[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
THE ANTHRAX VACCINE IMMUNIZATION PROGRAM--WHAT HAVE WE LEARNED?
=======================================================================
HEARINGS
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
http://www.house.gov/reform
U.S. GOVERNMENT PRINTING OFFICE
73-979 WASHINGTON : 2001
_______________________________________________________________________
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COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
HELEN CHENOWETH-HAGE, Idaho (Independent)
DAVID VITTER, Louisiana
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
----------
Page
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
THE ANTHRAX VACCINE IMMUNIZATION PROGRAM--WHAT HAVE WE LEARNED?
----------
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
vaccine.
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
threats.
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
country.
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
populations.
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
statement.
[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
record.
[The prepared statement of Hon. Elijah E. Cummings
follows:]
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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.
STATEMENT OF HON. JACK METCALF, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF WASHINGTON
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
protection.
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
personnel.
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
detected.
Does that mean the FDA would expect to find squalene in
childhood vaccines? If detected, could levels harm a 3-month
old?
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
FDA.
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
exemplary.
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.
STATEMENTS OF MAJOR JON IRELAN, 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
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
strength.
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
identified.
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
life.
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
hard.
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
program.
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
one.
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
myself.
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
reaction.
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
condition.
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:]
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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
end.
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
discontinued.''
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
future?
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
approached.
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
myself.
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
shot.
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
careers.
The program was and is a bad idea, no matter how well
intentioned.
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
point.
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
present.
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
testimony.
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.
[Recess.]
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
questions.
[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
proceeding.
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
company.
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
question.
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
vaccines.
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
happened.
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
you.
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
unsatisfying.
Mr. Shays. Mr. Chairman, could I just have another 5
minutes and then I could finish? Would that be all right? Thank
you.
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
practice.
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
liberties.
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
much.
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
times.
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
treatment?
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
this.
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
recommendations?
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
that?
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
deaths?
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
related.
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
races?
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
expert.
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
needed.
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
medication?
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.
Colosimo.
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
monthly?
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
way.
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
mistake.
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
expert.
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
conclusion.
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,
yes.
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
application.
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
anthrax.
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
attorney?
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.
[Recess.]
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.
STATEMENTS OF CHARLES CRAGIN, 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
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
individuals.
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
place.
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-
mail.
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
protected.
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
vaccine.
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
supplement.
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
label.
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
there?
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
perform.
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
humans.
I just wanted to make sure that at least the record
reflected that the colloquy may have been as a result of the
confusion.
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
facility?
Mr. Elengold. That was manufactured before the shutdown for
renovation.
Mr. Burton. And how old are some of those lots?
Mr. Elengold. Some of those lots I believe go back to about
1995.
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
produced.
Mr. Burton. You said you believe that. Can you say
categorically there would be no side effects from having
squalene?
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
effects.
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
autistic.
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
situation.
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
term.
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
capacity.
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
confirmation?
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
capability.
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
process.
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
battlefield.
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.
Chairman.
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
follows:]
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THE ANTHRAX VACCINE IMMUNIZATION PROGRAM--WHAT HAVE WE LEARNED?
----------
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
record.
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
questions.
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
F-16.
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
malingerers.
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
emergency.
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
has----
Mr. Shays. Is the gentleman's mic on?
Mr. Kucinich. Testing. It is. Thank you very much, Mr.
Chairman.
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
heard.
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.
STATEMENTS OF TOM HEEMSTRA, LEXINGTON, KY; DAN MAROHN,
PLYMOUTH, IN; PAT ROSS, BATTLE CREEK, MI; AND R. STEPHEN
PORTER, VIRTUAL DRUG DEVELOPMENT, INC., BRENTWOOD, TN
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
day.
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
anyway.
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
malcontents.
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
pilots.
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
documents.
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
ignored.
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
defend.
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
airline.
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
dismissal.
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
later.
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
doubt.
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
experience.
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
product.
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
individuals.
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
accurate?
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
that.
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
minority?
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,
right?
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
questions?
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
about----
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
them.
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
gradations.
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.
Ross?
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
humans.
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
anthrax.
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
Reserve.
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
moment?
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
services?
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
fly.
Ms. Schakowsky. Thank you.
Mr. Burton. Thank you, Ms. Schakowsky, and thank you for
yielding.
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
record.
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
need.
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
vaccine?
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
mandatory.
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
point.
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
vaccine?
Dr. Porter. It is an antibiotic. Yes, that is the timetable
for the negotiations. The FDA will further define that time
scale.
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
today.
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.
Heemstra.
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
own.
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,
no.
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
discharge.
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
unsatisfying.
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
logical?
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
effect.
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
21st.
Mr. Burton. Without objection.
Mr. Shays. Thank you, Mr. Chairman.
Mr. Burton. Thank you very much.
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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.
[Recess.]
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.
STATEMENTS OF KWAI-CHEUNG CHAN, 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
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
operations.
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
members.
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
have.
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
something?
General West. Yes, sir.
Mr. Shays. Isn't it logical that you might want to look at
it?
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
testify.
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
proportion.
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
today.
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
statement.
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
part.
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
protection.
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
program.
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
statistics.
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
that.
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
statement?
General West. Yes, sir.
[The prepared statement of General West and General Weaver
follows:]
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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
troops?
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
protection.
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
less.
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
be.
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
services?''
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.
[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
testimony.
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
here?
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
intelligence?
General West. I can answer concisely and explicitly what
you are getting at, but we will have to go to a classified
hearing.
Mr. Shays. I am just commenting on what you said, and I
thought you were saying your troops came across weaponized
anthrax.
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
were.
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,
correct?
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,
correct?
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
alternatives.
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,
sir.
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
it.
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
vaccines.
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
is----
Mr. Shays. Who are you reading from? Who is the document
from?
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
quoting.
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
this.
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
anthrax.
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
media.
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
Congress.
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
people.
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
ready.
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
correct?
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
capability.
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
says?
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,
sir.
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,
sir.
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
individuals?
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
leaving.
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
trend.
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
briefing?
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
antibody.
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
thing.
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
else?
General West. Sir, there are good answers to both of those
questions. DOD did not put an adjuvant in the vaccine of
squalene.
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
read----
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
strains.
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
that?
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,
sir.
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
hearing?
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
shot.
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
personnel?
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
reactions.
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
questionnaire.
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
anything.
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
issue.
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
together.
Mr. Burton. We will recess and be back in just a few
minutes then.
[Recess.]
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
Reservists?
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
communicating?
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
kind----
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
anthrax?
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
anthrax.
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
IND.
Mr. Burton. If it is not, why do they have to do an IND
then?
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
about?
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
military.
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
to----
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,
adverse----
Mr. Shays. OK.
Mr. Chan. That is where the mislabeling occurs.
Mr. Shays. OK. But 49 percent of the 86 percent had
reasons----
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
women.
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
them.
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
reaction.
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
testimony?
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
right.
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
you.
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
applied.
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
working.
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
force.
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
coincidence?
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
percent.
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
back.
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
more.
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
questionnaire.
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
structure?
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
high.
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
mean----
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
busy.
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
injection.
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
reactions.
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
harder.
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
there.
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
both.
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
question.
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
them----
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
heads.
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
that.
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
emphasized.
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
import.
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
troops?
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
separating.
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,
correct?
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
follow:]
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