[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
ANTHRAX VACCINE ADVERSE REACTIONS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
VETERANS AFFAIRS, AND INTERNATIONAL
RELATIONS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
JULY 21, 1999
__________
Serial No. 106-131
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
65-673 CC WASHINGTON : 2000
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
HELEN CHENOWETH, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Carla J. Martin, Chief Clerk
Phil Schiliro, Minority Staff Director
------
Subcommittee on National Security, Veterans Affairs, and International
Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois
ILEANA ROS-LEHTINEN, Florida TOM LANTOS, California
JOHN M. McHUGH, New York ROBERT E. WISE, Jr., West Virginia
JOHN L. MICA, Florida JOHN F. TIERNEY, Massachusetts
DAVID M. McINTOSH, Indiana THOMAS H. ALLEN, Maine
MARSHALL ``MARK'' SANFORD, South EDOLPHUS TOWNS, New York
Carolina BERNARD SANDERS, Vermont
LEE TERRY, Nebraska (Independent)
JUDY BIGGERT, Illinois JANICE D. SCHAKOWSKY, Illinois
HELEN CHENOWETH, Idaho
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Robert Newman, Professional Staff Member
Jason Chung, Clerk
David Rapallo, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on July 21, 1999.................................... 1
Statement of:
Chan, Kwai-Cheung, Director, Special Studies and Evaluation
Group, Natonal Security and International Affairs Division,
U.S. General Accounting Office, accompanied by Sushil K.
Sharma, Assistant Director, Special Studies and Evaluation
Group, National Security and International Affairs
Division, U.S. General Accounting Office; Major General
Robert Claypool, Deputy Assistant Secretary for Health
Operations Policy, U.S. Department of Defense, accompanied
by Rear Admiral Michael Cowan, Deputy Director for Medical
Readiness, Joint Staff, U.S. Department of Defense; Colonel
Frederick Gerber, Director, Health Care Operations, Office
of the Army Surgeon General, U.S. Department of Defense;
Colonel Renata Engler, chief, Allergy-Immunology Service,
Walter Reed Army Medical Hospital; and Susan Ellenberg,
Director, Division of Biostatistics and Epidemiology,
Center for Biologics Evaluation and Research, Food and Drug
Administration, accompanied by Dr. Miles Braun............. 74
Piel, Captain Michele L., U.S. Air Force, Stevensville, MD;
Lieutenant Richard Rovet, U.S. Air Force, Dover, DE;
Sergeant Robert Soska, U.S. Army, Fort Stewart, GA; Captain
Jon Richter, U.S. Air Force, Annapolis, MD; and Lieutenant
Colonel John Jensen, Great Falls, MT....................... 6
Letters, statements, et cetera, submitted for the record by:
Chan, Kwai-Cheung, Director, Special Studies and Evaluation
Group, Natonal Security and International Affairs Division,
U.S. General Accounting Office, prepared statement of...... 77
Claypool, Major General Robert, Deputy Assistant Secretary
for Health Operations Policy, U.S. Department of Defense,
prepared statement of...................................... 97
Ellenberg, Susan, Director, Division of Biostatistics and
Epidemiology, Center for Biologics Evaluation and Research,
Food and Drug Administration, prepared statement of........ 121
Jensen, Lieutenant Colonel John, Great Falls, MT, prepared
statement of............................................... 41
Piel, Captain Michele L., U.S. Air Force, Stevensville, MD,
prepared statement of...................................... 10
Richter, Captain Jon, U.S. Air Force, Annapolis, MD, prepared
statement of............................................... 35
Rovet, Lieutenant Richard, U.S. Air Force, Dover, DE,
prepared statement of...................................... 19
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut, prepared statement of............ 3
Soska, Sergeant Robert, U.S. Army, Fort Stewart, GA, prepared
statement of............................................... 26
ANTHRAX VACCINE ADVERSE REACTIONS
----------
WEDNESDAY, JULY 21, 1999
House of Representatives,
Subcommittee on National Security, Veterans
Affairs, and International Relations,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:05 a.m., in
room 2154, Rayburn House Office Building, Hon. Christopher
Shays (chairman of the subcommittee) presiding.
Present: Representatives Shays, Souder, Terry, Schakowsky,
and Tierney.
Also present: Representative Gilman.
Staff present: Lawrence Halloran, staff director and
counsel; Robert Newman, professional staff member; Jason Chung,
clerk; Bill Ochs, intern; David Rapallo, minority counsel, and
Earley Green, minority staff assistant.
Mr. Shays. Good morning and welcome.
In April, we heard testimony from three members of the
Michigan Air National Guard unit who suffered serious health
effects after receiving the anthrax vaccine. Their personal
stories conveyed the concerns of many men and women in our
armed forces about the long-term safety of a little-used
vaccine.
Their testimony also raised important questions about the
willingness and ability of the Department of Defense, DOD,
anthrax vaccine immunization program [AVIP], to acknowledge the
side effects and adverse reactions caused by the vaccine. We
address those questions today.
All vaccines cause reactions. In fact, that is their
purpose, to stimulate a response from the immune system. But in
doing so, vaccines also cause in some people varying degrees of
negative health consequences ranging from a sore arm to
potentially fatal hyper-sensitive or allergic reactions.
Due to its composition and the number of inoculations
required, the anthrax vaccine causes local and systemic
reactions at what DOD once called problematic rates. Some
reactions may become apparent as vaccine usage expands from a
few hundred people each year to 2.5 million members of the
military.
To capture the true rate of health effects and to detect
unexpected reaction trends, AVIP surveillance systems must be
sensitive and receptive to adverse events reports.
Are they?
Military doctors must be advocates for their patients, not
purveyors of program orthodoxy.
Are they?
Those receiving the vaccine must be free to seek medical
advice and pursue suspected associations between the vaccine
and their illnesses without fear of retribution or ostracism.
Are they?
Many think not. Service members report massive vaccination
sessions during which little medical information is imparted,
little medical history elicited, and no questions or doubts are
tolerated. They describe a program that often fails to offer
legitimate medical exemptions from the inoculation, glosses
over potential side effects, and aggressively denies any
attempt to link adverse events with the vaccine.
Others, like the Michigan National Guard members who
testified in April and those who are here today, face
intimidating official resistance when they ask whether the
vaccine may be a cause of their medical problems. As a result,
the number of AVIP-related cases in the Food and Drug
Administration [FDA], Adverse Event Reporting System, referred
to as VAERS, seems purposefully and implausibly low.
Despite the under-reporting inherent in a passive
surveillance system, VAERS is a tool DOD could use to gather
important data about the impact of the AVIP on troop health and
readiness. Instead, illnesses subsequent to vaccination are
attributed to coincidence or pre-existing conditions in the
interest of protecting the anthrax program rather than the
patient.
The practice of medicine, not public relations, should be
driving the adverse event reporting process. Whether the
adverse reaction rate is two-tenths of 1 percent or 21 percent,
DOD has an obligation, a profound obligation, to protect those
in the military force, in the force made ill by this force
protection program.
If women suffer adverse health effects at twice the rate of
men, DOD has an obligation to acknowledge and ameliorate those
effects. If a pure vaccine or fewer than six inoculations would
provide protection while causing fewer reactions, DOD again an
obligation to pursue FDA approval of those options.
We are going to proceed from the premise all our witnesses
share one interest, the health and safety of those in service
to the Nation. That is going to be our premise.
Thank you all for your time and your testimony this
morning. And again, welcome.
[The prepared statement of Hon. Christopher Shays follows:]
[GRAPHIC] [TIFF OMITTED] T5673.001
[GRAPHIC] [TIFF OMITTED] T5673.002
Mr. Shays. At this time, I would ask if Mr. Tierney has any
opening statement he would like to make for the record.
Mr. Tierney. I do not. Thank you.
Mr. Shays. Thank you, Mr. Tierney.
So at this time, let me first get some business out of the
way. And that would be to ask unanimous consent that all
members of the subcommittee be permitted to place an opening
statement in the record, and the record remain open for 3 days
for that purpose.
Without objection, so ordered.
And I ask further unanimous consent that all witnesses be
permitted to include their written statements in the record.
And without objection, so ordered.
And I am further going to ask unanimous consent to insert
in the hearing the record written statements from Randy Martin-
Allaire, Roberta Groll, and David Churchill, members of the
Michigan Air National Guard, who testified before the
subcommittee in April. And we asked them to update us on their
health and their efforts to determine whether the anthrax
vaccine played a role in their illnesses.
I am happy to report their health has improved somewhat,
but they remain very frustrated and disappointed over the DOD
response to their plight.
And without objection, we will put that in the record as
well.
Now we will welcome our first panel. We have five witnesses
who will testify. Captain Michelle Piel, U.S. Air Force;
Lieutenant Richard Rovet, U.S. Air Force.
Captain Piel is from Stevensville, MD, and Lieutenant Rovet
is from Dover, DE.
Now we also have Sergeant Robert Soska, U.S. Air Force--
U.S. Army, I'm sorry--Fort Stewart--excuse me, Sergeant--and
Captain John Richter, U.S. Air Force, Annapolis, MD, and
Lieutenant Colonel John Jensen, Great Falls, MT, and he is with
the Montana Air National Guard.
We welcome all of you here today, and as is our practice,
we swear in our witnesses, this being an investigative
committee. We do it for Members of Congress as well when they
testify before us. And we would welcome you to stand and we
will administer the oath. If you would raise your right arms
please.
[Witnesses sworn.]
Mr. Shays. Thank you. For the record, all five have
responded in the affirmative.
And I think we have you seated according to the way we are
going to proceed. We will start with you, Captain Piel.
And what we do is, we have the light on for, it will be on
for 5 minutes. We will roll it over another 5 minutes, and
certainly ask you to finish before that second roll-over is
done. And do know that your record will be--your full statement
will be in the record if you care to leave out some parts.
Capt. Piel. Yes, sir.
Mr. Shays. I am also going to say to all of you before you
testify, I have served in Congress 11 years, and I know for a
fact that military personnel do not like to come before
Congress. This is not something you look forward to. It is not
something you enjoy. And you do it with some recognition that
you put your careers in some jeopardy, even when we say you
don't.
And we certainly keep track of our witnesses and do our
best to make sure they are treated fairly as they complete
their career. But we know you are here at our request, and we
thank you for being here.
Captain Piel.
STATEMENTS OF CAPTAIN MICHELE L. PIEL, U.S. AIR FORCE,
STEVENSVILLE, MD; LIEUTENANT RICHARD ROVET, U.S. AIR FORCE,
DOVER, DE; SERGEANT ROBERT SOSKA, U.S. ARMY, FORT STEWART, GA;
CAPTAIN JON RICHTER, U.S. AIR FORCE, ANNAPOLIS, MD; AND
LIEUTENANT COLONEL JOHN JENSEN, GREAT FALLS, MT
Capt. Piel. Good morning, Mr. Chairman and members of the
committee.
Mr. Shays. I am sorry, Captain, I am going ask you to move
that mic a little closer to you. If it kind of gets in the way,
you could lift it up a speck if you wanted. Is it all right?
Can you----
Capt. Piel. It is fine.
Mr. Shays. OK. That is better. We hear your voice better.
Thank you.
Capt. Piel. First of all, I would like to thank you for
interest in the anthrax immunization program and also for
requesting my testimony today. The views which I will express
will be my own and in no way reflect those of the Department of
Defense, the Air Force, or my superior officers.
I am a C-5 pilot at Dover Air Force Base, DE. I hold the
position of aircraft commander and I am also a flight commander
within my squadron. My whole life I have wanted to fly and
serve my country. And as a graduate of the Air Force Academy, I
was able to achieve both.
I have had a very rewarding 13-year career, and I am
grateful to everyone who has helped me along the way. Today I
am going to talk to you about my experiences.
In October, I was healthy and flying operational missions.
I became ill the first of November and then again in December
following my first and second anthrax immunizations. On October
1st--excuse me, on October 21st I received my first
immunization from Lot 030. It wasn't until weeks later, while I
was flying a mission in support of Hurricane Mitch relief
efforts, that I became ill.
The right side of my head filled up with fluid while I was
on a return leg to Pope Air Force Base. After landing, the
flight surgeon grounded me. I had otitis media, which is an
inflammation, or an infection of the middle ear. And I also had
a very bad head cold.
These symptoms persisted for 3 weeks. My doctor back at
Dover and I discussed whether or not I should receive an
immunization at this time, and we felt that it would be
improper and that we should wait until I had fully recovered.
On November 30, I went to the flight surgeon's office to
get put back on flying status. He returned me to flying status
and I went straight to the immunization clinic to get my next
vaccination. Following the second vaccination, I felt fine
directly afterward. But later that afternoon, I began to feel
very tired.
I went home, straight to bed, and I did not wake up until
the next morning. I awoke feeling very ill, and I returned to
the doctor. The doctor was very surprised at my condition, the
change from the day before to that day. And, of course, I went
back on non-flying status.
And he asked me, what did you do differently between
yesterday and today? And I told him, the only thing that I
could think of was that I had my anthrax immunization.
In December, I had dizziness to the point it affected
everything that I did. I could not drive; I could not read a
page of paper; I could not concentrate. At the lowest point, my
vision blurred, which is very critical to me because it affects
my career as a pilot.
During this time, the diagnosis was viral labrynthitis,
which is an inflammation of the inner ear, and it can cause
dizziness because it affects your balance system.
I do not know exactly what was happening to me, but the
doctors assured me that within 4 to 6 weeks I would recover
from viral labrynthitis. Well that did not happen.
I saw many doctors over the course of the next 6 months,
and nobody could, I don't feel, adequately address my problem.
It wasn't until I began going to Walter Reed at the decision of
my wing commander, Colonel Greider, that I began to get my
problems recorded in my medical records and receive blood
tests, which would help try to determine what was causing my
symptoms. I have had a very slow recovery, with periods of
regression, but I strived to maintain a positive mental
attitude and recover my flying status and career.
I would like to talk to you know about deferral criteria.
The only information I was given at the time of the shot was
the trifold pamphlet, which we are all familiar with, what
every service member should know.
Although I did not have deferral, I have not received any
shots since November, during the first few months of my
illness, doctors asked me if I would like to continue my
anthrax immunizations. They even suggested taking incremental
doses to see what would happen.
Because I was still ill, I felt that this was unwise, and
no one pushed the issue. At this point, I was in a gray area.
There was no diagnosis, and yet I was still ill. I valued
my career, but I also couldn't afford to jeopardize my health,
because without my health, I have no career.
No I will talk about the VAERS system, Vaccine Adverse
Event Reporting System, and how that was communicated to me.
The doctors did not file a VAERS report on me. It wasn't
until May that I learned about the VAERS system. At that point,
I felt it would be wise for my doctor and I to file it together
because I wanted it to be accurate.
When I went to the chief flight surgeon at Dover Air Force
Base, my request met reluctance. I thought that any loss of
duty over 24 hours should be reported in VAERS. But he did not
agree that I had had a reaction.
So then I asked him what he did think was reportable under
VAERS. And he listed things like difficulty breathing, rash,
sweating, fever, nodules, and anaphylactic shock. My case
clearly did not fall within those criteria.
I asked him, what about effects on the immune system and
the nervous system, because I felt that maybe that was
happening to me. But I had no answer to that question.
At this point, I was confused because I was too sick to fly
and I was too sick to get another shot. But I wasn't sick
enough or in the right ways for it to be reportable.
There would be no data collection at Dover Air Force Base
if it wasn't for the fact that Lieutenant Rovet pursued the
issue. He followed up on all of our cases; he tried to help us
out. And all of his efforts were met with resistance and
discouragement.
However, when we reported our symptoms to our commanders,
it went up the chain of command to Colonel Greider. And when
our wing commander, Colonel Felix Greider, found out what was
happening at his Air Force base, he took the health of his wing
very seriously. That was when we had the series of briefings,
and we got a lot of attention at our base, to say the least.
The information that we got in the first briefings wasn't
adequate. And, dissatisfied, Colonel Greider decided to call a
timeout until our health issues could be addressed properly.
This is important to the collection of data because before he
called the timeout, there was no VAERS data from Dover Air
Force Base. There was no collection or reporting.
No one knew what was happening outside of our base.
I would also like to say that as far as diagnosis and
treatment within the medical community at Dover, I did not get
directed to Walter Reed. I got directed to from Colonel Greider
and put in touch with the immunology clinic, where they began
to actually record my symptoms in my medical records and give
me blood tests to try to determine what may have, what may be
wrong with me, besides the fact that I had an ear infection.
What they did find was that I had a positive ANA marker,
which is an auto-immune disorder, an indication of that. It is
not that I have been diagnosed with a specific disease;
however, my symptoms are consistent with having immune system
problems.
The last few months I have felt some improvement; however,
the fatigue is affecting how I live, and it is also affecting
whether or not I am capable of flying. I also have periodic
returns of the dizziness, which I also cannot fly in that
condition. And I also have headaches and other things which
affect me to a lesser degree.
I missed several weeks of work in January; I missed all of
work in December; I missed 3 weeks of work in November. I
missed a lot of work. And none of this was reported.
However, now it is. An IG complaint was filed at Dover
because when the VAERS reports were finally filed, they were
filed inaccurately. The most egregious error is that they
marked that the reports were self-filed, indicating that I and
the others that they filed reports on had filed it ourselves,
when, indeed, we had nothing--I had nothing to do with my VAERS
form. I saw it later, and I noticed that there were some
inaccuracies on the form.
What's happened since then is we have gone back and
corrected what is wrong with those forms. So at least adequate
information is making it to the FDA right now.
VAERS is important because it is our only way of tracking
this illness or I should say adverse events that may be
connected to the vaccine. I realize that a diagnosis and
treatment in cases of unexplained illnesses are complex. And I
know that the doctors had a very difficult time, and they did
not, or were not, fully prepared to take care of me at the
time.
But right now I am receiving excellent medical care. I do
not know the cause or impact of the ANA antibodies in my blood,
but my focus is on flying and getting healthy. I want my whole
life back.
I have testified today at your invitation because I believe
our military's health is critical to our Nation's war-fighting
readiness.
That concludes my statement. Do you have any questions?
[The prepared statement of Capt. Piel follows:]
[GRAPHIC] [TIFF OMITTED] T5673.003
[GRAPHIC] [TIFF OMITTED] T5673.004
[GRAPHIC] [TIFF OMITTED] T5673.005
[GRAPHIC] [TIFF OMITTED] T5673.006
[GRAPHIC] [TIFF OMITTED] T5673.007
Mr. Shays. Thank you. Captain, we are going to have
everyone testify, and then we are going to be asking you
questions. And your testimony is very important. I didn't want
to interrupt it, but I know that Mr. Gilman, the senior on this
full committee, would be chairman if he chose to, but he is
chairman of the national--international committee.
If the other members don't mind, I would welcome you to
give a statement.
Mr. Gilman. Thank you, Mr. Chairman. Thank you for allowing
me to intervene. I have to go back to the floor to conduct our
hearing on our major bill that's before the house, and I was
very much interested in Captain Piel's testimony, and I have
been glancing through the other testimony. And I hope to get
back to the committee at the earliest possible opportunity.
I want to thank you, Chairman Shays, for convening this
hearing today as part of your series of ongoing hearings
related to the Department of Defense anthrax vaccination
program. I think it is an important hearing.
I recall serving under subcommittee in the last Congress,
where we held a series of very productive hearings on the
subject of the Gulf War Syndrome. Those hearings led to much-
need legislation, providing valuable assistance to our Persian
Gulf war veterans and their families. And hopefully, these
series of hearings on anthrax will do the same.
While I no longer serve on your subcommittee, I have
followed your previous three hearings with great interest. And
after reviewing the background material from these hearings, I
find myself with more questions when I finished than before we
started.
It appears that this vaccination program was initiated in a
hasty manner, before a proper amount of research on the
effectiveness and safety of the vaccine was completed.
Even more distressing has been the reports of deliberate
down-playing of adverse reactions among our military personnel
who have received the shots to date. These reports, of course,
are all too familiar for those of us who investigated the Gulf
War Syndrome issue.
Then as now, there was the all-too-frequent case of
commanders who are more interested with following the official
public relations message rather than being concerned with the
welfare of the personnel under their command.
Mr. Chairman, these hearings are important, as they help
keep the Department of Defense focused on an uncomfortable
issue and remind both officials at the Pentagon and the members
of the public of Congress' determination to fully address this
subject.
Mr. Chairman, I commend you for your efforts and look
forward to today's testimony in our ongoing investigation.
Thank you, Mr. Chairman.
Mr. Shays. Thank you, Mr. Chairman. You need to get back to
that floor. I would just like to, before calling Mr.--
Lieutenant Rovet, just to acknowledge the presence of Janice
Schakowsky. I don't know if you have a statement, but she has
been a very active member of the committee, and a very helpful
one, besides Mr. Tierney. And also, we have Lee Terry, who has
been very active on the committee as well as the vice chairman
of the committee, Mark Souder.
Do any of you have any statement you would like to make.
[All nod in negative.]
Mr. Shays. OK. Thank you, because that helps. We will get
right back to our witnesses.
Lieutenant.
Lt. Rovet. Good morning, Mr. Chairman----
Mr. Shays. Good morning.
Lt. Rovet. And members of the subcommittee. Thank you for
inviting us here today. It is an honor to appear before you on
this important issue. But I must say at the onset that these
are strictly from my perspective at Dover Air Force Base and
don't reflect the views of the Air Force of the Department of
Defense.
I am a veteran of 14 years of service. I come from a wide
variety background in the Air Force. I was prior enlisted. I
worked my way up through the ranks, and it is an honor to be a
commissioned officer and serve in the Air Force.
And my job at Dover entails what we call health-care
integrator. And in that capacity, what I do is clinical
nursing, case management, and patient advocacy. All those are
very important to me. One that came to the forefront with this
issue is patient advocacy because you have to be a voice for
someone when they don't feel like they are being heard.
And that is not a knock against the folks of the medical
group or the Air Force at large. They are good people.
Some of the things we have seen at Dover at the onset were
a reticence upon the medical community to touch this issue. It
was viewed as let's say politically sensitive, professionally
risky to veer off the line on this issue.
I, myself, felt that in the beginning, but once I saw
people coming forward, I had some questions. And I voiced those
to my superiors. And I was not quite comfortable with the
answer, although I smartly saluted and about-faced and went
back and did my job.
Next, I started hearing some rumblings, and more people
came forward. Then it became a matter of core values, it became
a matter of, well, you are a patient advocate, you need to
start looking into this issue.
What I would like to do is just briefly outline for the
committee some of the adverse reactions at Dover, what we have
seen. So far, we have reported 30, but there will be 5 to 6
more within the next week. And it is fair to say, out of these
30, there are unexplained illnesses. That may not sit well with
the public relations machine or whatever have you, but if they
are not diagnosed, we have no answer to these peoples'
question, then logic states that they are unexplained
illnesses. These people are all being worked up for anthrax,
possible anthrax reactions.
I also would like to say that the vast majority of people
it seems can tolerate the vaccine, and this may be a vital link
to force protection, but I think we need to hash out these
problems here that weren't put up forth in the beginning, at
the onset of this program.
OK, for individuals, we have--some of these are multi-
symptoms that people may exhibit--6 report dizziness; 6 report
ringing in their ears; 10 report joint pains; 3 report muscle
pain; 3 report memory impairment; 2 report constant fatigue; 3
report numbness and tingling in various parts of their body; 1
reports photosensitivity, which the lights in this room are
probably bothering the individual right now; one reports having
a miscarriage post-vaccination, although the individual did not
know she was pregnant at the time.
One individual reports what they call having gray-outs.
That is like a pre-seizure, or it is something that we just
don't know. But he calls it a gray-out. One complains of
swollen and painful testicles; two report cardiac problems; one
reports chills and fever greater than 48 hours post-
vaccination; three report rash, swelling, and nodule at the
injectionsite; two report non-localized persistent rash; one
reports hyperthyroidism.
Again, when we say report, these are bona fide medical
work-ups. They do have hyperthyroidism.
OK, according to the anthrax vaccine insert, we have, right
now, according to the rhetoric that is out there, two mild
reactions, three moderate local reactions, and three systemic,
characterized by chills, fever, lassitude, and malaise.
Mr. Shays. Excuse me for interrupting you. Just so I
understand the testimony. You are saying what's reported is the
official documentation of the effect of the anthrax vaccine at
Dover? Is that what you are saying?
Lt. Rovet. It is not official yet, but according to the
insert, if we were to apply what's in the package insert, and
strictly this is my testimony, it is not the Air Force's, so it
is not official yet. I am just saying, if we were to apply the
package insert to what we have here right now, this most likely
would be what we have. But it is not a confirmed, they are not
confirmed reactions.
There is significant confusion in relation to these
categories, and especially in regard to what constitutes
systemic reaction. This I hope will be looked into further to
seeing that these are things that were not originally thought
through in the beginning as systemic reactions.
I would like to speak briefly about the medical cultural
climate that we see. I speak about the reticence upon the
medical community, and I am not painting wide brush across all
of the medical community, but providers, medical providers,
view this issue as politically sensitive and like to avoid it.
One clinical supervisor stated on July 15, 1999, my
providers won't touch this. They want nothing to do with it.
Initially, patients were thought of as malingerers, liars,
and hypochondriacs, that this is some sort of mass hysteria
akin to the polio vaccine when it came out. I don't, I cannot
see these honorable men and women coming forward all over the
country making this up or having some massive psychosomatic
illness.
Sir, this needs to be looked into for the health of our
country, for the morale and welfare of our troops. There are
too many questions that are left unanswered.
This vaccine was sold with a 28-year track record of safety
and efficacy. Now we notice that they say we don't know the
long-term effects. Things seem to be fluctuating daily,
recantations of statements. It was given to veterinarians on a
widely used basis. We found that is not true.
This is such a sensitive issue post Gulf war era. We have
veterans who are still sick and dying across this country, and
some are making the link to the vaccine. I am not doing that
here, but I find it interesting that we have unanswered
questions with that. We have similar complaints to Gulf war
illness appearing all over this country, and yet, we don't have
the foresight in some areas, and I am not finger-pointing, to
know that this was going to come up?
I work in an emergency downtown. I moonlight in the
evening. And I met an individual, a retired individual, who
injured himself. And we got to talking afterwards. And he knew
I worked in flight medicine.
He started to bring up the anthrax vaccine program. And I
listened, and I told him that it is obviously a hot topic. He
explained to me his symptoms that occurred a little bit close
to 9 years ago, and he perfectly described another individual
who is in this room today. Instead of using the word gray-out,
he used the word ``episode.''
His wife was in tears, and they were afraid to--and I said,
well you need to come forward and be evaluated. He goes, I am
afraid I will lose my benefits.
Speaking of fear, all through the squadrons on base, people
are afraid to come forward for they are going to lose their
flying status and lose their career if they come forward. For
every one individual that comes forward, there are three
individuals that will not.
These are many unanswered questions, sir. I just hope that
for the good of the country and the good of the morale of our
volunteer force that we will find some answers soon and press
on and get back to business.
Thank you, sir.
[The prepared statement of Lt. Rovet follows:]
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Mr. Shays. Thank you. Lieutenant Rovet.
Sergeant Soska.
Sgt. Soska. Congressman Shays, members of the committee,
thank you for inviting me to testify today.
This last year has been difficult for my family and me
because of the adverse effects I experienced after receiving
the DOD-mandated anthrax vaccinations. I receive the injections
as ordered on three occasions. The vaccine that I received came
from lot FAV 020.
These ordered injections were administered during my
deployment to Kuwait in support of Operation Southern Watch in
1998. Upon returning from Kuwait on June 10, 1998, I developed
problems with my right arm, and a sore spot in my right wrist
led to severe muscle spasm in my upper arm. These symptoms
advanced to burning sensation in my fingertips, radiated to my
left arm, and throughout the remainder of my body.
The pain in my ankle and joints at times is excruciating.
On many nights, I am unable to sleep through the night because
of the pain. I have trouble keeping food in my system. I have
problems such as joint-muscle pain, swelling on my hands and
feet, dizziness, memory loss, sleep disorders, one blackout,
night sweats, chest pains, and shortness of breath.
Environmental changes cause the symptoms to increase with
severity.
My condition continues to worsen. Problems and ailments
have developed throughout most of my body. As with most long-
term illnesses, some days are better than others, but the pain
is always there as a constant reminder of the hardship and
headache suffered by my family and me.
Although I continue to try to stay active and in shape, I
am afraid I could be fighting a losing battle. As mentioned in
my letter to Congressman Shays on April 29, 1999, many other
soldiers are having similar problems, flu-like symptoms,
chronic pain, and so forth.
The DOD reports that there are a low number of adverse
reactions while they report a high rate of success for the
AVIP. I have included in my reports that I sent to the Vaccine
Adverse Events Reporting System [VAERS], as an attachment to my
written statement. I hope those reports plus my testimony will
cast doubt on the DOD claim that the AVIP is a successful
program.
Soldiers who are getting sick are reluctant to report their
symptoms out of fear of reprisal. The uncooperative spirit of
military doctors makes bringing these symptoms to light seem
like a lost cause to soldiers. The feeling is that there is a
reluctance and even denial on behalf of the medical staff to
inform their superiors so that proper treatment can commence.
Many soldiers have approached me with concerns for my
condition. Our conversations, more often more of them realize
they have many of the same symptoms. These symptoms are
becoming prevalent in soldiers who did not even deploy to
Kuwait but underwent AVIP.
I addressed my concerns over the AVIP during the Persian
Gulf outreach meeting conducted by Mr. Rostker's staff at my
duty location. I was present for three meetings. All I heard
them say was, we need you to come forward; we want to know what
is happening to you.
However, in my opinion, the only thing that was really
accomplished was a reiteration that the vaccine is safe. I was
not the only person present that felt the meetings were an
ineffective mode of covering up the truth about the anthrax
vaccinations.
Soldiers are not being informed of the adverse effects as
stated on the product inserts, nor were they being told about
the various forms. I am charged with accomplishing the mission
of looking out for the health and welfare of my soldiers. How
can I accomplish my mission when the people who treat my
soldiers are turning a deaf ear to their reports?
I have been told to come forward and let you know what is
happening. I am here before you now, and like many, I am
telling what I know but I feel my testimony is falling on deaf
ears within the DOD.
My case is also unique. Since the onset of my symptoms, I
have been persistent to investigate both my physical ailments
and the program itself. I have written several Members of
Congress. I have had the backing of my chain of command and the
help of some outstanding doctors. I am one of the lucky ones. I
am now being sent to the clinics to find out what is wrong with
me.
But my question is, what will become of soldiers who have
not aggressively sought diagnosis and treatment but accepted
their plight? What will be done to ensure that they are getting
the same care?
Being an NCO is a rewarding career. I have invested 17
years in the proud service of my country. I have no regrets. I
did what was asked of me, and now I am sick. I must stand up
for what I feel is moral and ethically right. I am here to
testify that this program is wrong.
Procedures are not being followed as spelled out in the
AVIP documents. Soldiers are getting sick at an alarming rate.
Soldiers should not be made to feel afraid to come forward with
their medical complaints; soldiers need to come forward and
inform responsible and caring physicians of their symptoms.
When they do come forward, they should not be told the
symptoms are all in their heads or that there is nothing to
worry about.
Soldiers deserve better.
This concludes my opening statement, Mr. Chairman.
[The prepared statement of Sgt. Soska follows:]
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Mr. Shays. Thank you, Sergeant Soska.
Captain Richter.
Capt. Richter. Good morning, Congressman Shays, committee
members. Thank you for the invitation to appear before you.
Yes, my name is Captain Richter, and at this point I am really
happy I suffered through Public Speaking 101 in college.
[Laughter.]
I, too, am a C-5 pilot in the U.S. Air Force Reserve at
Dover Air Force Base in Delaware. Like my father and my
grandfather before me, who are both career Naval officers, the
military has been an integral part of my life. For over 12
years now, I have served as an aviator in both the Navy and the
Air Force.
I am not a malcontent nor do I have any personal vendetta
against the military. On the contrary, I have served proudly
and faithfully through Desert Storm in the Navy and through
Operation Provide Comfort and Northern Watch in the Air Force.
I am not here representing the Air Force or the Department
of Defense. These are my view and opinions only. I am simply
here to tell you my story.
In June 1998, I left the active-duty Air Force as a special
operations pilot at Hurlburt Field, Florida. I was accepted
into the Air Force Reserve and went to C-5 Galaxy pilot
training, which I completed in January 1999. Upon the return of
my unit in Dover, I was told that all personnel needed to start
the anthrax vaccine series of shots if they had not already
done so.
I had heard a few of my peers discussing the vaccinations
and possible unpleasant side effects in various cases and how
they would quit before being forced to take it. I dismissed the
talk as rumors and innuendo, thinking that the military
wouldn't vaccinate the troops with something unsafe or
unproved.
I took my marching orders, saluted smartly, and went to the
clinic for the first of my shots on February 3, 1999. I was
injected with lot number FAV 030. I had no noticeable negative
reaction. No one at the squadron asked me, nor did anyone at
the clinic question me if I had experienced any negative
reactions before I went in for my next injection.
On February 19, 1999, I submitted to the next shot in the
series, which were to be 2 weeks apart. I was again injected
with lot number FAV 030. Approximately 5 days later, the
problems began. My right shoulder joint started to ache, much
like when I had played catch as a kid without properly warming
up.
A few days later I noticed my left shoulder joint aching. I
thought it was odd. About a week later, I experienced pain in
the center of my spine, to the point that I had some difficulty
getting out of bed in the morning. These aches and pains lasted
for several weeks each before dissipating.
Again, there was no followup from any medical personnel to
discuss any possible negative reactions to the vaccine.
In April, my ankles and feet began to hurt as well as my
left thumb and index finger joints. I noticed swelling in my
hand. I was not starting to register genuine concern. I could
not get out of the bed without limping with pain for the first
few hours until my body loosened up.
Today the pain has stabilized mostly in my feet and left
hand, with an occasional flare-up somewhere new in my body.
Last week it was my hip joints; next week it may be something
else. I awaken and ease into my day with a couple of over-the-
counter Motrin. I cannot walk without a limp and severe
discomfort for the first hour.
Furthermore, if I am stationary for more than an hour
during the day, my joints and muscles stiffen, making movement
extremely unpleasant.
I have lost flexion in my left thumb, and it is still
swollen. I am a 36-year-old man with no previous history of
arthritic symptoms, and I was perfectly healthy before my first
anthrax shot.
In May, I learned that Colonel Felix Greider, 436th Airlift
Wing Commander, at Dover Air Force Base had boldly decided to
suspend all further vaccinations until information was
available on the vaccine and the concerns of his people were
addressed. I quietly applauded this gallant decision, as I
decided that taking a third shot in the series was not in my
best interest.
Shortly thereafter, the Air Force surgeon general,
Lieutenant General Charles Roadman, came to Dover to discuss
the anthrax vaccination program and hopefully assuage the
doubts of base personnel. I was not in attendance, but learned
through a few people who were that Lieutenant General Roadman
assured everyone the vaccine was completely safe and that only
a minute percentage of those military personnel inoculated had
a negative reaction.
Meanwhile, I was encountering more of my squadron mates who
were vaccinated that said they too had experienced various
reactions, including tinnitus, dizziness, muscle and joint
pain, and, in one case, gray-outs.
However, most were attempting to keep it low-profile and
did not readily discuss these matters for fear of reprisal.
In June, as I became more and more concerned that my
condition was not getting better, I took the initiative to
discern what is going on in my body. I learned from what is now
a full-scale anthrax information network among my peers that
1st Lieutenant Rovet and Tech Sergeant Domm were taking
information on anthrax vaccine reactions for entry into the
VAERS data base.
After meeting with Tech Sergeant Domm and speaking to 1st
Lieutenant Rovet over the phone, they convinced me to come
forward and go public, so to speak, about my condition and to
encourage others who were vaccinated and are having problems to
do so as well. They also gave me the number of the Allergy-
Immunology Clinic at Walter Reed Army Medical Center.
On June 23, 1999, I called the immunology clinic at Walter
Reed and was seen that same day. After discussing my symptoms
and stating my concerns about continuing the anthrax
vaccination program, the doctor ordered a series of blood
tests.
In paraphrasing our conversation, he told me he could take
blood tests to determine that I do not have rheumatoid
arthritis, but there are no tests that could positively link my
condition to the injection of the anthrax vaccine. The doctor
then gave me a temporary waiver from taking the next anthrax
injection until my blood-test results were returned for review.
He later informed that the results of the blood test
revealed that I was not positive for rheumatoid arthritis
factor.
Therefore, he stated, that he would in all likelihood
ultimately have to recommend that I continue the anthrax
vaccination shot series.
I told him that put me in a very tenuous situation, and one
that left me with only one clear option. The doctor went on to
say, and I am again paraphrasing here, that the threat of being
exposed to anthrax while on a deployment outweighed the
possible negative reactions that some military personnel might
have to the vaccination and that it was not a matter of if but
when some of our troops would come in contact with it.
I am unsure if this was his opinion or Department of
Defense policy. Apparently there is an unusually high level of
acceptable risk with this vaccine.
The squadron policy and I assume the 512 Airlift Wing
policy was clearly and unequivocally stated in June. We were
told the next time a drilling reservist comes into drill, he or
she will commence the anthrax vaccination series or continue
with the next injection if the series was already begun.
This policy was re-emphasized on or about July 7, 1999,
when I got a phone call at my home from my unit saying the next
time any reservist planned to drill he or she had to take an
anthrax shot or turn in an Air Force Form 1288, which is a
resignation form, or be subject to Uniform Code of Military
Justice Article 15 procedures.
Currently, approximately 60 percent of my squadron's pilots
are quitting the Reserve military because they have been forced
to make a decision to gamble with their health. I can only
assume that the people in the other specialties required to
execute the mission of an airlift airplane such as the C-5 are
leaving as well.
Word travels fast. Morale is at an all-time low. People are
trigger-shy about coming forward with their symptoms. There is
an air of fear and distrust prevalent throughout.
By coming here today, I have most assuredly fallen on my
sword. I recently made the rank of major, but I never expect to
be able to wear it because I will resign before I take another
anthrax injection. This is sad because I like my job. I love my
country. The military has always been a part of my life, and I
had planned on continuing to serve in it.
I am just a captain and a very small cog in the huge wheel
of the military, but I am the guy in the trenches of the DOD's
implementation of the anthrax vaccination program.
I am not a medical professional, but I am medically
qualified to discuss one thing, and that is the status of my
own health.
I was healthy before, now I am not. I know what is good for
me and what is not. And right now, taking another shot is not
part of the John Richter health-care program.
Those in command seem to have shrugged their shoulders at
the numbers of people leaving military with the attitude that
an order was given and it should be carried out. We are growing
tired of the denials that everything is OK when, in fact, it
isn't.
Over 12 years ago, I raised my right hand and solemnly
swore to support and defend the Constitution against all
enemies foreign and domestic and to obey the orders of the
officers appointed over me. I took that oath freely and
willfully. I knew that I could and would give my life for my
country, and on several occasions during the course of my
military flying career, I almost made that sacrifice, as have
many others.
But at no time did I ever agree to be slowly poisoned,
however well-intentioned, under the guise of being combat ready
so that every day is one filled with pain. That wasn't part of
the contract as I know it.
I have defended my country and I have obeyed the orders of
the officers over me, but taking another anthrax shot is not an
order I can carry out.
Thank you.
[The prepared statement of Capt. Richter follows:]
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Mr. Shays. Thank you, Captain Richter. How many years have
you served in the military, sir?
Capt. Richter. Almost 13.
Mr. Shays. Thank you.
Lieutenant Colonel Jensen. You will conclude.
Col. Jensen. Yes, sir. Mr. Chairman, distinguished members
of the subcommittee, I am Lieutenant Colonel John Jensen, wing
chief of safety for the 120th Fighter Wing, Great Falls, MT,
Montana Air National Guard.
I am here today in response to your invitation seeking my
views and experience with regards to the AVIP program. The
views expressed in my testimony are my personal views and not
meant to be taken as those of the DOD, Air Force, Air National
Guard, or my command.
As a military member since 1979, I was raised in a family
of military service, with my grandfather serving in World War I
and my father serving during the Korean conflict as a Marine
fighter pilot. I joined the Marine Corps in 1979, following in
my father's footsteps and am continuing to serve my country
today in the Air National Guard.
In my opinion, one of the biggest challenges to the success
of the AVIP program is understanding all of the issues and
perceptions that exist out there, even those perceptions that
do not follow the party line. I feel that if commanders in
senior leadership do not understand the intricacies of the
issues that have arisen out of the anthrax vaccine, they will
be ill-equipped to meet the concerns raised by the field.
Accurate, consistent, non-conflicting information is the
key. In my research to enhance my knowledge and understanding
of these issues, I have come across two areas that concern me
greatly. First, there appears to be a perception in the field
that they are not being given accurate, consistent information
on the vaccine, to include its safety and efficacy, and as a
result, they are losing or, in some cases, have lost their
trust in the DOD. Second, it is perception or lack of trust may
be impacting our force readiness.
The following is provided in hopes that the committee can
better understand and fully appreciate these two significant
challenges that I feel we face today.
Before proceeding, I would like to offer my view of those
who serve in the military today, as I believe this is a key
element in meeting the challenges cited above. There is no
doubt in my mind that those volunteers who serve their country
today are the most educated and best trained in our country's
history. They are trained and qualified to work, maintain, and
employ some of the world's most sophisticated equipment in the
most demanding of environments.
They are taught such things as risk-management, ethics, law
of armed conflict, and the importance of accountability. Since
my written testimony covers in great deal those items that
bring to light the concerns and challenges cited above, I will
address only a few in this testimony.
Acknowledged: The threat of a biological attack of anthrax
has existed since 1990. There is a vaccine available that
either by itself or in conjunction with chemical warfare gear
and/or post antibiotic treatment should significantly increase
one's survival rate if subjected to an anthrax attack.
Concern: Anecdotal evidence indicates the reaction rate of
AVA exceeds the product insert and what the field is being
told. Anecdotal evidence shows the AVA is at least temporally
associated with systemic reactions, hospitalization, cardiac
events, and symptoms similar to those suffered in Gulf War
Illness Syndrome.
The anthrax vaccine will not be completely safe based upon
the above concerns and/or due to the improper manufacturing
procedures identified by the FDA and testified to by the GAO.
Examples that I feel are fueling the perception that the
field is not being given consistent, up-front, accurate
information: The VAERS reporting system used to substantiate
the adverse reaction rates cited by DOD is perceived as not
being impartial. The FDA requests and encourages VAERS reports
on all reactions, even those that only temporally associated
with vaccines.
The AVIP program filters the VAERS system. It requires the
reporting of events that only result in hospitalization or 24
hours loss of duty. AVIP requires recording severe local
reactions and systemic reactions in the medical records but
directs that these will not be reported unless contamination of
the lot is suspected.
VAERS forms do not go directly to the FDA. They are
reviewed at least once more prior to reaching the FDA. This
filtering has one tremendous downside, it does not allow for
the identification of less severe reactions which may indicate
a problem that may be occurring in large numbers across the
population.
The public recently learned that the Secretary of Army
granted indemnification to the anthrax vaccine manufacturer in
1998. The DOD states this is a normal procedure to reduce
insurance costs to the company.
A Pentagon spokesman is reported in the paper as saying
that the last time an indemnification was given for a vaccine
was in 1976 for the swine flu.
Next, a letter of indemnification appears on the web,
signed in 1991 by the Secretary of the Army, granting
indemnification to PRI for the production of anthrax vaccine to
be shipped to MDPH, where MDPH was to bottle, label, and test.
This indemnification states, quote:
The obligation assumed by PRI under this contract involves
unusually hazardous risks associated with potentially severe
adverse reactions and the potential lack of efficacy of the
anthrax vaccine. These concerns stem from: a) the limited use
of the vaccine to date, i.e., tests prior to the approval of a
vaccine by the Food and Drug Administration are too small a
scale to permit accurate assessments of the types and severity
of adverse reactions. Only widespread use can provide this
assessment. And b) insufficient experience in mass immunization
programs to truly evaluate the efficacy of the vaccine.
Moreover, there is no way to predict whether the pathogen
against which the vaccine may be used will be sufficiently
similar to the pathogen used in tests to ensure vaccine
efficacy.
Mr. Shays. Is that still a quote?
Col. Jensen. Close quote. Yes, sir.
Mr. Shays. All of that is from the indemnification letter?
Col. Jensen. Yes, sir. I have a copy, if the committee
would like.
Mr. Shays. We do too. Thank you.
Col. Jensen. How does a health-care worker or commander
respond to this when presented it by a troop?
Unfortunately, accurate vaccine records identifying the
approximately 150,000 individual vaccinated during the Gulf war
with AVA do not exist. I have read that this vaccine's systemic
reactions are no worse than those of hepatitis A or typhoid or
other vaccines.
This may be true. But shouldn't the issue be, are the
actual reaction rates in line with the expected rates and types
for which the FDA licensed it, not how they compare to other
vaccines?
Some people say the benefit outweighs the risk. My only
question of this, and hopefully the committee can provide an
answer, is, what exactly is the risk.
My first impression of the vaccine's side effects were
those stated in the product insert and quoted by numerous
officials. Are those the risks? Or is the risk ending up like
those individuals that have previously testified before this
committee and those testifying here today, assuming the anthrax
vaccine is the cause of their ailments.
Finally, will this yet undefined risk increase or decrease
over time as the number of those vaccinated increase, thereby
increasing our data base.
Greatest fears: AVA, a potentially valuable force
protection tool may not be available: The program may be killed
by Congress due to poor communication, i.e., the field
perceives they are not being provided the whole story.
Force readiness is being compromised, the trust issue. The
following are some of the effects that the AVA program appears
to be having on our retention. I would offer that those leaving
over this have made a benefit-outweighs-the-risk assessment,
and their version is, the risk does outweigh the benefits.
Dover Air Force Base, supposedly 30 to 40 percent of the
air crew--pilots, flight engineers, loadmasters--have or intend
to resign vice take the vaccine.
Connecticut Air National Guard, eight pilots forced to
resign after they refused to take AVA. Note, some of these
pilots were part of a information-gathering team directed by
the commander. They refused to take the vaccine after the
issues raised in their research could not be answered.
Wisconsin Air National Guard, the story ran in the Madison
Newspapers, Inc., June 19, 1999: At least six pilots are
expected to refuse the vaccine. Note, one was in line to be the
next squadron commander.
Travis Air Force Base, 17 tanker air crew resigned from the
79th. Thirty-one pilots out of the 301st have submitted
resignations. The number is expected to climb to over 60
percent by the end of fiscal year 1999. That is 429 years of
flying experience gone.
I am told an IG complaint is pending due to an individual's
1288 reflecting job conflict as the reason for leaving, vice
AVA.
From the above, it appears that before units are even
moving to enter the theater where anthrax may or may not be
used, their combat readiness is being compromised, in some
cases, by as much as 50 percent.
Important note: People are not leaving because they have
read some article on the dark side of the web. They are leaving
because they have seen people with whom they have served for
years, and in some cases combat, take the vaccine, become ill,
and no reason given to as why other than we know it is not the
vaccine.
To the end, those with whom I have talked, state that they
are leaving because of the vaccine and that they have lost
their trust in their leaders.
In closing, I would ask not only the committee but those
commanders who read and hear this testimony to take an honest
look at the AVIP program, the issues raised above, and those
being raised in the field.
My purpose in testifying here today is not to kill the AVIP
program. I welcome a vaccine that would protect not only myself
but those whom I am entrusted to lead into battle, provided it
is truly safe and effective.
It troubles me deeply to watch outstanding service members
leave in the fashion that they are.
Finally, it would be irresponsible of me as both an
American citizen and military officer had I chosen the easy
path and declined your offer to testify here today.
Mr. Chairman, integrity begets loyalty, loyalty does not
beget integrity.
Thank you.
[The prepared statement of Col. Jensen follows:]
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Mr. Shays. Well, we have heard some very powerful testimony
from five very patriotic members of our country and of our
service. We thank you all.
Mr. Terry.
Mr. Terry. Thank you, Mr. Chairman. Indeed, powerful.
Captain Richter, I think all of us up here love our country,
and that is why we are here as you have spent 13 years in the
military. As I have sat here over the last hour listening to
testimony, I think if it was a condition to serve as a Member
of Congress we had to take the vaccination, I too would
probably take the same path that you are choosing.
Mr. Chairman, our hearings, at least, no pun intended, my
exposure to this vaccine has been more on the academic side. We
have studied protocol, testing, side effects or what has been
tested by the manufacturing process, quality control, and today
I think is the first time that we have truly seen the human
side, although it has been certainly why you have undertaken
this process.
The testimony we have heard here today is powerful, and
there are so many areas, so many questions that I want to ask
all of you, but I am going to narrow it down into two areas.
And, Lieutenant Rovet, I am going to start with you because you
are the first one that said it, the first one to ask really the
true magnitude of which our service personnel are experiencing
symptoms. And you know more than I do in the sense that
medicine has become more of a science than an art and that it
has to fit into specific pigeonholes and have certain labels
placed upon it, and that probably more the discussion, as the
lieutenant colonel has said, needs to focus not on
hospitalization for 24 hours but just the symptoms that we have
heard here today of a variety of different symptoms.
But you said, and Sergeant Soska also said, that probably
one of every three have come forward or voiced concerns. And
certainly I think that is probably more anecdotal than
scientific, the one in three. But why don't you explain and
draw out how you were able to base a conclusion that Captain
Piel, there's three others out there that are in the same
position that have refused to come forward.
The second part of my question is going to be, why have
they refused to come forward? But let's talk about, first, how
do you base that one in three?
Lt. Rovet. If I understand your question correctly, sir,
it's when an individual comes forward and we start seeing what
we believe is a trend, we go back and look at some of the
symptoms, the symptomatology of what they are presenting with.
My job as a case manager also, I was privy to data
throughout the air crew members that were sick for long-term.
So I would start looking and saying, well, we have a person
here who has a long-term illness who has not been really
diagnosed with something concrete. There is no concrete
etiology. So we would start drawing conclusions in our mind, or
just asking questions, not conclusions. It was more of a
hypothesis in the beginning.
And when they came in, we discussed, we listened, and it
was opened up to us from the air crew members that there were
more people out there experiencing the same side effects.
Mr. Terry. So these folks have reported some sort of
illness, gone to see a doctor, but reported symptoms that
weren't necessarily associated to the vaccine?
Lt. Rovet. Right. They were--I know Captain Piel, who was
captain at the time, had come forward with problems with
balance, what they call labrynthitis or otitis media, and that
was originally diagnosed as just strictly a medical problem
that we had a concrete etiology on. But also it was the timing
relation to the anthrax vaccine and the persistent dizziness
that started raising some questions. And then we saw other
people coming forward with this timeframe event of the vaccine
administration and illness and subsequent no concrete etiology
for their illness.
Mr. Terry. So there is, for these other three folks, there
is some medical record that will document an ailment or a
symptom?
Lt. Rovet. Yes, sir, there is.
Mr. Terry. All right. I was concerned when you said, or
envisioned when you said that one in three is that three knew
they were symptomatic but refused to come forward for fear of
some reprisals.
But what we are talking about is that one out of three is
not being associated with the vaccine.
Lt. Rovet. Right.
Mr. Terry. I mean that only one of three is associated.
Lt. Rovet. No. There hasn't been any conclusions drawn in
that area yet, but about the fear to come forward, there are
some people that have expressed it over the phone that they are
afraid to come forward.
Mr. Terry. All right. So when you testified that there were
30 cases currently and about five or six in the pipeline----
Lt. Rovet. Yes, sir.
Mr. Terry. First of all, how big of a field are we talking
about?
Lt. Rovet. Well, I don't have exact numbers.
Mr. Terry. Is it 30 out of 300; 30 out of 60?
Lt. Rovet. Right now, out of 1,100 people, a little over
1,100 people at Dover who had been vaccinated, these are what
we have now, the number 30.
Mr. Terry. All right. And then ballpark it based on your
earlier testimony there are probably about 90 folks that you
think probably have symptoms associated with the vaccine.
Lt. Rovet. Yes, for me to make that leap right now, without
scientific data, would probably be incorrect, but as a gut
feeling----
Mr. Terry. Anecdotal based on your experience though.
Lt. Rovet. Yes, sir.
Mr. Terry. It is a fairly significant percentage.
Lt. Rovet. Yes it is, sir.
Mr. Terry. Can I have just a couple more minutes?
Mr. Shays. Yes.
Mr. Terry. Captain Piel, I want to start with you. We have
heard discussion about reprisal, and we have heard it really in
two different categories. One was, as Captain Richter and
Lieutenant Colonel Jensen pointed out, is that one reprisal for
not taking the vaccination is mandated resignation. But you
hinted there may be reprisals for simply even reporting or
voicing concern that some of your symptoms may be related to
the vaccination.
Can you tell me where you would feel that? How, if you
could kind of focus or pinpoint that for me.
Capt. Piel. Yes, sir. First of all, I would like to say a
lot of people don't come forward because they have seen what
has happened to the people that were ill and then it become
know that it might be possibly due to the vaccine. In other
words, they have seen what has become of me in the medical
system and they realize----
Mr. Terry. Called a malingerer, a liar, and those type of
things.
Capt. Piel. And it appears a dead end. So why risk your
flying status if you are just suffering some of the mild
symptoms of joint pain or you feel a little bit tired. Why
should you go to the doctor if you feel you can continue to
operate airplanes? And that is why people don't come forward.
As for myself, this whole time period it really didn't seem
to matter what the doctor said because I thought it would just
be a few more weeks before I felt better. But it became
apparent that these comments were starting to erode my
character. And I was not being--sometimes I wasn't being
examined when I went into the doctor's office.
So that does not encourage one to go try to seek more help
from the same individuals that will not, that don't seem to be
helping you in the first place. And they dealt with me as if
they believed in their office and then sometimes I would hear
later that they didn't believe me.
But my commander and others believed me. And I think part
of the reason why it is easy for people to believe me in my
squadron because many people have felt mild symptoms.
Mr. Terry. All right.
Sergeant, would you answer that same question: What type of
reprisals from reporting, basis of your fears of reprisals, and
also from whom. And maybe your opinion of whether you think the
reprisals are what I would classify as a malicious nature of
trying to--I don't want to use the word cover-up because
everybody likes to use that conspiracy-minded terminology--but
if you think it is even related to minimizing the impact of
side effects from this vaccination.
Sgt. Soska. Mr. Terry, I can only tell what I have been
seeing with my soldiers.
Mr. Terry. All right. That is what we want to hear.
Sgt. Soska. A lot of the soldiers who are new to the
military--I am a career soldier; I have better benefits than
they do--if soldiers that are getting married and coming in
with family members that have various obligations that they are
just struggling to get by to begin with--several of the people,
many of the people that went with me to Kuwait during Operation
Southern Watch during 1996, we came back and we started cross-
talking amongst each other. I guess I was the worst of the
group with my condition.
And others started taking notice to that. I have told many,
you need to go, you need to get it checked out, you need to do
this, you need to do that. Many have listened, many have not.
Many are afraid to come forward, and I kind of feel like
the guy being pushed out the door with the door slam shut
behind me right now. But, you know, this is me and that is
them. I can only do what I feel is right.
Several of the soldiers have--I can tell you for a fact
there has been a survey on the web trying to characterize
systemic reactions, fibromyalgia and stuff like that they have
filled out. And others flat refuse because they are afraid that
if they do say something or if their name is used, that it is
going to have an impact on their career.
Now, what goes on in their head, I have no idea. But they
are afraid to come forward, if that answers the question, sir.
Mr. Terry. Well, it does. I think the fear is probably
real, but part of our job up here is to determine if that is a
personal opinion or whether that is a problem in the military.
Unfortunately, that may be as tough to decipher as it is
scientifically to link these symptoms back to the vaccination.
Appreciate the opportunity, Mr. Chairman.
Mr. Shays. Thank you. Mr. Tierney.
Mr. Tierney. Thank you, Mr. Chairman.
Mr. Chairman, I want to thank you for having these
hearings. They are obviously important, and hopefully we will
be able to come to some resolve that will address these issues.
Captain Piel, I wanted to ask you, were there any pre-
existing conditions that your doctor suspected you might have
had or discussed with you before the vaccination was given?
Capt. Piel. No, there weren't any.
Mr. Tierney. And was there any talk amongst your medical
people afterwards that they thought perhaps they had overlooked
some, or any conversation about that?
Capt. Piel. No, there hasn't been any conversation about
that to my knowledge.
Mr. Tierney. You indicated that you got good support from
your chain of command but you felt you didn't get good support
from the medical people that you went to. And how does that
work on your base? Where do the medical people fall in that
chain of command?
Capt. Piel. Well, they fall outside of--they have their own
chain of command on the base. So they don't report to my boss,
and he doesn't have anything to do with the medical group
either.
Mr. Tierney. And that is true all the way to the top of the
non-medical people at your base?
Capt. Piel. Well, I am not sure. I think the medical group
falls underneath the wing commander, but other than that, there
is nothing--that's where it meets, that's where the operational
side meets the medical side.
Mr. Tierney. Now your wing commander has been supportive?
Capt. Piel. Yes, sir, he has, and he has been trying to
help me get the right medical treatment.
Mr. Tierney. And Lieutenant, with respect to your wing
commander and his involvement with the medical people on base,
have you witnessed any interaction between them, any action by
the wing commander to try and address this issue with the
medical people?
Lt. Rovet. He has shown significant interest, sir, in the
health and welfare of his wing, as should be. A man of amazing
core values and personal fortitude and strength. Just wish you
could clone him. But he has--yes he has been very involved with
my medical group commander and my squadron commander, who both
are very wonderful people also who I know have been putting in
long nights, sleepless nights, over this program.
And just like to make a statement concerning our medical
program at Dover. Originally, we had some bugs to work out with
the adverse reaction reporting. There was--it just came so fast
and furious, the reactions and what not. And we may have not
handled things appropriately in the beginning. And as humans,
we learn our lesson. But I do believe that under the leadership
of Colonel Greider and Colonel Buck and Colonel Luna and down
through the AMDS squadron where I work, including public
health, we have a pretty good system now. And we have
identified some of the short falls, and we will be
aggressively, I can assure you, pursuing a cogent reporting
that can be very valuable to not only our service men but to
our country at large.
Mr. Tierney. Would you be a little more specific about what
has changed with this vaccine program on your base. Originally
there was a high threshold. What I mean by high threshold, when
patients were to come in, they would be--there was that
reticence in the beginning that I was talking about. The
threshold, a doctor would be viewed as a filter. The doctor
would say, if they would go ahead and check the box up in the
right-hand corner--I forget the box on the VAERS form--that
would be a provider saying, my gosh, you know, that is a bona
fide reaction; I kind of believe this. So that would lend
validity to the report.
To date, no provider has ever signed a VAERS form or
checked the box off.
OK.
Mr. Tierney. That hasn't changed? That continues to be the
case?
Lt. Rovet. That continues, but what we have now is lowering
of the threshold when more people come forward. And I think,
and I am not an epidemiologist, sir, but I think that will
statistically even out the more reports that we get coming
forward if we can start--the researchers at Brooks Air Force
Base, at the FDA, at Walter Reed--that's a problem in itself,
it is so spread out. Bureaucracies have a tendency to do that,
I guess.
Mr. Tierney. So I hear.
Lt. Rovet. But what I think what we are going to do is see
it work its way out in the end. The more data we get, we'll let
the numbers just work themselves out. So it is changing. It is
a lower threshold, and the medical group at Dover now is right
on it.
Mr. Tierney. Well, Captain Piel, do you think somebody in
your circumstance would be treated better today than you were
treated?
Capt. Piel. I definitely hope so, sir. I would suspect that
they would be treated better after everything that has
happened. Things have changed.
Mr. Tierney. Do you think they have made some positive
adjustments as a result of your situation and others.
Capt. Piel. I think that they are working on it.
Mr. Tierney. With room to go?
Capt. Piel. It is a very difficult problem, and it is not
something you can just solve or correct overnight.
Mr. Tierney. What might you suggest that could be done on
your base that would make it easier for somebody in your
circumstance? Going back to the beginning of your circumstance,
what would have made your experience----
Capt. Piel. Well, I think if my case had been forwarded to
Walter Reed sooner, that definitely would have helped because
Dover doesn't have a lot of doctors. We have a pretty small
clinic. It is not necessarily one of your large medical centers
where they can deal with all different types of problems. There
aren't specialists that you can go see. You get farmed out to
everyone else.
So if I had been forwarded to the immunology clinics at
Walter Reed sooner, that would have helped. You know, in the
process, I kept getting referrals to ear-nose-throat doctors,
and they can take care of my ear, but they can't take a look at
my whole body.
Mr. Tierney. OK. Thank you. Sergeant Soska, do you have a
feeling that there is a difference at your base also between
the way the medical professionals treated individuals and the
way that the chain of command did?
Mr. Tierney. Mr. Tierney, I can tell you from a personal
standpoint that and what I have went through for the last year
and the acceptance by both the division surgeons, both the
outgoing and the incoming, have been, they have been there for
me. In talking with Lieutenant Colonel Carrigan, who is our new
division surgeon, 3 hours on 2 separate days, took an active
interest in my situation after speaking out before the Anthrax-
Persian Gulf Illness Outreach program meeting we had there.
They took an active role in it. I would like to comment on
similar problems she had where it took so long to get to the
right areas. It was here, go here, and there was always a long
wait in between.
Yes, the doctors were trying. They didn't have the answers.
But it is just the way the system is set up, sir.
I feel that in my situation and in talking with Lieutenant
Colonel Carrigan, who apparently was a member of that hundred-
doctor meeting in Fort Detrick, my indication I got after
talking to him was that I think they realized there is a
situation here and they are trying to make an effort to just
see how big it is.
I can't say anything negative on that aspect about them. I
think there is genuine concern within the ranks and the leaders
themselves. They are seeing this happening more and more. And
just like myself--and I may add, the comments I make here are
mine, I am just saying what is happening to me and what I have
witnessed. And that is the impression I have been given, sir.
Mr. Tierney. Thank you. Lieutenant Colonel Jensen, you have
some particular problems in your division, I assume, because of
the Guard, those units having a different access to medical
attention than others do. Do you want to talk a little bit
about that?
Col. Jensen. If I understand you correctly, sir, our access
to medical care basically the shot in the Guard--my unit has
not received the shot yet. We are not due to receive it until
May 2000; however, due to operational commitments, I believe we
have approximately 100 individuals who have received the shot,
or the series.
In the Guard as in the Reserves, you are placed on active
duty for the shot. And that is for, my understand is I am told,
a medical requirement so if something happens to you, you can
come back and provide you. It also has the opportunity,
obviously, if you are on an active duty status, then you can be
given a direct order should you choose to refuse the vaccine.
For instance, if somebody were to have a reaction the next
day, if they were a traditional Guardsman or civil service
employee such as myself, primarily I would have to go and seek
medical care through the civilian community and/or come back to
the military community and attempt to file what they call a
line-of-duty statement in which--and that would only be filed
if the, as I understand it, if the medical community deemed
that the vaccine was causal to the condition.
The line-of-duty statement is filed if you have a loss of
duty. For instance, a hypothetical situation, or I will give
you a real case situation, if I may.
We have an individual that was in that series shot and he
was on active duty, placed on orders, I believe, or on a
Reserve active duty status, RUTA as they call it, and the next
day he took 24 hours of sick leave. He is a fireman and he is
on a 24-hour schedule out of his own sick-leave time due to
flu-like symptoms that he placed on his sick leave form as
caused by the anthrax vaccine.
He did not seek medical attention. OK? And as such,
basically he ended up taking 24 hours of sick leave. An
important note here, I believe, is that even if he followed the
line of duty status on that, the way I am told by my finance
officer is he would not be reimbursed for the sick-leave time.
He is only reimbursed if he physically or she physically has a
loss of pay.
So if you have sick leave, you haven't lost any pay.
Does that answer your question, sir?
Mr. Tierney. Yes. Captain Richter, does--secondarily to
obviously the medical implications of all this, the
individuals, it is disturbing to hear about the loss of trust
that you talk about in the--I'd like to hear your ideas of how
that trust might be restored in this instance.
Capt. Richter. Well, at this point I don't know. That is a
hard question to answer. I don't know if the trust can be
restored. The obvious thing would be at least, first of all,
come out and say there is a problem. Acknowledgement would be
99 percent of it. Continuous denial that these symptoms are
from some other cause is not helping matters. Like I mentioned,
Colonel Greider, our wing commander, went and stopped all the
vaccinations for a period of time until he could address the
situation, find out what was going on, try to allay everybody's
fears, and get it rolling again.
I don't know what the outcome of that--again, I am just a
reservist. So I am there only part time, unlike my counterparts
who are there all the time--active duty. But I got a feeling he
was called down to Washington and called on the carpet because
shortly thereafter Lieutenant General Roadman came up and said:
Hey, take the vaccine. There is no problem with it. The
percentages of people having problems is minuscule. These are
your marching orders.
So I think just an admission that well, maybe there are
more than just a few people having these problems would help. I
mean, that would start the ball rolling to be sure.
Mr. Tierney. Thank you. I just want to echo the chairman's
words that all of you show great courage coming forward here
today. And patriotism doesn't always take place on the
battlefield.
I want to thank you for your courage.
Mr. Shays. Congresswoman Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman. And I too want to
thank you for your personal courage in coming forward and all
the things that led up to today, and also express my concern
regardless of what one thinks about the vaccine that it takes
so much courage just to speak out on these issues.
I have a number of questions. I wanted, Captain Piel, to
note that in testimony that I don't believe that you read, that
you were told by some doctors things, comments such as, you're
depressed; maybe you just want to have babies; called a
malingerer; perhaps you need counseling.
These clearly are very demeaning kinds of things and would
contribute to your feeling of not being believed for sure, but
you also say that you still don't have--even now, I still don't
have a waiver. Can you tell me about waivers? How does one get
one? What do you mean by a waiver?
Capt. Piel. Well, a waiver, what I mean is to get a waiver
from further anthrax immunizations.
Ms. Schakowsky. And how does that happen?
Capt. Piel. I have no idea exactly the process for that.
Ms. Schakowsky. There is such a thing though? Can anyone
answer that?
Capt. Piel. Well, that is just under the guise that there
are waivers for everything. [Laughter.]
Ms. Schakowsky. Oh, OK. Can any of you testify to that?
Capt. Richter. I can comment on that. I am on a medical
waiver right now. It is just a temporary one, but I am on a
temporary medical waiver, and I do not have to take the next
injection until they figure out the results of my first visit.
I am now scheduled to see a rheumatoid arthritic doctor at
Bethesda next month. So I have a waiver that will take me
through August, until I go see him and he discusses what my
problem is.
Ms. Schakowsky. And while on waiver, are you allowed to
carry out your other duties. For example, would Captain Piel be
able to fly?
Lt. Rovet. Ma'am, I really think I could answer this one
cause it is in my department where we work.
Ms. Schakowsky. Take your time.
Lt. Rovet. Excuse me, Captain Richter, I didn't mean----
Capt. Richter. Go for it.
Lt. Rovet. What a waiver actually is, is more than just a
verbal granting of like a person has a doctor's note that says
you can't fly. It has to be sent up headquarters and has to be
evaluated and blessed and filter back down.
What they are looking at right now, and this is again my
perspective. It is not policy, but I think this is going to be
a logistical problem and a personnel problem that is going to
crop up here shortly. So we need to be pro-active on this
issue.
If individuals are seen and evaluated, and again the key
word is evaluated--who is going to be the actual medical body
that is going to evaluate and say this individual cannot
receive the vaccine? What they do is they put on the profile.
At that point, it is an official profile. And then they get
given a medical board.
What they are looking at doing is giving these people a C
code, waiver C code, which means they can continue out their
duties and fly, but they won't be able to go into Southwest
Asia or Korea, areas where high threat of bio-attack or
chemical attack. That is going to present its own nightmares.
Just a scenario, if a pilot's air crew member is in
Mildenhall, England, and that's OK. He can fly there. Then they
get a tasking to say go down range to Southwest Asia--there is
going to have to be a centralized tracking system of which
pilots are on C codes. So they will have to bump that air crew
member, put on somebody that can fly down there, who has the
anthrax vaccine, to complete the mission.
This is going to present some problems.
Ms. Schakowsky. But I did want to establish that there is
some kind of individual waiver policy that could exempt certain
people currently.
Lt. Rovet. Not right now in the Air Force. And, again, that
is just my opinion. But we are still looking for answers on
that, ma'am.
Ms. Schakowsky. OK. We'll try and establish that.
I wanted, Sergeant Soska, to ask you, you testified the
procedures are not being followed as spelled out in AVIP
documents. What did you mean?
Sgt. Soska. Well, ma'am, in my written testimony, on
January 27th I was given an MGC meningococcal, I believe is the
name of it. This was after--I was graciously overlooked; my
chain of command knew I was having problems after the first
three shots that I received. When I went down there for that, I
explained to the NCOIC in charge that hey, I am under B-12
replacement shots. For some reason my system will not retain B-
12.
And she concluded that, yes, it would be a bad time to do
it. But I did have to get what I call the MGC or meningococcal
shot.
Up to this point I was having problems all along in my
testimony, but after I got that vaccination, on the 29th, went
to PT, I did my normal profile PT thing, went home from work,
had two cups of coffee, was coming back into work, and started
feeling rough. After formation, I managed to get to the troop
medical clinic, which is right next door.
I remember being escorted back to the treatment room, and
then I don't remember much after that cause I was out of it. I
totally locked up. I didn't know what happened. I was out.
And, my understanding, I was reading some of the AVIP
documents and what else, and I don't fault the doctors. I think
they are outstanding doctors that have been taking care of me.
I just think there is a lot of areas that, you know, we're not,
we don't do all the time or we don't practice all the time. And
some of the stuff is falling through the cracks.
But it is in my medical records, but how come it wasn't
reported. It wasn't until later that I spoke up in the Persian
Gulf Illness meetings that, you know, the attention--my
attention got to the division surgeon, and they started really
looking into it.
So, forgive me if I ramble, I have problems staying on
track some times.
That's what I say, it's really not being reported like it
should. Others that have been with me, have been to Southwest
Asia and that have came back, are having similar problems. And
I reiterate, they are afraid to say something.
But, you know, the problem, the problem is there.
Ms. Schakowsky. Captain Richter, you said in your
testimony, ``The threat of being exposed to--the doctor went on
to say that the threat of being exposed to anthrax while in
deployment outweighed the possible negative reactions that some
military personnel might have to the vaccination'' and that it
was not a matter of if but when some of our troops would come
in contact with it.
So I want to get to the issue of threat versus the risk of
the vaccine and wonder what your feeling is that if the threat
is so great and if 99 percent of those who inhale anthrax
spores would die, which seems to be the science there, then at
what level do you feel the risk is acceptable? I mean, how
serious--if the threat is so great, at what point should the
Department of Defense say, well, this is what we have to do?
Capt. Richter. I don't know if I am qualified to answer
that really. For me, I can only speak for myself, I go in, I
drill once a month, I maybe take a trip down to the Middle
East. I have another job. I am an airline pilot out in the
commercial sector as well.
My health is my life, and the odds that I am going to go
down range to the Middle East somewhere and get exposed to
anthrax, I think, is probably pretty minute. If I was called on
active duty, it would be a different story, but, having said
that, my--at this point I just can't afford to gamble because I
have to feed myself with mostly my outside endeavors, my
outside job.
I think what he was trying to really lay out was the policy
of the DOD. I don't think that was really his opinion. When I
was discussing this with him, we were kind of in a continuous
tail chase. I kept telling him, well, if I feel this bad and I
pretty darn sure it came from the anthrax, then what is the
point in me taking another one if ultimately I am not going to
be any good to the military if I am not functional.
And that is when he was saying, you know, that a few people
may have a negative reaction; however, overall, we need to
protect the troops en masse, and that risk is worth taking, to
vaccinate everybody with the expense of a few.
Ms. Schakowsky. Well, maybe part of the answer then is in
my next question to Lieutenant Colonel, maybe you can answer
it. You said in your testimony, you would welcome a safe and
effective vaccine. I don't know if we are all in agreement here
that that is an important goal. I would think that we are, that
there is a real threat.
I had a wonderful briefing yesterday that convinced me that
there is enough reason to think that we need to find a vaccine.
Are you saying that we need to do more to develop a safe
vaccine?
Col. Jensen. Based upon what I have heard, what people have
told me, the anecdotal evidence, I think there is a tremendous
concern out there that the safety of the vaccine may not
entirely be what it was made out to be. You talk about what is
the risk. We are in a timeframe of dwindling budgets, where we
are constantly told that we are going to have to do more with
less.
If you take Dover, for example, if the numbers, if I
remember correctly in testimony here today, you have about
1,000 people that were vaccinated there. And out of those
folks, you have got six, is my understanding, that are still
permanently denef, some over 6 months after taking the vaccine.
The cause is still unknown.
You have got 30 people that are potentially being worked up
at Walter Reed. You heard testimony that related to the
potentially three times those folks that are out there are
having similar reactions but are not reporting them for a
variety of reasons.
That creates a far greater concern too that whether it is
caused by the anthrax vaccine or not, I have individuals out
there that are not being provided proper medical treatment, and
therefore we may have a false sense of security as their
ability to perform their job, thinking that they are 100
percent capable when, in fact, they are not.
You heard the numbers cited for those that are leaving the
Reserve squadron, let alone. So you may have, you know, if you
take the threefold, you may have upwards of 100 people or 10 to
12 to potentially 15 percent of your combat force which may not
be ready to enter or perform the mission that we are assuming
they are capable of.
And you have not even entered a theater yet before you can
be exposed to the vaccine--excuse me, exposed to the threat of
the weapon.
Ms. Schakowsky. So on the question of readiness, we need to
be concerned about the effect of the vaccine itself?
Col. Jensen. Yes, ma'am, I think it is the classic risk-
management or risk-analysis that has been preached by the Army
program that was developed and the Air Force has adopted, is
truly look at what are the cause and effects across the board
in that fashion.
Ms. Schakowsky. Thank you very much.
Mr. Shays. We have a system where, in the United States, as
a force protection we require, at least in phase one, for our
military personnel to take the anthrax vaccine for those who
are in areas that may require them to be protected. And then
there is a question of whether we go to phase two, which would
be the military personnel who aren't directly anticipated to go
into areas where they might even be exposed.
We have another country, Great Britain, that has decided to
use the vaccine and made it voluntary. And we have the French
who looked at the vaccine and decided that this would be a
mistake, at least so far.
And, I am struck by a lot of feelings as I listen to you
all make your testimony, and I heard the excellent questions
and responses to those questions, the questions asked by my
colleagues.
And I am also reacting to the varied circumstances each of
you have. Captain Piel, you are in the active duty. You aren't
a reservist; you are not in the National Guard; you don't work
for a commercial airline. But you are a pilot.
Capt. Piel. That is correct.
Mr. Shays. And my understanding is you fly C-5's?
Capt. Piel. That is also correct.
Mr. Shays. Yes. And someday, when you are out of the
military, there is the potential that you might continue to
fly. Is that also a possibility?
Capt. Piel. Sir, I was hoping to fly the rest of my life.
Mr. Shays. Yes. Sometimes, not often, but sometimes we have
had witnesses come before us, say with the Gulf war illnesses,
and you heard very important stories. But you kind of doubted--
sometimes I am just saying to myself, I didn't, I wasn't fully
convinced of every witness that came before us when it dealt
with the Gulf war illness.
So I believed the vast majority of them. And that is why
this committee moved forward.
But there is not a scintilla of doubt in my mind about the
testimony I have heard from you and others. You want to fly. So
you don't want to be sick, and yet your illness was at a point
where you must have made a determination that you might
endanger the command of your plane. So you stepped forward.
There are others who might be on the margin, who, if they
could have the faith that they would be treated with respect,
would step forward. And if they doubted--even if that doubt
isn't, if it's a doubt that they believe, even if it is not
justified, the doubt would lead them not to do what action they
should take.
You did the right thing. You weren't well and you came
forward. And now you are paying for it big-time.
Others saw that, and they are going to say, I am going to
do whatever I can to avoid coming forward.
So first and foremost, I just want to say, I really accept
the fact that you are dealing with some heart-wrenching
concerns.
Captain Richter, I will say to you, if I was a commercial
pilot, besides being a Reserve pilot, there is no doubt in my
mind. I wouldn't take the chance. And that doesn't pre-judge
how ultimately this committee is going to decide.
We have had three hearings. This is the fourth now. And we
don't know ultimately what we are going to recommend, but we
are going to be recommending some course action of the
committee itself.
But I have to tell you, I would do the same thing you are
doing. I would not jeopardize for a minute that source of
income that provides you the opportunity to support your
family.
And so it raises a lot of questions for this committee. Do
we suggest that this program be totally discontinued? We have
one source provider. We have old technology. Another is, do we
suggest to be voluntary? Another is, do we suggest that if you
are going to do phase one, you do it for the people who are
clearly going to be in the theater, but others you are not
going to phase two.
We are wondering why it is all right for the military to
deploy you in an area of concern, in a theater of concern,
after beginning the first shot--you can now be deployed. So the
military is given the option that they can send you into harm's
way, but you don't have the ability to say ``no'' to the shot.
You are not given that other option.
It would be interesting to know, and we will ask our next
panel, are you given the option since the military says you
need six shots that you should not be deployed until you get
six shots.
Another question that is raised is, what kind--how are they
treating people who, military personnel who have had the first
shot and have reacted negatively to it. Shouldn't that give you
additional rights to say ``no.''
So a lot of questions are being raised. And it is also a
fact that you have been very respectful of your command. All of
you have. And the problem we have is knowing how far we push
you without putting you in a different kind of harm's way.
Because no one could listen to anything you have testified and
say you haven't--in a sense, we are a command too. And we asked
you to be here and you accepted our request.
And, but you all have been very respectful.
It fascinates me, Mr. Rovet, that you have, you are not,
you a medical personnel. You are in that area. And so you are
stepping forward. Have you been asked to take this vaccine?
Lt. Rovet. No, sir.
Mr. Shays. So you are stepping forward because of what you
know, and if you didn't step forward and things happened in the
future, you would have to live with that the rest of your life.
Lt. Rovet. Yes, sir.
Mr. Shays. So, we appreciate you stepping forward for that
reason, among others.
So we have someone in active duty; we have someone who has
a medical background and has seen how it is operating and it's
not a pretty story. Sergeant, we appreciate your testimony as
well.
We have two pilots. What fascinates me is, in the area
where I have the most conviction that if I spent a good chunk
of my life learning to become a pilot, I would do nothing to
jeopardize my not continuing to fly. And yet we have in the
National Guard and Reserves, we have a plethora of talented,
capable people who are saying, I am not going to take this
vaccine; I am leaving.
And I have to believe that leaving--that you enjoy, Captain
Richter, and I will just--tell me the difference: You are
serving your country, that is clear, but do you meet all your
flying--tell me the difference of being in the Reserve and
being a commercial pilot.
Capt. Richter. Well, first and foremost, it isn't as much
fun.
Mr. Shays. Which way?
Capt. Richter. Being in a military pilot is probably more
fun than being a commercial pilot. I guess the most gut-
wrenching thing I have had to face, that while I saw myself
continuing to serve in the next 8 years, I am being forced into
a position where I take this shot and perhaps my condition will
get worse, perhaps it won't. I don't know.
But it is that fear of the unknown that will not only
affect my military flying, but it will also affect my
commercial flying. Everybody needs to be healthy to do their
job. We, as pilots, need to be 100 percent healthy to do our
jobs. And if there is any question or any doubt about what
something is going to do to you, at least----
Mr. Shays. What do you fly as a commercial pilot?
Capt. Richter. I am a prop pilot out of Dulles. I fly for
Atlantic Coast Airlines.
Mr. Shays. And in the military you fly?
Capt. Richter. C-5 as well.
Mr. Shays. Lieutenant Colonel Jensen, what do you fly?
Col. Jensen. I fly F-16's, sir. I am an instructor-pilot
with nearly 2,000 hours in the F-16.
Mr. Shays. OK. The bottom line to both of your testimonies
is we are losing a lot of good pilots. Is that not correct?
Col. Jensen. That's correct.
Capt. Richter. That's affirmative. A lot of them.
Mr. Shays. Yes. OK.
Capt. Richter. They just can't afford to take the gamble.
And most of them can afford to give this job up, as much as
they don't want to. Because it is, like I as I said, it's a
good, fun thing to do to be still serving your country.
Mr. Shays. I am going to have--the counsel is going to ask
a question that Mr. Souder wanted to ask, but beforehand I
just, I am going to do two things. One, I read again Mr.
Jensen--Colonel Jensen--what you read. This is a memorandum of
decision, and it deals with the authority under Public Act 85-
804 to include an indemnification clause in the contract.
And I am just going to read it again, and I am just going
to think of what people think who are being asked to take this
shot: The obligation assumed by MBPI under this contract
involves unusual hazardous risks associated with the potential
for adverse reactions in some recipients and the possibility
that the desired immunological effect will not be obtained by
all recipients.
Which, that in a sense means, the whole clause means it may
hurt you and harm you, and in the end, it may not even work.
And the company is being indemnified.
I understand why, but I can understand the concern when you
read that.
Now, I will end my part by just asking if any of you would
like to make a closing statement, because really you answered
the questions. I was able to get more into a monolog because
you really answered the questions of my colleagues.
Would any of you like to make a closing comment?
Captain Piel.
Capt. Piel. Yes, sir. There is one thing I would like to
say. I understand that we can make decisions based on
acceptable risks; however, I feel that we need to know exactly
what those risks are. And the VAERS system doesn't seem to be
adequately providing information.
And that is all I wanted to say.
Mr. Shays. Thank you. Lieutenant.
Lt. Rovet. Mr. Chairman, I would like to echo that.
Informed consent is based upon having information up front. I
know there may be some legalities that military may not need
informed consent. I am not quite aware of that. But I think if
this comes to light that the reaction rates are much higher,
and now the rhetoric is changing to the risk outweighs--I mean
the benefit outweighs the risk, we are opening up a moral
pandora's box that is worse than any dusting with anthrax
vaccine.
Mr. Shays. OK. Sergeant Soska.
Sgt. Soska. Congressman Shays, on a personal note. My son
told me about 4 or 5 months ago--excuse me if I get a little
emotional on this one--he says, dad, mom told us to pray about
you. And I asked him, why. He says, because she sees you
getting sick and it worries her. That hit home, sir.
It is not just about me. This is affecting a lot of people
that are having problems. And I encourage all soldiers in all
branches, and as a mentor, my command sergeant major said to
me, sergeant, don't put yourself in a position where things can
be misconstrued. They are having problems, and they are not
getting the help they need, they need to bring it to the chain
of command. The only thing you can do is advise them what to
do, nothing more, nothing less.
And I thank him for that.
That is all I have to say, sir.
Mr. Shays. Thank you, Sergeant. Captain Richter.
Capt. Richter. I think I have said enough, sir. I have
nothing else to add.
Mr. Shays. Thank you. You have been very helpful.
Colonel Jensen.
Col. Jensen. Sir, if I may take a moment to address the
question that was posed about risk and benefit?
Mr. Shays. OK.
Col. Jensen. I think one of the things when you get into
that risk versus benefit analysis is a true analysis of the
efficacy of the vaccine. And for that, I would offer this as an
area to explore.
On the DOD anthrax web page, they talk about the vaccine
efficacy, excuse me, has been tested against numerous anthrax
strains in animal models. They talk about the guinea pig and
the mice are poor animal models for anthrax vaccine testing.
However, they consider the rabbit to be a more appropriate one,
and the monkeys are considered the best. Yet I see nothing in
documentation that equates that to the studies that say, this
is why these are better models.
For example, yet mice are labeled to be poor, numerous
guinea pigs and mices have been tested and their reaction rates
or survival rates can range anywhere from 10 to 90 percent. The
rabbits I am unaware of what the rates are, but I am told they
are extremely good survival rates.
The few monkeys that have been tested have a very high
rate. Is the reason that the monkey and the rabbit are being
viewed as the more appropriate models because they appear to
survive the vaccine better? Or is there an actual study to
support that?
And on an interesting side note, the guinea pigs and the
mice that are considered poor animal models for this exposure
against inhalation anthrax, the mice have been used extensively
by the Air Force with regards to the Air Force Office of
Scientific Research, the folks that are doing the inhalation
studies right now, and have been for the last 4 to 5 years out
of the University of Arizona under Air Force contract.
They have been using mice extensively to examine the
respiratory effects that inhalation of jet fuel, in particular
JP-8, have. And they use that as the model to compare to human
studies. Mice are also used extensively, I am told, in cancer
research because of the ability to--or their life expectancy is
so short they can see that.
Guinea pigs, they state again, are poor animal models, and
yet my understanding is the guinea pig is used pretty much
exclusively to test the potency or the efficacy of the vaccine
before the lot is released.
So, you know, I kind of sit here and beg the question. OK,
in some cases, why is it good here, why is it not good there?
And just looking for the published studies that indicate,
because I have also seen other folks or heard statements by
folks out of the medical field that question truly what is the,
you know, have the models been actually made.
Mr. Shays. I'm beginning to think I should hire you as one
of our staff members. [Laughter.]
Col. Jensen. Do you have F-16's that I can fly here, sir.
[Laughter.]
Mr. Shays. OK. Well, I am just going to say one last point,
and that is that there is something we can do before our
report, and that is that we can encourage the military to make
sure, in their chain of command, they encourage proper
reporting and don't discourage people to step forward.
We can do that.
And I believe that would be something that we could have
some positive result on. And that would be something we can do
now.
Thank you very much. Been wonderful witnesses. Appreciate
you being here.
We will get to the next panel.
Our next panel is comprised of Kwai Chan, Director of
Special Studies and Evaluation Group, National Security and
International Affairs Division, U.S. General Accounting Office,
accompanied by Dr. Sushil K. Sharma, Assistant Director from
the same division.
Our second testimony will be from Major General Roger
Claypool, Deputy Assistant Secretary for Health Operation
Policy, U.S. Department of Defense, accompanied by Rear Admiral
Michael Cowan, Deputy Director for Medical Readiness, Joint
Staff, U.S. Department of Defense; Colonel Frederick Gerber,
Director of Health Care Operations, Office of the Army Surgeon
General, and Colonel Renata Engler, chief, Allergy and
Immunology Service, Walter Reed Army Medical Center.
And our third testimony is from Susan Ellenberg, Director
of the Division of Biostatistics and Epidemiology, Center for
Biologics Evaluation and Research, Food and Drug
Administration, commonly referred to as FDA.
I want to make sure we have enough seats there and that
everyone is comfortable. There will be one or two others who--
--
[Pause.]
Mr. Shays. Everybody I called, are they represented up
here. Is there anyone who is not sitting at the front desk.
OK. Whoever isn't at the front desk but will potentially be
asked to come forward, I will be asking them to step forward.
Do we have enough room there?
Yes. OK.
Are we OK, Jason?
OK. Is there anyone who is up who was not called but will
be potential witnesses so we have their name to give----
OK. Could you state your name please?
Dr. Braun. Dr. Miles Braun.
Mr. Shays. Doctor, I am going to have you, just so the
recorder can get it--do you have a card? Did you give your card
to the reporter?
Dr. Braun. Yes.
Mr. Shays. Just state your name again, sir.
Dr. Braun. Miles Braun.
Mr. Shays. Dr. Miles Braun, thank you very much.
If I could, I would invite you all to stand.
If you would raise your right arms, please.
[Witnesses sworn.]
Mr. Shays. Thank you.
I am going to state one bit of prejudice first and then
invite the testimony. And that is, I think the thing that
causes me the greatest concern and can make you a bit annoyed
is the thought that our soldiers and other military personnel,
our pilots, our airmen, and so on, our Navy personnel, Marines,
would feel in any way intimidated from stepping forward if they
thought they had an adverse effect.
And I am just going to go under the assumption that that
would trouble you as much, any of those of you--and that from a
military standpoint that this will be something that you will
make clear would not be treated well if you thought that any in
the chain of command were a part of that, and that just as you
might be, challenge someone who think they have an adverse
effect and you think they have not done it in a proper way, you
would be just, if not harder on those who would make someone
feel intimidated to step forward.
I do welcome this panel. It is an excellent panel. And we
will start with you, Mr. Chan, and we will then go to you,
Major General Claypool, and we will then go to you, Susan
Ellenberg.
Is it Doctor, am I? I am sorry.
Usually my staff corrects me. And I just have this feeling
you must be a doctor. So you can give me that check.
OK. Let's start.
Thank you, Mr. Chan.
STATEMENTS OF KWAI-CHEUNG CHAN, DIRECTOR, SPECIAL STUDIES AND
EVALUATION GROUP, NATONAL SECURITY AND INTERNATIONAL AFFAIRS
DIVISION, U.S. GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY SUSHIL
K. SHARMA, ASSISTANT DIRECTOR, SPECIAL STUDIES AND EVALUATION
GROUP, NATIONAL SECURITY AND INTERNATIONAL AFFAIRS DIVISION,
U.S. GENERAL ACCOUNTING OFFICE; MAJOR GENERAL ROBERT CLAYPOOL,
DEPUTY ASSISTANT SECRETARY FOR HEALTH OPERATIONS POLICY, U.S.
DEPARTMENT OF DEFENSE, ACCOMPANIED BY REAR ADMIRAL MICHAEL
COWAN, DEPUTY DIRECTOR FOR MEDICAL READINESS, JOINT STAFF, U.S.
DEPARTMENT OF DEFENSE; COLONEL FREDERICK GERBER, DIRECTOR,
HEALTH CARE OPERATIONS, OFFICE OF THE ARMY SURGEON GENERAL,
U.S. DEPARTMENT OF DEFENSE; COLONEL RENATA ENGLER, CHIEF,
ALLERGY-IMMUNOLOGY SERVICE, WALTER REED ARMY MEDICAL HOSPITAL;
AND SUSAN ELLENBERG, DIRECTOR, DIVISION OF BIOSTATISTICS AND
EPIDEMIOLOGY, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH,
FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY DR. MILES BRAUN
Mr. Chan. Thank you, Mr. Chairman.
Mr. Chairman and members of the subcommittee, it is indeed
my pleasure to be here today to share the results of our work
on the anthrax vaccine. And may I also introduce my colleague,
Dr. Sharma, and my staff in the back of me, Dr. Howard DeShong,
who helped me with this work.
As you know, many questions have been raised about the
Department of Defense anthrax immunology program. We have
previously reported to you a number of concerns regarding the
safety and efficacy of the vaccine. Today, I will present our
findings on four issues.
First, the extent to which data support the need for six
initial shots and annual booster for the anthrax vaccine.
Second, the relationship of--the relative merits and weaknesses
of passive surveillance system for monitoring adverse events.
Third, available data on differences on adverse reaction rates
between men and women. Finally, the disadvantages of the
current vaccine and the status of Federal efforts to develop an
improved anthrax vaccine.
With regard to the first question, what is the support for
the current regimen of six-dose schedule and an annual booster
shot? We found that the current six-dose schedule was
arbitrarily determined. No studies have been done to determine
the optimum number of shots required. And although annual
boosters are required, the need for this frequency and amount
of the booster dose have not been evaluated.
Second, with regards to what are the relative merits and
weaknesses of passive surveillance systems? That is the VAERS
system that you have heard about, which DOD used to determine
the rate of adverse events. We found that this system has
several advantages as well as disadvantages.
The advantages: It alerts FDA and CDC to previously
unreported or unexpected increases in reported adverse events.
It is also a relatively affordable way to supplement the data
collected on vaccines before they are licensed.
However, there are several disadvantages. Studies show that
adverse events are often under-reported in a passive
surveillance system. A former FDA Commissioner acknowledged
that under-reporting of adverse events in such systems and
cited one study showing that, ``Only about 1 percent of serious
events,'' are attributable to drug reaction reported to FDA.
That means 99 percent are not reported.
Also, outcomes with delayed onset after vaccination are
outcomes not generally recognized to be associated with
vaccination are often under-reported.
There is no mechanism within VAERS for a 1-, 3-, or 10-year
followup to evaluate vaccine reactions that have a long latency
period.
The limitations of VAERS suggest it is not a valid source
for assessing the rate of adverse events.
With regards to the third question, on gender differences,
we identify three DOD efforts which examine gender difference
with regards to adverse events. Data from these efforts show
that women reported twice the rate of adverse reaction than men
for both local, for example swelling, and systemic reactions,
for example malaise and chills. And we observed some
reactions--these reaction rates to increase with each
successive shot.
In addition, a high proportion of women than men reported
making an outpatient medical visit after a vaccination, and
more than twice the percentage of women reported that they
missed one or more duty shifts after their vaccinations than
men.
Finally, with regards to your fourth question, we found
that the current vaccine has several disadvantages. It is an
impure mixture of bacterial products using outdated technology.
The amount of protective antigen in the vaccine cannot be
precisely measured, and it varies from lot to lot as you
produce them.
There is some evidence that the current anthrax vaccine may
have diminished efficacy against certain virile strains of
anthrax. Also, the requirement for a six-dose schedule and
annual booster shots complicates the logistics of inoculating
all of DOD's troops and increases the cost of the vaccine
program.
Knowledge of anthrax infection in studies of experimental
anthrax vaccine indicate that a second-generation vaccine with
a more precise amount of protective antigen could be developed
and that fewer doses of the vaccine could be required.
In 1995, the U.S. Army Medical Research Institute of
Infectious Diseases developed a second-generation recombinant
vaccine against anthrax. The vaccine was tested on animals, but
clinical trials were not conducted in humans.
DOD currently considers such a vaccine an unfunded
requirement. The Department of Health and Human Services has
allocated funds to develop a second-generation recombinant
vaccine because of a perceived bio-terrorism concern.
In developing this second-generation recombinant anthrax
vaccine, researchers believe they will need to address the
additional problem of whether deliberately engineered or
natural strains of anthrax can overcome the protective immunity
of such a vaccine.
Mr. Chairman, this concludes my statement.
Thank you.
[The prepared statement of Mr. Chan follows:]
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Mr. Shays. Thank you very much.
Major General Claypool. Thank you.
Gen. Claypool. Chairman Shays, Representative Schakowsky,
Mr. Tierney, it really is a pleasure to appear before this
committee, and I would like at the beginning to acknowledge the
first panel. I truly do recognize that they are heroes and it
took a great deal of courage for them to come before this group
to testify.
I really think this kind of openness that your hearing is
provoking is indeed one of the things that help make America
great. And from the standpoint of the department in terms of
its encouraging individuals to come forward, in the department
policy, of course, is that individuals who have concerns about
their health care and health-care system should come forward
with their own individual complaints and we will do what we can
to solve them and fix that.
Mr. Shays. Could I just interrupt you a second to thank you
for making that statement. And also to thank you for not
objecting to having the military personnel speak first and that
you were here for two-plus hours to listen to them.
That is not always usual. Sometimes people of your rank,
out of protocol, say, I would like to go first. So, on behalf
of all three of us, I appreciate, one, your being here, and
second I appreciate your statement.
Gen. Claypool. We found it very illuminating, actually. And
it has been a long time since my kids say that I was a real
doctor. So the opportunity to sit and listen to individuals
with their medical problems was very illustrative to me, and I
would like to offer to any of them that any of us on the panel
here, the DOD members, that can help them get access to the
evaluation or care that they need--it looks like they are
already plugged into the right system. But we will do our best
to do so.
Mr. Shays. Thank you.
Gen. Claypool. I would like to focus the testimony
initially on five points about our program that I would like to
emphasize. No. 1 is that we know that anthrax exists this very
day as a weaponized agent in arsenals of countries hostile to
the United States. And as such, it presents a clear and present
danger to the U.S. forces around the world.
No. 2, the cornerstone of our defense against this biologic
agent is the anthrax vaccine, which has been licensed by the
FDA for nearly 30 years. The vaccine has an excellent safety
record and is highly effective.
Three, to date nearly 300,000 service men and women have
received nearly 1 million anthrax immunizations. And while side
effects do occur in some people, they tend, and I say, they
tend to be temporary, confined to an area around the
injectionsite and mild or moderate in most people.
In this age of no-notice worldwide deployments, immunizing
the total force is the only way to assure force protection
against this biological warfare agent, which, in the form it
would be used against us, is as deadly as the ebola virus.
And fifth, this is not a medical program. It is a
commander's program to prevent combat casualties and keep our
forces ready for battle. It is also a program for our soldiers,
sailors, airmen, Marine, to fulfill our national obligation to
do everything in our power to keep them safe and free from the
consequences of biologic war.
A number of studies listed in our written statement have
shown that the anthrax vaccine is a safe vaccine with an
incidence of adverse events that is comparable to other
commonly used vaccines.
On either side up here, there is a histogram that depicts
several vaccines, both new and old vaccines, and I think there
are sort of three points to take from this chart.
No. 1, systemic complaints such as headache, fever, joint
pain, fatigue, are common kinds of system complaints that we
see with the anthrax vaccine as well as the commonly used
vaccines.
Second, the incidences of these side effects to the anthrax
vaccine is comparable of that to the Lyme vaccine, diphtheria,
tetanus and pertussis, which is a common child immunization
agent, the typhoid vaccine, as well as hepatitis A.
The third interesting observation is, you can see--Colonel
Gerber made these slides, and I think he challenged my
vocabulary for knowledge of color--but one very tall vertical
bar, which I guess I will call turquoise, shows fever. With the
exception of fever, I think the other interesting feature is
the fact that the Lyme placebo, the placebo immunization used
in the Lyme product, shows a significant incidence as well.
And so we expect to have system effects, not uncommonly,
with a number of vaccines. And the anthrax vaccine is
comparable to those.
It is important for everyone to understand that any vaccine
carries with it a degree of risk. And the decision whether or
not to use this particular agent, as we have heard, must be
based upon an analysis of weighing the risks from the side
effects against from the risk from the disease the vaccine will
prevent.
In the case of the anthrax vaccine, the scales of balance
are clearly tipped in favor of its use to protect our military
forces.
Furthermore, in the case of protecting the entire force
against anthrax, the risk versus risk decision is not one that
can be left to the personal choice of each service man or
woman. An analogy is that the risk versus risk decision for
childhood diseases results in several mandatory vaccinations
for schoolchildren. This is because the risk of not immunizing
presents a public health threat that extends beyond personal
health concerns.
In the military, the risk of not immunizing affects the
capability----
Mr. Shays. Excuse me. Just hold off 1 second.
[A series of vote buzzers go off.]
Gen. Claypool. It's not an anthrax attack, I assume.
[Laughter.]
Mr. Shays. My astute counsel said that is six bells.
Gen. Claypool. Now, could I bargain for a little more time
to talk, or is that--[laughter.]
Mr. Shays. What we are going to do is have you finish your
statement, and we are going to have a few others so we may get
a little lunch break here. We will see. But let's have you
finish your statement.
OK?
Gen. Claypool. Yes, sir.
Mr. Shays. Thank you.
Gen. Claypool. The point I was trying to make is the risk
of not immunizing presents a public health threat that extends
beyond personal health concerns, and for the military, the risk
of not immunizing affects the capability of the entire military
unit and the success of the military mission.
Secretary Cohen and General Shelton said it more succinctly
when they wrote, ``Our commanders must know that all, not
simply some fraction of their forces, are protected from this
biologic threat. Soldier, sailors, airmen, and Marines fight in
teams. And they need to know that all team members are
protected from the anthrax.''
While we are aware of isolated, unexplained persisting
systemic conditions that have appeared in relation to the
administration of the vaccine, we are not aware of any pattern
of long-term side effects from the anthrax vaccine.
As is typical for other vaccines licensed at the time the
anthrax vaccine was licensed, the FDA did not require long-term
studies to be conducted after licensure was awarded. The
standards for recently released vaccines include provision for
post-marketing evaluation.
As we have gained additional experience with this vaccine,
we have come up with questions of our own, the answers to which
we feel would allow us to improve an already excellent vaccine.
And so the Department is convening at the end of this month a
team of military and civilian experts to design a set of
studies to better evaluate the long-term safety of anthrax
vaccine as well to answer some of these questions which we have
raised.
We are conducting these additional studies of the FDA-
licensed vaccine to conform with present-day, post-marketing
practices. It is important for all of us to establish every
reasonable degree of confidence in the minds of Americans, who
are all stakeholders in this important force health-protection
issue.
I would like to spend a minute talking about how we collect
data, that is about passive surveillance versus active. One
kind of surveillance is active surveillance in which all of
them, or more commonly, a cohort, are evaluated as to whether
or not they have had any side effects from the vaccine. This is
a tool that is often used in post-marketing situations.
It would be labor-intensive, cost-prohibitive, and would
not conform to civilian expectations for us to use this in all
2.4 million service personnel whom we will administer the
vaccine to. It is one method we have used in some of our
studies and will use in cohort manner in our ongoing studies.
Another type of active-surveillance method advocated by the
CDC in post-marketing evaluations is the large, linked data
base. DOD will utilize this approach in our research efforts
through accessing our immunization tracking program's data
base, the DEERS system, and through the large medical data base
residing at a tri-service defense medical surveillance system
here in the National Capital region of the Walter Reed
installation.
Passive surveillance is a common surveillance method
employed for the collection of adverse events. We know that it
does not give a picture of the total number of adverse events,
but it does provide a large pool of vaccine recipients from
whom we can collect information regarding the emergence of
spontaneous or infrequent reactions whose low numbers would
otherwise slip through a focused active surveillance system.
DOD uses a passive surveillance system developed
collaboratively by the FDA and CDC called the VAERS system. DOD
requires its providers to report through the VAERS system all
cases of loss of duty of more than 24 hours, hospitalization
for any reaction, or suspected contamination of the vaccine
lot.
However, it encourages all health-care professionals to
report all adverse events that they consider important and
clinically relevant, even if they don't meet the aforementioned
criteria.
It is also important to mention that patients themselves
are encouraged to and can input information into the VAERS
system, and many of them have already done so.
The department has set up a process to have all VAERS
reports, those reported by providers as well as by patients, to
review by an independent external review panel, called the
Anthrax Vaccine Expert Committee [AVEC]. The AVEC consists of a
special panel of experts from the Health Resources and Services
Administration, a component of Department of Health and Human
Services vaccine injury compensation program.
The AVEC uses explicit criteria for attributing causality
to adverse events coincidentally associated with the
administration of anthrax vaccine.
As of July 1, 215 VAERS reports have been received, of
which 174 have been review by the AVEC. They have found no
pattern of causality stemming from the use of the anthrax
vaccine.
In conclusion, the department is and will continue to be
vigilant in our surveillance for any unexpected reactions to
anthrax immunization. We are committed to fully investigating
all concerns or all questions on the safety of anthrax vaccine,
and will continue full and complete disclosure of all risks
based on objective evidence.
We know anthrax kills immunization protects. We know death
from anthrax is vaccine preventable, and that the Department of
Defense has a safe and effective vaccine to protect its service
members.
Immunizing men and women we place in harm's way to prevent
death or a serious injury is our moral and ethical duty, a
leadership responsibility we perform with great confidence. It
would be unconscionable for us not to do so.
Thank you, sir.
[The prepared statement of General Claypool follows:]
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Mr. Shays. Dr. Ellenberg, I think that we have three votes.
The machine is going to close in about 10 minutes and takes
about 8 minutes. I think what we will do is let people know
that they can have some lunch or something, and we will start
sharp at 10 of, barring they keep us on the floor. But I think
we will be out before then.
So we will start sharp at 10 of. Is that OK with you?
That's when we will start.
So we will reconvene at 12:50. We will recess, if you need
to get some lunch or something. Let's do that.
[Recess.]
Mr. Shays. Call this hearing to order. And I think we have
one remaining testimony from you, Dr. Ellenberg.
No, just slide that whole thing. Do you have enough room?
It is kind of difficult there. Are you OK?
Ms. Ellenberg. Yes, I think it is OK.
Mr. Shays. OK. Let me say, the bigger mic is not the one
that amplifies. So--that's it. Thank you.
Ms. Ellenberg. Mr. Chairman and members of the committee, I
am Dr. Susan Ellenberg, director of the Division of
Biostatistics and Epidemiology in the Center for Biologics
Evaluation and Research at the Food and Drug Administration. I
am accompanied by Dr. Miles Braun, a medical officer in our
Epidemiology Branch. I appreciate the opportunity to discuss
with you today FDA's Vaccine Adverse Event Reporting System
[VAERS], which is designed to receive and evaluate reports of
adverse events following vaccinations, and in particular, VAERS
reports related to anthrax vaccine.
My written testimony is more detailed and I ask it be
included in its entirety in the record. I would also like to
say that we very much appreciate the testimony of those on the
previous panel and wish to assure them that we will continue to
review and monitor these reports and that we encourage anyone
developing any medical problems following any vaccination to
report those to VAERS.
Vaccines are among the most significant public health
achievements of all time. They have been responsible for saving
millions of lives and improving health worldwide and are
extremely safe. Nevertheless, like all other medical
treatments, vaccines are not entirely risk free. While serious
complications are extremely rare, they can occur because
vaccines are administered to healthy individuals and because of
the virtual universal exposure of our population to different
vaccines, it is important to identify even these very rare
adverse reactions.
VAERS is a joint program of FDA and CDC. It receives
reports from vaccine manufacturers, health professionals, State
and local health clinics, and vaccinees themselves. To
encourage reporting of any possibly vaccine-induced adverse
event, the criteria for reporting to VAERS are deliberately
non-restrictive. The system accepts and includes any report
submitted, no matter how unlikely the connection with
vaccination might seem.
Such reporting system----
Mr. Shays. I am going to ask you to slow down just a little
bit. I think General Claypool was speaking a little more
quickly because of the bell, but we have time.
Ms. Ellenberg. We have more time. OK.
Such reporting systems are essential to the discovery of
potential rare adverse consequences of medical products that
may not become evident until many thousands or even millions of
people have been exposed to them. There are important
limitations, however, to the interpretations of the data
collected by such systems, as I will discuss later.
VAERS receives 11,000 to 12,000 reports per year. About 15
percent of these reports describe a serious event, defined as
an event that is fatal, life-threatening, requires or prolongs
hospitalization, results in permanent disability, or, in the
judgment of the physician, could lead to such an outcome in the
absence of medical intervention.
Most of the remaining 85 percent of the reports describe
self-limited transient events such as injectionsite reactions,
allergic reactions, and fever, and such events as irritability
and prolonged crying in infants.
Currently, all reports of serious events are followed up in
detail by a health professional. Medical staff carefully
monitor trends in adverse event reporting for vaccines. It
should emphasized that adverse-event reports can be submitted
by a health-care professional or a patient or anyone else. FDA
protects the confidentiality of individuals reported to have
experienced adverse events.
VAERS performs a critical function by generating signals of
potential problems that may warrant further investigation. It
is especially valuable in assessing the safety of newly
marketed vaccines, but it is important to recognize that VAERS
data alone are usually inadequate for drawing firm conclusions
or providing a basis for regulatory actions.
Probably its greatest limitation is its inability to
establish causality for most reports of serious events. This is
because most of the types of serious problems reported to VAERS
occur in unvaccinated as well as vaccinated individuals. When
large numbers of individuals are vaccinated, some of them by
chance alone will experience adverse medical events within a
few days of vaccination.
For this reason, the fact that an event happens to occur
shortly after a vaccine has been administered cannot by itself
lead to the conclusion that the event was caused by the
vaccine.
As of July 1, 1999, 215 reports of adverse events
associated with the use of anthrax vaccine have been reported
to VAERS. Of these, 22 are considered serious events, as
defined earlier. These reports describe diverse conditions with
no clear pattens emerging at this time. Some of these events
are described in detail in my written testimony.
The remaining reports describe a variety of symptoms,
including injectionsite pain and swelling, rash, headache, and
fever. With the exception of injectionsite reactions, all of
these reported adverse events can occur in the absence of
immunization.
I will skip any comment on the Anthrax Vaccine Expert
Committee, as that has already been described by the previous
panelist.
While the date gathered from the VAERS system can serve as
a useful tool in identifying potential problems, the reports on
anthrax vaccine received thus far do not raise any specific
concerns about the safety of the vaccine. As more people
receive the vaccine, the number of adverse events reported will
increase. The agency will continue to closely monitor and
investigate these reports.
FDA continues to view the anthrax vaccine as safe and
effective for individuals at high risk of exposure to anthrax.
Vaccine safety is a high priority of the Food and Drug
Administration.
I thank you for this opportunity to discuss VAERS and our
efforts to monitor and ensure the safety of licensed vaccines.
[The prepared statement of Ms. Ellenberg follows:]
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Mr. Shays. Let me say to you, I have a number of questions
that we have written down. I am going to follow the script
somewhat cause these are very important questions for our study
and I don't want to have my staff tell me later on that I
should have asked that question and that we need to get it
later.
So I am going to ask you, Mr. Chan, how does the number of
shots affect adverse reaction rates?
Mr. Chan. The six shots that are given over 18 months
period--what we found based on the--first of all, there are
differences between active monitoring and also passive
surveillance systems.
Mr. Shays. Bring the mic a little closer to you.
Mr. Chan. I am sorry.
Mr. Shays. Yes. Yes.
Mr. Chan. For the three efforts that we mention in our
testimony, I think we found that certainly the number of not
only the number of adverse events increase as after the first
one to the second one to the third one and so on, but also that
there is a type of adverse reactions very similar. They are
consistent, but really had not analyzed whether these things
are significant or not. I think it does suggest though that,
you know, DOD is pursuing looking at a possibility of reducing
a shot out of those six.
Mr. Shays. I am not quite sure what your answer is. I
asked, how does the number of shots affect adverse reaction
rates. And your are not giving me a very clear answer.
The followup question was after which shot in the series do
more people experience serious local or systemic reactions.
Mr. Chan. Yes.
Mr. Shays. After which shot in the series do more people
experience serious local or systemic reactions?
Mr. Chan. Well, first of all, I guess, to answer this
question, it's six shots, as we stated, was it was established
in an arbitrary manner. OK, so from a scientific point of view,
it went from a three-shot regimen through the animal study,
whereupon they found that in applying to humans, they found
that they had three cases of anthrax contracted.
So, that number has been raised from three to six,
particularly in the early study, in 1962 of Dr. Brachman's
work.
Mr. Shays. What GAO has done is basically look at what's on
the table, the documentation on the table. And it is your
testimony before this committee that the six shots is
arbitrary.
Mr. Chan. Yes.
Mr. Shays. That there is, what, no scientific evidence that
six is better than three?
Mr. Chan. What we were looking for was how was that
determined in terms of is it based on the antibody to the
antigen or protecting antigen, as we use, or is it based on a
tradeoff between what is the difference in reaction, you know,
in terms of the antigen level from three shots, to four shots,
to five shots, and six shots and see which one came out with
the right answer for you, looking for the optimum number of
shots. And we didn't find that.
Mr. Shays. OK. Major General Claypool or any of the people
with you, are you able to respond to that?
Gen. Claypool. I will take a crack at it. I mean, I think
this is a vaccine, as we said, that is 30 years old. Back in
the 1970's, when it was submitted for licensing, we do think
probably that--I think ``arbitrary'' may be a word that has
boundaries to it. I mean, certainly we don't think you need to
have 40 shots; we don't think one shot is sufficient. But six
shots is what the FDA has, indeed, states, goes along with
license assurification. And that is why we follow the FDA
guidelines in our program.
Now we do believe that there may be a case to be made for
fewer doses, and that is why we have developed a protocol, as I
think you know, to look at reducing the number of shots. And we
are currently working with the FDA to see if we can bring that
into reality.
Mr. Shays. I am going to make an assumption, General, that
you would welcome anyone else on your staff joining in.
Gen. Claypool. Yes, sir.
Mr. Shays. So I am not going to specifically ask. So, and I
am also going to make the assumption that if we have slight
disagreements that there won't be silence on it because, for
instance, Admiral Cowan, if what General Claypool is saying,
and you have some medical disagreement with that, I am going to
assume that if you don't disagree, you agree.
Adm. Cowan. Yes, sir. Certainly.
Mr. Shays. OK. OK.
Col. Engler. Sir?
Mr. Shays. Yes.
Col. Engler. I thought I might be able to help clarify the
answer to your question.
Mr. Shays. Thank you.
Col. Engler. All vaccines series, i.e., more than one dose,
are based on some immunologic science of priming the immune
system and then solidifying the immune response to create
immunologic memory that will protect you long-term. And so it
is a standard that many vaccines, you need more than one dose
to optimize the long-term protective response to the vaccine.
And as that immune response enhances with booster doses,
you will see more large local reactions. And some people who
are genetically predisposed to be what we call hyper-
responders, will make very robust immune responses, which many
manifest in some systemic symptoms, like low-grade fever or
chills that last only a few days.
Mr. Shays. So if you have someone who, Colonel, who has
reacted negatively on the first one, it is likely that they
will find it even more difficult with the second one, or the
third, or the fourth?
Col. Engler. That is true in most vaccines, but in the old
anthrax literature, it is described that the person who has a
reaction--we are mainly talking about local reactions with dose
one--may not have it with dose two, or may have it with dose
two and not dose three. And in actual fact, the local and self-
limited systemic reactions go down on the fourth dose, where
there is a time interval of several months. And the immune
system basically lowers again, because it is not being
challenged.
Mr. Shays. You use the word ``old literature''----
Col. Engler. I am talking about in the sixties.
Mr. Shays. Yes, that is old literature.
Col. Engler. For us, yes.
Mr. Shays. Given the kind of advances we make in medicine
and with vaccines, that is old literature, but we have an old
vaccine that we are dealing with. And it is basically your
testimony that it doesn't always follow but that the answer--
let me re-ask the question: Are you saying, in response to my
question, that if you have an adverse reaction with the first
one, that is not an indication that you might not have it, that
it is an indication you are more likely to have it with
followup?
Col. Engler. At the present time, we don't have clear data
to that fact. There is some data, as I said, in the sixties'
and seventies' literature that it is erratic. And so someone
can have a very large local reaction with the first shot and it
will be better with the second or completely gone with the
third.
And the other pattern, where it does seem to worsen from
shot to shot, is also observed.
Mr. Shays. OK. What's on the table is the GAO has basically
said there is no evidence--excuse me, that six shots is an
arbitrary determination and what Major General Claypool has
said is that this is--they are following the FDA basic
literature and not--excuse me, licensing. So let me have the
FDA jump in here.
Ms. Ellenberg. Well, I am not an expert on the anthrax
vaccine. My understanding is that the original clinical trial
that was done that supported licensure, in that study, the
people who received partial vaccination, but not the full
series, that some of those did develop anthrax, a small number.
But nobody who was fully vaccinated developed anthrax. So that
there is some suggestion there that more than some number of
doses provides more protection. But it is based on a small
number of cases.
That is the clinical data that I am aware of.
Mr. Shays. OK. Dr. Chan, why do passive surveillance
systems result in adverse-event under-reporting?
Mr. Chan. Well, it is a voluntary system, first of all. And
this is not just the case with this particular case of anthrax
vaccine. It is generally the case with most passive
surveillance systems. And there have been a number of studies
done to look at that, and in fact, even in applying it to the
medical device where we found in GAO's own study found that
less than 1 percent of the adverse events using medical device
have been reported to FDA. This is post-1980's. And we found
that is the case.
So that is the first point. The second thing is that if a
surveillance system also has in place a sort of a filtering
process whereby it requires individuals to determine whether it
should be reported or not, then you have an added problem of,
you know, reducing that total number.
And the third case is that, you know, a lot of people do
not realize that this is really caused by the vaccine itself or
whatever, and so they may or may not report it.
A passive system, in a way, it is a sort of sentinel
system. You really don't try to figure out, is there a larger
portion of adverse events that are occurring, but really what
kind of event that is occurring.
So, if you decide that this is not something you want to
report, then you lose sight of the fact that the intent of that
system is to capture some extraordinary events that it is
unexpected. And so, I think, you know, in listening to the way
this VAERS system is being applied for the anthrax vaccine, I
think it suffers from a number of these deficiencies to reach
this level of reporting that we find that's different in the
active system that we have noticed.
Mr. Shays. Now, bottom line, that would indicate to me that
the VAERS data should not be used as a source for determining
adverse reactions rates.
Mr. Chan. Exactly. And that is a pretty well-known fact.
And certainly we have talked with experts in CDC who have done
studies of this kind, and as we stated, the former Commissioner
for FDA also noted the same thing, based on a 1997 study--1993
study, excuse me, to show that, you know, less than 1 percent
of adverse events are reported.
Mr. Shays. Let me just have you put it--I am going to ask
you the question this way, and I am going to go down the line
here. Why shouldn't VAERS data be used as a source for
determining adverse-reaction rates? I want you to tell me why
it should not be used.
Mr. Chan. Well, because of the fact that people----
Mr. Shays. You have already said it, I just want you to
respond to the question as I have asked. So----
Mr. Chan. Well, first of all, you need to track the number
of shots given. That means the denominator has to be given,
very clearly. Second, you need to have a system by which people
do not under-report. OK? And third, it requires someone not
screened out any possible other events that may be related to
the vaccine. And ultimately, to follow through on those cases.
Mr. Shays. I don't understand the third one. Say that
again. I didn't understand. I know you said it. I don't
understand it. You will have to explain it to me.
You said, one, you need to track the number of shots. Two,
you can't have under-reporting. Three, filtering? I don't
understand filtering.
Mr. Chan. What I am saying is that you should not, you
know, theoretically you shouldn't have a criteria by which you
set out and say this is our product insert, if these are the
illnesses you have, then it is possible.
Mr. Shays. I see. OK.
Mr. Chan. But if it is not, most likely it is not, so let's
exclude that.
Mr. Shays. Let me put it in my terms. In other words, we
make, we determine that only certain types of symptoms would be
related to anthrax vaccine, and if there are these others, then
those are filtered out because they are not, we don't accept
them as being related. Is that what you meant by filtering?
Mr. Chan. Yes.
Mr. Shays. OK. General Claypool, I am happy to have you
defer the question to someone else, but I would like to ask
whether you have confidence in the VAERS system?
Gen. Claypool. I have a great deal of confidence in the
VAERS system to deliver what it is supposed to deliver. And
what the VAERS system does, it provides, as we have said, the
ability to look at spontaneous events or, No. 2, is to pull
from a large data base to pick up infrequent circumstances. And
as an example, which I think is very timely today, and Dr.
Ellenberg may be able to correct me, but, for instance, there
is a new vaccine out for rotovirus in children, and this is a
new vaccine. And it has been around a relatively short period
of time. About 1\1/2\ million doses of this vaccine have been
given.
Through the VAERS system, they have uncovered a cluster, I
think that is six or eight cases of children who have gotten
this vaccine who have developed a particular kind of small
bowel obstruction known as intussusception. And so what this
has done by this large data base with its passive reporting
system has allowed the CDC to ask the question, you know, maybe
we need to look at this data as to whether or not
intussusception is a problem with the rotovirus vaccine.
So the VAERS system has allowed the identification, or the
floating to the top, or the picking of this new problem.
Mr. Shays. OK, I am going to have my counsel--the committee
counsel, rather--ask a question. But I just need to be clear,
as I understand it. And the disadvantage is you are speaking to
someone who is not expert on this issue. The advantage is, if I
can understand it, the whole world can understand it.
And ultimately, we are going to get to that level. I was
given three reasons why the VAERS system is not appropriate to,
as a source of determining adverse-reaction rates. I was told,
one, we need to track the number of shots. Two, we can't have
under-reporting have it be valid, and we do have under-
reporting. And we have a filtering system.
I would like you to respond to that.
Gen. Claypool. The VAERS system is only one piece of the
equation. The other piece of the equation in terms of looking
at adverse events has to do with an active surveillance system.
And the department is engaging in plans to use two modalities
of active surveillance. One of them, as I mentioned, is this
large linked data base, which looks at linking the two large
data bases we have from tracking the immunizations plus the
Defense Medical Surveillance System, which is this large tri-
service located at Walter Reed.
And the ability to look at these two sources of data that
will allow us to identify people who have had the anthrax
immunization and to track that with various kinds of complaints
or problems that have occurred.
The other has to do with a cohort study; that is, to look
at some of the studies we are planning to design, and actually
have done, like the one at Tripler, where we do active
surveillance, looking at a cohort of people to look for
specific side-effect problems.
We can't do active surveillance on 2.4 million people. That
isn't a common practice in civilian, where we would track every
single individual. That would require us contacting them, you
know, after each injection.
Mr. Shays. Yes, Admiral.
Adm. Cowan. If I could perhaps state that in a slightly
different way. What you said about VAERS as the single way to
track is absolutely true. It doesn't track the shots. It
certainly will under-report side effects because it is
voluntary and it could be a filter.
Back in the sixties, NASA taught us that if you want a
system to run right, you make redundant systems within systems.
And so we have, as we have learned about this vaccine, we have
been attempting to do that. We have a Hoffman survey and a
Tripler study following a population of people. We know where
they are; we watch them very closely. And we will end up with a
statistically significant and accurate rate of the side
effects, the adverse effects.
The business of filtering is a very big one, and I am glad
that got touched on because it is the intent of the VAERS to
find the unexpected association. Nobody had the slightest idea
when swine flu came about that that would be associated with
Guillane Barre. And they started popping up. It is not a
natural association. You wouldn't have predicted it. And so we
want the sentinel out there that guides us to the unexpected
event. We want to do the measurements that tell us what the
actual incidence of side effects is. And then we track the
shots for the denominator.
We have got very good numbers on the shots. So all of these
things packed together, we are gaining an ever-better sight
picture of exactly what is going on with our population.
Mr. Shays. Thank you. I am just going to have the counsel
ask a question.
The Counsel. Which leads to the question then, what is the
adverse reaction rate for the anthrax vaccine. In planning the
program from its initiation and planning it from here forward,
what do you assume the reaction rate to be? Therefore, how many
patients do you expect to see? How many allergists will you
need to treat them?
Do you stick by the adverse reaction rates that are in the
product labeling, or have we learned something different in
these studies?
Gen. Claypool. You know, I think this entire anthrax
vaccination program represents a continuum which we continually
try to improve and make better. The product packaging, the
information that comes with it, is based upon the licensing of
the vaccine when it was given.
As we gather more information, we suspect, we feel
confident we will come up with a better estimate as to what
indeed reaction rates are.
As an anecdote, you know, at least three of us up here have
had at least a total of five shots each. So there have been 15
shots given up here. If I were asked, if I were polled about
whether I had a reaction, I would say, yes, my arm hurt; I
really felt achy for a day. It swole up. I actually had trouble
doing pushups because my arm was aching. And so if I were in an
active system, I would be picked up as a mild local or maybe
mild, even moderately systemic reaction because I felt sick
after the one shot.
But I wasn't. I went through my duties. I went through the
rest of the immunization series without any problem. So my
entry was not recorded as an adverse system, as an adverse
event.
So under an active surveillance system, these kinds of
things would be picked up.
The Counsel. And you have already found that the rate of
mild and moderate local reactions is higher than the product
labeling indicates that. Correct?
Gen. Claypool. We say we have already found. We have done a
number of different studies, and Colonel Gerber may be able to
speak to them specifically. But we looked at different cohorts
and differing populations, and, depending upon, you know, how
you are collecting the information, we do believe it will be
higher. Yes.
The Counsel. And then, Dr. Engler, what is the, what can
say, what is the relationship between a higher incidence of
local reactions and any suggestions or conclusions about the
incidence of systemic reactions? Is there a relationship
between the two?
Col. Engler. If your are talking about short-term, self-
limited, flu-like symptoms, low-grade fever, joint aches,
muscle aches, as people's large locals increase, those may also
be in tandem more frequent, reflecting the vigorousness of the
immune response. And there are, at least in our experience and
also in Colonel Hoffman's and Korea and the Tripler study, they
resolve generally within less than 3 to 4 days, and some
instances, for comfort, respond very well to non-steroidals,
like Motrin or Tylenol.
Mr. Shays. Yes, Dr. Sharma.
Mr. Sharma. Just, I want to make a few points here. First
of all, in the product inserts, the adverse reaction rates that
we see are from a different vaccine which has different
contents and ingredients. And I think there is an issue that we
had raised in our previous testimony; however, an assumption
was made that the two vaccines are identical and, therefore,
the adverse reaction rates would also be very similar. But this
is an assumption which hasn't been tested.
Second, following the licensing of this vaccine, we really
have very little information about its use. So we have no post-
licensing experience with this vaccine. The only time we had
was during the Gulf, when records were not maintained, and we
don't know.
This is the first time you are using this vaccine, and if
you compare the adverse reaction rates that DOD has presented
based on VAERS, which is 0.007, and they are true, by that
token, it is the safest vaccine. But when you look at the
active surveillance systems, you see a range of reaction rates
that, for some of these specific symptoms as many as 80 percent
or 90 percent close to people are reporting some adverse
reactions.
Now, I agree that a majority of them are temporary and
would disappear, but it is striking the upper range.
And second, something that we didn't know before, because
during the licensing phase, the clinic that the field trial
that was done had some problem in the sense that individuals
who were in that study had received both the vaccine, and a
determination could not be made which of the reactions were
attributable to the mark vaccine versus the current vaccine.
And second, and more importantly, the reaction-rate data
could not be differentiated with regard to the gender. So they
really didn't know how women were going to--what experiences
women had. This is the first time we have learned from the
active surveys that women are responding differently, reporting
twice the rate, and I think this is a great revelation. And I
think we would not have learned if we did not have such active
surveillance systems. And this is the point that I just wanted
to make it clear.
Adm. Cowan. If I could, sir, I would like to build on that
just a little bit. I think that is exactly right. We took the
best information we had off of the insert and the data that had
been done when we started. And we advertised those as our
adverse incidents. Adverse incidents, to my mind as a
clinician, come sort of in three flavors. There is minor local
reactions or minor systemic reactions that are very short,
self-limiting, don't require any, if only minimal, treatment.
If those become severe enough that they incapacitate a
person that he has to be treated, needs something more than
simple aspirin, then that is sort of another issue.
But those are reactions. And whether they are to the severe
end or to the mild end, we expect those to resolve and not
result in disease.
The thing that we are concerned about is the nasty
surprise. The association of a type of disease that is caused
by, that could potentially be caused by something like this
that would pop up, we want to identify that as early as
possible. And I think Dr. Sharma makes the case for having all
these different kinds of surveillances and studies ongoing so
that we learn very much up front from the numbers of people we
vaccinate as we go, and we don't miss cases or have diseases go
on or whatever, without knowing about it.
Mr. Shays. I am going to recognize Ms. Schakowsky, but I
just was trying to think, when we talked about the arbitrary
number of six, and we know that two is better than one, we
probably can agree that three is probably better than two, but
we are not quite sure, particularly from a military standpoint,
they may ultimately recommend it be three.
How many shots, when I was in elementary school in the
fifties, did I have in polio? Did I have one, and then one a
year later, or something? I don't--I remember it was a dramatic
event for me.
Adm. Cowan. Sir, mandatory vaccines for childhood illnesses
are profuse.
Mr. Shays. Much different?
Adm. Cowan. Well, no. They are very much the same. There
are ordinary vaccines like this is, but we started, probably
most of us, about 3 months. There are probably anywhere between
8 and 12, depending on the State and the time, smallpox,
diphtheria----
Mr. Shays. I had eight polio shots?
Adm. Cowan. No, sir. I don't know how many polio shots. Dr.
Engler may have more information about that.
Col. Engler. It depends on what year. Do you remember
getting the shots. You were in the shot series.
I don't know how young you are, sir.
Mr. Shays. What's that?
Col. Engler. I said, I don't know how young you are, sir.
So you might not have received the----
Mr. Shays. What is--I was born in 1945, and so I just kind
of remember them in the early 1950's.
Col. Engler. Yes, the inactive--at that time, there was the
injectable polio----
Mr. Shays. It was injected.
Col. Engler. That means that it is the shot form as opposed
to the oral. You may remember the sugar cube.
Mr. Shays. No. I had a shot. And I just remember not having
a lot of them. I certainly didn't have six of them.
Col. Engler. Well, at age 2 months and 4 months and 6
months, you probably would not remember.
Mr. Shays. That was just a simple question. [Laughter.]
Ms. Schakowsky.
The record will note that I did not get an answer.
[Laughter.]
That was simple.
Ms. Schakowsky. Thank you, Mr. Chairman. I wanted to
explore a little bit the difference of the reaction among
women, and wondered if any of you have any information on why
women might have more adverse and stronger adverse reactions.
Dr. Engler.
Col. Engler. I will certainly be happy to speak to that. It
is well known in the science of immunology that immunologic
responses of women in the antibody-producing side, are
enhanced. And there is some survival value to that in that the
mother transfuses her baby with antibody, and that is the first
way that you defend your baby from infection after birth.
That also has the downside that 70 to 80 percent of auto-
immune disease occurs in women. That is, when the immune system
gets confused and inappropriately causes inflammatory
destruction of self, of some organ, whether it is the thyroid
or, in lupus, multiple organ systems.
Ms. Schakowsky. So the questions to Captain Piel or the
comments that you are depressed, maybe you just want to have
babies, that she perhaps needs counseling, were not really
scientifically based, were they?
Col. Engler. Absolutely not. I think one of the challenges
in health-care delivery, both in and out of the military, has
been how women and their complaints presenting to the
traditional medical system are handled. And I think we are
certainly a long way away from where we were in that the
experiences of Captain Piel are less frequent than they used to
be, but education continues to be needed.
Gen. Claypool. I would like to say that each one of us was
offended by that assertion. I mean that is not the kind of
military system that we are part of, and that is not----
Ms. Schakowsky. Again, I want to say, General, that I
appreciate what you said at the beginning, too, that you really
encourage people to report adverse reactions and that you don't
want to have a situation where people feel fear about it or
feel that they will be intimidated.
When I was in the State legislature and there was a hearing
on home-delivered meals, and I asked the presenter from the
State, do we have any waiting list.
And they said, no, we don't have any waiting list. And then
it occurred to me to ask, do we keep track of people who are
asking? Do we know who is waiting?
And they said, no.
So, we don't want to be in that kind of situation that we
have very few reports. And, in fact, we have testimony in the
GAO report, which I had in front of me and now I don't--here we
go--that a former FDA commissioner acknowledged the under-
reporting of adverse events and passive surveillance and cited
one study showing that, ``only about 1 percent of serious
events,'' attributable to drug reactions are reported to FDA.
Are we making any estimates about the percent of reported
adverse reactions in this instance?
Col. Engler. That is a very widely quoted statistic, and I
would just like to comment that we know that there can be
substantial under-reporting to these systems. These are not
good places from which to make estimates of rates because of
that. But the under-reporting rate varies greatly, according to
a lot of different things. Could relate to the newness of the
product; it could relate to the seriousness of the event of the
time after the administration.
There are data from the CDC that suggest with regard to
vaccines that the more serious the event, the less problem
there is with under-reporting. So I think it would not be
accurate to assume that this 1 percent rate relates to medical
products across the board. I suspect there is a great amount of
variability.
Ms. Schakowsky. But still accurate to assume that it is
greatly--there is a great deal of under-reporting.
Col. Engler. It is certainly accurate to assume that, I
would say for most products, there is a great deal of under-
reporting, but as the data from CDC suggests the under-
reporting may not be so extreme for serious events after a
vaccine. I suspect we get better reporting for vaccines than
most drugs.
Ms. Schakowsky. Well, let me--as a result of the briefing
that I received yesterday, I think I feel clear about what the
benefit is to vaccinate against anthrax, that it is a threat
and that in almost cases it would be fatal. So we want to--but
in evaluating the risks, it seems yet appropriate to say, do we
have to take as many risks as we do to achieve that benefit?
And one of the really disturbing pieces for me is the
production of the vaccine itself and BioPort and its experience
and whether or not we are getting the kind of product under the
circumstances that we want from that company.
So just a couple of questions about that. Actually, I could
have a lot of questions about that.
In a June 30th hearing held by this subcommittee, BioPort
officials testified that its facility was closed after repeated
FDA violations and that they were delayed in reopening by,
``unforeseen circumstances.'' And they suggested that some of
the unforeseen circumstances included FDA's ``new''
requirements and evolving product standards.
So my question for the FDA is whether you implemented any
new requirements since the DOD contract was signed 9 months ago
that would not have been foreseen by BioPort and which would
have caused this delay?
Ms. Ellenberg. I'm sorry, that is just totally beyond my
ability to respond. We will be glad to provide, to get to the
right people and get that response back to you.
Col. Gerber. Ma'am, could I just interject, that you
mentioned that BioPort, the predecessor or the aftermath of the
MBPI plant, was involuntarily closed. I think it is very clear
that BioPort closed their plant to reconstruct the production
lines up there. They closed voluntarily on schedule to renovate
the plant.
Gen. Claypool. It was not because of the FDA findings. I
mean, it was part of the renovation to go ahead and address the
renovation issue.
Col. Gerber. It was a scheduled closure to redo the
production lines.
Ms. Schakowsky. OK. I guess what I will need, what I need
to be convinced about is why it is that we have a single
supplier that has had a history for problems dealing with the
quality of the product in the past that has been shut down that
has overestimated, underestimated by--is it--three times the
cost that the taxpayer would have to expend on this, that has
had enormous investment by the Department of Defense in terms
of all the renovation, why it is that we want to put all of our
eggs in what seems to me to be a fairly, given its history,
unreliable basket.
And I don't know, I suppose the devil is in the details,
but I would like to ask that general question.
Col. Gerber. Could I take a stab at this? You ask some very
good questions that we ask ourselves: Why all our eggs in one
basket? And we are working to resolve that.
I think there is a little interesting history here that
when you go back to the vaccine industry here in the United
States, back to the 1960's and 1970's, when there were 60 or 70
vaccine manufacturer plants in America. After some of the early
polio vaccine, even the threat of a catastrophic lawsuit caused
most of these vaccine manufacturers to close.
In fact, it is commonly known today that there are four, or
only four, principal, major vaccine manufacturers, probably a
dozen total. There is, again, the mere threat of a lawsuit is
enough to cause vaccine manufacturers not even to get into that
business. So----
Ms. Schakowsky. So we have immunized them against that. We
have given them--they aren't liable for mistakes, according to
our contract, are they?
Col. Gerber. If you are talking about the indemnification
issue, you know, in 1976 we started with the swine flu, when
the national swine flu vaccine, to indemnify that vaccine. But
the fact of the matter, most vaccines under the National
Childhood Vaccination Act are covered by Federal
indemnification. So it is not an uncommon practice.
Mr. Shays. But the answer was yes.
Col. Gerber. Affirmative.
Col. Gerber. So that's just a little history. There has
been no money in making anthrax in America, from the 1970's to
the 19--to the modern anthrax vaccine program. BioPort, I
understand, sold about 6,000 to 7,000 doses annually to
veterinarians, laboratory workers, so on, and so forth. So
there was really no need to have an additional vaccine plant.
Mr. Shays. Let me jump in if I could on this one and then I
will give you back the floor.
Ms. Schakowsky. OK.
Mr. Shays. When, and this relates to the question of sole
source. When did DOD begin work on a pure anthrax vaccine?
Col. Gerber. On a pure?
Gen. Claypool. I don't when they began to work on it, but
there is ongoing work that sometime back in the early 1990's,
at least probably 1993 or 1994, I'm guessing, is when the work
began.
Mr. Shays. And when did you discontinue it?
Gen. Claypool. It hasn't been discontinued. It is still
ongoing. I think what you are talking about is the recombinant
PA vaccine.
Mr. Shays. General, could we be clearer on whether your
definition of ongoing means that it hasn't been discontinued
but it is going no where. Is this, is this, are we under active
pursuit of a pure vaccine.
Gen. Claypool. Yes. Let me add. I would like to address
that. I appreciate the opportunity to do that. Back in 1994, in
about that time period, at that point, when we did not have an
AVIP program to immunize the total force and we did have the
current FDA-established vaccine and we didn't have the program
we have in place and we didn't have the ability to have the
total force immunized, we had an FDA fully licensed vaccine.
And so at that point, as you know Congress requires us to
have fiscal responsibility for our programs, there was dialog
and discussions, and at that time the best decision was made,
since we had a fully licensed vaccine by the FDA, it may not
make the most sense at that point to go ahead and continue with
the development of a new vaccine, given all the other kinds of
requirements that we have.
As you know, things have changed. We now have a total force
immunization process, and so what we are doing is we are
looking at ways to take this vaccine, and, if we can, go ahead
and----
Mr. Shays. OK. So the answer really is, that we don't have
an ongoing program for a pure vaccine right now. We
discontinued----
Gen. Claypool. No, sir, that is not correct.
Mr. Shays. OK, we are going to pin this one down because
this is really important. And let me just tell you where it
leads me. We were Camar and Great Britain, where they were
surprised, I think it is fair to say, that the United States
made a determination to take an old vaccine with impurities
under old technology that would probably not even get licensed
today under FDA, and they were surprised that we sought to use
this old vaccine when it was used for a few hundred a year and
then ratcheted up to millions.
And the negative, obviously would be, by developing a pure
vaccine, it would take time. The positive would be that it
would be a pure vaccine and you wouldn't have as many adverse
reactions.
And then this really gets to the point that Ms. Schakowsky
is raising. It is my understanding that the pure vaccine does
not have to be isolated, that it can be made in a plant where
other vaccines can be made. And, therefore, you are more likely
to have other players in this process. You wouldn't have to
have just this sole--a facility just solely devoted to this.
So that is why I am going down this route. And what I think
is on the table, honestly, and if I am wrong then we will let
the record correct it, but it is important we be really
accurate here. My understanding was, the DOD was pursuing a
pure vaccine and made a determination that we need to act now,
and the only thing we had on the table right now was this older
vaccine.
So we made a decision that we would go with that. And it is
my understanding that we are treading water right now in the
development of a new vaccine. Treading water to me is basically
going nowhere. And that is my interpretation, and if I am
wrong, I want you to correct it.
Gen. Claypool. On Friday, this coming Friday, Mr. Dave
Oliver, who had the opportunity to appear before your committee
recently, has directed me to go ahead and convene a group of
individuals that will help look at the question about the
feasibility of bringing from farm to market, or bringing to
production, this new capability. So I am having a task force
that includes members from MR----
Mr. Shays. That's fair. That's fair. But that is different
than what you said, it seems to me. That is saying that you are
considering resurrecting this.
Gen. Claypool. Well, the research--excuse me, sir--the
research has been going on. I don't know the details. It hasn't
received a lot of funding, and it hasn't received a lot of
priority on the list of priorities. But it hasn't been stopped,
it hasn't been stopped.
Mr. Shays. OK.
Now this testimony is from when?
I would love GAO to jump in on this because I am looking on
page 4, and you said: The vaccine was tested on animals, but
clinical trials were not conducted in humans. DOD currently
considers such a vaccine an unfunded requirement.
Gen. Claypool. Can we take that for the record and come
back with specific numbers. I am going to get those.
Mr. Shays. Yes, I would like--we can get specific numbers,
but I would like to have a sense of where we are at.
Gen. Claypool. I mean, me personally, I can tell you that I
am, you know, because of the--I truly believe that in the
environment in which the decision was made, when it was made,
it was made with the best available information at that point.
At this time, given the fact that Representative Schakowsky
identified the fact that we have all of our eggs in one basket,
not only with one producer but with one facility. And for
national security concerns, many of us have wondered whether or
not we need to have another facility just to be able to protect
our source.
Mr. Shays. And that part is a valid concern.
Gen. Claypool. So, what I am saying is, is that I think the
equation has changed. And because of that, I think it is
important to look to see whether we can take this new vaccine,
kick start it, jump start the basic research that goes to the
tech base, that gets the production. And this is what we are
trying to get at.
Mr. Shays. OK. I understand that, General. I am just--kick
start means it wasn't started. And I just don't want us to
quibble over terms. Whatever your understanding of the term and
whatever my understanding is, in the end we have to have one
sense of it. And I am not trying to put words in your mouth,
but my sense is that we have a dormant program, and you want to
kick start it.
And if my word dormant--if you want to elaborate on that,
but let me first have GAO jump in because they were the ones
who kind of introduced that concern. And then let me give you
some time to think about what you want to say about it.
Mr. Chan.
Mr. Chan. Let me try to answer this question. Give you a
little bit of perspective here. Since the alternative issue has
been raised about it. And then I certainly will ask Dr. Sharma
to supplement it.
The way I understand it is that as far back as----
Mr. Shays. Talk into this mic here. OK? Turn it.
Mr. Chan. Which way? This one? OK.
Mr. Shays. The bigger mic will pick it up, but the
amplification is in this mic here. OK? Thank you.
Mr. Chan. The way I understand it, as far back as 1988, the
Department of Defense with health affairs had decided that they
needed to pursue production of an anthrax vaccine, and at that
time, clearly, MBPI was the only producer. And they were the
ones that produced the vaccine for the Gulf war soldiers at the
time.
In 1991, around September of that time, they decided to
examine the possibility of having a second source to produce
the vaccine, using the same manufacturing process as well as
the same formula.
Mr. Shays. The old technology.
Mr. Chan. Yes, and that is with NIH and PRI. That is how I
understand it. But by 1993, they decided that they should not
pursue this course of action even though the building in Fort
Detrick had been prepared to supposedly produce such a vaccine.
Mr. Shays. You're not talking about creating a new vaccine.
Mr. Chan. No. It is the same thing. I am just trying to
give a perspective.
Mr. Shays. OK.
Mr. Chan. Meanwhile, I think as late as 1980's, everybody
had given some thoughts about it: This may not be the vaccine
to go in the long term and experiments had been done. As we
stated in our testimony that research had been done with a
recombinant PA vaccine, which is pure and clearly would not
have, possibly, impurities and have a much better control and
so on.
Mr. Shays. Let me interrupt you a second.
Mr. Chan. Excuse me.
Mr. Shays. Excuse me, I am interrupting you.
The advantage of a pure vaccine is you will have less
adverse reaction, one, and two, my understanding is that you
would be able to produce it in a plant that wasn't totally
dedicated just to this vaccine.
Mr. Chan. Exactly, the intent is to have a vaccine that is
non-spore forming so that in fact it would be safe to produce
it without dedicated building for that purpose.
OK. And as I understand it, and now may I quote General
Blank, who told me that as of 3 or 4 years ago, they
discontinued this effort to continue with, you know--so that is
why we said there is no further clinical trials being done on
this particular approach.
So our understanding recently is that HHS is thinking about
pursuing this.
Mr. Shays. OK. But that is what is on the table, and then
tell us where you think that is accurate and where you think it
is not.
Gen. Claypool. Yes, sir.
Adm. Cowan. I will make one quick comment. I think we need
to go back and find out exactly what is going on and bring it
back to you. I do know there is an $18,000 bonus of money that
has been given by the Joint Program Office for research in
animal and assay validation studies. Those are ongoing now.
It is likely, upon termination of that, at this point in
time, there are truly no more funds available for research
going beyond there. That should be resolved or get resolved at
this upcoming meeting that General Claypool said.
But we will get the accurate information back to you.
Mr. Shays. Well, well--yes, Dr. Sharma.
Mr. Sharma. Let me just sort of give you a little detail.
In 1995, that was the last year funding was provided for the
recombinant vaccine. At that time----
Mr. Shays. And the combinant vaccine is the new vaccine?
Mr. Sharma. Right. And at that time----
Mr. Shays. Recombinant, I'm sorry.
Mr. Sharma. Recombinant vaccine. All the basic R&D work was
done and they were ready to go ahead for clinical trials. But
since the funding was stopped and it was considered to be not,
you know, a priority, the researchers stopped there.
Now, we had also spoken to the commercial manufacturers,
because this was one of the issues that, you know, DOD was
dealing with. And we wanted to know two things: their, you
know, comments and reactions about the current vaccine or their
assessment, and their willingness to join in the partnership
with the Department of Defense or what their concerns were.
It is true indeed that the current vaccine requires the
dedicated facility, but Merck and Lederle and American Home
Products told us that if the Department of Defense would
consider a recombinant vaccine, that they would consider
production. One of the major difficulties is because they don't
buy----
Mr. Shays. Let me just--we are getting off a little. I
mean, what's on the table, I just want to nail down, is what I
understand is--and you have helped answer, Dr. Sharma--but I
think we are getting off a little here. The bottom line is we
have the older technology in use, and that is the policy to use
it. And we have a contract with a producer, the sole source.
And it is my understanding, based on the testimony of the
GAO, that this is--the program to go to the recombinant anthrax
vaccine is really basically on hold except, Admiral, for
$18,000 continuing research, which in my judgment is
practically insignificant to almost irrelevant but important
you mention it, just so it is on the record.
And that, General, whether it is a glimmer in your eye or
not, it doesn't make it an ongoing program. And so I think what
is on the table is that we aren't able, we aren't actively
pursuing that program as of now.
We may, and we probably should.
Col. Engler. Sir?
Gen. Claypool. Well I consider----
Mr. Shays. Now let me just say something. Before we all
answer. The deeply--Admiral, I am sorry, General, I am sorry to
interrupt you--but I just want to say to you that with no
disrespect, we will keep going down this road if you want to,
and I am happy to. But I am looking at the testimony today, and
it seems pretty clear.
I don't want to suggest you shouldn't go further if you are
comfortable, but----
Col. Engler. Sir, I would just like to add for the record
that the assumption that a recombinant DNA vaccine will have
fewer side-effect rates in terms of local reaction or systemic
flu-like symptoms is not necessarily true. The new recombinant
DNA Lyme vaccine has a very high rate of both local-reaction
side effect and systemic side effects. And there is a concern
in regards to perhaps some people being at risk for auto-immune
disease with that vaccine.
And we have, as an old vaccine person for many years, I can
tell you some of the, ``newer and better recombinant vaccines''
have actually had higher local-reaction rates because of some
of the other elements in--the concept that they are totally
pure is not technically correct, sir.
Mr. Shays. OK. I don't want to--I realize and I think it is
important to be technically correct, but as a general rule, is
it not true that a newer vaccine is more likely to have
benefits that will not have the side effects?
Adm. Cowan. Sir, I think we all agree that we should do
this. I have--perhaps this can bring this to closure. Recently
the National--this is one of the responses to the questions
that you had asked in preparation for this. Recently NI--the
National Institute of Allergy and Infectious Disease formed a
working group on anthrax vaccines. NIH, FDA, USAMRIID were all
there. Two meetings were held. The latest on February 19th. An
NOU is being developed to develop this new vaccine. It is
estimated that completion of phase one and phase two studies
and a surrogate model for proof of efficacy could lead to
licensure within 8 years.
So there is a current program. There is interagency
development under way. We are not going to have all the
information here, and so we will take the question. But it is
under way, sir.
And we all agree we should do that.
Mr. Shays. General, did you have anything you wanted to
say. Do you have anything you want to add to this.
Gen. Claypool. No, sir.
Mr. Shays. I interrupted you, and I apologize for not
letting you finish. Is there anything that you wanted to add to
this.
Gen. Claypool. No. I mean. I would repeat what Admiral
Cowan has said. I mean, I think that I consider this a live
program in the sense that we have been doing some things. Maybe
we could do more; we intend to do more. It isn't a foregone
conclusion that we will be able to come up with a product, even
in 5 to 8 years.
In the meantime, the anthrax vaccine that we have,
venerable though it is, is a safe and effective vaccine.
Mr. Shays. Just to make a point, this is an 8-year program,
but had we started in real aggressively it would be 3 years to
go, as my counsel has just whispered in my ear. And that is why
he is next to my ear.
Mr. Shays. So. All right.
Mr. Chan. Can I add a couple points here, somehow.
Mr. Shays. Sure.
Mr. Chan. I think it is important. When we talk about the
disadvantages of the current vaccine, one clearly was the
production problem because of the spore form, and that limits
you in terms of getting greater participation for competitive
production of that vaccine.
It is the second major problem, which I wish, you know,
that we should think about, is the fact that it is often used--
the reason why we cannot have a vaccine, IND-approved and all
that, it's because of the fact that we need human clinical
trials. And we can't do that.
And the advantage, hopefully, with a new vaccine is that
somehow you can, and as Admiral Cowan said, find a surrogate by
which you can correlate that fact that using animal study to
show that, in fact, it would give you the efficacy against
humans, thereby bypassing the human medical trials.
I think that is the major advantage of something new, if
that is doable. And they are looking into that, and there is
some science behind it, how it can be done and so on. And
certainly I think it is worthy of looking into because I think
that is the other major barrier for developing a new vaccines.
Mr. Shays. Dr. Sharma.
Mr. Sharma. I would just like to add, I think one of the
difficulties, we are saying things here for which I am not sure
we have complete evidence about its efficacy. Yes, it is true--
--
Mr. Shays. Sir, I am going to interrupt you a second.
[Chairman consults Ms. Schakowsky.]
Mr. Shays. Only one vote? Two votes?
I am sorry. Hold on 1 second.
[Consultation continues with counsel.]
Mr. Shays. I am sorry, we are going to be asking you to
come back. I think that we need to nail these down. I know you
all have been here a long time, but we are going to have two
votes. We will continue for a few more minutes, but I can't let
one go and then come back, because we still have two votes. So
I apologize for that.
I am sorry, why don't you continue.
Mr. Sharma. I think one of the problems with this vaccine
is that, you know, as Mr. Chan mentioned about the lack of
correlates, and when this vaccine was licensed antibody levels
were considered to be a marker, but subsequently we have found
that there is no relationship between antibodies level and
protection. And that raises this whole issue about the number
of the shots itself.
I mean, the whole premise of number of shots is that if you
reach certain level of antibodies your body has, then it will
protect you. So for that reason, if you can attain, you know, a
certain antibodies level with two shots, you as much protected
as with six shots.
And I think I have to really recognize Dr. Engler, who is
in my view an excellent clinician and researcher and from whom
I have learned quite a bit about the relationship between
antibodies and their implications.
With the recombinant vaccine, in addition to developing
surrogate markers for protection for which whereby we could
certainly know for sure that the vaccine will work or not, it
would also require fewer doses which certainly has, in the
current vaccine, a clear indication that the more shots you
give, and logically you would expect more reactions. So if you
have fewer shots, and the researcher that we have spoken to at
USAMRIID and in Camar in England, they certainly seem to
believe that you could easily reduce the dosage to two, or at
the most three. And that is quite a bit of improvement over the
current vaccine.
Mr. Shays. OK. Let me--we have about 8 more minutes. Do you
want to take about 5 minutes now and then come back or do you
want to just----
Ms. Schakowsky. Well, unless you want to follow this----
Mr. Shays. Yes, I am going to be asking you to come back.
And we are going to promise you that when we come back it will
only be 30 minutes, at the most. So you can judge how much time
you have left.
We have one vote, and then we have another. As soon as that
other vote is over, we will come back. And we have a few more
minutes if you want to just ask a few.
Ms. Schakowsky. I did want to followup on something that
was brought up by the other panel, and I am not sure who the
appropriate person would be to answer: the issue of the concept
of waiver, and if anybody is allowed to have one, under what
circumstances, do they exist. What's the policy?
Col. Gerber. If I could take that, ma'am. We refer to
waivers and deferrals, as you had asked us in your question,
Congressman Shays, we actually refer to those as exemptions. In
the DOD we have permanent and temporary exemptions, your terms
for waivers and deferrals.
In the DOD system, we have 11, I am sorry, 12 categories of
permanent and temporary exemptions: 5 categories of medical
exemptions and 7 categories of administrative exemptions. We
are presently, all services inputting those permanent and
temporary exemptions into the Defense Enrollment Eligibility
Requirements, the DEER system.
The Army was the first to input those. The Air Force is
inputting them now. And after the Air Force finishes, the Navy
is the third scheduled in line to input their medical and
administrative exemptions.
Let me just speak for the Army. That was the first in line
or the first scheduled to dump their exemptions into the
system. The Army, for example, records 5,779 exemptions in the
system; 92 percent of those, 5,700 exemptions, are for
administrative reasons. For example, a soldier has died. We
want to take him out of the system so he doesn't count against
compliance.
Ms. Schakowsky. That makes sense. [Laughter.]
Col. Gerber. The majority of those--well, the vast majority
of those are, for example, permanent changes of station: A
sergeant leaves my unit; while he is inbound to the next unit,
I want him to come off of my rolls so I am not beaten up for
non-compliance.
And then we have 8 percent of the remaining 5,700
exemptions that are there for medical reasons; 79 percent of
those medical exemption categories are for a medical temporary
pregnancy hospitalization or convalescent leave.
So, we are getting a very good handle on all the
exemptions, both medical and administrative.
Ms. Schakowsky. So, if someone exhibits some kind of an
allergic reaction or serious adverse reaction, are they ever
eligible for an exemption?
Col. Gerber. Absolutely. I am going to ask Dr. Engler to
expound on the medical aspect, but it is very common in our
system when our soldier, sailor, airman, Marine comes in and
requires some sort of exemption. For example, he has had a heat
injury or he has had a cold injury, we frequently write
permanent and temporary profiles to limit their duty for
temporary or permanent periods of time.
It is a very common experience, and I will ask Dr. Engler
to simply comment on----
Ms. Schakowsky. Well, let me just--then Captain Piel could
get, might be eligible or would be eligible for an exemption.
Couldn't fly in those particular areas but would--could you
explain this, it further?
Col. Engler. Yes. Anyone to any vaccine, travel vaccines
and other vaccines that may be indicated or required for
deployment, if there is a serious and persistent adverse
reaction, and the majority of the adverse reactions that we
see, we treat, and we continue the immunization with certain
interventions or special approaches. So in that case, there is
no need for a permanent medical exemption.
Really relatively rarely, if--and so none of these are
filed until the work-up is completed and the treatment is done.
And I think there may be some confusion in that initially a
temporary exemption or temporary delay until the situation is
clarified. And if then it is deemed that the benefit risk
ration does not justify continued immunization, then there
should be a submission of a medical exemption from that
vaccine.
Mr. Shays. We have 4\1/2\ minutes until the time is out.
And they will probably leave the machine open a speck longer.
As soon as the next vote, we will vote, and we will come back.
And we will get you out in 30 minutes, even if we want to
go further.
[Recess.]
Mr. Shays. I call this hearing to order again, and we are
going to get you out very quickly. Let me start with you,
Colonel Engler. And if you would tell me how many patients have
you seen at Walter Reed--this is for Colonel Engler--how many
patients have you seen at Walter Reed who present symptoms that
may be associated with the anthrax vaccine?
Col. Engler. In terms of referrals for specific adverse
reactions or prolonged?
Mr. Shays. Yes.
Col. Engler. At this point, from all over, and we have a
wide referral base, we are--I don't have the exact number--but
it is in excess of 40.
Mr. Shays. OK. How many have been sent from Dover Air Force
Base?
Col. Engler. At this point, my department has, I believe,
had six of those patients. And there are scheduled right now,
the rest of them to come down, not just to see my department
but other departments based on their symptoms.
Mr. Shays. And the rest constitute about how many?
Col. Engler. The 40 that I mentioned to you are independent
of Dover.
Mr. Shays. All right. And then six----
Col. Engler. Then six from Dover to date.
Mr. Shays. And are you expecting more?
Col. Engler. Yes.
Mr. Shays. How many more?
Col. Engler. The plan that I was informed because--I would
be happy to get specifics back to you cause I have been out due
to the death of my mother--but the plan is that all of them
will come to Walter Reed. If they have symptoms referrable to
neurology or endocrinology they may not come to my department.
So there is a centralized plan for Walter Reed to respond to
anyone who has a problem.
Mr. Shays. I am very sorry to hear about your mother. Is
this something very recent?
Col. Engler. Yes.
Mr. Shays. It's is good that you are willing to be here
under those circumstances.
I just would like to ask you, is the number closer to 30
from Dover, because that is the number being bandied about?
Col. Engler. Again, I have been told that the spreadsheet
that is being maintained has 31, but, again, it is plus or
minus, please----
Mr. Shays. I know. Is there any commonality of symptoms in
the patients you are seeing?
Col. Engler. No. There are maybe two patients that have
overlapping symptoms, you know, two here, two there, but for
the most part, they are distinct. What frequently, if you take
the whole group, not focusing on Dover alone, we see an awful
lot of the more severe large locals who have had flu-like
symptoms that may have persisted for a week, and the question
is, continuance or not.
Mr. Shays. Are the symptoms, any of them related to the
same kind of symptoms we see in Gulf war illnesses.
Col. Engler. There are a few patients that I am aware of in
detail that have overlapping symptomatology to Chronic Fatigue
Syndrome and Gulf war illness-like symptoms.
As you know, the symptomatology with Gulf war is somewhat
heterogeneous in that there isn't one single pattern of
symptoms.
Mr. Shays. Let me just yield to the counsel.
The Counsel. Any commonality in terms of ears or, you know,
audic nerves? We heard about ear infection before. There is a
lot of reports about tinnitus and ear-ringing.
Col. Engler. Right. Ringing in the ears. In the spread
sheet that we are compiling on those folks that we are seeing,
I have a total of four patients who, as part of their symptoms,
have had tinnitus. I would say that at least two of them are
still being tested as to whether they have had some damage to
their hearing just from the noise exposure, you know,
occupationally that they have had. So that needs to be
clarified.
But the patients have believed that their symptoms worsened
with a repeated dose of anthrax.
Mr. Shays. Thank you. Doctor, General Claypool, how many
immunologists does DOD employ or retain as consultants?
Gen. Claypool. I would have to check the records. I don't
know.
Mr. Shays. OK. That would be a number we would like to have
a sense of. When we dealt with the Gulf war illnesses, we found
that illnesses related to chemical exposure, expertise in that
area was rather slim. And I would want the same for the
allergists. How many you would employ as well.
Gen. Claypool. I will ask you a specific question. As
immunologists, you mean--allergy and immunology is usually a
conjoined or one flavor. So, we will come up with some numbers.
Mr. Shays. I think you get the sense of the areas that we
would like. And we would like to just know if there is
appropriate expertise or whether the military has the
appropriate expertise in these areas and the numbers.
Sorry.
Col. Engler. I was just going to comment that I think we
need to get to the numbers together cause they are in the
research division, there are research immunologists who
specialize in vaccine research. I am not privy to the exact
numbers. And there are clinical immunologists who manage
clinics.
Mr. Shays. The logic to it is, if we are going to have 2
million-plus, we are going to have some people who are going to
legitimately have symptoms and some severe reactions. And do we
have the expertise to cope with that. That is the basis for the
question. And we will leave that on the table that you will get
back to us on that.
Let me just as four more questions, unless there is a
followup. Let me--Ms. Ellenberg, if you would, you have said,
according to FDA, passive surveillance systems are essential to
the discovery of potential rare adverse consequences of medical
products that may not become evident until many thousands or
millions of people have been exposed to them. That is from your
statement.
And, is the FDA satisfied the DOD's surveillance efforts
using VAERS is being implemented consistently and thoroughly
enough to capture, ``signal events or unexpected adverse
reaction trends?''
Ms. Ellenberg. We don't have a way of monitoring exactly
how this is being implemented. The plans that have been shared
with us in terms of the reporting, the basis for reporting,
should be able to get us reasonable numbers of what we would
consider the serious events, if in fact all such events are
reported. And we have been told that the criteria that were
originally put forward are being expanded to include
significant medical events.
Mr. Shays. But you do have some concern about the fact that
this data is passive, it's not----
Ms. Ellenberg. I wouldn't use this kind of a system to
give, to come up with precise estimates of rates of adverse
events. You really need, as has been discussed previously, a
more active, more effort, a formal study to be able to produce
those kinds of estimates.
Mr. Shays. Just as it relates, and I know that Ms.
Schakowsky had asked the question, particularly as they relate
to women, a number of them, but would you accept the VAERS data
that says that women have twice the negative reaction that men
do or----
Ms. Ellenberg. Well, we can't make those kinds of estimates
right now from the VAERS data. We have a relatively small
number of reports. The actual--in our reporting system, there
are more reports for men than for women. We don't know what the
balance is in terms of who got the vaccine. So we really can't
make those estimates from VAERS data.
Mr. Shays. OK. I am sorry. Dr. Engler.
Col. Engler. I just thought it might be helpful to the
committee that the VAERS reports can be duplicative so that the
numbers--you know, there could be two or three for the same
patient, or if a person has a large local with mild flu
symptoms for dose one, two, and three, those are three VAERS
reports. So the frequency--it is not a system that will give
you the data for the side-effect rates that we put in a vaccine
information sheet or educate the patient about what to expect.
That is done with solicited surveys.
Ms. Ellenberg. But actually, we do search for duplicates.
The numbers that we are giving you, 215, were done after
duplicate reports were taken out.
Mr. Shays. The challenge is that the VAERS gets attacked
from both sides, but the DOD, you know, uses it as viable
information. I mean, this is documents that you have. And so,
it is just a little unsettling to me that we would base much of
anything on it, frankly.
Col. Gerber. Sir, could I just add that the chart that you
see depicted comes out of our office and what we are reporting
is the rate of reporting. We are not using that chart to depict
that that is the number of adverse reactions or events. It is
the rate of VAERS reports submitted, the VAERS form dash one.
Mr. Shays. Well, you basically, in the chart, say 65
adverse reactions of 890,888 cases of vaccinations given, 0.007
percent. I mean, that is given to make people feel comfortable.
And so, I think it is being used differently than you think it
is.
This is a PR document in favor of the vaccine.
Dr. Braun, is there anything that you want to say. I find
that people who don't participate sometimes have very cogent
observations cause they have been listening instead of talking.
[Laughter.]
No reflection on you.
Dr. Braun. Not at this time. Thank you for the opportunity.
Mr. Shays. I am going to assume that you are brilliant.
[Laughter.]
Ms. Ellenberg. That is why I hired him.
Mr. Shays. There is this wonderful picture of Attorney
General Mitchell--this is off the record--when he was working
with President Nixon, and he was described as the person who
had created the new Nixon. And he was described as brilliant.
And he never said anything. You just saw him sit in the biggest
chair at the White House. And then one day we got to see him
speak at Watergate, and we all had a different feeling.
[Laughter.]
OK, you are on.
Why did I say that? [Laughter.]
I'm counting on you, boss.
Ms. Schakowsky. A couple of things that I would like given
to me, one is, at an earlier hearing with different witnesses,
I had asked for a list of the producers of vaccines that also
get the same kind of indemnification. And maybe it is in the
process to get to me. But I haven't gotten it yet. And the
other is, I would like, Colonel Gerber, a copy of the waiver
policy, and also you gave some statistics on who--not waiver,
exemption policy. And I would like to see that and also some of
the numbers associated with that.
Dr. Sharma, you had your hand up and I didn't get to hear
what you had to say in regard to the issue of the differential
between men and women in their effect. I wondered if you had
some comments on that, on the gender issue?
Mr. Sharma. Yes, I think this is significant because if you
take a look at the percentages, we see two things. Overall
reaction rate in both men and women is in these active systems
significantly higher than what we had assumed it to be to date,
and second, these findings about differences in genders have
very specific implications about the dosing or over-dosing in
women. And I think I would like to--I mean, there is nobody I
know in this panel, perhaps there are, but at least I know Dr.
Engler has tremendous expertise and we have talked to, and
maybe she would like to comment on that. And she--I think it is
more appropriate at this point.
Ms. Schakowsky. Thank you.
Col. Engler. I think the challenges of making a vaccination
program like anthrax better as we learn and the science and
immunology of female immune responses versus male is still
somewhat in the growing phase. But we already know that inter-
muscularly the anthrax vaccine, a large local reactions, are
radically reduced. And the preliminary data, as far as I
understand, was presented in December 1998 to the FDA and they
just asked for larger numbers to allow us to change the route.
And that also helped women in terms of the large local
reactions.
And then, the other issue is that we would like to address
that fact that in the female population are probably going to
be more what we call hyper-responders. And in other vaccine
models we know that hyper-responders do not need the full
series. And in many vaccine models over time, tetanus was an
example, many of you may remember we used to get a booster
every 3 to 5 years, now we get it every 10 because it was
learned that it wasn't necessary because there was such a high
rate of hyper-response as you continue.
And I think we are learning the same lessons with anthrax
and that the program will evolve in that knowledge-base to make
it better.
Ms. Schakowsky. I think it is so important that we do
carefully examine this data because it is only in recent
history that we have even looked at the different impacts on
women in clinical trials. For years, only men were observed.
And so I think it so important that we don't have a one size
fits all when it comes to gender and the application of this
vaccine.
Gen. Claypool. And I believe in the license applications
too--excuse me--but I don't think that women were part of the
study when the initial license request was submitted. So that
is a valid thing that we are pursuing.
Ms. Ellenberg. I actually--because we don't have the data
on gender from the original study, nobody knows for sure, but
there are suggestions in the data that women were in fact
included. But I would have no idea what the ration was.
These were done in millworkers, and there is no reason to
think that there wouldn't have been women.
Ms. Schakowsky. I am trying to remember what my final--oh,
I know what it was. OK, I got it.
I don't know what you call it again, that information sheet
that is included with any vaccine.
Col. Gerber. Product insert.
Ms. Schakowsky. The product insert, were you saying--was it
Mr. Chan or Dr. Sharma--that it was based on a different
formulation? Is that legal? Are we allowed to do that, to put
information about a different drug in, you know?
Mr. Sharma. I think I am not a lawyer and nor is Mr. Chan,
but perhaps the FDA could comment on that. However, to be fair,
I think there was an assumption made that these are two very
similar vaccines. However, there is a difference between look-
alike and having the same gene. They are not identical, and we
do know, for example, there are some differences, some of them.
Certainly there is some suggestion from the clinical literature
that they are associated with higher reactogenicity levels.
One of them is that this vaccine has higher PA content, and
there is some suggestion from the different vaccines using
different PA content level that higher content levels are
associated with higher reactogenicity, for example.
Second, this vaccine uses aluminum hydroxides, and there is
some suggestion that similar vaccines, other vaccines, that use
aluminum hydroxides have higher reactogenicity. I think these
are important differences which I am not sure, and again we are
going back to the history, to what extent they were looked or
not looked. We have, you know, documentation of the IND that
was submitted and any written documentation that existed, which
is not much compared to the current standard. So it is really
hard to go back and say why they made that assumption, but it
is very clear they made an assumption, and everything that we
know about what is mentioned there is about from the other
vaccine, which was similar.
Ms. Schakowsky. It just seems to me, in terms of confidence
in the entire program, that it is really important that
accurate information be given, that there is good access to
information, that we monitor accurately and fully inform, and
that we process it well. And in that regard, I feel the
hearings that I have been at that I don't have that sense of
confidence that really any of those things happened.
Col. Engler. I would just like to add one comment to what
you just said that I think risk communication and communicating
with patients at a level that they can understand and that is
meaningful for what they experience following any therapy is a
continuing challenge for the health-care system in and outside
of the military. The CDC has for the standard vaccines, not the
travel vaccines, a whole staff dedicated to translating what we
call vaccine information sheets cause the package inserts
aren't real helpful to patients.
And we are in the process, actually, right now of having a
draft document that is being reworked by the CDC to have the
same kind of equivalent information as we give to parents of
children who are coming for their polio or DPT that is a more
balanced reflection of risk communication. And I think we all
here recognize that there is a need for improvement in risk
communication.
And I think, like with the Lyme vaccine, there is no VIS
yes, vaccine information sheet. So we are challenged in the
clinical arena to make our own. And I personally think that
before a vaccine is licensed, not just a package insert but a
VIS should be developed and marketed with it because right now
the clinicians are left a little bit to hang out to dry.
Mr. Sharma. I think I would like to have a comment to
follow Dr. Engler. I think she mentioned about the management
strategies that are available for other vaccines, and I think
DOD has an opportunity to develop such strategies, especially
as they pertain to women, especially as they pertain to people
who are hyper-responders. And I think we could really, you
know, learn something about this vaccine as it, you know, the
events are taking place.
But without those models, it is going to be very difficult
to know what is happening to people and something that we have
learned, I mean, people call us. Immediately after we started
the study we were getting about 100 calls a week between Mr.
Chan and myself. And these were calling from public telephones
because they were afraid, they didn't want to be identified
talking to us.
They see people there left and right are getting sick. Now,
it may be, you know, whatever, I am not questioning whether
those events were associated with vaccines or not, but they
want to be heard, they want to be managed, and such strategies
would certainly help gaining confidence of these individuals.
And DOD should consider using or developing models for
anthrax as they exist for other vaccines.
Mr. Shays. I think we can conclude here by just two
questions, and I would like to make an observation, and you
might as well. But the first question would be, on what basis,
and this would be to you, General Claypool, and others respond,
on what basis does the anthrax vaccine immunization program can
deploy troops or protect them from anthrax attack after two or
three shots when the FDA-approved regimen calls for six.
Gen. Claypool. We do believe that there is at least
evidence to suggest that there is some immunologic protection
afforded after two or three shots, but the issue is, is that
would we wait until they are fully immunized with six shots
before we deploy them. No.
We can't wait until, indeed, you know, a full force totally
immunized back within the continental United States before we
send them to theaters where there are.
So, we understand that they are not fully protected, but we
have started on our road for total force immunization, and that
speaks to the issue as to why the whole force has to be
immunized because of the fact that we don't have a short lead
time. We need a long time to get the force immunized. So that
is why we are doing it.
Mr. Shays. Does Dr. Engler--excuse me, not Dr. Engler--Dr.
Ellenberg, if you would--I used to have a girlfriend named
Ellen, that is what is confusing me. [Laughter.]
Dr. Ellenberg, if you----
Ms. Schakowsky. Too much information. [Laughter.]
Mr. Shays. And that can be off the record too. [Laughter.]
Mr. Shays. It was legitimate. It was before--many years
ago. [Laughter.]
Dr. Ellenberg, would you confirm that there is indication
that two or three shots is going to provide protection?
Ms. Ellenberg. I don't have the numbers from that study in
front of me. The vast number of people who--I mean, all the
numbers were relatively small--but the big majority of people
who did get anthrax in that study were people who did not get
any vaccinations. There were a few who were partially
vaccinated who also got anthrax, and none with the full
vaccination.
Now, I don't have the numbers in front of me to remember
there were in each group, that is, how many got the full
series, how many got partial. So I can't really--I would have
to check that.
Gen. Claypool. I didn't mean to imply that I think they are
fully immunized. In fact, you know, we deploy people after they
have one shot if they are going to a theater to start, so----
Mr. Shays. I know that. I know that.
Adm. Cowan. As a matter of fact, if I could share--well
there is some evidence, going back to the Brachman study, that
there is at least partial immunization. It is not our goal, and
we feel that we are running somewhat of risk, and we just don't
like doing this. But it is an interim measure that we have
taken as we go to the total force. When we get to the end of
the program, people will come in as a condition of employment,
and then we won't have to do things like this.
Mr. Shays. Yes, I hear you. What adverse reaction rate
would be too high? There must be some level in which we say, it
just isn't worth it.
Do we have any documents or memos or anything that have
tried to wrestle with this problem?
Gen. Claypool. I think in part, it would have to be on what
kind of an adverse reaction rate it would be and how long it
would last, for instance, if indeed we found X percent had
developed a significant neurologic problem that wound up in
paralysis, of course, that would obviously be the case.
I don't mean to be vague. We don't really have an answer.
Mr. Shays. That's fair. I think of Captain Piel, and she
wants to fly. And one of the things I hope is that we all can
find a way to get her healthy again so she can fly.
And, she is a casualty cause she can't--she can still
serve, but she can't serve the way she was trained.
Let me ask if any of you would like to just make a closing
statement or just an observation or something that you think
would contribute to the hearing or you just think you would
like to put on the record.
We will start with you, Mr. Chan.
Mr. Chan. Well, I think as you said, this is the third or
fourth hearing you have on this subject.
Mr. Shays. Fourth.
Mr. Chan. Fourth, I'm sorry.
I would like to make one observation. It seems to me that
if there is a way for us to all agree with the data, the
information that is being given out, being transmitted, being
told to the soldiers are in fact of consistent and reliable
nature. That, you know, to implement this program, I think
partly requires a lot of effort in terms of outreach and people
who can speak to the soldiers because, as Dr. Sharma said, we
have been partially the receiving end of a lot of phone calls.
And we understand a few of their pains.
And we cannot advise them anything further than go to the
VAERS system and report, and if they don't want to, we couldn't
force them. And as a result, I think, you know, the discussion
around the new vaccine needs to be clarified, if that is
important or not. The discussion about how do we get to where
we are in terms of the early Brachman study using a different
formulation basically showing cutaneous anthrax as the vaccine
for that particular disease, and then applying it to inhalation
anthrax, which is currently what we believe to be a threat, we
are using a different formulation, using different strains.
The idea of the fact that the current vaccine may not be as
efficacious against other strains in animal studies. The fact
that there are potentially concerns about reactions and
reactivities, and the differences among sexes, and all those
things.
It seems to me that we clarify a lot of things, because
this is really not a question of policy, what's important, but
rather, how would you implement this program in such a way that
in fact would not affect the readiness of our forces. And that
is where, you know, I think it is a greater concern than the
issue of the details.
Mr. Shays. OK. Thank you. Dr. Sharma.
Mr. Sharma. No. I will pass.
Mr. Shays. General Claypool.
Gen. Claypool. I do have a couple of comments I would just
like to make for the record, for that terminology. First has to
do with what we were discussing about vaccine immunization
indemnification. And, as I understand it and I am not an
attorney, of course, but as I understand it, the language that
is very commonly used in such indemnification talks about an
unusually hazardous risk.
Mr. Shays. Yes.
Gen. Claypool. That unusually hazardous risk should be
construed that it is a risk because of medical consequences of
the vaccine. It is because of the financial risk to the
company, for whom the government is providing indemnification.
And it is done, I think, in sisterhood or partnership with the
National Childhood Vaccination Injury Act that led to----
Mr. Shays. So, in fairness to the military, the terminology
is more the legalistic term that is somewhat of a boilerplate.
That is your point?
Gen. Claypool. I believe the ``unusually hazardous risk,''
as I say, is not from the vaccine, per se, but toward the
financial risk.
Mr. Shays. OK.
Gen. Claypool. That's the intent behind it. So, when the
Secretary of the Army talks about that, he is not talking about
the unusual risk from the vaccine.
Mr. Shays. OK. Fair enough.
Gen. Claypool. And No. 2 is, just to make an observation,
and that is, and we have talked about this, but it certainly is
important to evaluate all these individuals that are here and
the ones that are in Dover and the ones that are coming into
the Walter Reed clinic, but we ought not assume that there is,
necessarily, a cause and effect.
These individuals are ill and they need to have their
medical conditions rendered, but the fact that it occurred
temporally with relationship of the vaccine doesn't necessarily
make it a fact that it is due to the vaccine.
Mr. Shays. I think that is true, but, you know, if in doubt
you err on their side.
Gen. Claypool. Well, the thing we want to do is get them
well again and get them back in the cockpit. That is what we
want to do.
The third is, you asked us to provide a list of
immunologists, and we are certainly happy to do that. I just
wanted to hope that you don't assume that--because it will be a
low number. Dr. Engler told me that within the Army I think
there are like roughly on the order of magnitude of 20 or so
immunologists.
You don't need immunologists to take care of people like
this. You need immunologists to help direct research and look
at laboratory studies and that sort of thing. So, the important
thing, I think, is that we have the right specialty and the
right mix and the right mechanisms to take care of individuals
who are ill. And that will include immunologists, and we will
provide that number for you.
The last thing is I think--not last thing, one more thing--
is that there is ongoing research, and we can get, if you want,
numbers and specificity, but there is ongoing research on two
accounts that we talked about. No. 1 is the characterization of
the current vaccine, from the standpoint of the antigen that is
there, the protective antigen, the concentration, as well as
the other antigens that are part of it. So we are looking at,
this is the current vaccine.
And second, there is also ongoing characterization of a
surrogate animal model. That is how we are going to have to do
business in the future anyway with the FDA. We are going to
have to do it with surrogate models. That research is under way
and ongoing.
Mr. Shays. Let me just say, as a courtesy to people when
they close, I like not to generally jump in, but on this one I
just want to say, I know the military, when they put their mind
to it. So on this level here, I think we are pretty much in a
kind of a treading water position, and I think you all need to
determine where you are going to go.
But I don't have any comfort level that we are pursuing a
new vaccine and that this is on a fast track. I don't even
think it is on a slow track.
That's with all due respect, but your point is, it's there
to be considered and to be pursued and some element of progress
is being made.
Can we agree on that?
Gen. Claypool. Yes. I was trying to address more
specifically the GAO's talk about looking at surrogate models.
We are doing that. We are working on it.
And last, I really do appreciate, sir, the opportunity to
come before you. I am very, I am very much committed to this
program. I really do believe that the risk is real and that we
have a safe and effective vaccine when----
Mr. Shays. Just to clarify for the record: the risk of an
enemy using anthrax.
Gen. Claypool. Yes. And I think that the product that we
have has a profile of adverse events that is comparable to
other vaccines. We are continuing to look for this, for anymore
severe reactions, but I think it is the right program for the
country at this time.
Mr. Shays. Thank you.
Adm. Cowan. Sir, I am also grateful for the opportunity to
be here and speak. The only job I have ever held in my entire
adult life has been a Navy doctor, taking care of sailors and
Marines, and now being responsible for the other services too.
I am particularly grateful, and I feel obligated to comment
about the first panel, not only for their courage to stand up,
but my dismay that they had to have that courage, my dismay
that the leadership somehow stiff-arms people and that the
medical department pushes them away or makes access to care
difficult.
And, frankly, that just, I find that, I don't know, equal
parts, saddening and infuriating. And one of the major messages
that I go back with is my eyes opened up at our continuing
problem of getting our people in to do the right things for
them.
So I thank you very much for that, sir.
Mr. Shays. Thank you. Thank you for those comments.
Yes, sir, Colonel Gerber.
Col. Gerber. Sir, I was also struck, impressed with your
opening premise that we are all interested in the safety and
welfare of our service members, and I think you can assume--I
mean, that is job No. 1, that is what we do for a living. I
have been associated with the anthrax vaccine immunization
program everyday for the past 20 months. And the easiest part
of my job is accepting the national intelligence estimates that
are validated every year by the five war-fighting CINC's that
readily, beyond any reasonable doubt, depict an array of
anthrax weaponized threat arrayed against our servicemen.
The second part of my job is my overwhelming belief in the
safety and efficacy of an FDA-certified vaccine that we know is
safe, it's effective, just as safe, and as reactogenic as many
of the national vaccines that we employ.
So, thank you very much for this opportunity.
Mr. Shays. Thank you very much. Colonel Engler.
Col. Engler. I also would like to thank the committee for
the opportunity to participate, and for me, at least, a unique
experience. I would like to also, for the record, state that I
think the anthrax program and the lessons learned as we evolve
it are very important lessons that may someday have value added
for the taxpayers' money expended in a future flu pandemic.
As the ex-officio member to the National Vaccine Advisory
Committee, I think there is a serious concern of how do you
deliver a vaccine rapidly and effectively to millions of people
to save lives. And a flu pandemic in the future, where in
months we can see millions of people die, is an awesome
thought. And how we, as a military, will play in that, some of
the lessons learned from this program may add value to that
experience.
Mr. Shays. Thank you. Ms. Ellenberg, doctor.
Ms. Ellenberg. I would just like to say that we have made,
and will continue to make, the review of the VAERS reports on
anthrax a high priority. And we expect and are happy to
continue working with the DOD to enhance the effectiveness of
the reporting programs.
Mr. Shays. Thank you. Dr. Braun, would you like to make a
comment.
Dr. Braun. Thank you for the opportunity. I have no comment
to make right now.
Mr. Shays. Well, it has been a very helpful hearing. This
committee wants to weigh in on the right side, and we, I think,
we have some sense of where we want to move, but it is a
gigantic issue. The threat, the terrorist threat is real, the
threat that our adversaries may use chemical or biological or
even nuclear weapons to work their will is very real. Terrorist
threats are extraordinarily real. So, this is a big deal.
Thank you very much.
And, my colleague, any comments you would like to make.
Ms. Schakowsky. Let me just say, for my part, in closing
that in our understandable zeal to protect our service men and
women from the threat of anthrax and ultimately to protect all
Americans, therefore, what I don't want to see happen is that
we are willing to sacrifice good science, good medicine, good
production methods, and, ultimately, the good treatment of
those individuals who truly want to serve their country.
Mr. Shays. We will conclude by thanking the majority and
minority staff for their good work, as always, and
particularly, on bended knee, to thank our court reporter, Ron
Claxton, who is, who I am at his mercy. [Laughter.]
We will now adjourn. [Laughter.]
[Whereupon, at 3:07 p.m., the subcommittee was adjourned.]
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