving the anthrax 
vaccine, are being told there is no evidence to prove the 
vaccine is connected to their illnesses. I believe one of them 
during dinner last week had a seizure, did he not? He had a 
seizure. Did he have to be taken to the hospital? No.
    Since our hearing, one of these men--I guess it is in my 
statement here--since our hearing, this gentleman had a grand 
mal seizure and another fell as a result of his medical 
condition and required five stitches.
    Major General West sat here last week and told us that 
several groups of experts reviewed Kevin Edwards' medical 
information and determined that the anthrax vaccine was not the 
cause of his illness. What he failed to share with the 
committee was that the documentation provided for the 
evaluation of Kevin's condition was incomplete.
    Of the nine key questions on the form the Anthrax Vaccine 
Expert Committee evaluated, six were marked unknown. I find it 
troubling that this expert committee would rule out the 
possibility that the anthrax was linked to an adverse event 
when they did not have information on 60 percent of the key 
    Last week, we also heard from two individuals who lost 
loved ones in the last year. Nancy Rugo's sister was certain 
the anthrax vaccine caused her illness and impending death. 
Mrs. Barbara Dunn's husband worked at Bioport and received 11 
anthrax vaccine shots. After each dose, he suffered an adverse 
reaction. The Bioport physician was so concerned about Mr. 
Dunn's previous reactions that the dose he received was split 
in half and the halves delivered a week apart.
    Yet the Defense Department believes the individuals who 
testified last week and their loved ones were not injured by 
the anthrax vaccine.
    Last week Mr. Charles Cragin testified before our National 
Security, Veterans Affairs, and International Relations 
Subcommittee that because they are volunteers, no individual 
who is in the Guard or Reserve was going to be subjected to any 
penalties. Today we will hear from three individuals the truth 
of what is really happening in the field and how it is 
affecting military readiness.
    Lt. Colonel Tom Heemstra was a commander and pilot for the 
163rd Fighter Squadron in Fort Wayne, IN. While significantly 
lower numbers have been reported up the chain of command, 
Colonel Heemstra is aware of 21 pilots leaving the 163rd 
Squadron. To date, two of these pilots chose to return to the 
unit and were forced to take the vaccine as a show of loyalty. 
So far, 14 replacements have been hired. Many of these 
replacements require extensive training to be ready to fly the 
    Colonel Heemstra was grounded, forced out as commander and 
forced into retirement. All of these actions ended an exemplary 
20-year military career that began at the Air Force Academy.
    Captain Dan Marohn, also an F-16 fighter pilot in the 163rd 
Fighter Squadron, refused to submit to the anthrax vaccine. As 
a result, he was given the choice between a court martial and 
an Article 15 non-judicial punishment. He was fined and 
threatened with a jail sentence. Many others who did not have 
commitments simply resigned. Others transferred to non-
deployment positions to finish their time until retirement.
    Pat Ross, an Air Force Academy graduate, spent 16 years as 
a fighter pilot in active duty in the Air Force and 3 years in 
the Air National Guard. He was the squadron commander of the 
172nd Fighter Squadron in Battle Creek, MI. The 172nd Squadron 
was told to take the vaccine or leave the unit. The staff judge 
advocate told his squadron that if they refused to take the 
shot, they would be discharged with a less than honorable 
discharge. While the deadline to take the vaccine was postponed 
and no pilot has yet been ordered to take the vaccine, 15 
pilots resigned or left the unit.
    Because of Secretary Cohen's decision to mandate the 
anthrax vaccine, we have lost a substantial number of pilots 
and aircrew members. These pilots and aircrew members are 
essential to our military readiness. They are the backbone of 
every military operation. Without our Air National Guard and 
Reserve, the U.S. military would be unable to respond to any 
national security threat or emergency.
    The Air Force estimates that it takes about 9 years and 
almost $6 million to train and develop a fully qualified and 
experienced aviator. The General Accounting Office is providing 
results of their survey of Guard and Reserve pilots and aircrew 
members. I hope everybody listens to their report today, 
especially those at the Pentagon and the military. They learned 
that the adverse events for those who have taken the vaccine 
were much higher than has been reported to this committee. They 
learned that there is little support for a vaccine approach to 
biological warfare protection.
    Twenty-five percent of the pilots and aircrew members of 
the Guard and Reserve who were surveyed have transferred to 
another unit, left the military, or moved to inactive status. 
Anthrax was the main reason for one-fourth of these departures.
    What is more disturbing is that another 18 percent of these 
individuals plan to leave the service in the next 6 months; 61 
percent of those individuals stated that the anthrax vaccine 
was the main reason. So whether the Defense Department wants to 
admit it or not, with a potential loss of 43 percent of our 
Guard and Reserve pilots and aircrew members, we have a serious 
readiness problem.
    The written testimony provided by the Defense Department is 
a regurgitation of previous statements and completely ignores 
the topic of this hearing, readiness and retention. They state 
that for men and women who choose to serve their country, they 
do so in the knowledge that service is an honor. They go on to 
State that failure to provide protection against anthrax would 
be a dereliction of duty.
    Was the Department's failure to provide functional masks 
and suits a dereliction of duty? Is the Department's failure to 
fully inform the troops of the risks and benefits of the 
vaccine prior to the vaccination a dereliction of duty?
    When under scrutiny, the Department's first action was to 
attack the veracity and integrity of the accusers and their 
data. When the men and women in our Armed Services, individuals 
who have volunteered to give their lives to protect this 
country if necessary, questioned Secretary Cohen's program, 
these men and women were portrayed by the Defense Department as 
    The Defense Department has insulted the honor and integrity 
of anyone who has dared question the anthrax vaccine program. 
We have had numerous Air Force Academy graduates testify before 
the committee. I wonder how many malingerers manage to graduate 
from the Air Force Academy?
    It is clear that the anthrax vaccine program is the wrong 
approach to protecting our troops. We will hear today from Dr. 
Stephen Porter, the president and chief executive officer of 
Virtual Drug Development, Inc. He will offer another approach 
to providing force protection, a pre-exposure antibiotic.
    It is important that the Defense Department aggressively 
develop other means to protect our forces. We need functional 
protective suits and masks that are not defective and that will 
offer real protection for both biological and chemical threats. 
We need effective detection equipment, and our strongest 
protection against anthrax or any other biological and chemical 
threat is a strong defense ready to respond to any threat or 
    The hearing record will remain open until October 25.
    I now recognize my good friend, Mr. Kucinich, sitting in 
for the minority ranking member, Mr. Waxman.
    Mr. Kucinich. Thank you for holding this hearing. I think 
the question is well put as to whether or not this FBI program 
    Mr. Shays. Is the gentleman's mic on?
    Mr. Kucinich. Testing. It is. Thank you very much, Mr. 
    Mr. Shays. Maybe you could start over.
    Mr. Kucinich. I want to thank the Chair for holding this 
hearing. I think the Chair's concern here is well taken. The 
American people need to know whether or not this vaccination 
program is affecting the readiness of our Armed Forces. In 
particular, we need to know why members of the Armed Forces are 
not supporting this particular--the troops do not support this 
program because of concerns about adverse reactions.
    I think the questions that are being raised here in the 
committee are important and serious, and I look forward to the 
testimony of the witnesses.
    Mr. Burton. Thank you, Mr. Kucinich. Mr. Shays, do you have 
an opening statement?
    Mr. Shays. I do, Mr. Chairman. One year ago, the National 
Security Subcommittee, which I chair, held a hearing on the 
impact of the Anthrax Vaccine Immunization Program [AVIP], on 
Reserve component readiness, retention and morale. The 
Department of Defense [DOD], position then was essentially one 
of blissful ignorance. DOD had no data on how many National 
Guard and Reserve members were leaving due to concerns over the 
vaccine, had only the vaguest plans to collect any data on the 
question, but concluded nevertheless the impact of the 
controversial program was negligible. Those are their words.
    My dictionary defines negligible as ``so small or 
unimportant or of so little consequence as to warrant little or 
no attention.'' It appears DOD continues to believe the problem 
can be ignored, despite abundant and growing evidence of 
opposition to the anthrax vaccine effort.
    Today, we will discuss new data supporting the conclusion 
many reached long ago: The AVIP is having a substantial, 
detrimental impact on Reserve component readiness, retention 
and morale. The implications of the General Accounting Office 
[GAO], findings cannot be difficulties missed, diminished or 
defined away. Critical elements of Reserve component units are 
being rendered unready to perform their missions, and that lack 
of readiness is directly attributable to the AVIP.
    This data can be of no surprise to the DOD. The purposeful, 
and I stress, the purposeful failure, to gather information 
cannot excuse the consistent effort to mislead, misinform, and 
ignore readily available evidence of the program's drain on 
readiness. I, for one, am tired of the official dissembling on 
this issue. We want the truth. We want the truth. To the extent 
DOD acknowledges any Reserve component attrition to the anthrax 
program, blame is placed on inadequate communication of the 
threat and the response. But the survey results we will hear 
today point to a genuine lack of trust in the product, not the 
packaging. It will take more than a revamped Web site to 
address the legitimate concerns of those being asked to risk 
their civilian livelihoods in a force protection experiment, 
and that is what this is, an experiment.
    Behind these numbers are loyal, dedicated and skilled men 
and women who want to serve their Nation. They deserve to be 
    Mr. Chairman, I thank you for holding these hearings. I 
thank you for the hearing we had last week. But I want to say, 
my committee has had a number of hearings on this issue, and I 
sincerely believe the military is being blatantly untruthful to 
us. I believe this program is destroying our readiness. I 
believe that it must stop.
    Mr. Burton. I thank the gentleman from Connecticut. I want 
to say, the committee has held a number of hearings, but he has 
done yeoman service to this country and to the committee with 
his subcommittee chairmanship by really working on this. I 
really appreciate your hard work.
    I would like for the witnesses to stand now to be sworn.
    [Witnesses sworn.]
    Mr. Burton. We have Mr. Heemstra, Mr. Marohn, Mr. Ross and 
Dr. Porter. Let's start with Mr. Heemstra. We will go right 
down the line here. We would like for you, if you can, to keep 
your comments to 5 or 6 minutes. But if you run over, we will 
be lenient. But try to be as concise as you can. We want to 
hear your whole story.


    Mr. Heemstra. First, thank you on behalf of the backbone of 
our military force, the Enlisted Corps, and many of our 2.4 
million troops who do not, I repeat, do not support this 
anthrax shot program. I speak for them, because they cannot 
risk their career to speak out, but they thank me almost every 
    Thank you for the opportunity to address you. Focusing on 
Fort Wayne, the 163rd Fighter Squadron, in terms of readiness, 
retention and morale. My qualifications: I testified before the 
subcommittee in September last year. My background, a 20-year 
military career beginning at the Air Force Academy, where I 
received the best honor, ethics and leadership training 
available anywhere in the world. My career is highlighted by an 
opportunity to serve at Fort Wayne as the 163rd Fighter 
Squadron Commander.
    Many Guard and Reserve pilots sent you a message when they 
voted with their feet. We lost 260 pilots, from 12 percent of 
the units so far, which means we will lose 2,100 if this shot 
program continues. That will be $10 billion lost in training 
cost for a $130 million shot program, plus invaluable combat 
experience gone.
    DOD is either in denial or a coverup operation. In 
September, their answer under oath was ``only one quit from the 
Guard because of the shot,'' despite signed affidavits and 
testimony before Congress of eight resignations from 
Connecticut, and at that time seven pilots chose to leave at 
Madison. I estimated we would lose 15 to 20 at Fort Wayne. 
Within 1 week, 22 left from Memphis and decided not to take the 
biological oath of loyalty to this shot program. Plus 30 were 
lost at McChord, 20 at McGuire, 60 at Dover, and 50 at Travis. 
Wow. Wow.
    Let's not argue numbers any more. How about names, real 
people, faces, that I clearly see of my men who gave up on 
trusting their leadership and voted with their feet. Their 
names are represented by the coded initials on the graphic to 
protect their privacy in their followon careers. Can we have 
that graphic, please?
    These are the men who are gone. Twenty-one. Note the 
leadership at Fort Wayne falsely reported to GAO and the media 
that only 9 left, versus the 21 that are really missing. Two of 
these changed their mind, came back and agreed to take the shot 
reluctantly. But then, after the shot policy changed, the 
leadership offered to give them special permission, a waiver, 
to now violate current DOD policy and give them the shot 
    If I could have the next slide, please.
    If DOD or Fort Wayne wants to argue or fudge the numbers 
again, let's look at it another way, who they had to hire to 
replace the departed. They hired 14. Notice they still have 
five vacancies. But out of those 14, many were at various 
stages of flying currencies and qualifications, requiring some 
to attend formal F-16 schools, and, as I said, they still have 
five vacancies. Needless to say, a rebuilding program. Plus, 
two of the top three flying leadership positions are being 
filled and have been for most of the last 2 years with officers 
who are not even flying.
    For a real world deployment to Saudi Arabia, they had to 
get six pilots from two other bases in order to fulfill their 
obligation. Now, imagine this happening on a grand scale 
nationally, and you will get a picture of what I was trying to 
tell the subcommittee last September and warn my leadership of 
at Fort Wayne.
    Finally, the troops thank you for your courage, integrity 
and leadership on this issue. America's sons and daughters 
needed a voice in Washington. You heard, you listened, you 
acted to protect them and spoke the truth, despite whatever 
political, economic and career pressures you faced. The exact 
opposite approach and behavior from DOD has eroded, if not 
destroyed, their trust in military leadership. And rightfully 
so. DOD misled you, the Congress, the GAO, the American people 
and their own troops. They have betrayed the trust of us all. 
Webster defines that as treason.
    The arrogance of power and the abuse of power seemingly 
have elevated them above the truth and above the law, causing 
them to use an experimental, adulterated drug for an off label 
use on a large scale vaccination program, violating FDA 
protocol in administering it, while the FDA discovered a 
substance not approved in the vaccine, which DOD also denied, 
and then calling us conspiracy theorists or Internet 
    Further, they coerced, intimidated, threatened and punished 
in order to enforce this program. Reference my written 
testimony and chronology up through the present date, and my 
colleagues' testimony dating back to the Connecticut eight 
    One of my pilots, Captain Dan Marohn, sitting next to me, 
was even threatened with jail time after the policy was changed 
and he was no longer required to take the shot. They punished 
me by forcing my resignation as Squadron Commander before I 
testified. After I testified, they illegally grounded me. They 
damaged my personnel file and performance reports and forced me 
into retirement now, against my wishes, and in direct contrast 
to what the Headquarters Air Reserve Personnel Center says and 
    These actions clearly violate Whistleblower Protection 
laws, Title 10, U.S. Code, DOD Directive 7050.6 and Article 92 
of the UCMJ. These offenses and punishments are inconsistent 
with Assistant Secretary of Defense Cragin's declaration under 
oath that people in the Guard would not be punished for 
resigning and not taking the shot.
    On January 2, I filed an Inspector General report with the 
Secretary of Defense's office citing these violations, and have 
been largely ignored for the better of 6 months. Perhaps the 
Attorney General would enforce the laws that our DOD has 
    If DOD had listened to your committee when you called for a 
halt to the program, we would not have experienced the upheaval 
at Fort Wayne and Battle Creek. If they had listened 6 months 
ago, when you inferred that it was an illegal order, we would 
be well on our way to restoring the faith, trust and integrity 
our military institution absolutely requires, and out of that 
comes good order and discipline.
    If the lessons learned from the Rockefeller Report had not 
been ignored after the Gulf war, this abuse of power might have 
been checked. And if only we had received support from your 
colleague, the chairman of the Personnel Subcommittee, who went 
on record twice saying that DOD is using this vaccine in a 
manner other than it was what approved for, we might have ended 
the abuse. The FDA's term for that off-label use is 
``investigational,'' and that requires informed consent by law. 
This was a lost opportunity to be a watchdog and a defender of 
our military troops.
    But we now know the recipe for executing an illegal order 
and the results that follow: First, pick a bad policy that 
ignores U.S. law, FDA regulations, the historical and ethical 
lessons of Nuremburg, Agent Orange and radiation testing, that 
ignores basic human rights, congressional declarations of 
unlawful, ignores sick and injured people, Gulf war illness, 
improper influence and corruption in the acquisition process, 
and that ignores lack of testing and quality control standards 
consistent with historical failure of the program and lack of 
proven necessity, and then apply it on a massive, grand scale; 
add fear, intimidation, coercion, punishment, greed, careerism; 
throw more money into it, add politics to it, put it in the 
hands of some powerful, and the result is a travesty.
    I actually predicted the results of this policy failure 
last September when I said we will lose 1,000 to 2,000 pilots. 
We are on schedule to lose 2,100 if this program continues. I 
said we will lose 25 to 60 percent of our pilots at Fort Wayne, 
and we lost 55 percent. I said we will have sick people. Many 
of these will remain secretly sick to protect their careers. I 
said we will have a breakdown in trust. Correction, I should 
have said meltdown. I also said we are the guinea pigs. We know 
it, and so do you, and now the FDA has proved it.
    What can be done? Three things. No. 1, restore faith in the 
system. Protect your troops with legislation, since military 
careerism won't. Halt this program immediately based on its 
grandiose failure.
    No. 2, establish a process for safe acquisition of 
necessary, proven by the threat, force protection measures that 
will be effective and with full FDA oversight, regulatory 
authority and accountability for all vaccinations so we never 
go down this road again.
    And, No. 3, completely restore through funding, medical 
assistance and blanket immunity, all who were injured by this 
program, physically, medically, and occupationally, in their 
professional military careers. Please protect our military 
against future abuses of power.
    [The prepared statement of Mr. Heemstra follows:]

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    Mr. Burton. Thank you, Mr. Heemstra. We have been joined by 
a number of our colleagues. I think Chairman Gilman did have an 
opening statement. Do any others have opening statements? Would 
you raise your hand if you have a comment you would like to 
make. If not, we will recognize the chairman of the 
International Relations Committee, Mr. Gilman, and then we will 
get back to the witnesses.
    Mr. Gilman. Thank you very much, Mr. Chairman. I regret I 
was delayed. I had to open up our International Relations 
Committee that is examining our peacekeeping missions abroad 
and the policies involved therein, and I will have to return to 
that committee. But I want to thank you, Chairman Burton, for 
convening this morning's important hearing to review the 
Department of Defense mandatory anthrax vaccination program's 
effect on readiness.
    I want to thank subcommittee Chairman Shays, who has 
conducted an ongoing investigation with regard to this program.
    This morning we will be hearing, in addition to the pilots 
who are before us from the Reserves, the General Accounting 
Office, which is ready to report the preliminary result from 
their study, a study that I joined with our chairman in 
requesting. The GAO study examined the vaccine program's effect 
on morale and retention in our Reserves and National Guard 
units, and when this issue was first brought to our attention 
last year, brought to my attention by service personnel in my 
own congressional district, where we have a significant Air 
National Guard unit that flies our C-5's around the world, I 
feared that Air, Guard and Reserve pilots would be leaving the 
service in droves, rather than receive the shots, just as the 
gentleman before us now has indicated.
    As we will see this morning, this has happened throughout 
our Nation. I fully expect that the Department of Defense will 
continue to maintain its official position that the program has 
not had any detrimental effect on readiness.
    Throughout the life of the program, the Pentagon has 
maintained a ``see no evil'' approach to personnel separations. 
It is an unbelievable approach. Instead of examining the facts, 
they are trying to bury the facts. The reality is that we have 
a volunteer military that is heavily dependent on Guard and 
Reserve personnel for rapid deployment of forces overseas, as 
well as for sustained theater air operations. Without Reserve 
and Guard pilots, further deployments can literally not get off 
the ground.
    Many of the pilots who have left come from vital C-5 
transport units. Had the vaccine been implemented at Stewart 
Air Force Base near my congressional district, more than half 
of the pilots were prepared to resign. I mention that from 
information, direct information that I have received.
    When combined with the situation at Travis and Dover Air 
Force Bases, the Air Force airlift capabilities would have been 
severely impacted.
    The public relations campaign being waged by the Pentagon 
refutes this. The official message is that the majority of 
troops are taking the vaccine with only a small minority of 
disgruntled individuals refusing. It bears noting, however, 
that the Pentagon only lists active duty shot refusers in their 
public estimates. National Guard and Reserve members have been 
fully ignored.
    From the evidence I have reviewed, each National Guard base 
that begins to implement the vaccination program suffers 
attrition among its pilots that has been consistently averaging 
between 20 to 40 percent. This is not rumor, it is reality. Yet 
it is a reality that the Pentagon apparently refuses to accept.
    Irrespective of this, however, is the fact that our 
military, with its current quality of life problems, coupled 
with an unparalleled rate of deployment under the 
administration, cannot afford to continue losing highly 
qualified personnel from its Reserve and National Guard units. 
Regrettably, this fact does not appear to be a consideration of 
the current administration, which still maintains that any 
potential benefit of the program far outweighs the possible 
costs involved and its implementation.
    It is my opinion that while this program began with good 
intentions, it was initiated in a hasty matter before a proper 
amount of research on the efficacy and safety of the vaccine 
was completed. Moreover, the Pentagon has gone to great lengths 
to avoid getting a true picture of the number of adverse 
reactions and the impact that it has had on readiness. It would 
not be unfair to say that DOD officials have also engaged in 
the sustained pattern of deception regarding their testimony 
before Congress on this issue. Having served as a member of 
Representative Shay's subcommittee in the 105th Congress during 
his investigation of the Gulf war illness issue, I learned to 
view testimony from the Pentagon with a healthy dose of 
cynicism. I was pleased to see that the subcommittee report 
reached many of the same conclusions which led me to introduce 
legislation to halt this program until further study of the 
safety and effectiveness of the vaccine had been completed.
    Moreover, while the Armed Services Committee chose not to 
act upon my legislation, the language calling for independent 
studies was included in the fiscal year 2000 defense 
appropriations conference report. I might add that today we 
have the defense authorization before us in the full Congress, 
and, you know, this kind of approach can affect our overall 
approach to what the Defense Department needs and we want to 
support the Defense Department in their needs. But I am going 
to ask our officials in the Defense Department who are in 
charge of this program to truly examine the facts and make 
certain we are moving in the right direction.
    I was pleased to see that the General Accounting Office and 
the Food and Drug Administration have chosen so far to take an 
independent critical look at both the program, its effect on 
readiness and the manufacturing process behind the vaccine, a 
process that leaves a lot to be desired.
    It also bears mentioning that throughout this process, DOD 
officials have taken pains to avoid responding to the charges 
leveled in the report approved by this committee with anything 
beyond the official boilerplate response. Not once, to my 
knowledge, has anyone from DOD questioned the science behind 
the criticisms of this program.
    Furthermore, DOD claims, especially those relating to the 
number and percentage of systemic adverse reactions, increased 
after intense scrutiny was placed on the program. These issues 
have made reaching an effective solution to the problem 
extremely difficult.
    I cannot understand also the loss of records, pertinent 
records, with regard to this situation. DOD has been unable to 
provide medical records that we have requested saying they have 
been lost someplace, lost despite the confidentiality of some 
of those records.
    Once again, Chairman Burton, thank you for convening what I 
consider a very important hearing, important to our reserves, 
important to the security of our Nation.
    Mr. Burton. Thank you, Chairman Gilman.
    Mr. Souder, did you have an opening statement?
    Mr. Souder. Yes, I would like to make a few comments, and 
ask that this statement be inserted in the record.
    Mr. Burton. Without objection.
    Mr. Souder. This has been of particular concern to me 
because the Fort Wayne Air base has clearly been one that has 
been talked about nationally because we had some people of 
courage who stood up early on. I met with people from other 
bases as well. But in many cases, they did not speak out or as 
many would speak out as they did in Fort Wayne.
    But I want to make a couple of general points as well. As 
Lt. Colonel Heemstra pointed out in his testimony, in his 
chronology here, part of our problem in Fort Wayne and part of 
my problem as a Congressman is I am worried I am going to get a 
retaliation and get my base transferred.
    Colonel Heemstra has been through this once before, where 
they made an illogical attempt to move the F-16 base out of 
Fort Wayne. I would argue that even with this problem and with 
the Federal Government making it more difficult to retain 
pilots, if this base is not in Fort Wayne and instead goes to a 
less populated area, they would not have even been able to 
replace the pilots that were replaced in Fort Wayne because you 
need a populous area with which to attract pilots who are 
working in another job.
    So not only is Lt. Colonel Heemstra concerned about 
retaliation, I am concerned about retaliation in my district 
for speaking out early on and saying this should have been 
voluntary and I had deep questions.
    Second, one of the challenges that is faced by the local 
commanders in Fort Wayne is they also want to keep the base 
there. They are trying to figure out how to keep their units 
staffed, they are trying to do their duty as officers. That has 
been compounded by a poor decision by the Federal Government. I 
am one trying to work through both sides. I have a full base 
there of people who have been trying to implement the program 
that is ill conceived, but their duty is they believe to 
implement that program. They have at least tried to keep track 
of those health cases where they have had problems, and they 
are doing the best they can with competing demands, both at the 
grass roots level from their employees, and from the national 
system as a whole that is demanding the anthrax shots.
    Third, in addition to the people that have been referred to 
here, let me just say I have talked to many individuals, they 
catch me at church, they catch me at soccer events, airports, 
pilots who have stayed in, personnel who have stayed in, who 
are scared. Part of the reason they are scared is they saw what 
happened in the Gulf war and may have actually been complicated 
by anthrax shots there, and their concerns are if they have 
other jobs, if they are pilots in other places and doing this 
as a volunteer service, if later on we learn that anthrax had 
effects on their ability to get health insurance, is the 
government going to stand behind them?
    There is no clear evidence right now that the government is 
going to in fact stand behind them or acknowledge there are 
problems. The fact is, none of us really know for sure what the 
impact of this anthrax is combined with other shots.
    We hear some cases, and there appear to be some problems, 
we don't know how wide and extensive it is, and data is still 
coming in. But when I had a young pilot of 28 who came to me 
and said I have three kids, my income is working for, I forget 
whether it was United or USAir, an airline, he said can you 
guarantee me if something happens I am not going to lose my 
health insurance later on or lose my primary source of income?
    What can I tell him? Of course not. We are the Federal 
Government. We don't guarantee anything down the road. It is a 
very difficult situation for those young pilots whose lives are 
at risk.
    Sometimes it seems right now that the government is more 
concerned about the risk aversion for the government than a 
risk aversion for the very people who have decided to defend 
our Nation, and that is backward. It has happened in the anti-
terrorism area where we seem to be so worried about somebody 
getting blamed that we overreact sometimes because we are 
worried more about blame protection and future lawsuits to the 
Federal Government.
    So I want to thank the individuals who stood up. This has 
been a very difficult process for all of us. I hope that we 
would change our standard and say that if we don't expect 
civilian members of our government to be forced to take this 
shot, if we could not have this pass an FDA test, then why in 
the world would we have those volunteers who are willing to 
sacrifice for our country have to have this mandatory test?
    I yield back.
    Mr. Burton. Thank you, Mr. Souder. Do other Members have an 
opening comment or statement they would like to make?
    If not, we will return to the panel. We go to Mr. Marohn. I 
am not using your rank correctly, you are a Lt. Colonel?
    Mr. Heemstra. Yes.
    Mr. Burton. And you are----
    Mr. Marohn. Captain.
    Mr. Burton. I was an enlisted man, so I have to show 
deference to you guys.
    Mr. Marohn. My testimony today is emblematic of what is 
occurring to thousands of U.S. military personnel with regard 
to the AVIP. I come here today to speak for all those men and 
women in uniform who wonder when they awaken each day, whether 
they have in effect been made into guinea pigs by a Nation for 
which they would have freely given their lives to protect and 
    I come here today to speak for those who reluctantly 
submitted to a controversial immunization because they felt 
they had no other option.
    I was an F-16 aviator at the 163rd Fighter Squadron at Fort 
Wayne, IN. My performance reports, my awards and decorations 
and my leadership assignments all indicate I was an excellent 
pilot and officer. In civilian life I am a pilot for a major 
    My pilot training carried with it a service commitment that 
would not allow me to resign prior to the completion of that 
commitment. When I refused to submit to the vaccine, I was 
grounded, given the choice between a court martial or Article 
15, and fined, threatened with 329 days in jail if I did not 
pay that fine. Many others also refused the immunization. Most 
were able to resign. Some transferred to other assignments to 
complete their military careers and retire. But those of us 
under service commitments could only comply or face the most 
severe punishment.
    After being made aware we would have to submit to the 
vaccine and listening to Dr. Meryl Nass make her presentation 
in the spring of 1999, we felt compelled to step up our 
research on the vaccine and the implementation of the program. 
We learned that there were real and valid concerns about safety 
and quality control methods of the lab that produces it, and we 
learned that many in our military are living in fear, as 
mentioned by all of you.
    They feel they have no choice but to keep quiet and take 
the shot, because their commanders will not listen anyway, and 
if the commander is willing to take a stand against the 
program, he or she too runs the risk of punishment and/or 
    Careerism over good leadership and integrity is eroding our 
military. Every day more and more military people are losing 
trust in the institutions and the Nation that they have taken 
an oath to defend. My own case is illustrative.
    On December 5, 1999, our squadron received the verbal order 
to comply. The policy letter was ambiguous as to what action 
would be taken against those under commitment that refused. A 
letter requesting clarification was equally ambiguous. In the 
first or second week of January 2000 I received a call from my 
Ops Group commander asking if I was going to take the shot. I 
told him that I probably would not take it, but I would give 
him my final decision by February 13, the deadline to decide. 
About that time, I received a written order to comply dated 
January 8, 2000. The order said that violating the order may 
result in punishment.
    On or about January 9, anyone that had not given an 
affirmative response to take the shot was grounded. Please make 
a note, this was a full month before the deadline. I was told 
this action was taken to ``save our resources for the guys that 
are going to take the shot and deploy.''
    Please note that this occurred while--I already said that. 
On February 13 I did not submit to taking the shot. Later in 
the month in a conversation with my Ops Group commander, I was 
asked to reconsider. He also told me at that point that my case 
would be decided by the Indiana State Adjutant General, not by 
commanders at Fort Wayne.
    On June 7th, I received a letter from the Assistant 
Adjutant General for Air ordering me to appear in his office on 
June 24. Another pilot with a commitment who also refused the 
shot called to tell me he had received the same letter. When I 
reported as ordered, after meeting with the Judge Advocate, my 
appointed legal counsel told me that I was going to be charged 
with failure to obey the order of a superior officer and would 
be offered a court martial or an Article 15. After he explained 
the meaning and ramifications of each, I felt I had no choice 
but to accept the Article 15. I left Headquarters with an 
Article 15, a fine of two-thirds of 1 month's base pay, which 
was suspended for 30 days, and a feeling I had just somehow 
been railroaded into something that should not have happened.
    Less than a month later, a slowdown at the anthrax 
immunization program became known to a few people on the base. 
Within days of this temporary slowdown, two pilots 
rehabilitated and agreed to take the shot to return to flight 
status. Because of the current policy, they are not required to 
take the shot, but were asked to volunteer to take it to show 
good faith. Both declined, stating policy, and were allowed to 
continue to fly.
    The memo directing the slowdown was dated July 17th. On 
September 8 I received a letter from State Headquarters that I 
was in violation of the suspension of the fine for not taking 
the shot before July 24th, 7 days after the slowdown of the 
program. Nonetheless, I was to make arrangements to deliver the 
fine to my commander or face incarceration in the county jail 
for 1 day for each dollar of the $329 fine.
    I asked for and was granted time to discuss with counsel 
whether my punishment would be affected by the change. After 
explaining the circumstances, my legal counsel suggested that I 
write my commanders asking for a total review of my punishment 
and asking them to rescind the Article 15 and the fine. I am 
still waiting for a response.
    The AVIP has had a negative affect on our base. Morale is 
low and will be slow to rebuild. The squadron suffered a huge 
vacuum of experience, with a mass exodus of pilots who put 
their military careers second to principle.
    Looking beyond my own base, I ask where will we be in the 
future when it is time for others to deploy and more personnel 
take the same stand? Like me, they signed on the dotted line to 
give their lives for their country in battle, not for poorly 
thought out, badly implemented and totally unnecessary policy 
that puts their livelihood and perhaps life at risk. And if the 
sacrifice of my military career prevents even one more person 
from falling ill to the shot, it will have been worth the pain 
and suffering.
    I feel as many do that leadership is in denial over the 
effects of this shot. People are suffering from real 
afflictions after receiving it. How many more people have to 
suffer before the leadership takes notice?
    Instead of simply saying their symptoms are not related to 
the vaccine and would have arisen whether they took the shot or 
not, we need to apply scientific methods to determine the real 
cause and effect.
    In conclusion, the Anthrax Vaccine Immunization Program has 
already resulted in the loss of more personnel than the very 
thing it was designed to protect them against. The program 
deserves your urgent attention and concern.
    Thank you.
    [The prepared statement of Mr. Marohn follows:]

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    Mr. Burton. Thank you, Captain. We have been joined by 
Congressman Shimkus, and he has an introduction to make.
    Mr. Shimkus. Thank you, Mr. Chairman. I appreciate the 
opportunity to introduce the next witness. As a veteran and a 
West Point grad, this issue is very important to me. But the 
next witness is a 1981 graduate of the United States Air Force 
Academy, originally assigned at an A-10 squadron at Myrtle 
Beach, and then as an instructor pilot, then flew F-15's in 
Okinawa, then a tour as an instructor pilot, a tour in the 
Pentagon, left the active Air Force and commanded the A-10 
Squadron, National Guard, Battle Creek, MI, and flew in Kosovo.
    But, more importantly, he is the husband of my sister, my 
brother-in-law, someone I have great respect for. With that, I 
would like to welcome Pat here to testify to this committee. I 
left my committee to come listen to the testimony. Mr. 
Chairman, I appreciate the courtesy you have extended me.
    Mr. Burton. Thank you, Congressman. Does it create any 
problems in the family that you went to West Point and he went 
to the Air Force Academy?
    Mr. Shimkus. Well, we know that the Army Air Corps was 
first, so it is not really a big problem for us.
    Mr. Burton. Is it Captain Ross?
    Mr. Ross. It is Lt. Colonel Ross.
    Mr. Burton. You are recognized.
    Mr. Ross. The Army-Air Force game has not been played yet 
this year.
    Good morning, Mr. Chairman, and members of the committee. I 
am here at the request of the committee to highlight the loss 
of combat mission ready pilots and aircrew caused by the 
Department of Defense Anthrax Vaccine Immunization Program. I 
believe I am qualified to address this subject based on my 
graduation from the Air Force Academy, my 16 years as a fighter 
pilot in the active duty Air Force, and my 3 years in the Air 
National Guard.
    Most recently, I was the Squadron Commander of the 172nd 
Fighter Squadron, Battle Creek, MI, flying the A-10 Thunderbolt 
II. During my tenure as squadron commander, I was honored to 
respond, with my squadron, to a Presidential selective Reserve 
call-up in support of Operation Allied Force over Kosovo. For 
our efforts, the 172nd Fighter Squadron was recently honored as 
the outstanding Air National Guard Fighter Squadron of 1999 by 
both the National Guard Association of the United States and 
the Air Force association.
    However, less than a few months after earning these awards, 
I was directly involved in the process that played out over a 6 
to 8-month period resulting in the loss of almost 50 percent of 
the combat pilots in my unit. I will not only address these 
losses, but the ongoing punishment and coercion of the members 
of the Air National Guard who have refused to voluntarily 
submit to the anthrax vaccination, particularly at Battle 
Creek, MI.
    In the interest of saving time, I will not list here the 
chronology of events and policy changes that my unit went 
through from September 1999 until today. Rather, I refer you to 
my written testimony and the previous testimony to this 
committee by Major Russell Dingell and Major Thomas Rempfer in 
March and October 1999, concerning the loss of 25 percent of 
the combat pilots in the Connecticut Air National Guard. With 
an almost uncanny accuracy, that same chronology, coercion, 
threats of punishment and lack of integrity witnessed by the 
Connecticut officers occurred at Battle Creek exactly 1 year 
    The bottom line for my squadron, as directed by the 110th 
Fighter Wing commander, was you either volunteer to take the 
anthrax vaccine or you must leave the unit. The 110th Fighter 
Wing staff judge advocate stated that any member who refused to 
take the shot would be administratively discharged with a less 
than honorable discharge.
    To this day, not one pilot at Battle Creek has ever been 
ordered to take the anthrax vaccine. While the threatened 
deadline changed several times from January to March 2000, 
pilots began resigning, transferring or stating their intent to 
retire as early as November 1999. When the final retirement is 
effective at the end of the year, 15 pilots will have been 
coerced to leave the unit in order not to disobey an order that 
was never given.
    Add to those losses two current members of the 172nd 
Fighter Squadron who are grounded and are being threatened with 
punitive action, the same as Captain Marohn has testified, 
simply for not volunteering to take anthrax vaccinations that 
are now no longer required by DOD policy. That brings the total 
number of pilots that the American taxpayer spent millions of 
dollars to train and whose Operations Desert Storm and Allied 
Force combat experience cannot be replaced, to 17 pilots at 
Battle Creek.
    The effects of the anthrax vaccine program on my unit are, 
unfortunately, not unique. As I stated earlier, the Connecticut 
Air National Guard lost eight pilots. Other losses in the Air 
National Guard include 21 pilots of the Indiana Air National 
Guard that Colonel Heemstra talked about, 7 pilots of the 
Wisconsin Air National Guard, 22 pilots from the Tennessee Air 
National Guard, and 19 pilots from the Oklahoma Air National 
Guard. Losses in the Air Force Reserve include 58 pilots from 
Travis Air Force Base, CA, 60 pilots at Dover Air Force Base, 
DE, 30 pilots at McChord Air Force Base, WA, and 20 pilots at 
McGuire Air Force Base, NJ.
    These losses, totaling over 260 pilots, at over $1 billion 
in training costs alone, are from just 12 percent of the units 
in the Air National Guard and the Air Force Reserve. That is an 
almost tenfold negative return on the total cost of the AVIP 
program to date. None of these losses have been reported to the 
Congress, as was directed to Major General Weaver by 
Representative Shays during testimony to his subcommittee in 
September 1999. In addition, Assistant Secretary of Defense 
Cragin also testified that no one would be punished if they 
chose to leave the Guard or Reserve. Not only are two members 
of the Michigan Air National Guard being punished, but, as you 
have heard, also two members from the Indiana Air National 
Guard who were threatened with jail time.
    While I have focused on pilots of the Air National Guard 
and Air Force Reserve today, I would be extremely and deeply 
remiss if I did not mention the men and women noncommissioned 
officers who are being punished as well. As the backbone of our 
Armed Forces, these men and women are the true strength of the 
U.S. military. In many cases, they are bearing the brunt of the 
illnesses, administrative punishments, fines and less than 
honorable discharges.
    Why have all these individuals left the Air National Guard 
and Air Force Reserve rather than take the anthrax vaccine? I 
believe it simply boils down to one word, trust. They feel they 
can no longer trust the leadership when they say the vaccine is 
safe and effective. They feel they can no longer trust the 
leadership if they should become ill due to the vaccine that 
they will be taken care of by the country they are prepared to 
give their life for. They feel they can no longer trust the 
leadership when they are told to get educated, research the 
issues and then make their own personal decision, with no 
retribution. The actions of the leadership are in direct 
conflict with their statements to the troops, and to Congress.
    Morale has always been crucial to providing the 
overwhelming margin of victory for our Armed Forces during the 
conflicts that we have fought and won throughout our history. 
The Anthrax Vaccine Immunization Program is having an extremely 
adverse effect on morale and retention, and for the good of the 
U.S. Armed Forces, the program should be halted until the 
concerns of the Congress are satisfactorily addressed and a 
safe and effective source of vaccine can be assured.
    On behalf of the men and women who keep this great country 
of ours free, I thank you again, Mr. Chairman and members of 
the committee, for your concern.
    [The prepared statement of Mr. Ross follows:]

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    Mr. Burton. We have been joined by Mr. Cummings and Ms. 
Norton of D.C. Do either of you have any comments to make at 
the outset?
    No questions right now. We will proceed with Dr. Porter.
    Dr. Porter.
    Dr. Porter. Thank you, Mr. Chairman, distinguished members. 
May I have slide 1. I have several graphics, and I have also 
entered the testimony of an extensive proposal in addition to 
the prepared text.
    VDDI focuses on pharmaceutical product opportunities where 
general proof of principle has already been established in pre-
clinical or early human testing, and where the products will 
have novel or significant potential advantages over currently 
available products on the market. VDDI pursues early stage 
products qualifying for fast track approval, primarily in 
cancer, cardiovascular disease and infectious disease.
    Mr. Burton. Dr. Porter, it is going to be hard for us to 
follow you, so if you could pull the microphone a little closer 
and take your time reading that so we can follow you.
    Dr. Porter. VDDI pursues early stage products qualifying 
for fast-track approval, primarily in cancer, cardiovascular 
disease and infectious disease. As the name suggests, VDDI 
utilizes a virtual business model.
    Graphic 2, please. Virtual drug development entails a small 
core group of employees responsible for strategic management, 
regulatory strategy and financial control; outsourcing of all 
noncore business functions, including manufacturing, 
preclinical and clinical development.
    Slide No. 3, please. Global strategic resources and 
Internet-based enabling technology, and the use of electronic 
data capture and data submission to regulatory authorities. By 
adopting this model, VDDI believes it can reduce total drug 
development and program costs by at least 25 percent and 
development times by 50 percent.
    Slide 4, please. As the graphics demonstrates, we have a 
core team of employees and individuals that work on an 
outsourcing of noncore business functions through manufacturing 
and preclinical and clinical development.
    Graphic 6, please. In principle, a vaccine for anthrax is a 
good and necessary part of a complete protection package 
against anthrax, but the present vaccine program has suffered 
from a number of problems including, in military parlance, 
collateral damage or friendly fire casualties. Providing 
effective interdiction for persons threatened with exposure to 
anthrax endospores must remain a national priority. Despite 
numerous animal studies, the efficacy in humans of the AVA 
vaccine in the face of inhalational anthrax remains in serious 
    Practical issues surrounding providing the vaccine to those 
in need of it also constitutes a real problem. The rapid 
progress and fatal nature of this disease, the vague early 
symptoms and the distinct possibility of human-engineered 
multiple antibiotic resistance suggests traditional antibiotic 
intervention may be of limited utility. More importantly, 
recent knowledge of the cloning of additional virulence 
factors, for example, toxins from other bacteria, into the B. 
anthracis raises the possibility that the nature and 
pathogenesis of the disease can be manipulated to the point of 
rendering our current interdiction strategies impotent. 
Clearly, new ways to block the disease state at its earliest 
stages, before dissemination and production of its lethal 
toxin, represent an exploitable and potentially valuable 
addition to our abilities to combat this disease.
    I pose several questions. Would the utility of a novel 
prophylactic antibiotic regimen that provides active protection 
against all forms of anthrax, natural and engineered, be a 
useful addition to our treatment armamentarium against this 
bioweapon? Vaccines function by initiating the development of 
host antibodies that will quickly recognize B. anthracis or a 
component of its protein toxin. Unfortunately, it may be 
relatively easy for the enemy to genetically alter the surface 
of proteins. This also occurs naturally, without intervention 
by man, that these antibiotics recognize, thereby making 
vaccine treatment ineffective; or to use molecular biological 
techniques to insert the virulence genes into a different 
bacterium. More importantly, recent knowledge of the cloning of 
additional virulence factors--parenthetically, toxins from 
bacteria, cereolysin AB, into the B. anthracis host--raises the 
possibility that the nature and pathogenesis of the disease can 
be manipulated to the point of rendering our current 
interdiction strategies impotent.
    In addition, wouldn't the ability to use a technology that 
would allow for the near immediate deployment of our troops and 
personnel be of strategic and practical advantage over an 
immunization schedule that requires months to be deemed as 
possibly effective?
    Wouldn't the ability to deploy and store a small molecule 
treatment regimen that is stable in field conditions offer 
advantages over a regimen that requires refrigeration?
    Wouldn't the ability to offer a rapid scale-up and 
production of an alternative prophylactic and/or treatment 
confer significant advantages over an immunization program?
    Next graphic. Thank you.
    The University of Alabama and VDDI created an NAD 
synthetase technology that is mature and ready for 
optimization. The key to the success of this program will be a 
discovery program that can create a pharmaceutical product that 
has appropriate stability, absorption, metabolism and safety 
profiles that allows its use in animal experimentation and then 
human experimentation. The NAD synthetase enzyme is an 
essential enzyme for gram-positive bacteria, including 
methicillin-resistant staph aureus, vancomycin-resistant 
Enterococcus faecium, and coagulation aureus staphylococcus. 
This NAD synthetase is a ubiquitous enzyme that is found in 
both eukaryotes and prokaryotes cell lines, and we have 
distinct differences between the human and the bacteria forms 
of this enzyme.
    Next slide. Through a structure based directed Small 
Molecule Development Program and a platform technology, DARPA 
has funded $6 million of this development program and as a 
result, we have shown some excellent in vitro activity to date.
    Next. This is a structure of NAD synthetase enzyme with one 
of the congeners interdicted into that enzyme showing how and 
where it interferes with the activity of the enzyme.
    Next. This is a life cycle of the B. anthracis endospore 
going from the bottom left to the top. The spore outgrows, it 
requires NAD synthetase as a critical enzyme for further growth 
to the form the vegetative stage form, and at that stage, the 
exotoxins are released, and that is where most of the human 
damage occurs. The NAD synthetase molecule is putatively stated 
to inhibit both the early stage and the later stage of 
outgrowth of the B. anthracis organism.
    Next slide. These micrographs show the inhibition of the B. 
subtilis as a surrogate to B. anthracis using one of the 
analogs in a concentration-dependent manner, destroying both 
the vegetative and the spore forms of the organism.
    Next. Work done by USAMRIID showing several analogs against 
virulent and nonvirulent strains of the anthracis shows a 
concentration of MIC 100 micromoles per ML, showing significant 
activity against the Ames strains.
    Next. Following the completion of this early work, a formal 
preclinical development program will optimize the doses, 
institute allometric scaling, and characterize the safety in at 
least two animal models and complete the anthrax efficacy, dose 
response and pharmacokinetic profiling in animals. A formal 
Investigational New Drug application will be submitted to the 
FDA and it is proposed that two volunteer studies will be 
conducted: a single-dose, dose escalating safety, a tolerance 
study, a pharmacokinetic phase I clinical trial, to be followed 
by a multi-dose safety tolerance and PK phase I clinical trial. 
These studies will be correlated with information gained from 
preclinical animal safety data and correlated with efficacy of 
the human trial experience. Since it is unethical to conduct 
anthrax interdiction trials in humans, surrogates of plasma and 
tissue concentrations obtained from animal interdiction studies 
will be used as correlates and inferences for the human 
    The Food and Drug Administration has recently proposed 
regulations for the development of new drugs to be used against 
lethal or permanently disabling toxic substances, including 
agents that may be used in biological warfare. This is 
published in the Federal Register, Volume 64, No. 192, October 
1999, entitled ``Evidence Needed to Demonstrate Efficacy of New 
Drugs for Use Against Lethal or Permanently Disabling Toxic 
Substances When Efficacy Studies in Humans Ethically Cannot Be 
Conducted.'' The recent approval of Ciprofloxacin for B. 
anthracis treatment partially validates this approach.
    In collaboration with PPD Discovery, and the University of 
Alabama, VDDI will develop a preclinical and clinical strategy 
in accordance with these new regulations and will discuss the 
strategy with the FDA at a pre-IND meeting to be scheduled.
    In summary, the specific design of our lead compounds, in 
conjunction with our preliminary in vitro and in vivo data 
suggest that the lead compounds have minimum inhibitory 
concentrations against B. anthracis that are quite acceptable. 
The lead compounds have minimum inhibitory concentrations 
against MRSA, VREF, and vancomycin-resistant E. faecalis that 
is good or better than clinically proven antibiotics. Some of 
the lead compounds show specificity against gram-positive but 
not gram-negative strains, thus reducing some adverse effects 
of clinically approved antibiotics. Some of the lead compounds 
show excellent activity against virulent and attenuated strains 
of B. anthracis. The mechanism of action of the compounds is 
specific to prokaryotic cells and thus leading to significant 
safety profile for clinical use.
    The product development issues that remain to be resolved 
include development of parenteral agents, development of orally 
active agents, and development of a relatively long half-life 
    DARPA has supported the initial funding for this program at 
$6 million. USAMRIID has supported the early synthetic 
chemistry and in vitro studies with several strains of B. 
anthracis and has just agreed to refund $300,000 for this work 
to the University of Alabama. VDDI has received an NIH R43 SBIR 
phase I grant for $135,000. Additional support is requested 
from the Department of Defense and will be used to complete the 
synthetic chemistry and initiate the preclinical development 
program. Specifically, $2 million is needed immediately and 
will be spent as allocated by the time and resources as 
outlined in the extensive protocol and proposal that have been 
submitted with testimony. Additional funds necessary to 
complete this development program and their respective 
utilization are shown in table 1, which I do not have a graphic 
of, but is submitted in testimony. A greatly detailed time 
scale and deliverable assessment for this program is also 
included with the proposal.
    In summary, I submit the enclosed program outline for the 
development and commercialization of a novel oral 
pharmaceutical as testimony before your committee. I removed 
proprietary and sensitive information from that formal 
proposal. I thank you, committee members and Mr. Chairman.
    [The prepared statement of Dr. Porter follows:]

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    Mr. Burton. Dr. Porter, one of the problems I have is 
understanding a foreign language that I have never studied. I 
have absolutely no idea what you just said.
    Dr. Porter. I take that as a compliment, I guess.
    Mr. Burton. Well, I guess you could take it that way, but 
what I would like for you to do, Dr. Porter, if you could, 
because I think probably other Members have some questions 
about what you just said, could you very briefly give us a 
snapshot of what you are talking about; what, in effect, you 
just said in layman's language?
    Dr. Porter. The use of a rapidly deployable oral antibiotic 
that would be used as a prophylactic regimen during a period of 
engagement in the theater of war with exposure to biological 
weapons, particularly B. anthracis.
    Mr. Burton. So it could be used in a battlefield situation 
prior to contact with the enemy when you thought they might be 
using an anthrax-type weapon.
    Dr. Porter. That is the premise. I think most people in 
infectious disease research and people who work in Third World 
countries understand the use of prophylactic antibiotics, 
including tetracycline or ciprofloxacin as a means of 
preventing zoonotic disease exposure.
    Mr. Burton. Thank you very much. We have been joined by Mr. 
Walter Jones who has been very active in this. Have we been 
joined by any other Members? Ms. Schakowsky has joined us. Do 
you have any opening comments, Ms. Schakowsky?
    If not, we will now go to questions. Let me start, if it is 
all right, with those of you--Mr. Shays was the first one here. 
Mr. Shays, you have been very active in this investigation from 
day 1. Would you like to wait?
    Mr. Shays. I will pass.
    Mr. Burton. OK. Let me start with Mr. Heemstra. I think you 
probably covered this already, but do you feel that you have 
been retaliated against because of your testifying last year 
before this subcommittee?
    Mr. Heemstra. Yes, sir, very directly. I testified to the 
subcommittee on September 29. On, I think it was November 24 or 
25, I was grounded arbitrarily after I had been flying, you 
know, as a normal F-16, current, ready-to-go-to-war pilot. An 
arbitrary reason was that stress was affecting me, and I have 
many, a multitude of witnesses that will testify otherwise, 
that stress was having no effect on my performance.
    Mr. Burton. You have already talked about a number of the 
squadrons around the country that have been adversely affected 
by this program. I think one of the things that all of the 
Members ought to be aware of, and maybe you could explain this, 
is the impact on our readiness. A lot of people look at the 
Reserve as something that comes as a secondary part of any kind 
of military engagement.
    Would you explain how important it is that the Reserves be 
militarily ready and how that figures into the overall equation 
if we go into a conflict?
    Mr. Heemstra. Yes, sir. Increasingly, the Guard is being 
called up to help the active duty and relieve them on some of 
the deployments that have been going on. So as much as every 
year and a half, it seems that we are being called up to deploy 
to real world locations. In our case we had to get help from 
other units because we faced the anthrax shot. But 
increasingly, we are called upon. And if we are going to lose 
another 2,000 pilots--I understand from a briefing I received 
at the Air Force Academy a year ago that we are already 2,000 
pilots short nationwide--so if we lose another 2,000 because 
the shot program continues, that will be 4,000 out of about a 
14,000-strong pilot force that they would like to have. That is 
a huge chunk.
    Mr. Burton. So the Reserves around this country are an 
absolute, essential, immediate part of any defense program.
    Mr. Heemstra. Yes, sir. Not only are we called upon to go 
do those things, we are just as current and ready and 
experienced to go do those jobs, even though we only do it, 
many of us, in a part-time role.
    Mr. Burton. Mr. Marohn, why is it, Captain, that you just 
did not simply resign?
    Mr. Marohn. I was not allowed to, due to my commitment.
    Mr. Burton. How long was your commitment?
    Mr. Marohn. I believe it was for 7 years. My commitment is 
up this coming May 20.
    Mr. Burton. This May 20. So your commitment is up May 20.
    Mr. Marohn. Yes, sir.
    Mr. Burton. And yet they said they were going to fine you 
$300-some or 300-some days in jail.
    Mr. Marohn. That is correct.
    Mr. Burton. The DOD stated in their testimony that they 
have taken steps to utilize tools that more effectively relay 
information. How did your unit find out about the most recent 
slowdown of the AVIP, and is this normally how important 
information is disseminated to units?
    Mr. Marohn. It was just happenstance that they found out, 
and it was only disseminated to really just a few select 
    Mr. Burton. So they didn't sit down with the unit and just 
go through the whole thing and give you a complete story of how 
this thing was going to play out?
    Mr. Marohn. No, they did not.
    Mr. Burton. Just a few individuals knew how it, by word of 
mouth, it passed through the unit?
    Mr. Marohn. One of our ladies that deals with airfield 
management received a message just through happenstance, like I 
said that, hey, here is something, if you are interested; you 
know, tell whoever. Which she only disseminated the e-mail to 
people that she thought might be interested, those that were 
reluctant to take the shot, and obviously myself. I was very 
interested in hearing that. That is how I learned of the 
slowdown program.
    Nothing was ever called by any of the commanders in any of 
the commanders calls to tell everybody on a wide scale, hey, 
this is what is going on with the program right now.
    Mr. Burton. So you really didn't have the complete 
information that you and the rest of your unit needed?
    Mr. Marohn. Correct.
    Mr. Burton. Mr. Craigen said before this committee that 
Reservists were not going to be punished if they decided not to 
take the shot. How is that different from what you experienced?
    Mr. Marohn. Totally different.
    Mr. Burton. So what he said before the committee was not 
    Mr. Marohn. Well, I am sitting here today wondering 
whether, you know, if I pay this fine or not, whether I am 
going to go to jail. I have an Article 15 on my record right 
now. So I would say that that would be an accurate assessment.
    Mr. Burton. We need to talk to Mr. Craigen again about 
    Mr. Ross, you stated in your testimony that in only nine 
Guard units, representing 12 percent of the air National Guard, 
260 pilots chose to leave the Guard instead of taking the 
vaccine. Do you agree with the statement of the DOD when they 
say that documented losses from such cases are a very small 
    Mr. Ross. No, Mr. Chairman. Obviously, I think the numbers 
that were cited before, anywhere from 25 to 50 percent of the 
units, is more accurate. Just as Colonel Heemstra testified, 
this was not an unknown happening that was going to come on our 
unit. Once we got back from Kosovo last year, we knew that we 
were going to face this situation. I informed my boss and his 
boss, the one commander, that I anticipated that our unit would 
be no different from any other unit. There was no reason to 
think it wouldn't; 25 to 50 percent had been the running number 
in these units that preceded us. Battle Creek has not been one 
of the leading units due to our timing, so we could sit back 
and watch these other nine units. So we had the luxury, if you 
will, of seeing the experience and knowing that 25 to 50 
percent was more accurate.
    Mr. Burton. So when the military comes before this 
committee or one of our subcommittees and they tell us that it 
is a very small minority, that is blatantly false?
    Mr. Ross. Yes, Mr. Chairman, in my opinion.
    Mr. Burton. Article 134 of the Military Code and Article 
107 says that false official statements--and I presume a 
statement to the Congress of the United States would be 
considered a false statement if it is under oath--can result in 
a court-martial. So officers from the Pentagon that come over 
here and tell us one thing and then the facts say something 
else, they are in violation of the Military Code of Conduct, 
    Mr. Ross. Yes, Mr. Chairman, I believe they could be.
    Mr. Burton. I understand that lying is punishable under 
Article 134 and is punishable by dismissal, forfeiture of all 
pay and allowances, including retirement, and incarceration.
    OK. I think I have gone through--let me just go through, 
Dr. Porter, just a couple more questions. Are any of you 
commercial pilots?
    Mr. Heemstra. Yes.
    Mr. Ross. Yes.
    Mr. Marohn. Yes.
    Mr. Burton. You are all commercial pilots? Can you tell me 
real quickly if you know of any pilots who are in the Guard who 
have experienced dizziness or any side effects that may affect 
their ability to fly a commercial aircraft?
    Mr. Heemstra. Yes, sir, I do. I have heard of several 
incidents and of course those people don't want--obviously need 
to protect their careers.
    Mr. Burton. I understand that. But, you know, everybody in 
America ought to be concerned about this. The Congress people 
at this dais, we all fly back and forth to our districts or 
someplace in the country almost every week. The people in this 
room, people across the country, put their lives in the hands 
of pilots every week. And if they are getting vaccinations that 
impair their ability to fly a plane that is carrying passengers 
in this country, then that goes beyond just military 
preparedness and the military problems that can be incurred in 
a conflict.
    You are telling me that some of the pilots that have 
received the anthrax vaccine have had side effects that include 
dizziness and other things that could impair their ability to 
fly a commercial aircraft.
    Mr. Marohn. Sir, one of our pilots, after receiving the 
shot, was in the middle of a trip with his airline, and had to 
be removed from that trip because he was so sick.
    Mr. Burton. What kind of sickness did he incur?
    Mr. Marohn. He had slight dizziness, but more importantly, 
he had broken out in a cold sweat, feverish conditions, aches, 
and an unknown rash that had occurred. But it had wiped him out 
physically to the point where he was unable to perform his duty 
as a pilot.
    Mr. Burton. So the copilot had to take over?
    Mr. Marohn. They reassigned another pilot to that.
    Mr. Burton. How long after the shot did that take place, do 
you recall?
    Mr. Marohn. I don't recall.
    Mr. Ross. Mr. Chairman, I have also had some experience 
with that with a few of the pilots in my unit that did take the 
shot. Again, as was stated before, most of them are reluctant 
to come forward with any kind of a reaction. I will say that, 
you know, the folks that I know, to their credit, that the 
pilots do know the responsibility of flying sick, and will 
request to be removed from their trip or not even go on their 
trip and report in sick.
    The one instance that I can think of was one of the pilots 
had a numbing in his arm that he got the shot in that persisted 
for a fairly long time. He was understandably reluctant to say 
anything about it, and in between, he was on the schedule where 
he was taking shots every 2 weeks, so he was basically not with 
his airline for that first week and he was waiting to see if 
his arm would, in fact--the feeling would come back in his arm.
    So I think you will find that it is a very hard subject to 
approach a pilot out there, but you are absolutely correct in 
the effect. I don't know of any pilots that would knowingly fly 
sick, but this does affect their job as you say, and they then 
have to either come off the trip in the middle of a trip such 
as Captain Marohn said or report sick for the trip.
    Mr. Burton. I understand and I appreciate that, and I am 
sure they are very concerned about not only their safety but 
the safety of their passengers. But that does not alter the 
fact that if they are in the middle of a flight and experience 
dizziness or something that impairs their ability to get that 
plane to the ground safely, that it could, in effect, endanger 
not just themselves, but a whole host of people.
    Mr. Ross. Yes.
    Mr. Burton. Mr. Cummings, would you like to ask some 
    Mr. Cummings. Thank you very much, Mr. Chairman. I have a 
few questions here.
    Last week, we had another hearing on this same subject, and 
the testimony was troubling and it was--it made me feel very 
uncomfortable as to what the military might be doing with 
regard to this vaccine. We had some people who came in and 
talked about how their relatives died and they linked it to the 
vaccine. I want to make it clear that all of us up here, no 
matter what side of the aisle we sit on, are concerned about 
our military. Our military makes it possible for us to enjoy 
the freedom that we enjoy.
    So in that light, I just want to ask a few questions.
    Now, Mr. Ross, when the chairman asked you about the 
military coming up after you all testifying, and having 
contrary testimony to what you have stated, I am just 
wondering, might the difference--and I am certainly not here to 
defend the military, but I am just curious--might the 
difference be that they get--there is something called exit 
interviews, is that right? I mean something where you talk 
    Mr. Ross. Yes, Congressman.
    Mr. Cummings. OK. And just listening to what I have heard 
here this morning, I take it that sometimes those exit 
interviews may not always be accurate, out of fear?
    Mr. Ross. Yes. And I went through this period with my 
pilots in discussing this with them about exit interviews and 
being truthful. There are two viewpoints on this. A number of 
my guys wanted to be very activist, if you will, and make sure 
that they knew that they were leaving for the anthrax vaccine, 
and I did not discourage that. On the other side, as their 
commander, I also told them, at least at my unit, that the wing 
commanders, you know, if you were going to be disobeying an 
order, that there were serious consequences on that. So we 
tried to lead turn, the very thing you are talking about, and 
not forcing any action that did not need to go to that level.
    Consequently, on the exit interview then, when these 
individuals--as the commander I would get the first exit 
interview, and then my boss, and ultimately his boss, and that 
was the wing commander. A number of pilots--and I think that it 
would be fair to say that my unit would say to the 15 pilots 
that have left, that they did not all leave because of the 
anthrax vaccine. The way they will justify that is they will 
say it was not the No. 1 thing they left for, and I do not 
disagree with that. There are a number of pressures and other 
things on the Guard and Reserve in the first place, besides 
this shot. But certainly, when they come up and they say, you 
take the shot by this date or not, then it is somewhere in the 
factoring of the timing of that shot.
    So I think that you will find, and I think the GAO reported 
this, at least when they came to Battle Creek and they 
interviewed everybody that left, that the No. 1 reason may not 
have been anthrax with a certain individual; but if you look, 
it was the No. 2 reason.
    Mr. Cummings. I think that if you were to look at people in 
the military, the ones I have gotten to know, they, most of 
them, love their careers.
    Mr. Ross. Absolutely.
    Mr. Cummings. So I think you can put one and one together 
and come up with the right conclusions. But in the exit 
interviews, is it normally more than one reason?
    Mr. Ross. It varies with individuals, but there is usually 
cited, I would say, from one to three reasons. Again, one of 
the things that we did not know at the time as we were going 
through this was, there was a distinct fear amongst the pilots, 
even the ones leaving, that if they said they were leaving for 
anthrax, that they would somehow be punished.
    Mr. Cummings. Might we have situations where none of the 
three reasons--or the reasons were anthrax? In other words, I 
am talking about whatever documentation--you know----
    Mr. Ross. It is possible; it is possible.
    Mr. Cummings. What I am trying to get to is that I don't 
want--I saw where the chairman was going, and he talked about 
criminal violations and things of that nature with regard to 
these military officers that are going to be testifying in a 
few minutes. And as an attorney and one who is concerned about 
those kinds of issues, I don't want them to be set up so that 
when they come up here and testify, they are basing their 
testimony on documents, and then somebody says oh, we caught 
    Mr. Ross. I understand that.
    Mr. Cummings. I just wanted to see if we could just 
clarify, you know, what happens in that process. But the bottom 
line is, and if you will just allow me just a second, Mr. 
Chairman, I think what you have said is so important in that we 
should be concerned about the real reasons why people are 
leaving our military. We should be. That is very, very 
important. At the same time, I think it helps that if the 
people who are in charge know, I mean, and have knowledge as to 
why they are leaving, that is one thing; but if they don't have 
knowledge, that is another thing. I guess that is what I am 
trying to point out.
    Mr. Ross. Congressman, I think on the GAO survey you will 
find also that you have to be asked the question in order to 
respond yes or no to it. So I think that that is also part of 
the problem here. I know when guys interviewed with me, 
exiting, what questions I asked. But I also know, having filled 
out surveys as recently as last month, that I was sent by the 
Department of Defense as a Reservist, there was not one 
question in that survey as to why I had left my previous job 
due to the anthrax vaccine. It wasn't even covered in the 
survey and the survey was some 75 questions long.
    So I think you have to ask the question.
    Mr. Cummings. Thank you very much.
    Mr. Burton. The question was not even in the survey?
    Mr. Ross. No, not at all. And my wife received one as a 
spouse also, and there was nothing in her survey either.
    Mr. Burton. I think Mr. Souder was next. Mr. Souder.
    Mr. Souder. Thank you, Mr. Chairman. A couple of basic 
questions for the record.
    Colonel Heemstra, what percentage of the pilots in Fort 
Wayne work in the airline industry?
    Mr. Heemstra. I would say it is about three-quarters, about 
75 percent.
    Mr. Souder. Because I wanted to reiterate Chairman Burton's 
point. We talk about Passenger Bill of Rights. Part of the 
Passenger Bill of Rights ought to know the status of their 
pilots, and I know that in the private expressions to me from 
the pilots in Fort Wayne, that there was a lot of concern that 
if the airlines get over-jumpy, they may not employ people in 
the Guard, and this is a primary method of employment for 
people in the Guard. So one of the difficulties of us even 
having hearings like this is, it complicates recruiting and 
other things for the Guard, and yet the people have a right to 
know that. It is a very difficult balance.
    If you were--as I have met with different people in the 
Department of Defense and in the Guard. One of the problems is 
that they are trying to make decisions, to followup on Mr. 
Cummings' point, on the data that exists in front of them. And 
this data is at best mixed, and for multiple reasons, all of 
which are legitimate: career, punishment, keeping future 
options, we are not getting a full data base.
    How would you address that problem if you were in command 
at the Department of Defense? In other words, how would you get 
this accurate data?
    Mr. Heemstra. I think it is important to be in touch with 
your troops and that gets down to the grass-roots level. So 
GAO's survey was certainly helpful. And I met with the team 
before they came out to Fort Wayne and hit the bases that they 
interviewed, and we tried to find ways to get the real data up 
to you. That is probably the best way that I can think of. But 
as Colonel Ross was telling Mr. Cummings, in exit interviews 
you are not always asked the question. And also, to protect 
their careers, because many of these people transferred, they 
don't want to say that it was anthrax, because then that is 
going to affect their future careers.
    Mr. Souder. So the No. 1 thing is they ought to be seeking 
the truth through the questions, trying to track the data; when 
they give the shot, make sure there is a health register that 
is clear for everybody as to the after-effects. And if it is in 
dispute--for example, we have one case in Fort Wayne where not 
a pilot, but a technician who initially said he was going to 
take the test, and volunteered and went in to take the test, 
has had medical complications ever since that point, that it 
isn't showing up, partly because they are in dispute whether 
the medical complications came from the shot. But we ought to 
have some sort of an inventory of every single shot and whether 
there is even a dispute as to whether the followup is there. I 
sense that in Fort Wayne, that is becoming done more, and 
hopefully around the country, but you can't do a see-no-evil, 
hear-no-evil thing in trying to address this.
    I have another kind of general opinion that I think it is 
important to get on the record. When we started working with 
the antiterrorism issue about 3 years ago in the subcommittee 
that Chairman Shays now is head of, one of the trips with now 
Speaker Hastert, we went over to the Middle East, and we were 
at Prince Sultan and Incirlik. We met with the people who, 
several of the inspectors who at that point had been kicked out 
of Iraq, and one thing that became clear in talking to base 
commanders is that the blame game is partly what is driving 
this policy right now.
    In other words, everybody is afraid of having some sort of 
a terrorist attack when they are in command, and the punishment 
of several individuals in a symbolic way at Khobar Towers where 
we went to visit has made our commanders so jumpy that they 
are, in my opinion, skipping steps that normally would have 
been taken in vaccines and other antiterrorism things, because 
they are afraid of being blamed, and it has complicated our 
ability to address this whole question.
    Now, one thing that I hear from the Guard, which is a 
legitimate concern--I favor voluntary for the Guard, the Guard 
did not sign up in the same way, even though they are used the 
same way as regular military--there is a concern that the Guard 
and the Reserves would be treated as second rate if somehow you 
are voluntary and the regular military is not.
    Do any of you share that concern, or can we, in fact, have 
a difference even though you are going into the same arena? It 
is interesting to me that apparently the Department of Defense 
personnel, based on the same Embassies and the same areas, do 
not have to mandatorily take the shot. Department of State 
employees do not have to take the shot, even if they are based 
in the Middle East; it is voluntary. There clearly are some 
    Do you have any concerns that it could hurt the image of 
the Guard and Reserve if you are voluntary and the regular 
military is not?
    Mr. Heemstra. I think it is perfectly valid that they are 
treated differently since they are different, and many of us 
have civilian airline careers. For example, I have to have an 
FAA physical every 6 months to fly international, so if I had 
symptoms from the shot, I would have to decide whether to be 
truthful on that and let my doctor know, or not. So, there are 
some circumstances for Guard and Reserve pilots that are 
obviously different than active duty. But I think now that the 
policy has been slowed down where you are not required to get 
the shot if you are not going to be there on the ground more 
than 30 days, well, as Guard and Reserve pilots, we never go 
anywhere more than 30 days, because then we lose our full-time 
employee benefits through our airlines. So that usually--that 
policy now is very effective, I think.
    Mr. Souder. Mr. Chairman, may I ask one question of Mr. 
    Mr. Burton. Yes, and if you would, I would like you to 
yield to me after you ask that question.
    Go ahead.
    Mr. Souder. Mr. Ross, one of the concerns with the way the 
anthrax vaccine was developed was that they don't have FDA 
approval and that, in fact, we have concerns that it is not 
being cross-tested.
    In your proposed method, would that be FDA-approved and 
would it be cross-tested?
    Dr. Porter. I think you meant the question to Dr. Porter.
    Mr. Souder. Yes, I am sorry.
    Dr. Porter. We expect full compliance with the FDA 
regulations for approval of this product, and the unique 
difference that we offer is that because of the regulations 
that have recently been promulgated in the Federal Register, 
that we can fast track this approval through an abbreviated 
program that would be much different than a typical antibiotic 
development schedule.
    Mr. Souder. Would it be studied as to its cross-impact with 
other vaccinations that the forces are taking?
    Dr. Porter. It would not necessarily be required to be 
tested against adjunctive vaccines, but we would like to see 
that work accomplished in animal studies for sure, not in 
    Mr. Souder. Thank you. I yield to the chairman.
    Mr. Burton. His time has expired, but I really want to ask 
one quick question.
    The people on active duty who are flying who have a 3- or 
4-year obligation, or there is 1 year left on their obligation 
to serve in the military, that are pilots, would they not have 
the same concerns? Because when they leave the service, many of 
them want to become airline pilots and it has to do with their 
future incomes as well. Would they not be concerned about this 
as well?
    Mr. Heemstra. Yes, Mr. Chairman, they would be concerned if 
they had any symptoms, and those probably would be detected in 
the rigorous physicals that they have done by the airlines 
before they get their job. So they would probably be screened 
out and wouldn't even get hired.
    Mr. Burton. The reason I ask that is, GAO has not surveyed 
the active military, but I think a logical person would assume 
that the same concerns that you fellows have and the other 
people in the Reserve have, the active duty people would have 
because of the long-term problems that they might face.
    Ms. Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. I have just a few 
questions. I want to, once again, express my discomfort with 
the way that our members of the armed services have been 
treated by the Department of Defense. My husband is a pilot, a 
general aviation pilot. My experience with pilots is that they 
want to fly. They are not looking for reasons to not fly or 
making up symptoms of things that would disqualify one from 
being able to fly. So I listened carefully when pilots came to 
other hearings and gave reasons for their decisions and the 
pain that they felt, personal, emotional pain from not being 
able to fly, in addition to the symptoms that they connected to 
    But what bothers me, and Representative Souder described 
it, is that we are not somehow seeking the truth, that is how 
it feels to me; that in all of our hearings we have heard that 
there have been no long-term studies, there have been precious 
few short-term studies, there have been problems with the 
manufacturer, with the product that has been developed, and on 
and on and on.
    I have to tell you, and I have said this before, my initial 
response to this, my gut feeling before the hearings started, 
was ``be a man, roll up your sleeve, take the shots, that is 
the rule.'' And increasingly, as I have heard what has 
happened, I feel less and less convinced of that, particularly 
because it doesn't seem as if we are any further along now with 
answers. Yet, we seem to be further along with a fairly 
punitive approach.
    Mr. Ross, in some ways I think you answered the question. 
When we look at the findings in the GAO report, what you are 
saying and what others have said is that there is a possibility 
that reasons that were given other than anthrax because even 
after leaving, there could be some retribution. What could that 
be? What kind of risk is perceived?
    Mr. Ross. As Colonel Heemstra said, most of the transfers, 
short of a retirement from an individual, is transferring into 
the Air Force Reserve or into another job that is not a--a job 
that does not require the deployment. In most cases, in all 
cases at my unit, it was transferring to jobs, those that did 
stay either in the Air Force Reserve or into the National 
Guard, to non-flying jobs. So the concern is that there would 
be some sort of tracking or some sort of way to continue 
retribution on an individual who has chosen to leave the 
current flying position they are in, but they want to continue 
their service in the National Guard or in the Air Force 
    Very few--in fact, at my squadron, at my base, the wing 
commander would not accept anyone's resignation outright. No 
one was allowed to do anything other than transfer into the 
individual Ready Reserve of the Air Force Reserve, or retire. 
So if you wanted to resign, you had to first transfer to the 
Air Force Reserve and then resign from there. I surmised that 
that was because then there would not be the record of a 
resignation from my unit. That would be dealt with with the Air 
Force Reserve.
    Mr. Burton. Ms. Schakowsky, would you yield for just a 
    Ms. Schakowsky. Yes.
    Mr. Burton. One of the things--and you brought this up, and 
that is why I would like to at this time maybe give you a 
little information. We wrote a letter to the Department of 
Defense. They sent out two surveys, one to the active duty 
Reservists and one to their wives. It is a very voluminous 
document. There is not one question about the Gulf War Syndrome 
or about anthrax in here; and when we said, why don't you add 
an addendum to this so that that can be factored into the 
equation as to why these people are leaving, they wrote back 
and said they would not do that.
    So your question about the right questions being asked, the 
two surveys that were started to be sent out in August of this 
year, none of them, none of the questions referred to the Gulf 
War Syndrome or anthrax, and that is one of the major reasons, 
according to these gentlemen and others, that they are leaving 
the Reserves. So the Pentagon evidently does not want to know 
and they are not asking the question.
    Ms. Schakowsky. Thank you, Mr. Chairman. Let me just say 
that the responses to your inquiry as to why those questions 
weren't included seem fairly unsatisfactory to me. We have 
systems that are supposedly designed to track information, like 
the VAERS system, but again testimony that we have heard 
suggests that people are discouraged from using systems.
    Could I just ask one more question?
    Could it be that there is somehow an overstatement or 
exaggeration, or misperception of the retribution that could 
occur? Could it be more attributable perhaps to a rumor mill, 
you know how those things can get started, or to what extent 
are we looking at reality here from members of our armed 
    For anyone to answer.
    Mr. Heemstra. Well, I think a great example is being 
threatened to be put in jail. I think a great example is that 
my performance reports were tarnished, I was grounded illegally 
after testifying before you, and then finally forced to retire. 
So if you put something on your form that says that you 
transferred because of anthrax, and as Colonel Ross was saying, 
many of these people didn't have the option to retire. There 
are maybe 1 or 2 out of 20 even have the years in to retire, so 
most transferred. So when you go into the inactive Reserve, the 
reason I left was because of anthrax; when you try to come back 
in maybe to finish up your years, they are going to say well, 
you disobeyed a lawful order and your record is already 
tarnished anyway.
    So I don't think it is an exaggerated threat at all. I 
think many are still hopeful that--we know that it is a slow 
process--but that Washington will shake things up and get this 
thing straightened out and it will go away, and then they would 
like to come back in and still serve their country and still 
    Ms. Schakowsky. Thank you.
    Mr. Burton. Thank you, Ms. Schakowsky, and thank you for 
    Mr. Horn.
    Mr. Horn. Thank you, Mr. Chairman.
    Some of these questions should go to General West and 
General Weaver, but I won't be able to get here, so perhaps we 
can ask them the same thing and get their response in the 
    I am curious; to your knowledge, those of you on panel one 
here, the degree to which it goes up the hierarchy, both in 
terms of--let's say in the Army equivalent--I realize you are 
in the Air Force, but the wing or the regiment and so forth. 
How far up did it go to require vaccination of officers above 
you, and how about the technicians? So what was the criteria 
that you had to follow on your base for the people above you?
    Mr. Marohn. Sir, everybody that was in a deployable AFSC 
was required by our State to take the shot. Commanders were 
encouraged to take it to give the troops a sense of safety, I 
guess, and when Colonel Heemstra did not do that before the 
deadline, he was punished; unfairly, in our mind. But we were 
all required to take the shot, all the way from the enlisted--
    Mr. Horn. Did that go up on the air staff and the Joint 
Chiefs? Did they take it?
    Mr. Marohn. I believe so.
    Mr. Horn. How about the technicians? You never know where 
they are going to be under fire, but you need them.
    Mr. Marohn. All of the technicians were, I guess, requested 
to be in the front of the line, so to speak.
    Mr. Horn. So was anybody left out of that hierarchy?
    Mr. Marohn. Not that I am aware of. Only the people that 
were in a nondeployable AFSC.
    Mr. Heemstra. Sir, just to pick back up on that, there were 
reports that there was a unit--and I don't have this verified 
yet--in New York that, I guess they were required to take the 
shot. Supposedly 90 percent of them put in resignation papers, 
so they were going to lose 90 percent of their pilots. That 
would have totally shut down the unit, and we were told that 
the National Guard Bureau allowed them to not have to take the 
shot. So I am not sure what exemption they were granted. You 
know, maybe because they weren't going to be on the ground in 
the threat areas for a certain period of time, or what. But 
somehow, I think maybe somebody was treated differently in this 
process and the Guard Bureau might have been involved in that. 
And we don't have it verified; I am sorry.
    Mr. Horn. Well, that is interesting, because obviously they 
know that they can't fly very much if you don't have the 
technicians available, and they know they can go out for 
civilian occupations at three or four times what the Air Force 
is paying them.
    The Gulf War Syndrome was mentioned. That would be out of 
people in the 1990's. How about Agent Orange? Anybody still 
around from the Vietnam War on the technician side? Did you 
ever have any of that? Because that was another one the 
Pentagon covered up and denied for years, finally getting 
around to it, and that is why this sort of gets to me when I 
see this kind of situation happen.
    As was said, trust is what you have to have of the command 
above you, and if that trust breaks down, that is a real fault. 
And that is why I would be curious to have the generals reply 
to that, as to what were the exceptions and why were they 
excepted in the case of the Air Guard. And perhaps General 
Weaver can perhaps put that in the record, Mr. Chairman.
    Mr. Burton. Does that conclude your questioning, Mr. Horn?
    Mr. Horn. I would like General Weaver, who is director of 
the International Guard, what exceptions were made and under 
what conditions that you didn't have to take the anthrax 
vaccination. Apparently there were exceptions.
    Mr. Burton. We will ask that that question be answered.
    Mrs. Morella, I believe you are next.
    Mrs. Morella. Thank you, Mr. Chairman. I think this is a 
very important continuation of the hearings that you have had 
on this issue, because there is just no doubt that this whole 
concept of the readiness of our military, and since the 
announcement of the mandatory vaccination program in 1997, 
growing numbers of military personnel, particularly the Guard 
and Reservists, are choosing to resign rather than take the 
anthrax vaccine. Many of them are confronted, as you have 
stated in your testimony, with the option, take the vaccine or 
leave the service; or there are recriminations that may occur.
    Unfortunately, too many are choosing to leave. This is what 
we have seen in the GAO report. Questions about safety, 
efficacy, and the necessity of the anthrax vaccine program.
    So I just think that we have a responsibility to make sure 
that trust is there; because obviously, if the anthrax vaccine 
is safe and can effectively combat the threat of anthrax for 
our military, the Pentagon has failed to convince the very 
people that they are trying to protect. And I think that is 
what we want to get at. There are serious questions that have 
been raised, and this panel has helped to forward those 
questions to us, legitimate questions that have to be addressed 
in order to ensure our military receive the answers that we do 
    I guess having heard--and I thank you for coming before us, 
you are very courageous to give us your stories, but I would 
like to direct questions to Dr. Porter, because Dr. Porter 
seems to be pointing out that maybe there is an alternative 
that should be strongly considered. It appears as though your 
antibiotic for protection against biological weapons is one 
that would really assist. It also appears as though you already 
have--in your testimony you said, I think, you got $4 million 
as a start? When I look at your chart, ultimately, over a 4-
year period we give you $16 million?
    Dr. Porter. We are asking for an additional almost $17 
million to complete the development program through the 
approval processes, and $2 million immediately.
    Mrs. Morella. $2 million right away.
    Dr. Porter. And $6 million has already been allocated 
through DARPA over a period of time to UAB.
    Mrs. Morella. I know there have been a few questions asked 
of you about this. It sounds as though this is really on a go, 
a go path. And from what I think I heard you say to someone 
else, FDA is also going to be involved with looking at an 
approval process? Where are you? Do you have competition? What 
do you think you could do with this?
    Dr. Porter. As far as we understand, there is no 
competition relative to the target. There is ``alternative 
antibiotics'' that are available, but we think we have a unique 
advantage relative--vis-a-vis to the previous work done at 
USAMRIID and some of the mechanistic activity of the compound. 
We think that we have a compound that is a small molecule that 
is a pretty well-defined drug development process through the 
regulatory agencies. The FDA will be integral in the ``buying 
in,'' if you will, of our development scheme. We think there 
has been a road map for that relative to the recent approval of 
ciprofloxacin, Cipro, which is a drug well known to the 
military for the use in this indication, and also they are 
currently stockpiling that compound. We think we have an 
advantage relative to the fact that this compound, as we are 
designing it, will have a much more narrow spectrum; therefore, 
an obligatory lack of some the broader-spectrum antibiotic side 
effect profiles that Cipro represents.
    Mrs. Morella. Do you see it as a substitute for the anthrax 
    Dr. Porter. Our premise is that you have 2 to 8 hours 
before your body recognizes the anthrax, grows it out and then 
releases the toxin. The white cells that are found in your 
body, engulf the organisms that is the spore. Our premise is 
that if you were there before those spores were resident in the 
body, that those white cells would immediately be involved in 
the killing process if there is antibiotic resident within the 
body. You need to take this antibiotic for up to 60 days, 
because some of these spores can live almost in a dormant 
fashion within the lungs for 60 or more days, and this is well 
known and well described in animal trial work.
    Mrs. Morella. Is General Weaver going to say that he thinks 
you are on the right path?
    Dr. Porter. I can't speak for General Weaver. We have had 
discussions with Dr. Anna Johnson-Wagener, we have submitted a 
formal proposal to them almost a month ago relative to this 
process. As I said, they should have been aware of the work 
done by USAMRIID and the funding that was associated with that. 
They have helped facilitate the repayment of certain funds to 
UAB, which we thank them for. But we think that we offer a 
viable alternative approach that could be--in relatively short 
order, provide a solution to the deployment and distribution 
and safety profile of a compound that would be used to prevent 
the toxic reactions to these biological weapons.
    Mrs. Morella. Your timetable is what, about 4 years?
    Dr. Porter. About 4 years, correct.
    Mrs. Morella. If I could just briefly ask you, gentlemen, 
if you have any comments about this possible alternative 
vaccine and what you think we should be doing in the meantime? 
What suggestions do you have for us? Any of you who would like 
to venture. It doesn't even have to be about that vaccine. I 
mean, do you think that we should right now say forget 
mandating voluntary? Because I know in some instances it is 
mandatory, in others it is voluntary, but it appears to be 
    Mr. Heemstra. Well, the new drug sounds hopeful, so I think 
we wouldn't have the attrition results that we are experiencing 
now and the readiness problems that we are having. So I think 
safety has been the No. 1 issue for the pilots that have left. 
And I think if we had had a voluntary shot program, we probably 
would have had maybe 10 percent, maybe 20 percent that would 
have taken the shot, similar to the British who have a 
voluntary shot program from what I understand. So I think a 
voluntary shot would fix things right now. And like I said, for 
the Guard and Reserve, with the policy the way it is now, not 
requiring it for if you are not going to be on the ground more 
than 30 days, that is going to save some of the retention 
problems that we were having before that.
    Mrs. Morella. Do Mr. Marohn or Mr. Ross want to add 
anything to that?
    Mr. Marohn. I think anything other than what we have right 
now would be much better.
    Mrs. Morella. You think a moratorium right now?
    Mr. Marohn. I think if this drug were proven safe and it 
was well documented, then I would not have a problem taking 
something like that.
    Mr. Ross. I agree, Congresswoman. At least a moratorium 
right now until the issues that have been raised by the 
committee are addressed. That, as a minimum, would help in the 
short term. I do think that Colonel Heemstra talked about in 
his testimony, too, some long-term suggestions so that, you 
know, the next vaccine down the road does not fall into the 
same category. Again, I think we get back to trust at that 
    Mrs. Morella. Thank you.
    Thank you, Mr. Chairman.
    Mr. Burton. Thank you, Mrs. Morella. Chairman Gilman, I 
understand you have a question.
    Mr. Gilman. Thank you. I will be brief. Just, Dr. Porter, 
you say it is going to take you about 4 years to develop your 
    Dr. Porter. It is an antibiotic. Yes, that is the timetable 
for the negotiations. The FDA will further define that time 
    Mr. Gilman. What should be done or could be done in the 
interim period to prevent this present vaccine that has so many 
problems from being utilized? What can the military do to make 
some sort of a temporary method of providing a proper vaccine?
    Dr. Porter. Well, they have a whole basket of defense 
processes, including interdiction, physical interdiction, 
clothing. Also antibiotics are routinely part of their retinue 
against bioweapons, including ciprofloxacin as a treatment 
regimen, and I think they could help explore the use of that as 
a prophylactic regimen, although it has worked on animals in 
that regard.
    Personally, in my opinion, I do not have direct obligatory 
knowledge of all of the problems associated with the vaccine, 
but my personal opinion is I think broad-based deployment is 
not the issue. I think a voluntary use or a use with the 
highest risk of exposure among the military personnel would be 
a prudent approach, and perhaps a moratorium on the other uses 
of the vaccine until further safety has been tested.
    Mr. Gilman. Did you have an opportunity to examine the 
present vaccine that is being utilized?
    Dr. Porter. Only what is in the public domain. Only the 
information available to the members of this committee.
    Mr. Gilman. Based upon your information from the public 
domain, what is your assessment of the present vaccine?
    Dr. Porter. My assessment, it is probably not much 
different than most vaccines. It has that attendant risk, 
usually in the 1 percent range, and that risk is well-known and 
a risk-benefit program for certain disease states of other uses 
to immunological approaches to infectious diseases.
    I think in this particular case those risks may have to be 
balanced against the benefits associated with the program. I 
have no real opinion as to whether this should be taken from 
the market, for example, but I do feel it fits with many other 
vaccines relative to its safety profile, as far as percentage 
of adverse events.
    Mr. Gilman. Thank you, Mr. Chairman.
    Mr. Burton. Mr. Jones, thank you for visiting with us 
    Mr. Jones. Thank you.
    I am going to be brief, because I know we want to get to 
the next panel. But I must say I want to compliment you and 
this committee.
    Two weeks ago, on the Armed Services Committee, we held a 
hearing regarding readiness; and we had the Joint Chiefs. I 
asked the question of all three--Navy, Marine and Air Force--
are your pilots getting enough time in the cockpit to be combat 
ready? The answer from each one, Mr. Chairman, was no. So my 
point is, if we are having Reserve pilots that are leaving the 
Reserves because of this vaccine, then this readiness problem 
is going to really be serious next year if we are still holding 
these hearings, because we have got a problem now.
    What I would like to ask Mr. Heemstra, Mr. Marohn and Mr. 
Ross, when--after Secretary Cohen made the decision to mandate 
this shot, how long after that order to mandate the shot did 
you start becoming concerned? Do you remember the first couple 
of months after you heard that this was going to be an order 
that you and the Guard would have to take this shot? Mr. 
    Mr. Heemstra. Congressman, I think the order went out late 
1997. We didn't start hearing much about it until the spring of 
1998. So it was around March. Right away, we got some civilian 
help from Dr. Nass.
    Mr. Jones. So initially, when the decision was made, there 
was no effort to educate you or your unit as to why this shot 
was necessary and how the Department of Defense felt this shot 
was safe. Did you not have any type of education process?
    Mr. Heemstra. Yes, there was no formal education on that. 
It was just us doing research ourselves via the Internet and 
getting Dr. Nass to come, and then we started hearing what DOD 
said the story was.
    Mr. Jones. Mr. Marohn, the same question to you, sir.
    Mr. Marohn. The only education we got on the vaccine came 
at the time when we were given the verbal order in December 
1999. That is when the program of educating us on this was 
really begun. Otherwise, we had sought out information on our 
    Yes, they did bring somebody on the base to try to let us 
know the safety of it, but what we were hearing was contrary to 
what we had found on our own.
    Mr. Jones. Mr. Ross.
    Ms. Ros-Lehtinen. At Battle Creek, we were a little bit 
further down the line of units that got this. Although we did 
have about a year after Secretary Cohen mandated the program in 
the fall of 1998, we had about 12 enlisted members of the unit 
volunteer to support a deployment to the Middle East. Those 
individuals were vaccinated. Some have testified to Congressman 
Shays' committee as to their illnesses.
    We knew somewhat in 1998, after that first year when these 
individuals were starting to report sick, that something would 
eventually occur. We were unable to get any answers from the 
leadership at our base. They flatly refused to talk about any 
individuals being sick, and they were handling that case for 
another year. So it was not until the unit returned from Kosovo 
at the end of Operation Allied Force in September 1999 that we 
focused on the fact that we were going to have to take this 
shot within the next 6 to 8 months.
    Education from the Department of Defense then began in 
December 1999. So almost 2 years after the mandate.
    Mr. Jones. Yes, sir, Colonel?
    Mr. Heemstra. Yes, sir. The education that was provided was 
after we talked with Dr. Nass initially there. They brought 
somebody in from the University of Colorado, a doctor who was 
an expert on vaccines, so it was about an hour or hour and 15 
minute lecture. He spent the first close to 40 or 45 minutes 
talking about vaccines and how great they were and then the 
last 20 minutes on the anthrax. So it was obvious that their 
education attempt was just propaganda. The biggest example of 
that would be somebody asked him a question about different 
strains of anthrax, and he was taken off guard and didn't 
really realize there were different strains of anthrax and 
didn't answer the question very well. So we were more educated 
than he was concerning anthrax.
    Mr. Jones. Let me ask each one of you, knowing that you 
still have friends that are in the Reserves in these squadrons 
and you have conversations with them from time to time, do you 
anticipate--I mean this for each one--do you anticipate some of 
your friends are saying to you we are probably not going to 
stay in much longer if they are going to mandate this shot? Are 
you hearing that, or is that not----
    Mr. Heemstra. Yes, sir, I have been directly told by some 
of the guys that have taken the first three shots they will not 
take any more shots. So their careers are very short-lived.
    Mr. Marohn. Sir, I was a technician leading up to this. I 
was hired by a major airline in July 1999 shortly before we 
were going to be required to take it. I was going to be the 
only person that would resign as a technician over this because 
I felt so strongly about it.
    Most of other technicians that stayed on board and received 
the shot are I don't think as willing now to continue to take 
part in the program, and I know of two specifically that are 
seriously considering and actively pursuing a different career. 
So far, they have yet to fill my position from a year and a 
half ago as the training officer because they cannot get 
anybody in there that wants to not only give time, which they 
got out of the active duty for, they want to spend time with 
their families now, while the fact of deploying every year, 
more mission capabilities being added to our squadron and now 
this, I don't think people are going to continue to stand for 
it. I think you will see a lot more exit of pilots, especially 
technician pilots, in the future.
    Mr. Jones. Mr. Ross.
    Mr. Ross. I definitely think, Congressman, you will find 
that since my unit has returned now from their AEF commitment 
No. 7, they took their three shots to get over there, the 
program is in the current hold position that it is, they will 
not be required to take any more shots, but in the interim here 
I think you will see another three or four who have felt that 
they now did their duty and are ready to leave. Then, once 
again, when the shots are started back up, some of those folks, 
as Colonel Heemstra said, not take the fourth shot.
    Mr. Jones. Thank you, Mr. Chairman.
    Mr. Burton. Mr. Shays. I want to thank Mr. Jones for his 
interest in this and his work on this. He has been working on 
it for a long time. Good fellow.
    Mr. Shays. Mr. Jones is a real hero on this issue, and I 
really thank him for participating in this hearing.
    Mr. Chairman, I particularly thank you. Our subcommittee 
has attempted to look at this issue, but we have needed your 
stature and the stature of the full committee to get a little 
deeper. I also appreciate your participation in the hearings at 
the subcommittee level.
    Mr. Heemstra, you are Mr. Heemstra now, but when you came 
before us, you were a Lieutenant Colonel, is that correct?
    Mr. Heemstra. Yes, sir. I think my status is in question. I 
was forced to sign my retirement papers. I signed them about 60 
days ago--I wasn't aware that the policy had changed 3 days 
prior to signing them, because, as we said before, the base did 
not want that information out that the policy had changed. When 
I found out, I withdrew my retirement papers with the 
Headquarters Personnel. I have documents saying my papers were 
withdrawn. So I should be still in. However, Fort Wayne does 
not acknowledge or recognize these official documents, so they 
say I am out. So I have no idea what my status is.
    Mr. Shays. They say you are Mr. Heemstra. You believe you 
are still Lieutenant Colonel. When you came before the 
committee, you were Lt. Colonel.
    Mr. Heemstra. Yes, sir.
    Mr. Shays. That was on Wednesday, September 29th.
    When you opened your testimony, you said, I humbly submit 
these views, which are shared by the majority, not as a rebel 
to change policy but as a servant and a civilian soldier 
interested in examining this policy and the best interests of 
my Nation and my former troops.
    You also went on to say, as you know, we are the guinea 
pigs. We know we are the guinea pigs. You know we are the 
guinea pigs. As one Senator shockingly told us a few months 
ago, you signed on the dotted line when you joined, giving up 
those rights of ordinary citizens, so roll up your sleeve and 
obey orders.
    We may have sure rendered these rights to our superiors, 
but it was into their care and their trusteeship to take care 
of those rights.
    You said a lot of other things that day.
    At that hearing, Mr. Burton asked a question of Mr. Cragin, 
and Mr. Burton said, well, let me go forward with the rest of 
these questions, and then he can answer if he would like. From 
1996 to 1998, the Air Force lost 369 pilots in that 2\1/2\ to 3 
year period. It is estimated this year it could reach as many 
as 340 in 1 year when the paperwork is processed in September. 
Many tracking the numbers have remained mute because of what 
happened to Deborah J. Aigen, an Air Force pediatric nurse, who 
in a letter to the military newspaper Stars and Stripes raised 
concerns about the vaccine's side effects and so forth. Is that 
also a figment of someone's imagination?
    Mr. Cragin: Would you--I am going to ask General Weaver. I 
have his facts and figures in front of me, Mr. Chairman, but I 
would prefer to have you hear from General Weaver since I am 
looking at his attrition numbers for the last 5 years.
    Now, Mr. Weaver starts to answer the question. And then he 
says, our retention rate--and we are the busiest Reserve 
component force of all the Reserve component forces. In fact, 
75 percent of the Reserve component forces called up for Kosovo 
were Air National Guardmen and women. We have the best 
retention rate in the Air National Guard of all services, over 
90 percent.
    Talking personally, personally to all the commanders, to 
include the 122nd, there are challenges with explaining, with 
discussing as they are with the members of their unit on the 
anthrax issue. But when it really gets down to it, we have 
10,700 people inoculated for anthrax in the Air National Guard, 
with one known refusal documented.
    He was trying to give the impression that when it comes to 
anthrax, there was only one.
    That is almost 10 percent of our force. Now, there is a lot 
of anecdotal evidence out there about all these pilots leaving 
the force when they are forced to do so. Well, we already have 
10,000 individuals voluntarily taking anthrax shots, some of 
which right now are in the combat operation in Northern Watch. 
So when I hear all these other figures about these mass 
resignations and what not, they are just not there.
    That is what General Weaver said.
    Now, we asked General--I asked General Weaver, I would make 
a request that any person who leaves the Reserve or National 
Guard be specifically asked if any anti-anthrax vaccine was a 
factor in their decision and to what extent it was; and then I 
said, I will followup and see that it is done.
    General Weaver: Yes, sir, I will do that. Yes, sir, I will 
do that.
    Then we see questionnaires sent out to our military, not 
even asking the question about anthrax. And then when the 
chairman says please ask the question about anthrax, they say, 
    Now, in the hearing you had last week, Mr. Chairman, which 
was an extraordinary hearing, you again had victims. Mr. 
Heemstra, Mr. Marohn and Mr. Ross, you are victims, and all the 
people you serve with are victims, in my judgment. They are 
also brave military personnel who wanted to serve their country 
under the trusteeship that you have in the military.
    Mr. Chairman, you had one, two, three, four, five, six, 
seven, eight, nine individuals who testified, in addition to 
Dr. Alexander Walker at the request of the minority. Now, Dr. 
Alexander Walker is a professor of epidemiology, Harvard School 
of Public Health, and he made the point to us, almost like the 
military, it is a concept of acceptable loss. You do a vaccine, 
there are going to be some people who have an adverse effect, 
which was in essence to say all these people may be before you 
who you, Congressman Shays, may think of as victims, but they 
may be just the very few, the very few with acceptable loss.
    Now, the interesting thing is that we know they don't 
represent--those witnesses last week did not represent that. In 
other words, the totality of those who may have been perceived 
as victims.
    I want to ask each of you, do you know anyone who has taken 
the shot who has had adverse side effects?
    Mr. Heemstra.
    Mr. Heemstra. Yes, sir, I know several at the base, that 
some are secretly sick and will not come forward, some that 
even in their family situation have not made it a known fact 
that they have taken the shot.
    Mr. Shays. Mr. Marohn.
    Mr. Marohn. Yes, sir, I do. I know of several. I know that 
one of the men in our life support is currently under review, 
and they are seriously looking at the shot as a causal effect 
in his current medical condition. They are also reviewing his 
    Mr. Shays. Mr. Ross.
    Mr. Ross. Yes, Congressman. I would say I personally know 
in the neighborhood of 15 individuals that are still at the 
base. Some of the individuals at Battle Creek that I know 
personally testified to your subcommittee, and you have had 
their testimony in the record from Battle Creek.
    Mr. Shays. Thank you.
    Now, Dr. Alexander Walker at one point said there will 
always be costs. This is in the transcript of last week dated 
Tuesday, October 3rd. There will always be costs. I think we 
see this in every form of medical treatment. That even the 
safest ones, that there are--there are costs, and it is always 
a judgment as to what the best thing is to do for the 
individual in front of you. With vaccines, unlike antibiotics, 
the question is much more difficult, because the benefits are 
in a sense theoretical, as if this person is never exposed to 
attack, then he is not going to derive any benefit from the 
vaccine. So the individual that you see, who has had adverse 
effect, in that instance is being laid against no benefit, just 
a theoretical benefit that the person had, and that is very 
    Then he goes on to say--excuse me--and I asked him, don't 
you think there should be some kind of presumption that maybe 
this person might be that one isolated, very small person, 
statistical individual that maybe should have some ability to 
say no? I mean, we are not talking military order. I mean, we 
are not taking the military order. They get court-martialed if 
they don't take it. But, medically speaking, would that be 
    And the question that preceded was, if someone had an 
adverse effect, couldn't we make an assumption that they were 
that, in the words of Dr. Walker, the few who had a statistical 
negative effect with that anthrax and then should they be asked 
to take the second, third, fourth, fifth or sixth shot?
    Mr. Walker: I can obviously only speak from the point of 
view of civilian medicine. I don't know the military. It is in 
the general society. I think it is a bad practice to compel 
vaccination. People may make mistakes, but I think it is just a 
violation of fundamental liberties.
    Now, this was the witness intended to boost up what the 
military was doing. Then he said it also provides the 
groundwork for a lot of fear.
    Then he continues, so your question presupposes that the 
fever and headache was actually a marker of someone who would 
go on to have seizures and blackouts and so forth afterwards?
    I don't know if that connection is true, but that is what 
you look at. You look at people who have had a particular 
adverse effect, and then you look back at their experience with 
the vaccination and compare it to the people who don't have the 
    So then I said--Mr. Shays: So the bottom line is in a six 
series, having six shots, when we start to see adverse effects 
continue to grow, from a medical standpoint, it would not be 
unreasonable to say maybe this is someone who we shouldn't 
continue requiring to take the vaccine?
    Dr. Walker: In fact, that was commonly what we did with the 
old pertussis vaccine, that there were children who had fevers 
and so forth, they reacted poorly, and they typically got half 
doses or withheld doses. Nobody knows whether that affected the 
safety of the vaccine, but it was common practice, and 
obviously so--I added the obviously so.
    I would like, Mr. Chairman, to just conclude by asking that 
we submit for the record these two--without objection, I 
request that----
    Mr. Burton. Without objection.
    Mr. Shays [continuing]. These two surveys, and what I 
consider an obnoxious letter, but let me just not paraphrase it 
that way, a letter from Mr.--let me make sure I am getting it 
correct, Dr. Rosker.
    Mr. Burton. Without objection.
    Mr. Shays. Excuse me, sorry to hold you up. It is from 
Bernard Rosker, August 25, 2000, and it was addressed to Dan 
Burton, chairman of the committee.
    Mr. Burton. Without objection.
    Mr. Shays. Then I would just like to also ask that--we had 
written Mr. Cragin and Dr. Weaver a letter of--General Weaver, 
I am sorry--November 3rd. I would like that letter--we were 
expressing concern about the accuracy of information provided 
by you to the Subcommittee on National Security and so on, when 
he said, ``but when it really gets down to it, we have had 
10,700 people inoculated for anthrax in the Air National Guard 
with one known refusal documented.'' We would like our letter 
put in the record and Dr. Weaver's response to us, and that was 
dated November 10, 1999; and also the letter to Honorable 
Charles Cragin of October 7th, and then his response of October 
    Mr. Burton. Without objection.
    Mr. Shays. Thank you, Mr. Chairman.
    Mr. Burton. Thank you very much.
    [The information referred to follows:]

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    Mr. Burton. If there are no further questions of this 
panel, I want to thank you very much for coming back. We 
appreciate your standing up on this issue. I know it has caused 
you some problems. Hopefully, we will get this thing resolved; 
and maybe, the good Lord willing, we will get you back to 
flight status one of these days.
    Dr. Porter, thank you for the education. Thank you very 
much. I am learning more every day.
    With that, we will now have the next panel come forward.
    The next panel is Mr. Chan of the GAO and General West and 
those accompanying them. If there is going to be testimony 
given by others than Mr. Chan and Mr. West, we would like those 
to stand so they can be sworn.
    Would any of the witnesses like to take a 5-minute break 
before we start the panel?
    Generals, would you like to take a quick break before we 
start the panel? We may be here for some time.
    Mr. Chan, you and the folks from GAO, would you like to 
take a 5-minute break?
    The cameraman? Just to show you that we do care about the 
media once in a while, we will take a 5-minute break. We will 
be right back. This is for you.
    What network are you from? CBS. Just tell CBS that we do 
care about you guys, once in a while.
    Mr. Burton. If we could have the witnesses come to the 
table and stand, please.
    [Witnesses sworn.]
    Mr. Burton. We will start I guess like we did the last 
panel, at the left. Mr. Chan, are you ready with some kind of 
opening statement----
    Mr. Chan. Yes, sir.
    Mr. Burton [continuing]. From the GAO?
    Mr. Chan. Yes, sir.
    Mr. Burton. OK, Mr. Chan, proceed.

                       AIR NATIONAL GUARD

    Mr. Chan. Mr. Chairman and members of the committee, it is 
my pleasure to be here today to discuss the preliminary results 
of our ongoing work on the impact of the DOD's anthrax vaccine 
immunization program on the Air National Guard's and Air Force 
Reserve's retention of trained and experienced personnel.
    Specifically, I am going to report today on, one, the 
impact of the vaccination program on retention; two, the basic 
views of Guard and Reserve pilots and other aircrew members 
regarding the program; and, three, the extent of adverse 
reactions experienced by anthrax vaccine recipients.
    As you know, these components provide essential support to 
critical defense operations on a worldwide basis. They provide 
strategic and tactical airlift, aerial refueling, troop 
transport, aero-medical evacuation and augment DOD's overall 
fighter force.
    To conduct our work, we developed, pretested and validated 
a questionnaire that was sent to over 1,200 randomly selected 
Guard and Reserve pilots and other aircrew members. These 
included pilots, flight engineers, load masters, navigators, 
crew chiefs, and others. Collectively, they represent about 
13,000 service members.
    We administered the survey on an anonymous basis between 
May and September 2000. The overall response rate was 66 
percent. The information we are presenting today has been 
weighted to represent the population of those Guard and Reserve 
pilots and other aircrew members who are currently active and 
assigned to a unit.
    Before I discuss the results of our survey, let me discuss 
the context of this subject.
    In August 1998, DOD began a mandatory anthrax vaccine 
immunization program for its 2.4 million U.S. military 
personnel, including Active and Reserve component personnel.
    As you know, Mr. Chairman, this program has been the 
subject of much controversy. Some members of the Armed Forces 
have expressed concerns regarding the safety and efficacy of 
the anthrax vaccine. Those refusing the vaccine have been 
disciplined under service-specific policies for disobeying a 
lawful order.
    While some Reservist and National Guard members have 
publicly stated they have resigned or transferred to non-flying 
positions that do not require the anthrax vaccination at this 
time, DOD officials have denied such losses were due to the 
anthrax vaccine program.
    It is important to note that DOD neither collects uniform 
records on such changes of status, nor has it done any survey 
to assess the extent and impact of such losses.
    The Reserve components are currently experiencing 
difficulties in filling their ranks with new recruits at a time 
when DOD is relying on them more heavily to conduct operations 
around the world. Specifically, the retention of pilots and 
other aircrew members have been and continues to be a problem 
that could impact readiness. Without adequate numbers of pilots 
and air crew, the Guards and Reservists could experience 
difficulties supporting the Active force in its worldwide 
    In addition, it costs the military an average of almost $6 
million to train and develop a fully qualified, experienced 
aviator, which the Air Force suggests takes about 9 years.
    Turning to the results of our survey, I have three findings 
to report: First, the anthrax program is having adverse impacts 
on the retention of Guard and Reserve pilots and aircrew 
    As you can see on slide one, an estimated 25 percent of the 
pilots and aircrew members of the Guard and Reserve in this 
population had either left the military altogether, transferred 
to a non-flying position in another unit, or moved to inactive 
status. Below that line, you find, additionally, 18 percent of 
those still participating in or assigned to a unit reported in 
our survey their intentions to change their status, including 
leaving within the next 6 months.
    While several reasons influenced their decision, both 
groups ranked the anthrax immunization as the most important 
factor for their decision for the change, followed by other 
reasons such as employment opportunities, unit workload and 
family reasons.
    Of those who are either separated or no longer in military 
flying status because of the anthrax vaccine immunization 
program, 43 percent stated that they would likely return if the 
anthrax programs were done away with. So 43 percent of the 25 
percent in there.
    Each of these groups, those who have left and those who are 
planning to do so, have accumulated an average of more than 
3,000 flight hours, which symbolizes a seasoned and experienced 
work force.
    Second, the anthrax vaccine program is very unpopular among 
Guard and Reserve pilots and crew members. As you can see in 
slide two, despite DOD's high visibility campaign to educate 
service members about anthrax immunization programs, two in 
four, or 39 percent, said they are moderately or very 
dissatisfied with the timeliness of the information provided to 
them on the DOD anthrax Web site, over half, or 54 percent, on 
the completeness of the information, and three in five, or 58 
percent, on the accuracy of the information provided. Finally, 
three in four, or 74 percent, found the information to be 
moderately or very biased.
    With regard to their views on the anthrax program, you can 
see on slide three, whereby 65 percent indicated that they have 
no support for the anthrax program. Three out of four, or 76 
percent, indicated they probably would not take the shots if 
the anthrax immunization program were voluntary; and 9 out of 
10 indicated that they would probably have safety concerns if 
additional vaccines for other biological warfare agents were 
added to the military immunization program.
    Mr. Chairman, this last finding has important implications 
for DOD's future biological warfare vaccine initiatives.
    Finally, adverse reactions are seriously underreported to 
FDA's Vaccine Adverse Events Reporting System [VAERS], which 
is, as you know, a passive system. Service members apparently 
do not trust military health care providers or supervisors 
enough to discuss their reactions with them. It is therefore 
important for you to know that the statements made by FDA and 
DOD on the safety of this vaccine are based on limited data 
from some service members.
    Moreover, there has been no systematic followup to obtain 
data on the clinical conditions. As you can see on slide four, 
42 percent of the respondents reporting they had received one 
or more anthrax shots. Of those taking one or more shots, 86 
percent reported experiencing some type of local and/or 
systemic reactions; 71 percent reported being unaware of VAERS 
itself. Further, 60 percent of those experiencing the reaction 
had not discussed them with military health care personnel or 
their supervisors, half of them citing fear of loss of flight 
status and possible adverse effects on their military or 
civilian careers and ridicule as reasons for nondisclosure.
    For some local and systemic reactions, the reported 
duration was more than 7 days. In my written statement we have 
a table showing the list of some 20 different reactions which 
the respondent had checked out. Some of these reactions could 
have implications for work performance. Since many individuals 
are not reporting their reactions to military medical personnel 
or to the various systems, the actual duration, the extent or 
impact on unit individual and ultimate resolution of these 
reactions are unknown.
    Mr. Chairman, this concludes my statement. Thank you.
    Mr. Burton. Thank you, Mr. Chan.
    [The prepared statement of Mr. Chan follows:]

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    Mr. Burton. I think, Mr. Shays, you had a chance to review 
the GAO report last night, did you not? Mr. Chan just completed 
his statement. I think you had that report last night.
    General West.
    General West. Sir, I will not make any comment on the GAO 
report because I did not get it last night. I do not have it 
yet, and I don't know what the results were other than what I 
just saw before you.
    Normally, we would receive the report, we would have an 
opportunity to respond, that response then would be reviewed by 
them, and we would have a chance to discuss that, and that has 
not happened yet.
    Mr. Burton. Were you briefed about it at all, General?
    General West. I was not, no, sir.
    Mr. Burton. What we would like to do then--Mr. Chan, did 
you brief DOD about this?
    Mr. Chan. Yes, sir. Last Monday, before the past hearing, 
we briefed three of his staff, at least two are present here. 
We gave them, in fact, very in-depth presentations beyond what 
we sent to you.
    Mr. Burton. Who were those that you briefed? Do you recall 
their names?
    Mr. Chan. I remember two names, Colonel Gerber and Colonel 
Randolph, plus another person.
    Mr. Burton. Are those staff members of yours, General West?
    General West. They don't work directly for me, but they 
work on the anthrax program, and they are both good and 
competent people. One of them is here today. So if you have 
questions for them----
    Mr. Burton. The only thing is, I was wondering why you 
weren't briefed by them about that. Do they normally brief you 
when you are going to testify before Congress if they have been 
briefed by GAO?
    General West. Well, sir, I knew that they had had a meeting 
with FDA, but they weren't given a copy of the report, and we 
have not had any opportunity to respond to it. It would be 
improper for me to give you an official DOD response to 
something that has not been delivered to us yet.
    Mr. Burton. Well, we will not quibble about that now. I 
hope in the future if GAO does give staff members a lead time 
appraisal or in-depth report on one of their findings that they 
will be given to the superior officer, like you, General West, 
so you are prepared to testify before the Congress. In any 
event, maybe you can, after you review it, along with your 
staff, you can give us some written response to it.
    In any event, if you have an opening statement, why don't 
you proceed?
    General West. We will look forward to doing that, sir, and 
certainly I am very interested in pursuing some of the things 
that he presented on those charts and some of the things that 
my staff talked to me about. We will need to see the report 
before we can do it.
    Mr. Shays. Could I interrupt to ask a question?
    Mr. Burton. Sure.
    Mr. Shays. General, were you aware that the GAO was going 
to be making testimony today? Were you aware that you would be 
on the dais with them?
    General West. Yes, sir, I was.
    Mr. Shays. Did you ask for their statement?
    General West. I wanted a copy of the report.
    Mr. Shays. I asked a question. It wasn't that. I asked if 
you asked for their statement today?
    General West. I didn't specifically ask for it, no, sir.
    Mr. Shays. Why not? When you come before this committee, 
you don't want to know what other people are going to say?
    General West. Yes, sir, I do. But----
    Mr. Shays. And is it your practice that when you come 
before these committees you don't ask to know what other people 
are going to say that are going to appear on the same panel 
with you? Is that your practice? You just simply don't ask?
    General West. No, sir, I do want to know what is going to 
be presented to you, and I want to be able to respond to it. I 
would have loved to have had a copy of the report so I could 
    Mr. Shays. I am not talking about a report. I am talking 
about their testimony, and I can't believe that you wouldn't 
have wanted to know what the testimony of the other people was. 
They have to submit it before today. You had to, didn't you?
    General West. Yes, sir.
    Mr. Shays. Wasn't it logical that GAO would have submitted 
    General West. Yes, sir.
    Mr. Shays. Isn't it logical that you might want to look at 
    General West. Yes, sir.
    Mr. Shays. And isn't it logical that you might then just 
care to ask to see it? Wouldn't you have just asked the people 
that work with you to get a copy of the statement?
    General West. Getting a copy of the statement or knowing 
what they are going to say is not the same thing as an official 
response to a report.
    Mr. Shays. Just start with the statement. It is logical 
they have a statement to make; and I would think, thinking that 
the Army likes to be prepared, that you would simply have said 
I would like a copy of all the people that are going to 
    General West. I was briefed on what they intended to say 
and what they were going to present as testimony.
    Mr. Shays. That is important to know. It is important to 
know you were briefed on what they intended to say. It is a 
little disingenuous--with all due respect, you say their 
report. This is testimony that they are giving.
    Your report is going to be given when, Mr. Chan?
    Mr. Chan. Hopefully within 2 to 3 months. It is not 
complete. That is why we call it preliminary results, sir.
    Mr. Shays. It is not a report yet, is it?
    Mr. Chan. No, sir.
    Mr. Shays. Let me ask you something else, Mr. Chan. Is 
there anything in your statement that you have given today that 
basically is new, that wasn't submitted to us last night?
    Mr. Chan. No. If I can say, we have shared with the three 
people we mentioned in much greater detail than what I 
presented today to you.
    Mr. Shays. I just want to explain something. I feel like 
when you come before us that we have to know specifically what 
you are saying, because if we don't ask it the right way, you 
give us a false impression. The false impression I had was this 
is all news to you, and in fact you were briefed yesterday 
about what they were going to say. Isn't that true?
    General West. Sir, there was nothing disingenuous about the 
statement. I merely want----
    Mr. Shays. Just answer my question, and then you can tell 
me how you want to qualify it. You were briefed yesterday on 
what they were going to say, is that not correct?
    General West. I was briefed earlier in the week, not 
specifically yesterday.
    Mr. Shays. So you pretty much knew what they were going to 
say today?
    General West. Yes, sir.
    Mr. Shays. OK, thank you.
    General West. But there was nothing disingenuous about my 
answer. I only wanted to get on the record that I can't give an 
official DOD response to a report that we haven't received yet 
nor haven't been given a copy of, as you have. That is not 
disingenuous, sir.
    Mr. Shays. No, but it is disingenuous, because what we have 
is their testimony, and you were briefed on their testimony, 
and so you can comment to their testimony, not to their report. 
You have every reason, an obligation, to testify to what they 
said today.
    General West. I can comment on what they say, and I am very 
willing to do that, and every answer that I give you will be an 
honest answer. What I can't do is give you an official DOD 
response to a report we haven't received.
    Mr. Shays. I don't want an official. I want your response.
    Mr. Burton. Thank you, Mr. Shays.
    Before we hear your testimony, your opening statement, 
General West, before we began this recent round of hearings on 
the anthrax program, we invited the vice chairman of the Joint 
Chiefs of Staff to appear, but he requested that others on his 
staff appear on his behalf. Of course, we are disappointed that 
General Meyers has not joined us to share with us his opinions 
as well as those of the chairman, General Shelton.
    Our concern is to what degree the chairman and vice 
chairman are personally aware and engaged on this issue and the 
problems that have been presented at our hearings. My concern 
is that they may be letting staff handle the problem and they 
aren't getting all the facts.
    Readiness of our Armed Forces is the direct and personal 
responsibility of the chairman, vice chairman and the Joint 
Chiefs of Staff. Retention is a readiness issue of significant 
    Has the Joint Staff and the DOD been asleep at the switch 
in not discovering what the GAO has found out that has an 
adverse impact on the readiness arising from the AVIP program?
    These are things we want to find out. We would like to make 
absolutely sure that, even though this report is not going to 
be completed probably for a month or two, that the graphs, 
charts and findings that have been reported by Mr. Chan and his 
associates today are conveyed to the chairman and vice chairman 
of the Joint Chiefs of Staff as quickly as possible.
    As Mr. Shays said, it is troubling that several people, one 
in particular that is here with you today, was briefed in more 
depth than we were about the statements and the information we 
received today, and yet it appears as though you weren't given 
a full briefing by your subordinates, who are here with you 
    I would hope in the future, if we have future hearings, if 
GAO or some other entity in the government briefs your staff 
people that they will make sure you get a full briefing on what 
was said so you are prepared.
    Mr. Shays. Mr. Chairman, General, I want to apologize to 
you in referring to you as the Army, since you obviously are 
part of the U.S. Marine Corps. I apologize. You also wanted to 
make a point about it being an official report. I interrupted 
you. I apologize for that.
    My problem, sir, though, is that you gave the implication 
that you didn't know anything about this report, that it was 
news to you, when in fact your people were given this report 
and you were briefed. I don't even concede that you weren't 
given a thorough briefing.
    So whether you have a report that you can give an official 
comment on, you have a history with us, and the history is you 
seem to give implications like only one person refused to take 
anthrax, when in fact we know more did; and that is why I have 
this sense of concern about how you communicate with us.
    So I just would like to know, you were briefed, correct, on 
this statement that was going to be made by Mr. Chan?
    General West. Sir, I was briefed. I was given a full 
briefing by my staff. They are good staff, and they do a good 
job. I made one point, and that is--and you just said we got 
the report. We didn't get the report. We still don't have the 
report. If you have it, you have it, and I don't.
    Mr. Shays. I don't have a report.
    General West. But the only thing I said was I can't give an 
official DOD response to something we haven't received.
    Mr. Shays. But you can give a response to what you have 
heard today, is that not correct?
    General West. I can and I will.
    Mr. Shays. And all the statistics that were involved, that 
were presented here?
    General West. Yes, sir.
    Mr. Burton. General West, we are ready for your opening 
    General West. Thank you, sir. I am just going to make a few 
comments. I had a prepared oral statement I was going to make, 
but, as you know, I have appeared here several times and you 
have heard some of it before, so I am not going to use that 
    I am just going to make a few points in response to what we 
have already heard today, because I think they are important. I 
have been here several times. I have never given you one 
statement that was a false official statement. I have never 
given you one lie, never called anyone a malingerer; and I 
don't intend to do that today.
    I have been in this job 14 months. During that time, I have 
spent every working day of my life working on the anthrax issue 
in one way or another. When I came to this job, I quickly 
realized that there was a lot of contention about it and that 
there were differing opinions about it, and I started my job by 
going to the opposition side, sitting down with them and 
listening to their concerns.
    I went through them one by one. I have met with people that 
are sick and believe that they had an adverse reaction. I have 
met with people that have read things on the Web site that 
caused them concern. I have tracked those things down as best I 
could, one by one.
    I need to tell you that, after that 14 months of effort, I 
am honestly and sincerely convinced, more than ever, that the 
anthrax vaccine immunization program is the right thing for the 
Department to do. I am going to try to quickly tell you why I 
believe that.
    If I could ask the lieutenant with me to hold up just a 
simple chart--I don't have anything to put up on the screen. 
Show the Desert Storm picture, please. That is not just a 
picture that somebody dreamed up. That is an actual depiction 
of a combat seen during Desert Storm.
    I was on the ground on the south side of that picture. I 
was looking into the burning oil wells and the smoke over 
there. Later, I had to lead my men through that. We did that, 
and when we got to the other side, what we found was that our 
adversary on the other side of that snug had weaponized 
anthrax. It was colorless, it was odorless, it was tasteless, 
it is very difficult to detect, and if you breathe it and you 
haven't been vaccinated, in 3 to 4 days you are probably going 
to die.
    We had a force on the battlefield that was not protected. 
We found out that the threat that we had suspected, but we 
validated it, we found out that it was bigger than we thought 
it was.
    In the process of the investigating and the peacekeeping 
force going in and meeting with some of the Iraqi people, 
meeting with some of their counterparts in the Soviet Union 
that had worked on this program, we found that they had a lot 
of bad stuff and that that stuff would kill you very, very 
quickly if you weren't protected. We found out that the enemy 
had gone so far that they had deployed into the battlefield, 
that their unit commanders had parameters under which they 
could use it, and they even had flare pistols loaded with the 
right color flare to shoot to let their troops know that they 
were getting ready to deploy a biological weapon and they 
should don the appropriate equipment to give themselves 
    We had a responsibility to the mothers and fathers of 
America to provide the best protection that we could come up 
with against that kind of threat, that existed not just there 
in Southwest Asia but in other places in the world as well. The 
protection that we came up with was the anthrax vaccine. It was 
approved by the National Institutes of Health. It was approved 
by the Food and Drug Administration. It had been reviewed by 
the Centers for Disease Control. It has since been reviewed by 
a vaccine expert review committee. And all of them, the people 
that we pay to make these kinds of decisions, these kinds of 
certifications and give us these kinds of recommendations, told 
us that the vaccine was safe and that it was going to be 
effective, used against a threat that we were planning to use 
it against.
    We wanted that kind of protection for our force. So we did 
it. We went forward with it.
    The Secretary conducted a long review. He got all of the 
data and all the information that he could, and then he made a 
decision based on a recommendation of the Joint Chiefs of Staff 
who have also taken this vaccine, as has the Secretary and the 
Deputy Secretary and myself and the majority of the senior 
leadership in the Pentagon.
    No matter how good a pilot a person like Lieutenant Colonel 
Heemstra is--and I assume he is a good one, and I assume that 
everything he told today was the truth as he believed it--but 
no matter how good he is, if he goes to the battlefield and he 
is unprotected and the enemy uses a threat they have already 
got that will kill him, he is not going to be any good to us in 
a few days.
    As a commander, if I go back there and the enemy uses it 
and I haven't used protection that all the people we depend 
upon to tell us if something is safe and effective, I have a 
lot of letters to write to a lot of mothers and fathers telling 
them why their sons and daughters died on the battlefield when 
I could have protected them. I did not want to do that, and the 
Secretary did not.
    I encourage all of the members of the committee to go sit 
down with the CIA, get a full brief on this threat, find out 
how bad it is and where it is and how many people we think have 
it. I don't think there will be many of you that will not want 
to not provide protection against that threat after you hear 
the briefs, sir.
    Mr. Gilman talked about us not responding to your 
committee's report. We did respond. It was over 70 pages. It 
had a lot of medicine and science in it that he talked about 
wishing that we would look at, but apparently it didn't make a 
difference or was not reviewed.
    I am concerned about some of the data that the pilots gave 
out here today about the numbers within their units, and I 
learned some things today that I need to go back and 
investigate. But I can tell you that I have a chart on each of 
the six components of our Guard and Reserve forces, all six of 
them, the Army National Guard, the Army Reserve, the Navy 
Reserve, the Marine Corps Reserve, the Air Force Reserve and 
the Air National Guard, and in the year 2000 they all have a 
lower attrition rate than they did in 1998 when we started this 
    So if somewhere in between their story and our official 
charts there is a discrepancy and we need to get to the bottom 
of that, I promise you that I am going to do the best that I 
can to do that and tell you where those differences are. 
Because I haven't come over here, nor do I believe the other 
people that came with me, lied to you about our retention 
    Retention is very important to us. To be honest with you, 
losing, as I told my friend, Congressman Jones, who I have a 
great deal of respect for, and he mentioned this at the last 
hearing without saying my name, but I don't mind it being 
used--losing one serviceman or woman for no other reason than 
they have been led to believe they should not take a vaccine 
that is only meant to be good for them is a concern to me. That 
is a problem. Losing--I am an aviator myself. Losing one good 
pilot out of a unit that is trained with that unit, that is 
current in his airplane and ready to go to war is a retention 
problem, it is an attrition problem, and I do not want to have 
    I welcome the committee's oversight and the committee's 
help to make our program better, and you have done some things 
and led us to some things that have made it better. But we need 
your help to make it better, not to stop it. Because if we stop 
it, we are going to send people to work every day in an arena 
where weaponized, aerialized anthrax that can kill them in 3 to 
4 days can be delivered on them at any moment; and I don't want 
to come before you and tell you that I had protection against 
that threat and didn't use it.
    Things like the witness that would have been to my left 
told you about earlier, we are very interested in those things. 
We are pursuing them. Dr. Wenguard is one of the DOD people 
that came before you as a witness before. She is interested in 
it. We have helped fund that.
    But as he said, it is 4 years away. And once he has that, 
once it is approved, how do you know that the enemy has used 
something that is tasteless, odorless and colorless and very 
difficult to detect? And after you give them antibiotics and 
you give it to them for 60 days, I may be wrong, but I don't 
believe it provides you continuous protection. It is just for 
that interim period of time that you use the antibiotics to 
kill what has already contaminated your body. We need something 
better than that, because we can't predict when they are going 
to use it, and we probably won't know that they have until 
people start to die.
    There is nothing disingenuous about this kind of testimony. 
It is just the way I see it as a commander.
    Mr. Burton. Thank you, General. Does that conclude your 
    General West. Yes, sir.
    [The prepared statement of General West and General Weaver 










    Mr. Burton. General, how did the Iraqis who had the flare 
gun that they were going to fire to show their troops that they 
had dispensed the anthrax, how were they going to protect their 
    General West. I don't know that fully, sir. I assume that 
they used a vaccine that the Soviets provided them. It is not 
like our vaccine. It is a different one.
    Mr. Burton. You don't know from our intelligence sources 
whether or not they were going to wear protective clothing or 
whether they were vaccinated?
    General West. I know that they had some protective 
clothing. It would not have been enough to provide them full 
    Mr. Burton. Do you know anything about the vaccination 
process with the Iraqi army?
    General West. I know a little bit about it. I know----
    Mr. Burton. Were they vaccinated?
    General West. Some of them were, yes, sir.
    Mr. Burton. How many?
    General West. I don't know that.
    Mr. Burton. Were all of them vaccinated?
    General West. I don't know that either, sir.
    Mr. Burton. Well, it seems to me from our intelligence 
services after the war, it seems to me the first thing that you 
ought to know at the Pentagon, if you thought there was a 
threat from anthrax and you knew the enemy was going to use it, 
that you would find out what they were doing to protect their 
troops. It seems to me and I believe that it probably was not a 
vaccination. It was probably protective clothing and other gear 
to protect their troops.
    But, in any event, that would be the first thing I would 
think the Pentagon would want to do is find out--if they were 
going to use some kind of a biological substance, that they 
would find out how they were going to protect their troops.
    General West. We did want to know that, and we asked those 
questions, and we have part of the answer. We know that they 
had protective gear, we know that some of them were vaccinated, 
we know that they planned to shoot it forward from their 
positions with the wind blowing south in the hopes that only 
our force would be exposed.
    Mr. Burton. Well, General, in World War I they were using 
mustard gas and they were firing it one way and it was blowing 
back the other way, so the wind does change. I don't think that 
is probably a real good answer because it seems to me that the 
first thing they do is figure out how to protect their troops 
in the event that they use the biological weapon.
    But let me go into some other questions, because we have a 
vote, and Congressman Shays is going to come back----
    General West. I think General Weaver had a short statement 
he wanted to make, sir.
    Mr. Burton. Oh, I am sorry, General Weaver. Did you want to 
go ahead and make your statement right now?
    General Weaver. It is up to you.
    Mr. Burton. Sure. Go ahead. But I do have some questions.
    General Weaver. Mr. Chairman, distinguished members of the 
committee, and especially my good friend Congressman Ben Gilman 
who I have known since 1985 personally and professionally, I 
appreciate the opportunity to address the committee today 
regarding recruiting, retention and readiness in the Air 
National Guard.
    As you know, the Air National Guard is a volunteer force 
but also an integral part of the total Air Force. Our units 
deploy to every theater as part of the Air Force's air 
expeditionary force. Consequently, our recruiting, our 
retention and our readiness have a direct bearing on the 
success of the total Air Force.
    Mr. Chairman, to give you an example, through AES, Air 
Expeditionary Forces 1 through 10, approximately 25,000 Air 
National Guardmen and women deployed alongside their active 
duty counterparts, and over the next 30 months, over half of 
the Air National Guard force, 50,000, will deploy in the 
upcoming AES. In the Air National Guard alone, we provide over 
20 percent of the aviation package and about 8 percent of the 
support package, so we truly are a very integral part of our 
total Air Force.
    I am pleased to also report that we met our recruiting goal 
for fiscal year 2000, but we fell short of our end-strength by 
approximately 300 people out of 106,000 strong. It was not 
easy, but with the help that we received from Congress, we were 
able to put more recruiters in the community and increase our 
advertising budget.
    On our retention front, we had an equally good year. Our 
attrition rate for fiscal year 2000 was 10.7 percent. This is 
in line with and could end up being an improvement, which it 
is, over the last year's rate of 11.3 percent, the best of all 
of the military forces in DOD, and I am very proud of that.
    I understand the committee has some concerns regarding the 
impact of the anthrax vaccine on recruiting and retention, and 
I, too, looked carefully at any and all factors that could 
impact personal readiness rates. Since December 1999, we have 
asked commanders to report to us the results of exit surveys of 
departing members. These surveys track any and all reasons why 
a person was leaving the Air National Guard. This is from 
December to October of this last year, sir.
    As of August 31st, we have had over 100 enlisted, over 30 
pilots and 60 nonflying officers that have self-reported, self-
reported that anthrax was one of the reasons that they were 
leaving the Air National Guard. I emphasize that these are 
self-reported reasons. There may be more, and I know there are 
more. The exit surveys are voluntary, and we have to take them 
at face value, but it is an indicator.
    Is it possible that someone is leaving because of the 
anthrax but not indicating the reason on the survey? 
Absolutely. Some may indicate employer problems, when it is 
really pressure from their family. But I must emphasize that 
the Air National Guard still has the best attrition rate of any 
Reserve component. Every loss, every loss of our trained 
personnel is regrettable, but we cannot allow these losses to 
deter us from protecting our men and women from a real threat; 
and as the director of the Air National Guard, I owe them no 
    Mr. Burton. We would like to have your testimony submitted 
for the record, both of you, if we might.
    I don't understand--excuse me just 1 second.
    I don't understand why in the surveys that were sent out, 
and I wrote a letter to the Pentagon about this, that there 
isn't one question to the spouses or to the servicemen and 
women about anthrax. You have known about the concern of the 
Congress, many Members of the Congress, about anthrax for a 
long time, and I cannot for the life of me figure out why you 
would send out a questionnaire to all of the members of the 
Reserve and their wives and not have one single question about 
Desert Storm and the side effects, or anthrax.
    Can you give me--even after we asked about an addendum 
being attached to it, the Pentagon came back and said no. Why 
is that?
    General West. Sir, I wasn't part of designing the survey, 
but I will tell you what I know about it.
    The survey that we put together was designed to go out and 
ask people what their reasons were for being unhappy with or 
leaving the service, and we wanted their answer. We didn't want 
to suggest one to them.
    The survey that GAO did, from what I know about it, was 
almost exclusively an anthrax-related survey to two components 
of our Reserve forces. They asked them a bunch of yes and no 
questions about anthrax; they offered them a shopping list of 
reactions and asked them if they had had any of those. Whereas 
the survey people tell us that you get a more accurate response 
if you go out with a survey that asks the people why they are 
leaving and let them come up with their answer, anonymously, no 
names on the survey, rather than suggest what the answer would 
    Mr. Burton. But General, there were all kinds of specific 
questions on that survey. I will be glad to give you a copy of 
it. Have you read it? Have you read the survey? The survey goes 
into all kinds of things. I mean----
    Here it is, right here. ``What is your spouse's present pay 
grade? Have you ever served in the U.S. Armed Forces or Active 
duty or National Guard Reserve? Are you currently in the Armed 
Forces?'' And then it has 57, it has 102, it has 114 questions.
    ``In your opinion, how do the following groups or 
individuals view your spouse's participation in the National 
Guard Reserve?'' This is the spouse's questionnaire. ``If your 
spouse is mobilized or deployed more than 30 days, how likely 
are you or your family to make use of the following military 
    They go into everything, but the one thing they don't ask 
is about something that is very relevant to all of the people 
in the military right now. Because we have a Web site, and they 
are hitting on that on a regular basis, and when we asked the 
military, why didn't you ask one single question about the 
anthrax vaccine, they said, well, you know--they didn't have an 
answer, except they were not going to put that in there.
    If you don't ask the question, you are not going to get the 
answer. There is no place for them to volunteer that on here, 
except comments on the back, but a lot of these people are very 
concerned that their comments, if they pertain to the anthrax, 
as you have heard from the testimony of these officers who 
testified, or previous officers that testified today, they are 
afraid it would reflect bad on them, get them an Article 15, a 
dishonorable discharge and court-martial or financial penalty 
or jail sentence.
    General West. Well, the survey that was sent out was an 
anonymous one, and they didn't have to put their name on it, 
and I know that the people that put it together I believe were 
well motivated to do a good survey. They went out and sought 
professional expertise to help put it together. When we got the 
letter suggesting that we had an addendum to that and they went 
back and talked to the people that helped put them together, 
their suggestion was that if you put an addendum question like 
that on the end of the survey that you will bias the results.
    Mr. Burton. When did they start working on this survey, do 
you know?
    General West. I don't know.
    Mr. Burton. Was it 6 months ago, a year ago, 2 years ago? 
When did they start working on this survey?
    According to staff, they started working on the survey 
about a year ago, a year before the survey went out.
    The problem with the anthrax vaccine and the concerns about 
it have been around for 2, 3 or 4 years, so they knew well 
before this survey was put together that was a major concern of 
the military and possible retention, and for that not to be 
included in there just mystifies me.
    I have to run and vote. Congressman Shays will come back 
and reconvene the hearing as soon as he gets back, and then I 
will take the Chair when I get back, but I should be back here 
and Congressman Shays should be back in about 5 or 6 minutes. 
We stand in recess.
    Mr. Shays [presiding]. I am going to call the hearing to 
order, but I am doing it over here, if it is all right. I am 
going to take a deep breath.
    What has been established so far at the hearing I think is 
that the GAO has documented that we have a lot of people 
leaving our forces in large measure because of anthrax. What 
you countered, General, last was that the--I am sorry. General, 
you countered by basically saying those numbers were not your 
numbers, and you disagreed with it, and you feel that the 
attrition is not as bad as it was before. That is your 
    My general sense, too, General, is that you then had shown 
a picture that said that you were in the Gulf war and that your 
forces came across weaponized anthrax, correct?
    General West. We came across evidence on the battlefield 
that there was weaponized anthrax there that had been deployed 
forward in the theater.
    Mr. Shays. I am not playing a game with you, I just said 
that you came across weaponized anthrax. So what are you 
saying? You seem to be qualifying it, so what am I not hearing 
    General West. That the intelligence reports, the small unit 
commanders' notebooks that we had, the warning devices that 
were recovered indicated that the enemy had it deployed to the 
forward battlefield. I did not personally see one of those 
weapons, if that is what you are asking me.
    Mr. Shays. So you did not see this. I mean, there was a 
very dramatic picture, but your troops did?
    General West. Sir, we would have to go into a classified 
setting to give you a full answer to what you are getting at, 
but I can tell you without breaching intelligence rules that 
documents and signal devices and interrogations that we did 
from people that surrendered told us that it was deployed to 
the battlefield and that the peacekeeping force later confirmed 
that was true.
    Mr. Shays. So it was not our troops, it was captured 
    General West. I can answer concisely and explicitly what 
you are getting at, but we will have to go to a classified 
    Mr. Shays. I am just commenting on what you said, and I 
thought you were saying your troops came across weaponized 
    The reason why that is interesting to me is that we also 
had hearings on Gulf war illnesses, and just to deal with this 
word disingenuous, we had witnesses from the DOD who said our 
troops were not exposed to chemicals. And then they qualified 
it by defensive use of chemicals--excuse me, defensive--
offensive use of chemicals. So that was the word I didn't 
capture. I didn't think about it.
    Then we had a witness who came to us who actually had a 
video of us blowing up Kamasia, and we had it--we scheduled a 
hearing on a Tuesday, and the week before, on a Friday before 
Tuesday, now--we are in a position now where DOD is saying our 
troops were not exposed to, and now they are saying offensive 
use of chemicals, and we had a witness who actually had videos 
of the canisters of chemicals, chemical agents at Kamasia, and 
blowing them up and the plumes going up and spreading and 
showering over our troops.
    So, at 12 o'clock on a Friday, DOD says, we are going to 
have a press conference at 4 o'clock in which at 4 o'clock they 
acknowledged that our troops were exposed to defensive use of 
chemicals, which meant I guess, in layman's terms, that we had 
blown up, and it wasn't offensive, it was defensive. I didn't 
care if it was offensive or defensive. I just wanted to know if 
our troops were exposed to chemicals. So now we found out they 
    What is interesting to me is now you are describing a 
circumstance in which I thought you were saying our troops came 
across weaponized anthrax, and you are not saying that, 
    General West. No, sir. I know of no biological weapon being 
used. I did not find one, I did not see one, nor none of my 
troops reported seeing one. We did find----
    Mr. Shays. I am sorry.
    General West. We did find documents that said that they had 
been deployed there.
    Mr. Shays. Documents, but not the actual chemical, anthrax, 
    General West. Not the antibiotic anthrax, no, sir.
    Mr. Shays. Right. The implication that I got and maybe no 
one else got from this was there are troops lined up and when 
they went through the field and--I think the picture you showed 
us was the oil wells, correct?
    General West. Yes, sir.
    Mr. Shays. So all that smoke is all that oil which we 
thought would have an adverse affect on our troops, but the 
implication I got--incorrect, but happy I asked--was that they 
went through this and on the other side they came across this 
weaponized anthrax, not used, but they came across it. And now 
you are telling me there are documents, and we learned from 
captured soldiers, enemy soldiers, that we had that.
    General West. We learned from several areas that I couldn't 
talk about.
    Mr. Shays. OK. I understand. I understand.
    I would like to have another briefing on this issue with 
the CIA. I want to make sure I am doing the right one. I would 
love it if you would go with me when I do that.
    General West. I would be glad to, sir.
    Mr. Shays. OK. Now, no one has ever questioned, General, 
your sincerity about your belief in the program. What I 
question is your total conviction to this program may distort, 
frankly, your better judgment, and that you are kind of like 
building the bridge over the River Quai and you are doing it, 
and you take such pride in it that we need to go forward when 
maybe you are not--maybe you need to step back and take another 
look. And that is the purpose of the hearing, to learn these 
other facts. You believe they have the weapons; I know they 
have the weapons. You believe they could use it; I believe they 
could use it.
    Now, let's look at what your policy is doing.
    One of the things we know is you are using a 1950's 
technology vaccine. You are not using a modern vaccine. You are 
using a vaccine where you try to crunch it all together and you 
try to get out the vaccine, but it is not pure, and that is one 
reason why you need to have six shots. So is it inappropriate 
for someone on this committee to suggest maybe that you not use 
that vaccine and that we develop a modern vaccine as a way to 
do it? You would probably say we need to act now. I don't think 
it is inappropriate.
    I think you are putting our troops at risk. Has anyone in 
the FDA or anyone from HHS said to you that this vaccine can 
and should be used as a weaponized prophylactic?
    General West. They have told us that the vaccine is safe, 
that it could be effective in protecting against aerialized 
anthrax. They have told us that the vaccine that has been 
released has been tested and proven to be pure. And it is the 
only protection we have. I would love to have a vaccine that 
could only be given in one shot, or something that could be 
taken as a pill. But those things are 3 or 4 years away. There 
is only one thing today.
    Mr. Shays. So this is important, though. You are 
establishing a fact. You think in the next 3 years we could 
have this threat. So you have made a decision--maybe you 
didn't, but you are carrying out the order now so you are 
speaking for DOD and you are defending it, so maybe in 3 years. 
Maybe if we have started a few years earlier we would be done 
by now and we wouldn't be even getting into this argument, but 
the bottom line is you are saying in maybe 3 years we could 
have this vaccine. So then the issue that we could logically 
have is should we wait 3 years?
    General West. I think the 3 years is probably optimistic, 
but we have been working on things for a while. We do not have 
anything that is immediately around the corner in terms of 
promise that is better.
    Mr. Shays. General, that is my version of disingenuous, and 
I should be more respectful. I am having a problem with that 
answer. The reason I am having a problem is the implication is 
that we are on a full-steam-ahead exercise to develop a new 
vaccine, and that is not true, is it?
    General West. I would say we stop short of being on a full-
steam-ahead. We have funded programs that are exploring 
    Mr. Shays. Exploring alternatives is not developing a 
modern vaccine, using modern technology for a modern vaccine to 
replace this vaccine. You are looking at alternatives, but you 
are not developing a modern vaccine, a vaccine in which you can 
isolate the protein and you know it is pure. You are not doing 
that. We discontinued it. We were doing it. We discontinued it. 
Have you started it back up? What is that program called?
    General West. I don't know the program title. There is a 
funded R&D effort to develop a new vaccine. There is a funded 
program to reevaluate the six-shot protocols.
    Mr. Shays. How much spending are we doing on that?
    General West. I would have to give you that for the record, 
    Mr. Shays. Well, because the fact is, we are really not. 
The fact is, we don't have an all-out effort to replace this 
vaccine. We stopped it. We started to--what we are doing is we 
are developing an old vaccine, and we are using Bioport to do 
    Now, the problem with it is Bioport's vaccines haven't been 
approved. Why haven't they been approved? The ones they have 
done, the lots haven't been approved. Why not?
    General West. The lots that Bioport has made, because their 
license hasn't been reapproved by FDA since they built their 
new facility.
    Mr. Shays. Right. And the reason why they had to build a 
new facility is the old facility they used made the old lots. 
But in today's technology, we don't allow that old plant to 
operate. It wouldn't pass today's standards. So it is true that 
the lots that we have used on our troops at one time were 
approved under an old standard, but under the new standard they 
can't be approved, isn't that correct?
    General West. They are approved under the current standard 
that FDA has.
    Mr. Shays. No, no. See, the new law, the Bioport isn't 
getting under--they can't reach that new standard. They can't 
meet it.
    General West. They haven't yet? I suspect that they will.
    Mr. Shays. Well, they haven't. Well, you have been saying 
that for a while.
    General West. Yes, sir. I wish I could tell you today they 
have, but they haven't yet.
    Mr. Shays. No, but there is a reason why. It is a different 
standard. It is a tougher test. But it is an old technology. It 
is a 1950's technology. It is a 1950's technology that doesn't 
use modern means. This is a plant that has to be isolated. You 
can't do anything else in it, because it is an old technology. 
If you used a new technology that we use for other vaccines, 
you wouldn't have to have an isolated plant, isn't that true?
    General West. I suspect that you would still want to 
produce something like anthrax in pretty much an isolated 
facility, but it is definitely true that they are--that they 
tried to build a new manufacturing facility for two reasons. 
One was to modernize it as best they could in terms of what was 
available today for production and also to meet the increased 
production rate that DOD would require for a program of this 
size, which is one of the reasons that the State of Michigan 
didn't want to keep it in the beginning. But FDA tells me that 
the vaccine that we are using does meet today's standards for 
purity, sterility and safety.
    Mr. Shays. It met the standards when it was approved. The 
new lots are not meeting the standard, and it is even under a 
new plant, because the standards are higher, and they are 
higher because we want to protect the people who get these 
    General West. We haven't tested the new lots yet, but there 
is no need to until they have a license to produce it. Because 
without a license, if it passed the test, we wouldn't be able 
to use it.
    Mr. Shays. Now, at one time DOD had made a request to use 
this drug as an experimental drug and they were turned down. 
Why is that? Why were they turned down? DOD was turned down.
    General West. I am personally not aware of DOD asking to 
use the vaccine as an experimental new drug. I will ask that 
question of all of the people I work with when I go back; and 
if I am wrong, I will correct it for the record.
    Mr. Shays. For the record, I can't verify it either. So on 
that issue, I can't make that claim. But I would like you to 
help me in responding, and maybe Mr. Chan or Mr. Sharma, could 
you help me on this issue?
    What did DOD request that they ultimately withdrew? They 
made a request in terms of the use of anthrax. Were they asking 
for its use as an experimental drug, or were they asking to 
have it approved as a weaponized agent?
    Mr. Sharma. Bioport has submitted an IND to FDA which is on 
the record asking for change in labeling to include that it is 
approved for--against inhalation anthrax.
    Mr. Shays. Against weaponized anthrax.
    Mr. Sharma. That is correct.
    Mr. Shays. Because when FDA approved this drug, they did 
not approve it as a prophylactic against a weaponized agent, 
anthrax, isn't that true?
    Mr. Sharma. The labeling does not say specifically against 
inhalation, but I think to understand this you have to 
understand the context under which this vaccine was developed 
and the specific language.
    When this vaccine was developed, it was developed to 
mitigate the disease among the mill workers, and the number of 
such workers or people at risk were extremely small. And it 
specifically states that it is approved for the population at 
risk. As a matter of fact, the 1985 FDA's advisory committee 
defines who are those people at risk, which does not include 
the military or the people--the troops who will be exposed in a 
battlefield scenario.
    Mr. Shays. The bottom line, the recommended uses for 
immunization with an antigen is recommended for individuals who 
may come in contact with important animal hides, furs, 
bonemeal, wool, hair, especially goat hair and bristles, and 
for all personnel in factories handling these materials and for 
individuals contemplating investigational studies involving 
anthrax. And it was contact, touch.
    Mr. Sharma. That is right, yes.
    Mr. Shays. It wasn't by air. It wasn't an aerosol.
    Now, isn't it true that Bioport wanted this to be approved 
to also be a counter as an aerosol?
    Mr. Sharma. That is correct.
    Mr. Shays. And they withdrew their application, or it is 
still pending?
    Mr. Sharma. No, it is still pending.
    Mr. Shays. So FDA has not approved that?
    Mr. Sharma. That is correct.
    Mr. Shays. When General West talks about FDA has approved 
this, what did they approve it for? What did they approve this 
anthrax vaccine for?
    Mr. Sharma. The labeling, as I said, does not specifically 
state the scenario, other than the fact that it defines 
population at risk, and those populations at risk do not 
include the military or battlefield exposure.
    Mr. Chan. Can I answer this question?
    Mr. Shays. Yes.
    Mr. Chan. As far back as 1996, the Department of Defense 
reviewed possible use of this against aerosol anthrax, and they 
themselves state the following, and let me read it from the 
Defense Department's report: Current anthrax vaccine is not----
    Mr. Shays. Move the mic a little closer to you and lower it 
down, if you would.
    Mr. Chan [continuing]. ``The current anthrax vaccine is not 
licensed for aerosol protection. Preliminary information based 
on animal studies show vaccine confers protection against 
aerosol exposure. Considerably more data will be needed to 
support a request to change FDA license to accommodate a dosage 
regimen appropriate to aerosol protection for humans.'' And 
then they stated ``The objective would be to achieve a 
shortened course for vaccination requirements.''
    So there are basically two fundamental issues here. One 
    Mr. Shays. Who are you reading from? Who is the document 
    Mr. Chan. This is the DOD's reports.
    Mr. Shays. Do you have a date?
    Mr. Chan. It is called System Threat Assessment Report 1996 
on Bioagents, and this is a nonclassified paragraph that I am 
    The point I am trying to make is that there were two 
problems back then. One, they need to make sure that, in fact, 
they can apply it for--as a preexposure prophylactic. That is 
the first thing. The second thing is that they would really 
like to change the regimen of six shots over 18 months, because 
we are willing to do that logistically. So, essentially, that 
is what they request from the internal request, looking for 
    As I remember, the FDA's response, which they have gone 
through with extensive briefings the conclusion was based on a 
memo by Dr. Freedman which basically says that if you use this 
vaccine for this purpose, it is not inconsistent with the 
labeling of this product. That is basically the wording that 
has been used. So I don't think--you know, not inconsistent 
does not necessarily imply, I don't know, that it is consistent 
with the labeling.
    Mr. Shays. That is what we have to do. We have to 
constantly mince words.
    Mr. Chan. Exactly. But that is what is stated. So what you 
find is often that has been given as an answer to aerosol 
    Mr. Shays. They didn't say it is consistent. They said----
    Mr. Chan. They said it is not inconsistent.
    Mr. Shays. Mr. Sharma.
    Mr. Sharma. I think I would like to add that that was a 
letter which from a legal perspective, is a personal 
communication from FDA to DOD. It is by no means an official 
FDA endorsement that can be incorporated into the labeling, and 
that is why Bioport has submitted an IND for a label change.
    Mr. Shays. I want to just be very clear on this. This is 
basically a letter from FDA that does not have the backing of 
hearings, does not have the backing of response. It is 
basically the FDA writing a letter to the DOD which enables 
them to be able to say somewhat that FDA has signed off, but 
technically, in a court of law, it won't have much strength. Is 
that your statement? I don't want to put words in your mouth.
    Mr. Sharma. I think FDA has--when they are changing the 
labeling, they have procedures; and this does not, you know, 
fit under their procedures.
    Mr. Shays. This does not meet the requirement of the 
regulations if you want to change it.
    Mr. Sharma. Right.
    Mr. Shays. OK.
    Mr. Burton, I haven't done this, and I would be happy to 
have you go through this question.
    Mr. Burton. If you would like to proceed for a minute or 2, 
that would be find. Go ahead, because I have some other 
questions I want to ask.
    Mr. Shays. General Weaver, I want to run a short video.
    General Weaver. Yes, sir.
    Mr. Shays. This tape shows you testifying before our 
subcommittee on September 29 of last year. In this you stated 
under oath that we have 10,700 people inoculated for anthrax in 
the Air National Guard with one known refuser documented.
    The second half of this segment is a closed circuit 
briefing to the Air National Guard. In this you responded to a 
question about the refusers by stating that after the segment 
shown on the news that you clarified that quote: ``we had other 
people with no commitment to walk.'' However, staff has 
reviewed your statement after the segment we just saw, and 
there is no reference to ``other people with no other 
commitment walking.''
    Would you tell me again, General, what the punishment--
well, just let me go with that. Just show the video.
    [Video shown.]
    Mr. Shays. General Weaver, that just seems so inaccurate.
    General Weaver. May I explain? Our interpretation, we the 
Air National Guard, when we were going through the--trying to 
get the right information on the anthrax, considered a refusal 
was one who had a commitment to the Air National Guard. That 
has always been at that time, up until that hearing, our basis 
for people leaving. I mean, individuals can walk out of the Air 
National Guard who have no commitment for whatever reason.
    If I had the statement to do over again, I would have 
changed it. Because I certainly was aware that other 
individuals walked out of Connecticut, but at my level we had 
no written documentation except for what was being said to the 
    Even today, getting the accurate information of people 
leaving the Air National Guard, asking them--after Congressman 
Shays asked me to start questioning why our Guardsmen and women 
were leaving the Air National Guard, it is very difficult to 
get an accurate picture, especially when in light that one of 
the previous witnesses today who requested a transfer but had 
no reason--had put down no reason to include anthrax, just 
requesting the Air National Guard--or to leave the Air National 
Guard to go to the Air Force Reserve. So at the end of that 
hearing, Congressman Shays, our commanders got all together, 
and we had a senior leadership conference to address this 
issue, because it is an extremely big issue for us. I mean, we 
are Guardsmen. We can walk.
    Mr. Burton. Would the gentleman yield, please?
    General Weaver. Yes, sir.
    Mr. Burton. Mr. Shays.
    Mr. Shays. Yes.
    Mr. Burton. If people are on duty overseas, they are 
operational, even though--can they walk?
    General Weaver. Well, no, I wouldn't expect them to walk 
under an order of being overseas, sir.
    Mr. Burton. So the point is, even though they are 
volunteers and they are in the service, if they are 
operational, if they are overseas, they can't walk.
    General Weaver. I wouldn't expect them to, sir.
    Mr. Burton. OK. I got to tell you, General, after watching 
that and remembering the statements, you know, we in Congress 
deal with thousands of issues on a regular basis. And when 
people from an agency, particularly the Defense Department and 
the Pentagon come over here and testify, and they make a 
statement like only one person has left because of that, you 
know, we take that at face value.
    Then we see something like this, and then we hear these 
Reservists come in, and they testify that many, many people 
have left various Reserve units around the country and one of 
the main reasons is because of the anthrax vaccine and the fear 
of it. And then you say only one. It really looks like there is 
a deliberate attempt on the part of the Pentagon to mislead the 
    Then when you say that you are trying to get all of these 
facts and you are trying to get all of this information so that 
you can make an informed judgment and really see if there is a 
problem and you send out questionnaires to the spouses and to 
the members of the Reserve and you don't even ask a question 
about a relevant issue, even though it has been in the news for 
2 years, 3 years, it looks like you don't want to hear that 
answer because you don't want that answer to be something that 
you have to deal with. And it really is troubling.
    General Weaver. Sir, I disagree with that, respectfully.
    Mr. Burton. You do?
    General Weaver. Yes, sir. And I can only speak for the Air 
National Guard, sir. I can only speak for the Air National 
Guard. As the controversy with anthrax heated up over a year 
ago with our Guard family, and as I said to Congressman Shays 
previously, got all of our commanders together to discuss how 
we could get the right information out there and what we needed 
to do to find out if there truly was a problem and if there is 
a problem, what we needed to do to fix it.
    We had Dr. Craig Polin from the Mayo Clinic come in and 
talk to all of the senior leadership of the entire Air National 
Guard. We didn't have the right number--we didn't have the 
accurate numbers that we needed to say, because we heard the 
anecdotal evidence by some of the previous witnesses about 
thousands of pilots leaving the Air National Guard.
    Sir, for the record, I have got what we have done in the 
last 5 years as far as our total pilots in the Air National 
Guard. I can say it is very consistent. In fact, in 1999--from 
1996, 301 pilots short; in 1997, 269 pilots short; in 1998, 246 
pilots short.
    Mr. Burton. General, let me interrupt you for a moment. The 
gentlemen that testified who were on-line pilots for the Air 
National Guard testified that, yes, there are replacements 
coming in, but they don't have the combat training, they don't 
have the training that they did, and what you are losing is you 
are losing an awful lot of people who are qualified to go into 
combat immediately with people who are not yet combat-ready, 
and that you also have to have additional training for those 
    Did you not hear what they said? In one unit there was five 
vacancies still vacant, and the ones that have been replaced in 
large part have been replaced by people who are still in the 
training process that are not yet ready for combat, as were the 
ones who left. Now, don't you think that is a problem?
    General Weaver. Yes, sir, it is.
    Mr. Burton. Especially in view of the fact that it costs $6 
million to train a pilot to have him ready to go into Kosovo or 
Iraq or someplace else. So you can use numbers, numbers fly and 
sometimes people stretch the truth about numbers, but when you 
are talking about a combat-ready military, they have to be 
    Mr. Shays. Would the gentleman yield?
    Mr. Burton. Yes.
    Mr. Shays. I would just like to--again, I thought you all 
were saying something different. I thought you were disputing 
with the first panel that you haven't lost as many people, and 
it is good to listen, because what you are saying is, you have 
lost more people, but you are just replacing them, isn't that 
    General Weaver. Sir, I can give you the figures of the 
attrition rates----
    Mr. Shays. No, no, you are losing more people, you are just 
replacing them, or are you claiming under oath that you are not 
losing more people? And please be careful.
    General Weaver. Yes, sir. Can I go through these figures 
with you, sir, and I would like to submit them for the record 
as well.
    Mr. Burton. Sure.
    Mr. Shays. Can we see them?
    General Weaver. I only have the one copy, sir.
    Mr. Shays. Let me interrupt you, but you will have a chance 
to go back. You all did know that this is what the hearing was 
about today.
    General Weaver. Recruiting, retention and combat 
    Mr. Shays. When you say, General West, you will get back to 
us on this, you should be fully prepared to deal--respond to 
anything dealing with retention, correct? General West, I mean 
you are the one who made the comment. I was thinking--like you 
said, well, we don't have an opportunity to respond to this. 
You should know exactly what your retention is and everything 
dealing with the military, right, and you would have it 
available to us and we don't have to wait for it, correct?
    General West. I should be as absolutely prepared as I can 
be, sir, and answer all of your questions honestly, and that is 
what I am trying to do.
    Mr. Shays. So you should be prepared to take the different 
bases that were discussed and be able to tell us if we have 
lost more or less, correct, in retention, correct?
    General West. If we have lost more or less than the report 
    Mr. Shays. Do you agree or disagree with the numbers you 
have heard today?
    General West. I have no reason to disagree with them, but I 
haven't analyzed them, nor have I tried to explain them, and I 
will do it as soon as we can.
    Mr. Shays. Yes. We will do it today.
    General Weaver. Congressman Shays.
    Mr. Shays. Yes.
    General Weaver. Between the losses and the gains for the 
last 5 years, I think that will give you a good indication.
    Mr. Shays. I just want to know losses first.
    General Weaver. Losses are pretty much average from 1996 
through 2000. In 1996, we entered 353 losses, 189 for 
retirement, 164 separated; 1997, 122 retirement, 147 separated, 
for a total of 269; in 1998, 168 pilots retired, 205 separated, 
for a total of 373; in 1999, 131 retired, 211 separated, for a 
total of 342.
    Mr. Shays. Is the retirement rate going down or up, and are 
those who are separating going down or up?
    General Weaver. The actual retirement rate is going down, 
    Mr. Shays. So you are having more leave earlier, correct?
    General Weaver. That is correct. We are running from about 
164 that separated in 1996 to about 266 in 2000.
    Mr. Shays. Just hold on a second. I just want to make sure 
I am understanding. So, overall, you are losing more now, not 
to retirement, but they are leaving earlier. Isn't that true?
    General Weaver. That is correct.
    Mr. Shays. Isn't that really our point? Obviously, when 
people retire, they retire. But you are having more people 
leave earlier, and that kind of has an implication.
    General Weaver. Yes, sir. But also, since 1996, we have 
been brought into the forefront of combat capability with the 
AEF. We are performing almost 500,000, approximately, work days 
more than at the height of Desert Shield, Desert Storm in work 
in the Air National Guard. So there are other stressors.
    Mr. Shays. I would concede to you willingly that there are 
other reasons today why people may want to leave besides 
anthrax, but wouldn't it be sad, really sad, if the thing that 
trips them over is anthrax? Because these are the people who 
aren't retiring, they are leaving early, and I would think that 
you would be able to tell us to a person why each one left, to 
a person.
    Which gets me to the issue that when you appeared last 
year, you said, let me just--well, first off, oh, let me do 
this. Let me just end my participation in the hearing by saying 
that, in response to General Weaver--OK, this is where the 
question begins: I would make a request that any person who 
leaves the Reserve or National Guard be specifically asked if 
anthrax vaccine was a factor in their decision and to what 
extent it was. And I then said, and I will be following it up 
to see if that is done.
    General Weaver. Yes, sir.
    Mr. Shays. And you said yes, sir, I will do that. So tell 
me why all these people left.
    General Weaver. I can't tell you for each specific one, 
    Mr. Shays. Why not? There are not that many, in your own 
words. I mean, there are a few hundred. I would think you would 
specifically, particularly after this hearing, after you 
basically say you will do it, I would think you would 
specifically want to know why they had left. It would be great, 
because you could either prove you are right or wrong. You 
could prove you are right or wrong. You would have the answer, 
and we wouldn't have to spend millions of dollars to find out.
    You would just simply--maybe even you could do it yourself. 
You might even fly them in. You might say, I need to know why 
you left. Is our anthrax program the reason why you left? 
Afterwards, you may find that they did. You may find that your 
statistics are somewhat similar to what you find from GAO, and 
you might still decide to do the program, because you believe 
you need to do it. But you will have better information.
    General Weaver. Sir, we do have, after your advice to me 
and counsel to me last September 29th, we instituted, only in 
Air National Guard, a survey that we asked the commanders. I 
cannot direct them to do it.
    Mr. Shays. You asked the commanders or you asked the 
    General Weaver. No, sir. We asked the commanders to conduct 
the exit survey. Because, sir, I am trying to get to the same 
point that you are.
    Mr. Shays. OK. I just want to understand.
    General Weaver. So we asked the commanders to counsel each 
individual leaving concerning--and again, I asked them, I can't 
direct them to do anything. I am the Director of the Air 
National Guard, not the Commander. I can only do it by asking 
through their adjutant general to see if there was that problem 
with anthrax.
    If I can give you some anecdotal----
    Mr. Shays. Not anecdotal yet, let's talk specific. Because, 
basically, we made a request that you specifically ask if 
anthrax vaccine was a factor in their decision, and you said to 
me you would do that.
    General Weaver. I would do that, yes, sir.
    Mr. Shays. I don't think you have.
    General Weaver. Sir, there are only certain things that I 
can do as the director of the Air National Guard. I cannot 
command the State Adjutant General to do--really, he is the 
commander in chief of those military forces within that State. 
I asked every one of them, to include the Adjuvant General, to 
let us research, do the exit surveys to why our individuals are 
    Mr. Shays. So you didn't ask if they are leaving 
specifically because of anthrax?
    General Weaver. Sir, that is in the other category, and the 
exit survey that we get----
    Mr. Shays. That is what the issue is, it is anthrax. Now, I 
need to know if you did what you said you would do. I need to 
know if you specifically asked, and I want to see the document 
that will prove to me that you did it, because we are getting 
to this kind of game where I have to ask the perfect question 
to get an answer that I just want. And I don't get mad with 
people when they don't play games. I am not trying to prove a 
point one way or the other, I just want the truth.
    General Weaver. I want to give you the truth, sir.
    Mr. Shays. I want to know what document you can show me 
that specifically asks the generals of our National Guard, the 
Adjutant Generals of our National Guard, specifically what 
pilots have left in particular because of anthrax.
    General Weaver. It doesn't say anthrax, sir. It does not 
say anthrax.
    Mr. Shays. I understand anthrax.
    Mr. Burton. Would the gentleman yield real briefly?
    Mr. Shays. If I could just not lose this question----
    Mr. Burton. I don't want to lose that question. This 
bears--the previous panel, you will recall, indicated, and I 
don't know if you were here at that particular time, that there 
is some pressure put upon the members, on the exit questions, 
about whether or not or what the reasons are they are leaving, 
and many of them are afraid to use the anthrax as a reason 
because of possible repercussions from their superiors. I just 
thought that ought to be thrown in the equation.
    Mr. Shays. And that is the reason why I responded when we 
were making reference that the commanders were being asked to 
kind of do this, because you all have heard your men and women 
say they have been under pressure to give different answers. 
And I got to believe you want to know the truth.
    General Weaver. Yes, sir, I do.
    Mr. Shays. And if you want to know the truth, it would 
strike me that you might just say here is an envelope, here is 
the question; please give it to every one of the people that 
have left, is anthrax a factor in your decision, and, if so, 
what is it? It is not a lot of people. You would have given it 
to each one of those individuals, and you could have basically 
just dumped them on your desk and said I did what you asked, 
Congressman, and I said I would do it, and I did it, and here 
is the answer. And I don't think you have done what you said 
you would do.
    It was specifically about anthrax. So the question comes 
back to did you specifically do what you said you would do 
about anthrax?
    General Weaver. No, sir, I didn't. I put out a survey and 
asked the commanders to respond in kind why our people are 
leaving. It wasn't concentrated on anthrax, sir.
    Mr. Shays. But that was what the question was all about. 
Isn't it?
    General Weaver. Yes, sir.
    Mr. Shays. OK. I am not trying to embarrass. I just want to 
feel like when we are a committee, we can ask a question and we 
get an answer, and we deal openly with each other. Not just 
honestly, but openly, and we don't play games. And I am just, 
given your last answer, I don't want to embarrass you further, 
because I think it is an embarrassment, if I show that second 
shot, where you basically have said that you said something 
else, that you didn't really say.
    Mr. Burton. I think the whole enchilada should be shown, 
Mr. Shays, so I will request to put the video up there. Then I 
would like to ask some questions, General.
    The following is a transcript of a video shown of M.G. 
Weaver, September 29:

    Mr. Shays. How many are leaving? In some Air Guard units, 
attrition among pilots and technicians may be as high as 30 
percent, but DOD appears unable or unwilling to discern a 
    Announcer. General Paul Weaver, Director of the Air 
National Guard, testified that the number of pilot resignations 
have been exaggerated.
    General Weaver. So when I hear all of these other figures 
about these mass resignations and whatnot, they are just not 
there. There are challenges with explaining, with discussing, 
as they all are, with the members of their unit on the anthrax 
issue. But when it really gets down to it, we have had 10,700 
people inoculated for anthrax in the Air National Guard, with 
one known refusal.

    M.G. Weaver, October 26, 1999.

    General Weaver. I also just received a fax, and it said, a 
question for General Weaver. You recently testified to Congress 
under oath that when it really gets down to it, we had 10,700 
people inoculated at that time for anthrax in the Air National 
Guard with one known refusal. Previous to your testimony, seven 
pilots from the Madison Air National Guard F-16 unit refused to 
take the vaccine, as did eight of the Connecticut National 
Guard A-10 unit. Were you aware of these refusals?
    What you needed to also understand, my further comment is 
that I said we had other people who had no commitment, who 
walked instead of taking the vaccine. We are a volunteer 
organization. For the ones who had had a commitment at that 
time, we had only one refusal. I was very much aware, and, as I 
said, we had in my sworn testimony as well, is that we had 
people that had decided to, what I consider make a decision, a 
non-informed decision, to leave our Air National Guard family.

    Mr. Burton. I will pick up where Mr. Shays left off in the 
statement. Staff has reviewed your statement, General Weaver, 
after the segment we just saw, and there is no reference to 
other people with no commitment walking. Would you tell me 
again, General, what the punishment for an officer to lie is?
    General Weaver. I am sorry, sir?
    Mr. Burton. Staff reviewed your statement after the segment 
we just saw and there is no reference to other people with no 
commitment walking. There is no reference to that. Should there 
have been a reference to that?
    General Weaver. I believe what I thought I had said during 
that, that I had made the implication that I was aware of other 
individuals leaving the Air National Guard.
    Mr. Burton. Well, I guess the bottom line is, General, that 
the troops, many of troops feel like they were misled in that 
closed circuit briefing. How do you respond to that, to these 
people that feel like they weren't told the truth in that 
    General Weaver. Sir, I have briefed the senior leadership 
of our Air National Guard, the Adjutant Generals, on our 
challenges within our Air National Guard family, concerning 
anthrax. They are all working toward the same end in that all 
the right information, our commanders' tool box, all of the 
information that we could get out to our troops so they can 
make an extremely informed decision, be in their hands prior to 
them making a decision to leaving their career, if that is 
their so desire.
    Mr. Burton. Well, we had nine people last week, we had four 
today, I guess we could bring in many more people in the 
military to state, you know, that this was a major concern of 
theirs, and that is why they left, or decided to be 
transferred, but I don't know that we need to do that.
    Let me go on to a different subject. Last week we received 
a report, and I am going to address this to the GAO, from 
Congressman Metcalf, one of our colleagues that has been doing 
a lot of work on the anthrax vaccine, and it was about the 
discovery of squalene in the anthrax vaccine.
    Could you explain the significance of squalene being found 
in the anthrax vaccine?
    Mr. Chan. First of all, let me say that it was a total 
surprise to us that something like that was found. As you know, 
we have done a study for Congressman Metcalf. It took us an 
extraordinary amount of time to get it done, because we thought 
it was a pretty straightforward question that was asked of us.
    But we issued a report on it, and basically we have 
received from the DOD and FDA, that there was no such thing 
used in the vaccine, and in fact we were proposing a means to 
develop an assay to detect possible antibodies to squalene that 
some of the ill Gulf war era veterans have and of course GAO 
would not be the right agency--let me say it that way--to 
develop the assay ourselves, to show the presence of antibodies 
was there. So we left that for DOD and FDA, and basically they 
recently initiated research to develop such an assay, but also 
to show that, in fact, the current vaccine, anthrax vaccine, 
doesn't contain such an adjuvant, or additive.
    Our understanding is that as DOD had requested, Stanford 
Research Institute to do a number of tests on the lots that are 
available, and whereupon they found nothing there at the trace 
level, the test they did. So it was a surprise to me and to my 
colleagues that when FDA went ahead and did a test, a much more 
refined test, and found traces of squalene in the anthrax 
vaccine itself.
    Mr. Burton. Let me get this straight. I want everybody to 
understand. The Department of Defense said there was no trace 
of squalene, right?
    Mr. Chan. That is right.
    Mr. Burton. And then FDA came back and they did testing and 
they did find squalene?
    Mr. Chan. Yes, sir.
    Mr. Burton. Now, tell us about squalene. As I understand 
it, squalene stimulates the immune system to fight off a 
specific biological agent, right?
    Mr. Chan. It is an adjutant--my understanding is the only 
adjuvant that is used in vaccine that is approved by FDA is 
aluminum hydroxide, alum, and nothing else. But using this 
particular additive, an oily substance, like liver oil the 
intent is that it helps to increase the immune response to the 
antigen, OK, thereby coming out with greater amount of 
    Mr. Burton. I want to put this in layman's language, 
because we have talked about this and this is very important. 
It will increase the anthrax vaccine as far as fighting a 
specific strain of anthrax. But as you told me, it also can and 
will suppress the person's immune system against other things. 
Is that correct? It causes an auto-immune response.
    Mr. Chan. The only information we have is based on animal 
studies. Right now we, as you have requested us to do, is look 
at this chemical significance of the presence of squalene in 
the vaccine itself.
    Mr. Burton. And?
    Mr. Chan. And you asked us. I am sorry.
    Mr. Burton. But in the animal studies, did it not suppress 
the immune system?
    Mr. Sharma. We have just started looking at this issue at 
your request and we have, at least, found one article, it is a 
recent article, that was published by a researcher in Canada in 
which it does show that squalene does have a harmful effect on 
the immune system. But we have not done very thorough, 
systematic research of the literature. We have, so far, only 
found one because it was published around the time, right after 
we had issued our report. So we happened to have reviewed it. I 
am sure that, you know, there is more research because in the 
new vaccines that are in the development stage, a lot of 
different adjuvants are being used.
    Mr. Burton. I guess the point I am trying to make is it 
seems to me that the Food and Drug Administration and our 
health agencies, as well as the military, before they started 
using on a widespread basis the vaccine for anthrax, would have 
found out every component part of that vaccine. And you have 
found squalene in lots of the vaccine that the military said 
did not contain squalene, and yet the FDA found it. And there 
is a body of evidence that indicates that squalene depresses 
the immune system if it is in a vaccine.
    Has the military checked that out? Has the FDA checked that 
out? And, if not, why wasn't that done before you started 
immunizing all these people with the vaccine? That is the first 
    The other thing I would like for you to answer is, you 
know, you said that there had been testing done on the vaccine 
and that FDA had, in effect, given approval. I don't know of 
any testing that has been done, maybe you can give me some 
information on an aerosol anthrax bacteria. Has there been any 
testing on an aerosol that you know of by the FDA or anybody 
    General West. Sir, there are good answers to both of those 
questions. DOD did not put an adjuvant in the vaccine of 
    Mr. Burton. It is in there. It is in the lots.
    General West. Yes, sir. And FDA was here last week and they 
testified before this committee, and it is on the record that 
they tested the vaccine for squalene and it wasn't there, that 
they subsequently developed a more sophisticated test for 
squalene, and they found a trace amount, and they also said 
that it would have took 2 million times that much to act as an 
adjuvant in the vaccine. They said that squalene existed in 
almost everything in the environment, and if you get your test 
sophisticated enough, you can find it.
    They told us you can put a fingerprint on a piece of glass, 
and when you analyze that, there will be squalene in it that 
came out of your body because your body makes it. The issue was 
whether we put it in the vaccine to be used as adjuvant, and I 
don't believe we did, and we said that. And I stand by that 
answer. I believe FDA thoroughly supported that in testimony 
last week.
    Mr. Burton. Just 1 second. We had Baylor University experts 
that told us that there was enough squalene in there to cause 
adverse impact on the immune system.
    General West. FDA disagrees with that. They believe it 
would take 2 million times the amounts that they found in--they 
were the one that did the analysis. They are the ones that we 
paid to do this and to make these kind of decisions, and they 
said, we do not believe that DOD or anybody else put squalene 
in the vaccine. It's a very minute trace amount and won't make 
a difference.
    Mr. Burton. When you are talking about adverse reactions, a 
lot of the military people leaving the military and being very 
concerned about it, and the adverse reactions that I am going 
to put in the record in a few minutes, you would think you 
would want to have really all the consultation and advice you 
could possibly get. If Baylor University, one of their 
scientists down there, said there was enough in there, 
squalene, according to his research to cause an auto immune 
response, then that should have been at least factored in. But 
none of that had even been checked out.
    Let me ask you something else: How many strains of anthrax 
will the vaccine deal with?
    General West. We believe that the vaccine that we are 
using, because it is based on a protective antigen approach, 
will work against any strain of anthrax. Can I say we have 
tested it against every strain? No. I can't even say I know for 
sure how many strains there are. But the scientific and medical 
theory of a protective antigen vaccine, it should work against 
anything that is anthrax. Will it work against something that 
isn't? I guess not, sir.
    Mr. Burton. Well, I think you ought to contact Dr. Dorothy 
Lewis of Baylor University and check on her research too, 
because I think it is relevant to what we are talking about.
    Can you illuminate a little bit about the various strains 
of anthrax? I think when I talked to you yesterday, you said 
that there were some things that could be added to the anthrax 
bacteria that could have made it difficult for the anthrax 
vaccine to deal with it. Is that not correct?
    Mr. Chan. Let me first answer the question. Instead of my 
comment about it, let me quote the person who testified before 
you last week, what he said to you, because it is his 
publication that I would refer to.
    Mr. Burton. OK.
    Mr. Chan. Because, remember, the question was really the 
non-human primate would be a better model for humans, because 
we cannot expose humans to aerosol attack.
    Let me quote: In the non-human primate aerosol challenge 
model, AVA, that is anthrax vaccine, since we had only one, 
protects against two strains, including the so-called vaccine 
resistant Ames strain. Experiments are ongoing to test the 
effectiveness of anthrax vaccine which is the anthrax vaccine, 
against a geographically diverse collection of strains. In the 
guinea pig intramuscular challenge model, 8 of 32 strains 
overcame the immunity induced by anthrax vaccine to the same 
degree as did in the Ames strength.
    So by that statement, we have at least 32 strains----
    Mr. Burton. And according, as I understand what you just 
    Mr. Chan [continuing]. That we tested. I think it says a 
total of two or three strains against aerosol challenge.
    Mr. Burton. So they tested 2 or 3, and there are 32 
    Mr. Chan. Yes, sir.
    Mr. Burton. They said in guinea pigs, at least eight of 
those strains overcame the vaccine and caused infection.
    Mr. Chan. That is right.
    Mr. Burton. So what you are saying is according to the 
guinea pig test, and it was not on primates, it was not on 
monkeys or other animals that are more closely related to human 
beings, they have not had any testing like that. But on the 
guinea pigs, it still would infect the person who was injected 
or who got the aerosol in at least 8 of the 32 strains? Did you 
know that, General?
    General West. Sir, I know the guinea pig model, when used 
against most vaccines, does not produce 100 percent results. I 
know that the test that gives us the most validity for an 
aerosolized channel is the human primate model, and in every 
test that we did, it was effective, and against every strain 
that we tested it against, it was effective. The medical and 
scientific community that we have gone to tells us that it is 
reasonable to assume that it will protect against every strain 
of anthrax.
    Mr. Burton. Mr. Chan, do you have any more information on 
    Mr. Chan. Well, let me give you my own personal 
understanding, the way it has been answered, that, in fact, I 
remember you asked the question about the regimen of six shots 
and when someone stops, what would happen.
    The answer was as long as you have the antibodies, the PA 
level is high enough, then we can increase it. To me it sort of 
suggests that we really don't know enough about the science of 
this vaccine. In a sense that somehow the correlation between 
the level of antibody to at least the animal models, they are 
not quite the same. That means the higher level of antibody you 
have, does not mean you have greater amount of protection.
    So as a result, I think it is, as DOD I understand is 
doing, is to try to figure out what is the right measure in 
terms of correlates, so one, in the future vaccine we develop, 
we need not expose humans for testing in terms of efficacy. But 
right now it is very unclear.
    So for one to say most likely it works, we can just keep on 
giving them shots and start all over again or not start over 
again and continue, I am not quite sure where the science is, 
    Mr. Burton. I have some more questions.
    Mr. Cummings, do you have some questions, sir?
    Mr. Cummings. Yes, I do, Mr. Chairman.
    General Weaver, last week when we had our hearing, we had 
an opportunity to see some pictures of a young man who, I will 
tell you, it looks like he had been burnt, almost, I guess, 70 
percent of his body, and there was no other explanation for 
this than this vaccine.
    Then we had the sister of a young lady come in who had 
died, and I think we had a wife of a gentleman who had died. He 
worked at Bioport.
    I guess the thing that is so troubling about all of this, 
one person said something, I don't know, did you see that 
    General Weaver. No,sir, I was TDY.
    Mr. Cummings. I think the thing that touched me, and I am 
sure it touched other committee members who saw it, there was 
one gentleman who said I am willing to die for my country. I am 
willing to die for my country. Even after he had gone through 
all of the problems with anthrax, a lot of problems with 
anthrax, the vaccine, but he expressed tremendous 
disappointment in the way he had been treated by his country. 
And I think for all of us, it was a very painful experience, 
because we are guardians. We are supposed to make sure that 
people are treated right and we have certain expectations ever 
the military, as I said a little earlier, right after Chairman 
Burton questioned you earlier had made some statements earlier.
    I guess what I am trying to get at is do you think, based 
upon what you know, that we need to revisit this whole policy, 
this vaccine policy? I am just curious. I mean, maybe I am 
putting you on the spot, but I am just asking you a personal 
opinion, if you have one.
    General Weaver. Sir, when we began the need and the order 
went out to inoculate our individuals for anthrax, I too 
personally, as a guardsman, and I have been a guardsman since 
1975, had questions about the need and the efficacy of the 
    I asked my medical people, because it was something that we 
had heard in Desert Shield-Desert Storm, and I was there in 
Tehran on the flight of skewed attacks, of why now, and is the 
shot safe?
    I heard a lot of information and realizing that there was 
so much information out there that we needed, and having an 
all-volunteer force in our Air National Guard family, that 
there would be questions in regards to that, and especially 
with both Agent Orange and the Gulf War Syndrome still there.
    We probably did a less than satisfactory job, in fact, we 
did a less than satisfactory job in the very beginning, in 
educating our men and women in our Air National Guard 
concerning the threat and the efficacy of the shot.
    Realizing that there were concerns, big concerns by all of 
us, we made a concerted effort to start educating our people, 
to understand the threat, and then to understand the efficacy 
of the shot. We brought in our experts, who we thought were 
experts, Dr. Craig Polin from the Mayo Clinic, and I think 
probably he singly, along with the flight surgeons, virtual 
flight surgeons on the Web, but I sent Dr. Polin's comments 
that we are on the right track. Having already understood the 
threat and got that education, but we still didn't get it down 
into the units. We didn't do a good job. Admittedly, we did not 
do a good job.
    We have come a long way, thanks to the help of this 
committee and these hearings as well, to educate our kids on 
why the shot, why the necessity of it. As I--and I just 
recently returned from Northern Watch, I leave for Southern 
Watch tomorrow, in talking to all of our individuals that are 
out there, I feel that now that we have turned the corner on 
them understanding, not only the threat, but the need for the 
shot and the efficacy of the shot. But it wasn't without a lot 
of heartache and pain, I should say, when we saw fellow 
guardsmen and women leave the guard for misinformation, what we 
thought was misinformation.
    Mr. Cummings. Well, you know, it is interesting you said 
that, because I asked the same gentleman that said he was 
willing to die for his country, I asked him if he had it to do 
all over again, would he do it. Would he take the shots. And he 
said he would not take the shots. But he said something else 
that was so interesting. He said I found out more information 
on Mr. Burton's Web page than I--I mean, he said it was a 
phenomenal amount of information, and the military had not done 
anything near that.
    I guess the question becomes, first of all, when you say 
``the threat,'' you mean the war threat?
    General Weaver. The real threat. The individuals or 
countries we feel have anthrax.
    Mr. Cummings. I just wanted to make sure it wasn't a threat 
to harming them.
    General Weaver. I know, sir.
    Mr. Cummings. You know, I tell you, this thing really 
troubles me, because we also had--they showed a picture of a 
little girl, I think it was a little girl, and her mother had 
died, which is about 4 or 5 years old or something like that. I 
thought about it, and I said here we are, this great country, 
and we are supposed to be looking out for our service people 
who are willing to die for their country, and here is this 
little girl that is going to grow up without her mother. I 
guess what I am trying to get at is at some point, at some 
point, I think we have to admit that maybe, just maybe, we made 
a mistake, or maybe we need to do something another way.
    I think sometimes I get really frustrated sitting here, 
because it seems like it is so hard for people to admit, that 
maybe we did make a mistake. Because, I will tell you, I often 
say we have one life to live, and this is no dress rehearsal, 
and this so happens to be that life. And if you have people 
suffering the way they are, that is a problem.
    Let me just hit two other questions----
    General West. Sir, could I offer one comment on that, 
because I really think this gets to the heart of the issue of 
one of the reasons why we are here.
    Mr. Cummings. Please do.
    General West. I was as touched by all those pictures as you 
were. It tears my heart out the same way it tears yours out. 
But the fact is that the way that those pictures were used and 
the way those stories are told is one of the reasons why people 
would elect not to take the shot and get out. Specialist 
Edwards is sick. There is no question about that. He deserves 
great medical care, the best our country can give him.
    But the truth is, when we brought him back from his 
deployment to one of those high threat areas, he went to Brooks 
Medical Center and was evaluated and they made a diagnosis, and 
they determined that his condition wasn't related to the shot. 
We then sent him to a civilian independent review, at Emory 
University, and they agreed with Brooks' diagnosis. We sent 
that information to the anthrax expert review committee, and 
they got more than a 9 billet card with information of yes or 
no. And they ruled on it. And nobody believes that it was 
related to the anthrax vaccine.
    I talked to his father afterward, because I felt very badly 
for him and for his father and what they were going through. 
His father had been led to believe it had been conclusively 
proved that his son's problem was the anthrax vaccine. When we 
put things on our Web site, everything we put on there as best 
we know it, meets every standard of honesty and integrity we 
can expose it to. Some of the other people putting out 
information are putting out innuendo and supposition and 
sometimes misinformation, and it is scaring people, it is 
causing them to make a bad decision, and it is affecting lives 
and careers. That is one of the reasons we had to have these 
many hearings.
    Mr. Cummings. Let me ask this, I am almost finished, Mr. 
Chairman. Are you trying to tell me that you believe, and help 
me now with this, I don't want to put words in your mouth, that 
anthrax vaccine has not caused illness or the death of 
    General West. I believe that there have been some reactions 
to the anthrax vaccine. I believe that most of them have been 
very minor. I believe that the ones that are serious are lower 
in number than most of the other vaccines that we give, and 
that the benefit far outweighs the image or the negative 
    I do not believe specialist Edwards' condition is related 
to anthrax. I have no knowledge of the young lady whose sister 
died. That was a surprise to us. We asked about her, we wanted 
an opportunity to investigate that so we would have good 
answers, but we weren't allowed to know who that was going--
that story was going to be about, so we haven't finished 
investigating that one yet, but we will. And if we find out it 
was related to anthrax in any way, we will come back over here 
and tell you that, honestly, man-to-man, face-to-face. But 
those people that were here last week, there was only one at 
this table that there had been a diagnosis that it was related 
to anthrax, and one that is in dispute. The others, there was 
no known connection.
    Mr. Cummings. Now, Mr. Chan, do you agree with what he just 
said to my last question based upon your investigation?
    Mr. Chan. Well, I am not a doctor, first of all, so I 
wouldn't make the statement, whether I know it for sure one way 
or another.
    Mr. Cummings. I know that.
    Mr. Chan. But the survey we did, to me is that we are but 
the mouthpiece for the soldiers, and if you look at the numbers 
and if you actually see all the written comments they made, 
these guys, both men and women, are very knowledgeable, way 
beyond the Web site information. They check on everything. They 
know the information well. They challenge even what we wrote 
down and they check behind them.
    So I am not quite sure that, first of all, I would state 
that they would look at the Web sites and information they 
receive and accept them in faith. They challenge us when we 
visit them. But fundamentally what I find is that I would like 
to have DOD look at the information we received. When we state 
that for those people receiving one or more shots, 86 percent 
of them found they have reactions.
    Now, I am not sure whether it is death or anything, but the 
level of illness as I look at it, it is quite comparable with 
the ones we informed this committee a while back from Korea, 
where there was an active monitoring. That was based on only 
two shots. Here the average is close to three-and-a-half to 
four shots. But the frequency and types are very similar.
    My point is, I don't know if there is a pattern, but for 
someone to say there isn't a pattern, before they gather the 
information, at least from researchers' points of view, I have 
a problem with that.
    I also have a problem to say that we assume people, as they 
exit, that they would tell or not tell the truth. We asked the 
question, and 30 percent of them said they weren't telling the 
truth in the exit interviews in our survey.
    So I think there is a lot of problem in terms of the 
information that they are receiving, but also there is a 
problem in terms of trust. I would guarantee you, sir, that if 
I wrote down that our survey is done by DOD, you would have 
different sets of answers, regardless of how we protect them. I 
would guarantee you that. Because when we visit some of those 
people, they said who is GAO? Why are you guys here asking 
this? I actually had to write a letter explaining to the 
people, ahead of time, that GAO is sending you a form, a 
    By the way, we are doing it at the request of Congress, 
with this committee and so on, to explain to them. Some people 
called and said we don't trust you. So we have to go through 
that hurdle ourselves to increase the response rate.
    I am not sure whether this is a cause and effect, but I 
must say that the information that is being sent, at least the 
information that we talk about it from a passive system, and is 
therefore limited. Out of the entire response we had, there was 
something like a total of 16 or so forms on file, and we saw 
all these illnesses that they believe is--they actually checked 
each one, shot after shot. We have all the data. We can analyze 
them all. We haven't done that yet, but we will.
    I think, you know, what I am saying is that the information 
is out there, and the important thing is to gather them, do not 
draw a conclusion about them until we analyze them, because the 
front line, the people have spoken. And I think at least for 
me, I want to present to you what they are saying before I draw 
    Mr. Sharma. I would like to add, as we show in our chart, 
you know, 70 percent did not report their reactions, and 60 
percent did not discuss their condition with the military 
health care provider or their immediate supervisor.
    To me, this is very telling, and the reason why I believe 
this, I will share with you. Some of the experiences we had 
when we went to different sites in different parts of the 
country, these were the Air National Guard and Reserve units. 
Both Foy and I, and we had some other team members, we went to 
different places.
    We came across, and I will describe to you three frequently 
reported symptoms that aren't listed in the product insert. 
Every vaccinee has some knots, and we recognize that. Some have 
worse than others, like typhoid. They do go away, not a big 
deal. But here what we are talking about is we had one person 
who had a big knot 3 months after he received his last shot, 
his entire unit brought him to us. Look, you want to see what 
the reactions are? Here is the reaction. It was a knot the size 
of a tennis ball, hard like a rock.
    Despite the fact that he had the reaction, this guy told us 
he was given another shot. He had this problem after shot two, 
which is 2 weeks' interval. In that 2 weeks, he got another 
shot on top of that knot.
    We went to another place, here is a pilot, who came to us 
at midnight. He was afraid because we were running a focus 
group, people were not trusting the military officials, and we 
have shared this information, by the way, with DOD officials 
during our exit interview, exit conference. This guy is a 
pilot. He is in his 40's, very seasoned. He waited until he 
made sure everybody else left, because he didn't want to be 
seen that he was seeing us, at which time Mr. Chan called me in 
his room.
    This guy literally cried, and he said, look, look at my 
hand. His fingers were bent. And we tried to straighten them 
out. They were just bent. He said I don't know if it has to do 
with anthrax. I really don't. But all I know is I didn't have 
it before, now I have it.
    This guy was very angry at himself because he could not 
maneuver the plane, and he had to use the wrist and what was 
bothering to him was the fact that he was risking the life of 
his other crew members. And what was bothering to me and us was 
that this was the condition that perhaps can be treated, but he 
is not coming forward. He does not trust the system.
    I think there is a very compelling message that 60 percent, 
are not discussing with their health care professional. Now, 
with this huge number, there is a very strong message. 
Something is not right.
    Mr. Cummings. Last but not least, General West, when you 
hear what we just heard, I guess the question becomes what kind 
of evidence does it take to come to the conclusion that just 
maybe, just maybe, we are going in the wrong direction, and 
maybe we need to suspend things until we can figure out what is 
going on?
    I often sit and I wonder when people make decisions, can 
they put themselves in the place of the people who may suffer? 
And I wonder if you had the knots, and if you went through the 
kind of changes and with you were--or your son was going to 
these gentleman at midnight, at what point do we have to get 
to? How many people have to die? How many people have to 
suffer? At what point do we get to when we say wait a minute? I 
am not talking about just forget about it, but at least say 
wait a minute, what are we doing here?
    The other thing that concerns me too is how that must 
affect the morale of our military. We up here are very 
concerned about that morale. We try to do everything that we 
can to keep it up. I am just wondering how do you think--assume 
that you don't believe that, that you don't buy it. It is out 
there. Soldiers are believing it.
    So how do you deal with that? I am sure you want a military 
that has high morale too, right?
    General West. Absolutely, sir.
    Mr. Cummings. How do you deal with that?
    General West. I want the leadership of our department to 
have the trust of the people that serves under us. That is very 
important to me. It is very, very bothersome even to hear a 
report about it, and we are working hard to make the education 
system better. We are working hard to make the varies reporting 
system better. We went to extra lengths to have the review 
committee made up of all civilian personnel, not DOD personnel.
    We are trying to followup on every one of these. If there 
was a serviceman, and I assume there was, because much his 
testimony, that had a knot the size of a tennis ball on his arm 
where he got the shot, he should not have gotten another shot. 
He should have been given a medical exemption, not asked to 
take another one, until we found out for sure what caused that 
knot. As long as there was any doubt, he shouldn't have gotten 
another shot, and he should not be required to resign because 
of that.
    Mr. Cummings. That leads me to another question, Mr. Chan. 
Did you find people who had suffered adverse effects, who then 
said, you know, look, I shouldn't be doing any more of this 
until I get this thing figured out? Did you all find people 
like that in your research? Do you follow what I am saying? I 
am going back to what General West just said.
    See, I can't figure out at what point, in other words, 
these people you are saying are suffering along. Some may 
suffer adverse affects after the first shot, some maybe the 
second. And they hear all of these things about the effect of 
the vaccine. So they have got to be saying gee, it got me too.
    Did you find people to say wait a minute, we want to say 
time out?
    Mr. Chan. Well, one of the things that I found was that, 
you know, I mentioned the word ``trust.'' Let me give you an 
example of that, whereas you asked General West, who has said 
he is working very hard to improve that.
    We visited a number of sites, as you know, to try to answer 
the question, and at the end we realized we had to send a 
questionnaire, because we found what we were told officially 
and what the people were telling as was different. We said how 
do we get to the truth, except to send it in the mail to the 
individuals at their home, not even through the base.
    The soldiers, the pilots and so on, first of all, they will 
not talk to us if their wing commander was there. They would 
not speak. OK. If the person is there, they would wink at me 
and say that's a lie, like that. So, you know, an organization 
cannot operate as a unit, a fighting unit, when you have these 
kinds of dissensions.
    My own view is that--but the interesting thing is that the 
commander himself often has the same problem. They said, you 
know, I remember talking to one who said you know, I have to do 
this. This is ordered. I cannot change this. I understand their 
concern, I want to help them, but I can't. So they worry about 
is my group any different than other groups? That is the first 
    The second thing, what we found was surprising enough, in 
one case we found a commander was the sickest person among the 
rest of them. But he is not reporting about it. They are being 
good soldiers. It is a legal, lawful order.
    So I think, you know, it is basically, I don't think it is 
just the soldiers themselves and the pilots and air crews, but 
I think it may be higher up, they have similar issues. But it 
is just not being raised at that level.
    Mr. Cummings. Thank you.
    Mr. Burton. Thank you very much. Mr. Shays, I think what I 
will do is I will give you the gavel, you go ahead and ask your 
questions and you recess when you finish your questions, 
because I have a series of questions I have to ask you, 
gentleman, as I haven't gotten to them.
    Mr. Shays. Why don't we just adjourn and both come back 
    Mr. Burton. We will recess and be back in just a few 
minutes then.
    Mr. Burton. If we could have everyone take their seats, we 
will try to wrap up our hearing here in the next half-hour or 
45 minutes. I have a number of questions, and I am sure Mr. 
Shays does when he returns. So you will go ahead and start my 
questioning and then when Mr. Shays gets back, I will defer to 
him, because he is next.
    Mr. Chan, your testimony today focuses on the Reserve and 
the Guard. Have you conducted focus groups around the country 
with active duty service members?
    Mr. Chan. Only indirectly, sir, because while we visit 
those places, sometimes we get a request from the active side 
saying why, how come you are not talking to us? We have our 
story too. So we did a couple of those. As you know, the 
logistics problem really we had trouble applying it.
    Mr. Burton. I understand. It was rather limited. I think 
you are probably going to get a request from this committee to 
do a wider one. I know it is going to keep you awake nights 
thinking about that, but we want you to do a wider one. In any 
event, based upon the limited experience you had with active 
duty members, were their concerns pretty consistent with the 
    Mr. Chan. I would think so. It is a similar issue, but I 
would not think they have the liberty to change that.
    Mr. Burton. I understand. But with the ones you talked to, 
was it pretty consistent with what you heard from the National 
Guard and the Reservists?
    Mr. Chan. Yes. In terms of issues concerning the program 
itself, my answer would be yes.
    Mr. Burton. Thank you.
    Mr. Wicker, we haven't asked you any questions, but what is 
your assessment of problems with the message that DOD is 
    Mr. Wicker. When we visited a number of units in starting 
this whole program, or starting this effort, we sat down and 
talked to the pilots and aircrew and the commander at that 
particular unit would, you know, basically think we didn't 
have--we had no influence on picking the individuals that 
showed up.
    In going through all of those various units that we talked 
to, one thing basically came to mind afterwards, that people 
were complaining and upset about the fact that the 
communication around the anthrax program seemed to be on pretty 
much of a one-way street, from the top down. Folks expressed a 
lot of concern or irritation over the fact that when they 
raised an issue, they raised a concern. The first reaction 
seemed to be in most cases to ignore it, pass it off, say don't 
pay any attention, it is not a problem.
    If they brought up a study, an expert or someone else that 
had a different slant on the anthrax program, again, the 
typical response was to attack the credibility of the source, 
either the individual or the study or whatever the particular 
individual brought up. That, in a nutshell, is basically the 
    Mr. Burton. Of problems you ran into?
    Mr. Wicker. Yes. People similarly don't trust the 
information they are being told about this program, it is very 
clear from the onset. They don't--and it is because of 
apparently some of these attitudes that they have observed that 
I guess they have reached that conclusion.
    Mr. Burton. Yes. General, both of you generals, are you 
familiar with these things?
    General Weaver. Yes, sir.
    Mr. Burton. Is this part of your educational program on 
    General West. Yes, sir.
    Mr. Burton. This is the kind of stuff that some of my 
colleagues give out in the campaign. This says anthrax used as 
a biological weapon represents a grave and urgent threat to 
U.S. Armed Forces. Anthrax is 99 percent fatal, as deadly as 
the Ebola virus. We have a safe and effective FDA approved 
vaccine to protect you against the deadly effects of weaponized 
    FDA approved. The FDA has approved a vaccination for 
anthrax used as a weapon as an aerosol?
    General West. Yes, sir, I believe they have: I can tell you 
three steps to why I believe that.
    Mr. Burton. Wait just a minute. My staff says they have not 
approved it. You got a letter--what was it? It is under 
investigation right now, is it not?
    General West. No, sir.
    Mr. Burton. It is not under investigation?
    General West. It is not.
    Mr. Burton. Just 1 second. We have the IND downstairs. Do 
you want us to go get it?
    General West. No, sir.
    Mr. Burton. If we have the IND, it hasn't been approved by 
the FDA, has it?
    General West. The FDA has sent the department a letter and 
they have sent you, sir, and your committee a letter, saying 
that they believe that use of the anthrax vaccine against an 
aerosolized threat, it will both provide safe and effective 
protection and it is not an off-label use, and I can produce 
that letter.
    Mr. Burton. Well, I know of the letter you are talking 
about, but it is not licensed for that. It has not been----
    General West. Sir, the only thing the license says is it 
protects against bacillus anthracis. It doesn't say the skin, 
it doesn't say swallowing it, and it doesn't say breathing it. 
It just says it protects against bacillus anthracis. That is 
the license.
    Mr. Burton. Well, there is a procedure that the FDA goes 
through to approve a vaccine, and I don't believe this has gone 
through that approval process. Now, if you know something I 
don't know, I would like to know about it.
    General West. Sir, it has. They have testified to that 
effect before this committee, that they have approved the use 
of this vaccine. It is not an IND.
    Mr. Burton. Why does Bioport have an IND right now?
    General West. They submitted an IND because in the 
beginning, as I understand it, and I wasn't here then, but in 
the beginning the question was raised by the opposition group 
as to whether or not the use of the vaccine against bacillus 
anthracis also included the aerosolized part of the threat. So 
Bioport wanted to go to FDA and get that clarified. But before 
that ever had to be acted upon, the FDA communicated with the 
Department, and subsequently with the Congress, saying that 
they had reviewed it, and they considered that an appropriate 
use. That didn't need to be acted on any more.
    Mr. Burton. Mr. Chan, do you have any information on this? 
Either one of you?
    Mr. Sharma. I think there is truth in everything. It is 
true that when a drug or a vaccine is licensed by FDA, it can 
be used for any indication. It is considered as off-label use. 
It is really up to the practitioners. So when they say it can 
be used, yes, it can be used, but you are asking a very 
technical question which is, has it been licensed as opposed to 
their telling you it is OK to use? For that, the way our Office 
of General Counsel has explained to us, that Bioport has 
submitted an IND, which is, that we--it is an investigational 
new drug, and FDA has not acted upon it. So that means that it 
is still pending.
    Mr. Burton. It is still in the investigative stages?
    Mr. Sharma. For that particular use.
    Mr. Burton. Against an aerosol?
    Mr. Sharma. That is correct. But it is also FDA saying, 
which is technically correct, and that is what, you know, 
General West is using, that, yes, you can go ahead and use it, 
because once it is licensed, you can use it for any other 
indication. But if you want to, make sure that it is covered to 
protect yourself, then you have to go through the process which 
is what Bioport is doing.
    Mr. Burton. Mr. Chan, you read something earlier regarding, 
I think it was what the DOD said.
    Mr. Chan. Yes. I am trying to produce a document, 
unfortunately I don't have it with me, but I went over a little 
bit about the fact that DOD earlier stated in 1996, that, in 
fact, the current anthrax vaccine is not licensed for aerosol 
protection. OK.
    Now, as Dr. Sharma has said, one can use it off-label. That 
is the difference here. When you apply for a license, it is 
intended for that use, and you want to license it, it requires 
you have data in terms of safety and efficacy.
    Mr. Burton. What about the data and the safety and the 
efficacy? You said guinea pigs had been tested and there were 
eight strains of anthrax it did not protect against. What about 
monkeys and other primates?
    Mr. Sharma. I think we cannot comment on this question. We 
have not looked at it, and I think this is something--we don't 
specifically know what data has been submitted in support of 
licensing for inhalation of anthrax.
    Mr. Burton. Submitted to the FDA?
    Mr. Sharma. Right.
    Mr. Burton. Have we requested that, the information that 
has been submitted to the FDA?
    General West. It has been partially discussed here in 
previous testimony, and they talked about the human primate 
studies and the fact that every Rhesus monkey that had been 
vaccinated with at least two shots and then exposed to an 
aerosolized challenge survived, and they also testified that 
they did not believe it was an off-label use.
    I would agree with what Dr. Sharma said, except for that. 
This is not off label. The people that the country pays and 
depends upon to make that ruling have written the department 
and the Congress and said we don't consider it off label. Or 
    Mr. Burton. If it is not, why do they have to do an IND 
    General West. They don't, sir, because now there is a 
written opinion on it.
    Mr. Burton. So the Bioport people are just doing this for 
the heck of it, not because it is necessary?
    General West. I don't believe they are doing it at all now, 
nor do I believe FDA is working on it.
    Mr. Burton. We have the IND from Bioport. We have it now.
    General West. I believe that was submitted before we got 
the FDA ruling, it wasn't required. But I will go back and 
check that to make sure I am correct.
    Mr. Burton. We would like to have that checked by both 
staff. Did you have a comment?
    Mr. Chan. No, I don't.
    Mr. Burton. Let me go on to some other questions.
    General West, you have no idea, I guess, how the squalene 
got into the anthrax vaccine. You say it was a naturally 
occurring thing?
    General West. That is what FDA testified last week, sir. We 
didn't know it was in there at all. Their original analysis 
indicated there wasn't any in there, and then when they came up 
with a more sophisticated test, they found a very, very minute 
portion of it in the vaccine in two of the samples that they 
conducted, I believe. But their statement to us was that it was 
nothing to be concerned about, and it would take 2 million 
times that much to act as an adjuvant.
    Mr. Burton. We have a difference of opinion from another 
scientist which I mentioned to you a few minutes ago.
    Why is it that--you know, would be of the things that 
really concerns me is there is a lot of tainted vaccine that is 
not being used, but it is being kept in the case of an 
emergency. I think there are several million doses of the 
vaccine being kept, which will be injected into the military 
personnel in the event that we are having an attack or if there 
is an emergency.
    Why is it they are keeping that vaccine? If it is tainted 
or if it is contaminated?
    General West. Well, there is vaccine that has been produced 
that is in three categories. There is a vaccine that has been 
produced that is certified and safe for use, which is held by 
Bioport and shipped to the facilities that we want to use it at 
about the world.
    There is a second group that has been manufactured by 
Bioport, but has not been released and has not been tested and 
cannot be until Bioport gets their license and has an approved 
testing methodology and procedure that FDA will allow to be 
used to test that vaccine. It may or may not someday become 
available for use. That will be FDA's decision, not ours.
    There is another----
    Mr. Burton. Why does Bioport have to get a license for that 
again, that category?
    General West. Part of the certification process they are 
going through includes how they make the vaccine, how they 
store the vaccine, how they test the vaccine, how they expose 
the animals to run the tests to assure that the vaccine has 
efficacy, how they run the test for potency, and those 
procedures haven't been finally approved by FDA for the new 
facility yet.
    Mr. Burton. Oh, for the new facility. So the vaccine that 
is ready for use right now was produced in the old facility and 
it did pass muster?
    General West. The vaccine we are using now was produced in 
the old facility and has passed muster, in most cases has 
passed muster more than once.
    Mr. Burton. What about the third category you are talking 
    General West. The third category of vaccine is a batch of 
vaccine that was found in subsequent tests to not have the 
required amount of femoral preservative in it.
    Mr. Burton. That is mercury?
    General West. It is the preservative that----
    Mr. Burton. That is not it? Oh, themorol.
    General West. It causes the vaccine to remain good once the 
vial is open. In those lots of vaccine, for some reason a very, 
very minute amount of the femoral has bonded to the glass. The 
vaccine is still sterile, it is still good, we are not using 
it. We have no plans to use it. It is not perfect because a 
little bit of the femoral has bonded to the glass. Scientists' 
opinions are that it would still do its job, even though it is 
not suspended in the solution, but because it is not perfect, 
we are not going to use it. But we made what we thought was a 
prudent decision to keep that locked up at Bioport until we had 
more vaccine, because I would submit that if there was a large 
scale terrorist attack somewhere in the Nation, and that was 
the only vaccine we had, we may want to offer that under an IND 
for emergency use. But we were not saving it to use on our 
troops. We are just keeping it because we think it would be a 
prudent thing to have those lots as opposed to nothing.
    Mr. Burton. I see Mr. Shays has come back. Do you have 
questions, Mr. Shays?
    Mr. Shays. Mr. Chairman, I have questions, two basic areas 
of questions. They both involve GAO report. I would like the 
GAO to look at these--I shouldn't call it a report, because 
what it is, it is the GAO statement, and it is the chart from 
their statement. I would like you to walk me through it again, 
Mr. Chan and Mr. Sharma, and then I would like you, General 
West, to comment on what they are saying.
    Mr. Chan. OK. This chart applies to only those people who 
are still in the military, not those who have left. What the 
chart said, the first bar graph suggests then out of all the 
people who receive one or more shots, 86 percent of them have 
one or more adverse event. OK.
    Of that same group of people----
    Mr. Shays. Of the 86 percent----
    Mr. Chan. The total.
    Mr. Sharma. Of those who received one shot.
    Mr. Chan. That is the denominator. That is the population. 
Of those who received a shot or more, 71 percent did not know 
about the risk at the time they responded to us.
    Mr. Shays. So it is not 71 percent of the 86 percent. So 
they received the shot and had an adverse reaction?
    Mr. Chan. Right.
    Mr. Shays. So of the 86 percent, 86 percent who took the 
shot, one or more shots, 86 percent had an adverse reaction.
    Mr. Chan. Right.
    Mr. Shays. Of that amount, 71 percent of the 86----
    Mr. Chan. No, 71 percent of 100 percent did not know about 
the risk, and also did not have any discussion with the 
    Mr. Shays. Of all the people that took the shot, 71 percent 
didn't know about VAERS.
    Mr. Sharma. I want to make correct. The 60 percent pertains 
    Mr. Shays. Hold on second.
    Mr. Sharma. I am sorry. 60 percent----
    Mr. Shays. Hold on. I don't want to go where you are going, 
because I want to make sure we all understand. I want to make 
sure I understand and I want to make sure the general 
understands. We are saying 71 percent who took the shots did 
not know about VAERS?
    Mr. Chan. Yes.
    Mr. Shays. Now, I want you to explain what VAERS is, for 
the record.
    Mr. Chan. It is a passive surveillance system on adverse 
events that the recipient can report under any kind of event 
they want to report.
    Mr. Shays. It is 71 percent of the people who took the shot 
did not even know they had the ability----
    Mr. Chan. To report.
    Mr. Shays. Did not know they had the ability to go 
somewhere to say they had a negative reaction.
    Mr. Chan. Exactly, yes.
    Mr. Shays. What you are saying is almost--it is pretty 
obvious. Go to 60 percent.
    Mr. Chan. 60 percent did not discuss----
    Mr. Shays. 60 percent of everyone that took the shot?
    Mr. Chan. Yes. Did not discuss any reactions they have with 
the military.
    Mr. Shays. OK. So did all 60 percent--is this 60 percent 
who had an adverse reaction? Is it 60 percent of 86 percent?
    Mr. Chan. No, it is the whole thing.
    Mr. Shays. OK.
    Mr. Chan. Then the only one that is misleading in here is 
that out of all of the people with reactions, 49 percent of 
them said that it is because of fear of loss of flight safety, 
    Mr. Shays. OK.
    Mr. Chan. That is where the mislabeling occurs.
    Mr. Shays. OK. But 49 percent of the 86 percent had 
    Mr. Chan. Yes. For those who could report, they didn't do 
so for fear of the following reasons, and we picked the ones 
that, you know, particularly in terms of loss of flight status, 
adverse affects on career and so on, because that is usually 
what we were told in our focus group when we asked them: why 
don't you report?
    The other reason they said, well, I don't think it was 
serious enough, that kind of thing. Or, in fact, I went to see 
somebody else. I went to civilian providers rather than the 
military, and those kinds of reasons.
    Mr. Shays. I am sorry to be redundant, but I want to just 
make sure. Given your last comment, I want to make sure, is it 
49 percent of 60 percent or 49 percent of 86 percent?
    Mr. Chan. Eighty-six percent. Sorry.
    Mr. Shays. General West, what are the implications of this, 
if they are true?
    General West. I am very concerned about that. There are 
some things we want to look at very hard. I am puzzled by it, 
because I know that VAERS is covered in our informational 
video, it has been covered in the informational brochures we 
hand out, it has been covered in our directive to commanders, 
it has been covered in our instruction program to doctors. 
There is no way that GAO should go out to the field and learn 
that 71 percent of people taking a shot don't know how to 
submit a VAERS. That is a real problem for me, and we have to 
fix it.
    Mr. Shays. Let's go to the first one. Eighty-six percent 
had one or more reaction. That wouldn't surprise you because 
almost everyone would have a negative reaction to some degree.
    General West. If you include the minor reactions, redness 
and swelling, probably so.
    Mr. Shays. So that doesn't surprise you, the 86 percent?
    General West. No, sir, although it is a little higher than 
the other surveys.
    Mr. Shays. How about the 60 percent who chose not to 
discuss their adverse reaction?
    General West. That is a big concern to me.
    Mr. Shays. But are you surprised by it?
    General West. Yes, sir.
    Mr. Shays. Why would you be surprised since we have had so 
much testimony, and I am sure even if you are not here, in 
other hearings you would be briefed on it, that some of our 
soldiers and sailors and marines and air crew, in this case we 
are talking air crew, they felt intimidated about reporting the 
fact that they had adverse reaction. I mean, they felt 
intimidated because you weren't, you know, taking the party 
line. The party line is take your shot and get on with life. So 
why would you be surprised?
    General West. I am surprised because, initially, as Major 
General Weaver said earlier, I think our education program and 
information programs were lacking. We have put a lot of effort 
and a lot of time into making those better.
    We have sent people to some of the sites. One of the things 
we learned was that, as soon as the opposition group learned 
that we were going to be starting vaccinations somewhere, that 
they showed up a week to 10 days prior and started an 
information campaign, to include putting posters up on light 
poles aboard base and scheduling town meetings and things like 
that. They even advertised it on their Web site. They have 
instructions about how to put up those posters to get people 
out to hear their side of the story.
    Faced with that kind of a challenge, we tried to beef up 
our information campaign; and one of the things we tried to be 
sure of is that everybody knew about the VAERS system. So that 
is an alarming and disappointing number to me, and we owe you 
an answer on why that is true.
    Mr. Shays. But General West, we have had continual people 
come under oath, and they are your military people, they are 
people that you can trust, who have said they have felt 
intimidated from coming forward and expressing anything to do 
with their possibly leaving or not feeling well. They have said 
that they have not felt comfortable in doing that. So I am 
surprised you are surprised, because it fits what we have been 
told. So you shouldn't be the last to know.
    I would like to have you comment on what I read earlier, 
and I don't need to go into it in great detail. Dr. Walker, who 
is from the Harvard School of Public Health, who was basically 
a witness, came to talk about the fact that you have certain 
adverse effects in any vaccine, and you look at the good far 
outweighs the bad and you make a determination. But in it he 
said, I can obviously only speak from the point of view of 
civilian medicine. I don't know the military. In the general 
society I think it is a bad practice to compel vaccination. 
People may make mistakes, but I think it is just a violation of 
fundamental liberties.
    Now, I understand that when you are in the military, you 
give up liberties, so I am not going down that route as much as 
I am mentioning the fact that you hold these men in trust. And 
believe me--you are in the military, I wasn't; you have risked 
your life in the military, I haven't--so I stand in awe of 
that, and I know for a fact that you care about your men and 
    But what I don't understand is that it would strike me that 
if you had a negative reaction, why that wouldn't justify not 
going to the second, third or fourth or fifth vaccine, 
inoculation. That is what I don't understand. It would seem to 
me that if they are under order and you know there are going to 
be some people that have a negative impact, that you would 
simply say these people who are responding in a negative way, 
under no circumstances should they be under an order--should 
they be under an order to take it, should they be potentially 
court-martialed if they don't.
    Isn't it a fact--and I will let you answer both questions, 
obviously. Isn't it a fact that you have had some people who 
have said that they have had an adverse reaction where you have 
ordered them to take it, and when they haven't, they have 
potentially been court-martialed? That has been a threat to 
    General West. It is a fact that I have had reports of 
people having adverse reactions and being required to take a 
shot. I am not specifically aware of that resulting in a court-
martial. I am aware of a case where it almost did, and we got 
involved to stop that when we learned of it.
    But it should not happen. If a person has a reaction, they 
should immediately be given a medical exemption, and they 
should not be required to take another shot until we can 
determine what caused the reaction and whether or not it is 
safe to give them another shot. If they truly had a reaction, 
we probably never will determine that it is safe to give them 
another shot. They should not be under court-martial, they 
should not be charged with anything, they should continue to 
serve proudly, and it should not be a negative mark in any way.
    Any of those cases like that are true--and I heard Dr. Chan 
talk about one of them a moment ago. I hope he will share that 
information with me, because I want to go and fix that. Those 
are wrong. They shouldn't happen.
    Mr. Shays. General, it is an easy thing to solve. You 
contact everyone under your command and you tell them that 
anyone who has had an adverse reaction shouldn't be required to 
take the second or third shot or fourth shot. It is an easy 
thing to do. We already have testimony from an expert that 
nobody challenges that some people will have a negative 
    So, again, I used the word court-martial. I am trying to 
train myself not to be so precise, because you are precise 
coming back, and I didn't really just mean it to be court-
martialed. Isn't it true that there are people who have been 
disciplined, who have a record that shows that they have not 
taken--obeyed the command to take the shot, and the reason they 
did it, bless their hearts, is they believe they are being made 
sick from this, and they think they shouldn't have to take the 
second or third shot. They took the first, so it wasn't like 
they just said, I am not doing this. They took a shot, they saw 
they had a bad reaction, they said, don't give me the second or 
the third or the fourth.
    Isn't it true there have been more than one under those 
circumstances, not court-martialed, who have been disciplined?
    General West. I hope there are none that we didn't catch 
before the disciplinary process finished itself. If there are, 
we need to go back and fix those. If you will make me aware of 
them, I will try to do that.
    Mr. Shays. What do you mean ``didn't catch''? Are you 
saying that you do not believe that there is anyone who refused 
to take the second or third or fourth shot because they--it 
wasn't because they had an adverse reaction of a previous shot?
    General West. If they had minor redness or swelling or 
soreness for a day or two, that should not have been a reason 
not to take the second shot. But if they had something beyond 
that, they should not have been required to take the shot, and 
they should not have been disciplined.
    Mr. Shays. But I think that we have had testimony, and I 
can give you the names, General, of people who have come before 
us, and I think that it can be documented by this report that 
there are people who had more than just what I might have 
gotten when I got the polio vaccine and I had a redness when I 
was much younger. But I think that you know that, too. I do. I 
really do. I really think that you know that we have had this 
kind of testimony. Isn't it true that we have had that 
    General West. I am aware of some cases where a person has 
been charged, and when we have reviewed the facts on it, we had 
determined that they deserved and needed to be examined by a 
doctor and the doctor make the determination whether they 
should have another shot. If there is someone that fell in that 
category that was subsequently disciplined, I would like to 
have that person's name, and I will go back and make that 
    Mr. Shays. Would you define what you mean by review, a 
doctor reviewed it? What? A doctor looked at it and he looked 
at the report and said, no, you get a second shot? How do you 
define review?
    General West. In most cases, I would define review as that 
person seeing the doctor personally, talking to the doctor, the 
doctor asking him questions, the doctor reviewing his medical 
history and making a qualified and competent determination as 
to whether or not there is a reaction.
    Mr. Shays. Because I can almost concede to you that we 
could both disagree on whether we need anthrax and whether we 
need one that has the recombinant which is a newer anthrax that 
isolates the protein that does the job the way it should do it 
and without more than--without up to six shots. We could have 
all of our disagreements about that.
    General West. I want that, too, sir.
    Mr. Shays. No, but you don't want it bad enough to have 
done it and done it full speed ahead. Because there has been a 
time when we haven't done it. We just went with the old 
vaccine. So you don't want it as much as I think you should.
    But I think that none of us could disagree with this: If, 
in fact, you have the right to order someone to take a vaccine 
and they have an adverse effect, I sincerely believe that you 
have no viable system to really know who are the bad ones, who 
are reacting in a way where they shouldn't have the second or 
third shot. I would like to know if the GAO has come to that 
same conclusion?
    Mr. Chan. This is from meetings with some of the pilots and 
their crews in various places, but I can recall one case where, 
I think General West is correct, when people have said I have 
reactions to it and they were sent to Walter Reed for 
examination, and at least from these people they said that 
Walter Reed granted them waivers for not taking another shot. 
Whereupon, the command basically said that they were giving too 
many waivers, so from then on they don't send them there, they 
send them to Andrews Air Force base where no more waivers would 
be granted. That is what I heard. I am trying to relate this to 
    Mr. Burton. Would the gentleman yield?
    That is almost criminal. If a person has had a reaction and 
they send him to Walter Reed and they are getting waivers from 
getting another shot and in order to minimize the number of 
people getting waivers they send them out to Andrews because 
they won't give them waivers out there, man, that is bordering 
on criminal negligence.
    Mr. Chan. These are testimonial evidence that is given to 
me and my colleagues here, and we were told that, and we did 
not go and verify those. I just wanted to let you know that.
    Mr. Burton. We want to have GAO do that.
    Go ahead, I am sorry, Mr. Shays. I just think that we will 
make an additional request of GAO not only for the active 
military but to check with Andrews Air Force Base and the 
personnel, and I would like to put those people under oath, if 
necessary, bring them in to find out if they were instructed by 
their superior officers not to grant waivers when waivers 
should have been granted and that they were diverting people 
from Walter Reed because too many waivers were granted, because 
that is highly questionable. So we will make that request, and 
I want to talk to you about that.
    General West. Sir, I absolutely agree with you that what 
you said is exactly right, but I don't believe you are going to 
find that to be true.
    Mr. Burton. Well, we are going to check it out, General.
    Mr. Shays. General, we may not find that to be true, but we 
did have a witness last week who testified that he had an 
adverse reaction, and he was not examined, the doctor just 
looked at his papers. So it sounds to me like we don't have a 
very good standard that is universally applied and properly 
    You would agree with me that if someone has--excuse me, I 
don't mean with me. You would agree that if someone has an 
adverse reaction that you should determine whether, in fact, it 
is related to the vaccine before they are given another one, is 
that true?
    General West. Yes, sir.
    Mr. Shays. But you can't speak with total confidence that 
that is the case?
    General West. We published an exemption policy, we sent it 
to our commanders, and we sent it to our medical people and 
told them that is what we wanted. That is the way it should be 
    Mr. Shays. But we send mixed messages. That is the problem. 
The military sends mixed messages. So it is the message and the 
mixed message.
    When I first opened my office, when I first was elected, I 
heard someone answer the phone, and they said, Congressman 
Shays isn't here, and I was in the next office, and I thought, 
this is interesting. I thought--I called the staff person in, 
and I said, I just heard you tell somebody I wasn't here. She 
said, yes, but you said you didn't want to be bothered. So I 
said, I don't want to be bothered now. So what I had to say to 
my staff person is you heard, that is correct, but I didn't 
want you to lie; I just simply wanted you to say that he is 
busy. That is the truth.
    But the point I am trying to make to you is, there is--I 
gave two messages as far as that person was concerned, and I 
think the military is doing that. You don't want this program 
to potentially be jeopardized, because you so strongly believe 
in it that the mixed message that I think you are sending, 
whether you intend to or not is, tough it out like a soldier 
and get your shot and obey orders, because you have to, because 
in the battlefield we need to make sure you have the shot. You, 
in the end, have the right to do it, but if the message is or 
if the result is that people are being forced to take the shot, 
then we got a big problem.
    The last slide and then I will yield the floor, if I could 
just look at the last slide. Walk me through that slide.
    General, do you have that copy in front of you?
    General West. No, sir.
    Mr. Shays. Would you just hand him a copy of it, please? I 
am sorry, I would have thought you would have asked for it, but 
I will make sure you got it.
    Would you go through the slide, please?
    Mr. Chan. Basically, you see the slide has two rows. The 
first row represents the people who have changed their status 
by leaving, by moving to another unit, by being inactive, OK. 
That represents 25 percent of the total number of people that 
we sampled.
    Then the second row basically represents those who 
remained. That means the 75 percent of the people who are still 
with the active military. So it is--unfortunately, we are 
rushing through this thing.
    Let me walk through the first row there.
    Twenty-five percent----
    Mr. Shays. I am in no rush, so you don't have to be. Let me 
just say, this is very important.
    Mr. Chan. Twenty-five percent have changed their status, of 
which the top reason for their change is anthrax, which 
represents 25 percent of those who--now, when we asked that 
question, we said, of these eight or nine different reasons, 
from family reasons to other employment opportunities to 
OPTEMPO and all of those issues, they checked only one reason 
as your top reason. That is how we picked that. And 25 percent, 
or one-quarter of those people picked anthrax program as the 
reason for their change in status.
    Then, we asked the question: If the anthrax program becomes 
voluntary rather than mandatory, would you return? And 43 
percent of those said, yes, they would.
    Mr. Shays. OK. And you have explained the 61 percent?
    Mr. Chan. The 61 percent--and that is why I am saying it is 
a little bit difficult in terms of comparing apples and 
oranges. First of all, the 18 percent is of the 75 percent who 
are still there. So in fact, if you try to sum the two, there 
is a tendency for some to do that, it is 25 percent plus 13.5 
percent, and 13.5 represents 18 percent of 75 percent. So the 
total number of people who either left, changed their status or 
intend to leave in 6 months is a total of 38.5 percent of total 
    Mr. Shays. With all due respect, we must have asked you to 
come to this hearing too quickly, because you probably could 
have made it simpler. But let me just put it in my words, OK? 
And if I can understand it, the General clearly can.
    My understanding is, of all the people who left, of all the 
people who left, is the 25 inactive and the 25 anthrax just a 
    Mr. Chan. Yes, absolutely, yes.
    Mr. Shays. OK. So basically, you are saying 25 percent of 
this group left of 100 percent, correct?
    Mr. Chan. Yes.
    Mr. Shays. And it is just a coincidence that it is 25 
    Of the people who left, and they could only give one 
reason, you only allowed them to give one reason, there could 
be other reasons, but they could only give one reason, 25 
percent said it was anthrax. That was the reason if they could 
only pick one reason.
    Mr. Chan. Yes.
    Mr. Shays. Of the people who said anthrax, if only one 
reason, you are saying that 43 percent of them would have come 
    Mr. Chan. Yes, sir.
    Mr. Shays. OK. Now, when you allowed the others the--of the 
75 percent who are left, you said what, 18 percent would leave?
    Mr. Chan. Eighteen percent, right.
    Mr. Shays. Within 6 months.
    Mr. Chan. Yes.
    Mr. Shays. And you only allowed them to use one reason?
    Mr. Chan. In this case, we allowed them to pick one or 
    Mr. Shays. They could pick one or more. So they could pick 
a lot of reasons. But then you said, of that, which is the most 
important? You asked it a little differently. Sixty-one percent 
said anthrax was a key factor.
    Mr. Chan. Yes, sir.
    Mr. Shays. OK.
    Mr. Chan. And let me give you the next reason. Family 
reason is 16 percent. That is the next highest.
    Mr. Shays. What? Say that again.
    Mr. Chan. Family reason, 16 percent; other employment 
opportunities, 16 percent; OPTEMPO, 10 percent. So just to give 
you a comparison.
    Mr. Shays. So for comparison purposes, it is more than 
three to one.
    Mr. Chan. Yes, that is right, sir.
    Mr. Shays. Now, in your statement, you said the overall 
response rate was 66 percent. What is that issue? Sixty-six 
percent responded?
    Mr. Chan. That is right. As you know, we sampled the 13,000 
troops that represent--that are pilots and air crews.
    Mr. Shays. And you got a 66 percent response?
    Mr. Chan. Wait a minute. To sample that, we have 1,253 
questionnaires sent out. We received 66 percent return on the 
    Mr. Shays. So 1,253, and it was sent at random. You didn't 
pick out----
    Mr. Chan. At random. So what we said is that it could be 
representative of the entire 13,000.
    Mr. Shays. No, I mean statistically, getting a sample of 
1,253 out of 13,000 is extraordinary. And statistically, to get 
a 66 percent response is extraordinary.
    Mr. Chan. It is quite good in the sense that we have to 
send these questionnaires to the individual's home address, and 
some of them may be deployed, and some of them may not be 
around, so we account for that. What we were hoping for is 
above 50 percent to give us a reasonable random sample. So it 
is pretty good, given the circumstance.
    Mr. Shays. So how confident are you that this is a good 
representative model of the entire 13,000?
    Mr. Chan. Very much so. It would give us--most of my 
answers would give us a cost limit of maybe plus or minus 4 to 
7 percent.
    Mr. Sharma. Ninety-five percent confidence. Our confidence 
interval is 95 percent on these numbers.
    Mr. Chan. Plus or minus 4 to 7 percent.
    Mr. Shays. So this is Guard and Reserves.
    Mr. Chan. Yes, sir.
    Mr. Shays. Pilots? Air crew.
    Mr. Chan. Air crew, yes, sir.
    Mr. Shays. So what can we draw about the entire force 
    Mr. Chan. We haven't done that.
    Mr. Shays. But are there implications here?
    Mr. Chan. The only implication to draw from is, you know, I 
really don't--I can't answer that question because I think we 
can try to sample those people and find out. We did have some 
focus groups where we----
    Mr. Shays. So your point is that this is air crew, and it 
may be more or less with different--if I was a pilot, for 
instance, and I believe that my reactions and my sensitivity, 
and I am a commercial pilot, I might be a little more concerned 
about--I mean, I am just trying to think here. What seems to 
show up on our radar screen are pilots, and part of the reason 
is that they are one of the most costly to train. Our air crews 
in general are the most costly to train and the most 
significant when we receive a loss. So it is an extraordinarily 
high number, from my standpoint.
    I would like to know, General West, how you react.
    General West. The numbers are high. The numbers are a 
concern. I have already said one is too many.
    I believe that there are a couple of things that impact the 
results of the survey. One of them is how actively the 
opposition group has been encouraging people to send them out, 
to fill them out and send them back. I think the committee even 
had a Web site that asked similar questions that encouraged 
people to get their input in.
    There were things like Mr. Edwards' situation that was put 
up on the wall here during a press release. This is a committee 
of the Congress of the United States. That picture went up 
there and went to the homes and the bedrooms and the living 
rooms of America; and, at the time, nobody here knew whether or 
not there was a connection between the fact that he was sick 
and he also took an anthrax shot.
    All of these kinds of things, and as actively as the 
opposition group have worked against it, as much publicity as 
this has gotten, the fact that it was sent to the two 
components of DOD where we have had the most problem, the Air 
National Guard and the Air Force Reserve, is going to give you 
the worst statistics that you can collect and come up with on 
this issue. But they are still too high. They are still too 
    Mr. Shays. General, let me just respond. General, of all 
the answers you could give me, I think that is one of the 
worst, because I don't think of you as the opposition.
    General West. You don't think what, sir?
    Mr. Shays. I don't think of you as the opposition. Just the 
term ``opposition'' is kind of almost alarming to me. These----
    General West. I wasn't speaking of you then, sir, I was 
speaking of----
    Mr. Shays. No, not me, not me, but even the people. I 
    General West. They call themselves that on the Web site. 
Their name is the No Group.
    Mr. Shays. Let me just ask you, are these witnesses today, 
are they part of the opposition? Those three individuals that 
testified earlier, are they part of the opposition?
    General West. I can show you dozens of e-mails that they 
sent back and forth within the No Group.
    Mr. Shays. No. What they are, are your fellow soldiers and 
sailors and marines and air crew. That is what they are. These 
are your family.
    General West. I think they are, sir, and I am very 
disappointed that they have chosen to leave.
    Mr. Shays. That they have chosen to what?
    General West. That they have chosen to leave the service. I 
wish they were all still in. I wish they were all still doing 
what they were trained to do and say they enjoyed doing. I am 
very disappointed that they have been misled into saying this 
was a bad decision.
    Mr. Shays. So you think this is being misled.
    General West. I do, sir.
    Mr. Shays. Well, you know, I was going to go out 
graciously. I don't feel inclined to do that. I mean, just 
think of what you just said. They have been misled. Think of 
it. Have they been misled, or has this Congress been misled?
    I was content to leave General Weaver out of it. Did he 
mislead? And mislead doesn't even mean lie. Mislead means kind 
of distort the truth, give implications that something happened 
that didn't happen.
    Only one person--the implication was only one person 
decided to leave when, in fact, you know, and we should have 
known--there was the term ``walk.'' I think we have been 
dealing with being misled and when the military, the people who 
are the trustees mislead, how can you blame your rank and file 
for not having trust in you? I don't have trust in what we have 
been told by the Pentagon, and I sure wouldn't if I was in the 
military, because I would see it up close and personal.
    We have had too many witnesses, General. We have too many 
witnesses that have said their companion officers have said, 
take it. We have had too many witnesses say that: You didn't 
have an adverse effect; you know, just tough it out. So I 
mean--and we have had too many witnesses who said when they 
were sick they didn't get the care they needed and yet they 
were ordered to do it. So ``misled'' I think is a wrong term 
for you to use. And I guess you have used it so it is on the 
record. I feel you----
    General West. I am sorry you feel that way, sir. I can tell 
you that----
    Mr. Shays. I feel that you have misled us. I feel that 
General Weaver has misled us. I feel that DOD has misled us. I 
didn't say lie, I said misled.
    General West. Every answer I have given has been as honest 
as I could possibly portray it.
    Mr. Shays. I think ``possibly'' gives you too many outs.
    Let me just, with the last--Joint Chiefs, I would like to 
end with this. When was the last briefing that the chairman or 
vice chairman of the Joint Chiefs personally received from a 
representative of OSD, which is the Office of the Secretary of 
Defense, regarding the AVIP?
    General West. I don't remember the exact date, sir. It 
would have been approximately, when we had them all together, 
it would have been approximately 4 months ago when we were 
making a decision whether to go on with phase one or to scale 
it back.
    Mr. Shays. So approximately 4 months ago. How long did the 
briefing last?
    General West. Probably 45 minutes. But it was briefed at 
several levels before--I mean, you normally will brief the 
staff, and then you will brief the 1-stars, you will brief the 
vice chiefs, they will have a read-ahead when they come in. The 
briefing usually goes fairly quickly just because they are so 
    Mr. Shays. I know they are very busy, but you have said 
this is a very important program. Are they aware of all of the 
problems that have been talked about in all of these hearings?
    General West. I certainly believe that they are generally 
aware. They are probably not aware of 100 percent of the things 
that are discussed here, but certainly we would have a 90 
percent solution or so, in that area.
    Mr. Shays. Thank you. Thank you, General.
    Mr. Burton. Thank you, Mr. Shays.
    Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    Have you all taken a vaccine, the full regimen?
    General West. Yes, sir. I have only had five. When I came 
to this job, I had not taken it because I had not been to the 
two theaters that we were vaccinating, nor was I scheduled to 
go there, but given the job that I had, I felt that I should. 
And it takes 18 months to get them all. I have only been here 
14. But I will take the sixth, as soon as my 6 months is past.
    Mr. Cummings. Have you had any side effects?
    General West. No, sir. I literally got the first shot in 
the field and then got in my car and drove to the Pentagon the 
same hour. I haven't had anything beyond a little bit of minor 
soreness and a little bit of an ache a few seconds after the 
    Mr. Cummings. What about you, General Weaver?
    General Weaver. Sir, I have had all six. When we first 
began, I asked all of my leadership to show the example, if 
they would take the shot, and they all did. No adverse 
    Mr. Cummings. General West, you said something that I just 
want you to clarify for us. You know, sometimes hearings can 
have the effect of--sometimes they don't end up in law or 
policy, but they can have an effect. Have these hearings had 
any effect on what is going on with regard to the vaccine, or 
any other hearings in the Congress that you know of in the last 
year or so?
    General West. Sir, I would say it has had two effects. One 
of them is very good, and one of them has made the problem 
    The good effect that it has had is that it has caused us to 
go back and reexamine everything that we are doing, and that is 
congressional oversight, and that is good. That is good 
government. We need it. We thank you for it. The program is 
better today because of it.
    But it has been bad because all of the publicity that it 
has gotten and all that has been written about it and all that 
has shown up on TV about it, and some of the things like--and I 
said this at the last hearing, but when you take a half a 
million people and give them a shot, some of them are going to 
get sick, and if you put everybody that gets sick on the stand 
or if everybody you put on the stand is someone that also got 
sick without connecting it medically and scientifically to a 
vaccine reaction, that is publicity that doesn't help.
    Mr. Cummings. Now, when I listened to Mr. Chan, he talks 
about this 86 percent of the people, talking about the side 
effects. You know, one of the things I guess that--I have 
listened to all of the witnesses, and I try to give the benefit 
of the doubt as best I can. And I don't know about being 
misled, I just haven't gotten to that point. But one thing I 
have noticed is that it seems as if you are really--you are in 
this position, and maybe that is how they teach you to be in 
the military, and it seems like you are rigid, and you are 
holding that ground.
    I think that what bothers me about that, being rigid--and 
like I said, I won't go as far as to say misled--but being 
rigid, is that I really--deep in my heart, I believe that while 
you are standing there and being rigid, I really do believe 
people are suffering. And that is what bothers me. You know, I 
don't see----
    You say you feel this compassion. I am going to tell you, 
if I heard the stories that I have heard, first of all, I would 
want to say, OK, these are human beings, these are my men and 
women, and I would want to say, well, wait a minute. You know, 
let me see--you know, let me look here at this 86 percent. Who 
are these people?
    And you were here. You were here. You heard the stories, 
you know, just like we heard them. And I still feel that you 
are there and you are at the gate and you are saying, no. But 
at the same time, people are suffering.
    I will tell you, I guess there is a time to be rigid, but 
there is also a time to have compassion and for all of us, all 
of us, none of us are perfect, and for us to really take a 
close look at what we are doing.
    Now, one of the things that you said was you talked about 
the medical exemption, and you said something that was very 
interesting. You said that if there was a side effect, you 
believe that person--I talked about the knot, Mr. Shays talked 
about the side effect, and you said if they had a side effect, 
which would be almost anything, I guess, that they should not 
be made to go on, you know, continue the shots. Is that what 
you said?
    General West. Anything beyond minor local reaction. And I 
would define minor local as redness, soreness, minor swelling. 
If it goes beyond that, if it causes a knot that doesn't go 
away in a couple of days, if it causes the person to be dizzy 
or to have nausea or to feel tired or to feel dizzy, those are 
things that should be investigated, and that person should have 
an exemption until we get to the bottom of that.
    Mr. Cummings. Now, when I get a shot, immunization, 
whatever, they always give you--first of all, the doctor 
usually tells you, if you have these problems, this is what you 
need to do, and a lot of times they give you a written document 
saying, if you have problems, call us immediately.
    Do we have something that says to folks in the military, if 
you have anything beyond this, what you just described, first 
of all, you should see the doctor immediately. But, more 
importantly, and that is what I am most concerned about, does 
it say, you don't have to continue to take these shots if it 
has--is there anything written anywhere that says that, says 
that policy that you told us that you believe in?
    General West. Yes, sir. It is in two places. It is in our 
medical exemption communication to the commanders, and it is 
also in some of the information that AVIP puts out. I am going 
to ask Colonel Randolph, if you don't mind, if he would expand 
on this a little bit. He was sworn earlier, and he works with 
it every day.
    Mr. Burton. Colonel Randolph, if you want to scoot up 
    Mr. Cummings. Why don't you pull your chair up? You would 
be more comfortable.
    Colonel Randolph. Colonel Randy Randolph, I am the Director 
of the Anthrax Vaccine Immunization Program Agency, which is an 
office under the Office of the Army Surgeon General.
    We are the focal point for information. We run the DOD Web 
site. We started the toll-free information line. We answer e-
mails, questions from soldiers, sailors, airmen, marine, moms, 
dads, spouses. We do outreach visits. We visit various posts, 
installation camps.
    We also go to various forums to which we are invited to 
provide education. The education includes not only educational 
outreach materials such as the silent training aids that were 
brought up earlier but video programs and briefings, PowerPoint 
information, wallet cards with the anthrax vaccine Web site on 
it, and much, much more.
    Mr. Cummings. The things you just stated, are those pre and 
post shots?
    Colonel Randolph. Yes, Congressman, they are both. They are 
    Mr. Burton. Would the gentleman yield?
    Mr. Cummings. Yes.
    Mr. Burton. You know, I listened very carefully to your 
answer, and I don't think you answered Representative Cummings' 
questions. Do you give to the person getting the shot a piece 
of paper that says, when they get the shot, if you have an 
adverse reaction, do this, and if you have an adverse reaction 
that is severe enough besides redness or whatever, you don't 
have to take another shot. Do you give them a document, a piece 
of paper at the time of the shot that explains this to them?
    Colonel Randolph. Congressman, before they start the 
program, they get education and a piece of paper, it is a 
quadfold pamphlet that not only gives them information about 
adverse reactions, side effects to expect, the minor lumps and 
bumps, what people have self-reported in terms of headaches, it 
also gives them very clearly how to file a VAERS report. It not 
only gives them our Web site--and you can go to the front page 
on our Web site and click and file one of those reports--but it 
also gives them the toll-free information number to the FDA to 
file that report.
    Mr. Burton. If the gentleman will yield for one more 
    Colonel Randolph. I didn't finish the answer to your 
question, though.
    Mr. Burton. I know, but do you give that to them 
simultaneous with the--getting the shot, or do you give that to 
    Colonel Randolph. And then, yes, sir, they are supposed to 
get it when they get the shot, and then the information is 
supposed to continue afterwards. There are written policies in 
all four services that mandate that.
    One of the reasons we started the Web site is, in fact, 
because the quad-folds and the PowerPoint briefings we found 
were not, in fact, given in all of the cases. So to improve on 
that educational process and make it more available, we put it 
on the Web site.
    Mr. Burton. One more followup question. When did you start 
this program? When did you start giving them this information?
    Colonel Randolph. We started giving them information from 
the very beginning of the program.
    Mr. Burton. No, I mean the document.
    Colonel Randolph. Sir, the pamphlet was given to them in 
March 1998 during the accelerated program during Desert 
Thunder. I was the person responsible for FedEx'ing 30,000 of 
those pamphlets into Desert Shield/Desert Storm. The pamphlets 
at that time did not include the VAERS reporting. That came as 
a lesson learned. People wanted us to put the VAERS report on, 
and so the subsequent product did have the VAERS report on it.
    Mr. Burton. I see some people in the audience shaking their 
    Mr. Shays. Mr. Cummings, I don't want to defer you from 
your questions, but if you are going to stay on this issue, I 
would not interrupt you, but if you are going off to another 
issue, I would ask----
    Mr. Cummings. I am going to stay on this.
    Mr. Burton. Mr. Cummings still has the time.
    Mr. Shays. When you are ending this part, I would love to 
just jump in.
    Mr. Cummings. Sure.
    When was it changed?
    First of all, Mr. Chairman, we would like to have--do you 
have the old document, the old card? I would like to have that 
as a part of the record, and the new card.
    Colonel Randolph. We can provide it for the record, and we 
can provide all the dates that they have had changes. They have 
changed about four or five times.
    Mr. Cummings. When did the VAERS report information come 
onto the card?
    Colonel Randolph. Congressman, I would have to take that 
for the record to give you an exact date. I believe it was the 
fall of 1998, but I would be disingenuous to guarantee that was 
the date.
    Mr. Cummings. And what brought that change about?
    Colonel Randolph. Input from customers, input from this 
committee and Mr. Shays' committee that is what they wanted to 
see. They wanted us to address--oh, and, also, the GAO study 
recommended that VAERS information be given to our service 
members, family members, everyone.
    Mr. Cummings. And so can you give us the language? I mean, 
just--I mean, if you can, the language of that part. Did it 
say--I mean, I know you can't say exact words. I am not asking 
    Colonel Randolph. OK. I will provide the pamphlets for the 
record so you have the exact language.
    But in paraphrasing, it does say, if you suspect any kind 
of symptom or adverse event subsequent to a dose of vaccine, 
whether or not it is related to the vaccine or not, we 
encourage you to file a VAERS report with the FDA. Then we give 
them our Web site; and, like I said, it is on our Web site; and 
we give them the FDA toll-free information number.
    Mr. Cummings. Is there something that says that you won't 
be given an Article 15, I guess I am using the right term, or 
be court-martialed if you refuse to take--and I am not talking 
about on the card. I mean anywhere, anywhere where they would 
have access to the information, if you refused to take further 
shots if you have--when you have side effects?
    Colonel Randolph. I can't say honestly whether or not it 
says in any policy that we have written that if you believe you 
have a symptom or an adverse event subsequent to taking a dose 
you won't be called a whistle-blower or anything else if you 
report it.
    Mr. Cummings. Do you think, based upon what General West 
just said, that would be appropriate?
    Colonel Randolph. I think all of us are saying that not 
only from the preliminary results we have seen today and the 
numbers that they indicate and what that might implicate about 
trust that we need to do a better job educating. And, yes, 
Congressman, I agree that is one of the points that needs to be 
    I spend 12 to 16 hours a day, every day, to include many 
hours on the weekends, personally talking to service members 
and family members. I did it again this weekend. I care very 
greatly about it. And it is gravely disappointing to me that, 
A, the information is not getting out to where it needs to get 
out; and even beyond that, that if you believe the preliminary 
results, it indicates they distrust the information that is 
there anyway. That is very disappointing.
    Mr. Cummings. Why do you think that is? I mean, you know, 
we have the military on the one hand saying--we have General 
West saying that these guys should not be punished, and I guess 
one theory would be that they want to be macho, I guess, I 
don't know, but the distrust. I mean--and it is almost like a 
culture of fear that seems to be running rampant.
    And you are doing the job you are doing. You seem to be a 
real sensitive kind of person, and you seem--I assume you are 
doing a good job. But something is going haywire. Something is 
wrong. Something is awfully wrong when you have that kind of 
fear, when people are sneaking in in the middle of the night, 
people winking and stuff like that. I mean, something is wrong.
    I guess what I am concerned about is whether we are all 
missing the boat. Something is missing, and whatever is missing 
creates this culture of fear, culture of distrust, culture of 
illness that we seem to be turning our heads to a certain 
degree and saying that it doesn't--I mean, if these guys and 
women really believe that this is happening, believe me, some 
of them, it is happening to some of them. And I guess I just 
want us to get to the bottom line.
    I have often said that what we do so often is that we meet, 
meet, meet with no results. That is why I asked the question, 
whether the hearings were having any effect. I asked that 
question earlier, because I think that is so important, 
because, see, we may not see you all for another year.
    Mr. Burton. Oh, yes, we will.
    Mr. Cummings. Oh, OK. But in the meantime, whenever we see 
them, Mr. Chairman, you know, there is going to be more people 
that are going to go through more changes. I guess that is 
where I am trying to get to. I am trying to make sure that when 
the dust settles that we have had an effect.
    Colonel Randolph. Congressman, you have had an effect, this 
committee has had an effect, Congressman Shays' subcommittee 
has had an effect. Everything we take into consideration. We 
have changed educational products multiple times. We have added 
educational--we did not have the DOD Web site at the beginning. 
We didn't have a toll-free information line. The toll-free 
information line is just an absolutely wonderful instrument, 
because people can connect with warm bodies and talk to them, 
and we can answer their specific questions and their concerns. 
If they have a medical evaluation problem, we can get them to 
the right health care provider to be taken care of.
    You hit on one other thing, too. Perception is nine-tenths 
of the law. Education is to try to change those perceptions. If 
they perceive that there is a problem with the vaccine, then we 
have got a challenge, a bigger challenge, to give them fact-
based evidence that says otherwise.
    Mr. Burton. Will the gentleman yield?
    Mr. Cummings. I yield to the gentleman.
    Mr. Burton. I just talked to some Desert Storm soldiers and 
they have--and I have also talked to some who weren't in Desert 
Storm, and they said that there are some documents out at 
Walter Reed that we are going to subpoena that deal with 
adverse reactions and what constitutes an adverse reaction and 
how people should go ahead and get the shots, even though some 
of those adverse reactions go beyond just redness. We are going 
to get those documents.
    I want to ask you one more time, Colonel. On this fold-out 
that you say they give to the recipients of the shots, does it 
specifically tell the person who is getting the shot that if 
they have any adverse reaction, they do not have to take 
another shot? I don't care about the VAERS. I don't want any of 
that. Does it say, if you have an adverse reaction, you can 
report it. And we are saying an adverse reaction beyond redness 
and minor things, that you do not have to take the other shot. 
Does it say that anywhere?
    Colonel Randolph. Congressman, I will have to take that for 
the record. I believe it talks about medical exemptions, but I 
am not sure.
    Mr. Burton. I want to see that document, and I want the 
committee to have copies of that document. Because you referred 
to, while the VAERS reporting is mentioned on there, but you 
did not say that it specifically tells them that if there is an 
adverse reaction, they don't have to followup with the shots.
    Colonel Randolph. No, Congressman, I didn't say that at 
all. You are right.
    Mr. Burton. OK. Well, I want to see that, and I want to 
have that for the record.
    Colonel Randolph. Someone has passed me a note that perhaps 
I said I was the one responsible for sending pamphlets to 
Desert Thunder.
    Mr. Burton. 30,000, you said.
    Colonel Randolph. Someone said that I might have said 
Desert Shield/Desert Storm back in 1989 and 1990.
    Mr. Burton. No, Desert Thunder, you said.
    Colonel Randolph. OK, good.
    Mr. Burton. When you finish, I have a number of questions I 
want to ask.
    Mr. Cummings. I am almost finished.
    General West, did you have something?
    General West. I want to respond to something you said 
earlier. It is very important to me as a leader.
    I was very sincere when I said that I was concerned and had 
compassion for everybody that was here last week. And we have 
already taken some steps to try to be sure that the people that 
were here, whether they were anthrax reactions or not, get the 
very best treatment that we can provide them and that we take 
care of that cost concern that was mentioned that was new 
information to me. But I want you to believe that there is 
nothing more important to me as a leader than taking care of 
the men and women that give their life to keep this country the 
best place to live on the planet.
    But the other side of it for me is that I may be leading 
them across that next line of departure, and it may be against 
one of those adversaries that have got this very, very bad 
agent that they can use against us, and part of my compassion 
is to get them to best protection that I can.
    I mean, yes, after spending 14 months following every lead 
I can followup with and tracking down every complaint that I 
can and studying everything I can find about it and talking to 
as many experts as I can get to, I am convinced that it is a 
safe and effective vaccine and that it is something we have to 
use against a very, very real and very, very devastating threat 
until we get that better medicine that Mr. Shays talks about.
    Mr. Cummings. Do you see us getting that better medicine 
anytime soon?
    General West. No, sir. I see us working harder and harder 
on it all the time, but with today's approval processes and R&D 
timeframes and the cost of it and the way it has to be tested 
and the number of months that takes and the amount of data you 
have to collect, it is going to be a matter of a few years, not 
months. I wish that wasn't true.
    Mr. Cummings. This is my last question, and I guess it is--
again, I am going back to, how do we have an effect? General 
West, you said that, you talked about this policy, and I still 
don't think that it is the policy that if you have an adverse 
effect, what the chairman was talking about, if you have the 
adverse effect, you don't have to continue to take shots and 
you won't be--and this is my part, won't be court-martialed or 
given an Article 15, I don't know the military terms, but you 
know what I am talking about, go through some trial process. 
Now, that is not--you are saying that is or is not written 
somewhere, anywhere? Is it written anywhere?
    General West. I don't remember it being written down 
anywhere that if you have a reaction and don't take the shot 
that you won't be disciplined, but it certainly says in the 
published exemption policy that you are not required to take a 
shot if you have a reaction that goes beyond a minor local 
event level. And nobody is going to be disciplined until they 
have a chance to see a lawyer, until they talk to their doctor. 
They are going to get that information, but I promise you that 
we will go back and review and see if there are better ways 
that we can communicate that.
    Mr. Cummings. Thank you.
    Thank you, Mr. Chairman.
    Mr. Burton. Thank you, Mr. Cummings.
    We have a number of military personnel here who are in the 
audience, and we are going to meet with them, General, when we 
get through and go over the testimony today, and we will be 
asking you and the Colonel and General Weaver to come back in 
the not-too-distant future. I still have subpoena authority, 
and we can have hearings after we adjourn sine die, and I 
intend to have hearings on this because I think it is of such 
    Let me just also say that I am very concerned about some of 
the information that we have not received. We talked about the 
data base that tracked the shots given to our troops during the 
Gulf war. We have been told that that has been lost. I don't 
know how in the world you followup with a six-shot regimen of 
anthrax vaccine when you don't have any record of the first or 
second shots, and yet the Pentagon tells us they have lost that 
information. How can that be?
    General West. Sir, I don't have a good answer for that 
question. I didn't know we had told you that.
    Mr. Burton. Well, that has been told to us, and we will be 
subpoenaing from the Pentagon immediately any information 
whatsoever regarding the shots that were given to our troops 
during the Gulf war, and if there was--if it was lost, I want 
to know--in the subpoena we are going to ask how it was lost, 
and we are also going to ask how in the world they could, in a 
coherent way, continue to give shots, a regimen that is 
supposed to be given in a sequential timeframe, without knowing 
who got the previous shots and when. So, you know, we want to 
know what happened with that.
    Do you think that the Gulf war veterans that are ill have 
squalene antibodies in their blood?
    General West. I don't know, sir, but if they do, I don't 
think it came from anthrax vaccine.
    Mr. Burton. You don't know, though, do you?
    General West. Well----
    Mr. Burton. Have you tested anybody to find out those who 
have suffered from the Persian Gulf Syndrome, have you tested 
any of them to see if they have squalene in their bodies? I 
want to know that.
    General West. I would have to get that.
    Mr. Burton. If one of our enemies used one of these other 
threats tomorrow--I am talking about one of the other 31 
strains of anthrax vaccine--or if they use something that was 
totally different--let's say they used another biological 
weapon, and there are lots of biological weapons. We have 
talked to a lot of people who said there are a number of 
biological weapons that could be used. The most common one 
would be anthrax, but if they used one of these other 
biological or chemical weapons, how would we protect our 
    General West. Well, there are intelligence reports of other 
biological weapons that are being pursued; and at the same time 
they are pursuing them, we are pursuing the most effective ways 
to counter them.
    But the only way we have now is what I would consider some 
very primitive detection capability, some protective clothing 
and equipment that works but has to be maintained and kept 
clean and kept--filters changed very, very rigorously and very, 
very devotedly, and there are other medical solutions that are 
being pursued. But, beyond that, I don't have a better answer. 
It is a very, very ugly threat and a very, very big problem. We 
believe in this case we did have protection.
    Mr. Burton. I know one thing, if I were Saddam Hussein and 
I knew that you did have an effective anthrax vaccine and I was 
going into combat with you and I didn't think there was 
anything that you were going to do with a nuclear retaliatory 
effort or anything else like we threatened to use in Desert 
Storm, I would use one of those other agents. I sure as heck 
wouldn't use one I thought you had protection for.
    Anyhow, you had a comment, Mr. Shays.
    Mr. Shays. General Weaver, I just realized that I need to 
ask you just this question. It is not a trick question. It is 
just intended to be prepared for your document.
    You have already said that you didn't specifically ask 
those people who were transferring or separating whether it was 
related to anthrax, but you did say you did send out a document 
to your commanders to survey for why they were transferring or 
    What would be the date of that document? I know you don't 
have it here, but what would be the date? When did you make 
that request?
    General Weaver. One moment, sir.
    Sir, my staff tells me that we made it right after the 
senior leadership conference, which would have been in the 
November 1999, timeframe. We had a hearing----
    Mr. Shays. It would be a document that would be in November 
or December of last year?
    General Weaver. Yes, sir.
    Mr. Shays. That will say that you have requested it. It 
will be a written document?
    General Weaver. Sir, I asked. I cannot request.
    Mr. Shays. Let's not get into that. The bottom line is this 
document you are giving me is going to be dated last year, 
    General Weaver. I will check that for sure, sir.
    Mr. Shays. But you anticipate it is last year's document?
    General Weaver. According to my staff.
    Mr. Shays. Thank you.
    Mr. Burton. Let me just ask two remaining questions: 
According to Tulane University, some of the Gulf war veterans 
that are ill have squalene antibodies in their blood. Did you 
know that, General?
    General West. Sir, I was not part of the Gulf war illness 
study. I have read the Tulane report. I don't know that--I 
don't know whether it has been confirmed. I just don't know 
enough about that to give you a good answer.
    Mr. Burton. Well, according to the GAO and some others we 
have talked to, squalene does have a repressive effect on the 
immune system; and if squalene was found in the antibodies or 
in the blood of these Gulf war veterans, I would like to know 
how it got there, if it wasn't in the vaccine. So that is 
something else we need to check. I don't know if any of the 
lots of the vaccine that were used in Desert Storm are still 
available, but if there is we ought to take a look at that and 
have it analyzed. I would like to have you take a look that if 
you could.
    The last thing I would like to ask you is, we have a letter 
from the Association for Civilian Technicians, which I will 
place in the record, regarding their support of legislation to 
hold the anthrax program in abeyance until it is proven safe 
and effective.
    As you know, civilian technicians are in the Guard; and 
their full-time job is working for the Guard. If these 
individuals become sick from anthrax vaccine and can no longer 
serve in the Guard, they will lose their full-time job as well. 
The civilian technicians are a critical component to keeping 
our planes flying. How many technicians have lost their job as 
a result of the anthrax vaccine? Do you have any idea?
    General West. No, sir.
    Mr. Burton. Can you get that information for us?
    General West. I should be able to, yes, sir.
    Mr. Burton. Would you do that?
    We have a lot more questions which we would like to submit 
to you for the record. If you could answer those and send them 
back to us, we would really appreciate it, General Weaver, both 
of you.
    I want to thank Mr. Chan and the people at GAO. We 
appreciate it. You will be getting a further request from us, 
and I know you are going to love it, because it is going to 
involve a lot of work.
    In any event, we will have further hearings on this, and we 
will have further questions for you, so we will be back in 
touch. Thank you very much.
    We stand adjourned.
    [Whereupon, at 4:40 p.m., the committee was adjourned, 
subject to the call of the Chair.]
    [The prepared statement of Mrs. Chenoweth-Hage and 
additional information submitted for the hearing record