[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
DEFENSE VACCINES: FORCE PROTECTION OR FALSE SECURITY?
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HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
OCTOBER 12, 1999
__________
Serial No. 106-130
__________
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
65-604 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-HAGE, 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
C O N T E N T S
----------
Page
Hearing held on October 12, 1999................................. 1
Statement of:
Bailey, Sue, M.D., Assistant Secretary for Health Affairs,
Department of Defense; Major General Randall L. West,
Special Assistant to the Secretary of Defense for
Biological Warfare and Anthrax, Department of Defense; Lt.
Col. Randy Randolph, Director, Anthrax Vaccine Immunization
Program Agency, Department of Defense; Cedric E. Dumont,
M.D., Medical Director, Office of Medical Services,
Department of State; Kathryn C. Zoon, Ph.D., Director,
Center for Biologics, Evaluation and Research, Food and
Drug Administration; and Kwai-Cheung Chan, Director,
Special Studies and Evaluation, U.S. General Accounting
Office, accompanied by Dr. Charla.......................... 26
Crowe, Admiral William J., Jr. (USN Ret.); Jack Melling,
biologics development center, the Salk Institute; Milton
Leitenberg, senior scholar, Center for International and
Security Studies at Maryland; John B. Classen, M.D., MBA;
Major Sonnie Bates, Pilot, USAF; Major Thomas L. Rempfer,
Pilot, USAF Reserves; and Neal A. Halsey, M.D., director,
Institute for Vaccine Safety, Johns Hopkins University..... 129
Letters, statements, et cetera, submitted for the record by:
Bailey, Sue, M.D., Assistant Secretary for Health Affairs,
Department of Defense; Major General Randall L. West,
Special Assistant to the Secretary of Defense for
Biological Warfare and Anthrax, Department of Defense; Lt.
Col. Randy Randolph, Director, Anthrax Vaccine Immunization
Program Agency, Department of Defense, prepared statement
of......................................................... 31
Bates, Major Sonnie, Pilot, USAF, prepared statement of...... 176
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 6
Chan, Kwai-Cheung, Director, Special Studies and Evaluation,
U.S. General Accounting Office, prepared statement of...... 87
Classen, John B., M.D., MBA, prepared statement of........... 165
Crowe, Admiral William J., Jr. (USN Ret.), prepared statement
of......................................................... 132
Dumont, Cedric E., M.D., Medical Director, Office of Medical
Services, Department of State, prepared statement of....... 50
Halsey, Neal A., M.D., director, Institute for Vaccine
Safety, Johns Hopkins University, prepared statement of.... 198
Leitenberg, Milton, senior scholar, Center for International
and Security Studies at Maryland, prepared statement of.... 153
Melling, Jack, biologics development center, the Salk
Institute, prepared statement of........................... 145
Rempfer, Major Thomas L., Pilot, USAF Reserves, prepared
statement of............................................... 189
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut:
Letter dated September 23, 1999.......................... 219
Prepared statement of.................................... 24
Zoon, Kathryn C., Ph.D., Director, Center for Biologics,
Evaluation and Research, Food and Drug Administration:
Chart concerning stages of review and regulation......... 57
Prepared statement of.................................... 60
DEFENSE VACCINES: FORCE PROTECTION OR FALSE SECURITY?
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TUESDAY, OCTOBER 12, 1999
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 1:15 p.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Morella, Shays, Horn,
Terry, Waxman, Cummings, Kucinich, and Schakowsky.
Also present: Mr. Jones of North Carolina.
Staff present: Daniel R. Moll, deputy staff director; Mark
Corallo, director of communications; David Kass, deputy counsel
and parliamentarian; Renee Becker, deputy press secretary;
Corinne Zaccagnini, chief information officer; Carla J. Martin,
chief clerk; Lisa Smith-Arafune, deputy chief clerk; S.
Elizabeth Clay, professional staff member; Robert Briggs, staff
assistant; Robin Butler, office manager; Heather Bailey,
legislative assistant; Nicole Petrosino, legislative aide; Phil
Schiliro, minority staff director; Phil Barnett, minority chief
counsel; Sarah Despres and David Rapallo, minority counsels;
Ellen Rayner, minority chief clerk, and Jean Gosa, minority
staff assistant.
Mr. Burton. The Committee on Government Reform will be
called to order.
Would you raise your right hands, please?
[Witnesses sworn.]
Mr. Burton. We will have more Members coming. On Tuesdays
we usually have Members getting in later, so I apologize for
all of our members not being here, but they'll be coming and
going.
Good afternoon. A quorum being present, the Committee on
Government Reform is called to order; and I ask unanimous
consent that all Members' and witnesses' written opening
statements be included in the record. Without objection, so
ordered.
We're here this afternoon to discuss the development of the
U.S. defense vaccine policy. The Subcommittee on National
Security, Veterans Affairs, and International Relations chaired
by Mr. Shays has conducted a series of hearings looking at the
Defense Department's current anthrax vaccine program. The full
committee today will examine the overall picture of vaccines
for defense.
As part of our ongoing investigation into vaccines we're
examining their safety, efficacy, the importance of informed
consent, the concerns about vaccine ingredients, purity, and
the long-term safety concerns. We're looking into the role of
vaccines as a defense mechanism for biological warfare. Is it
viable and appropriate to use vaccines as a defense mechanism?
Will it be possible and practical to develop vaccines to
protect against all known and potential biological threats?
Much has been said by numerous government officials about
the biological warfare threat. We've been told in previous
hearings and in testimony prepared for today that, ``At least
10 nation states and two terrorist groups are known to possess
or have in development a biological warfare capability.'' Are
all these nation states our enemies? How many are confirmed to
actually have weapon dispensable anthrax poised and ready to
launch?
Intelligence and military officials have testified that it
is relatively easy to develop and produce chemical and
biological weapons. However, they've also testified that it's
much more difficult to successfully deploy chemical weapons.
For instance, the Deputy Commander of the Army's Medical
Research and Materiel Command testified in 1998 that, ``An
effective mask casualty producing attack on our citizens would
require either a fairly large, very technically competent,
well-funded terrorist or state sponsorship.''
In March 1999, another expert stated, ``The preparation and
effective use of biological weapons by potentially hostile
states and by non-state actors, including terrorists, is harder
than some popular literature seems to suggest.''
We've also been told that anthrax is the most likely
candidate for a biological warfare threat. What is the basis
for that determination? With the aggressive information
offensive the Department has launched into its military members
and the American public, it's made to sound like the equivalent
of the Cuban missile crisis. If that's so, then those who are
in harm's way and the American public deserve to know the whole
story. A State Department fact sheet on chemical and biological
warfare states, ``The Department of State has no information to
indicate that there's a likelihood of use of chemical or
biological agent release in the immediate future. The
Department believes the risk of the use of chemical biological
warfare is remote, although it cannot be excluded.''
There are several issues that need clarification regarding
the current anthrax vaccine program, including answering why
the United States is the only member of NATO that mandates this
vaccine. We have on the screen all of the nations of NATO and
their attitude toward mandating the anthrax vaccine, and you'll
see the United States is the only one that does that.
The Defense Department would have us believe that the
concerns raised about the anthrax vaccine are minor and by a
small and vocal group. In fact, on their website, Major Guy
Strawder states,
Much of the hand wringing and bizarre allegations about the
vaccine is coming from a vocal minority of people who think the
field is where a farmer works and gortex is one of the Power
Rangers. Most of these folks have never spent a single moment
in harm's way and have no appreciation of what that sacrifice
means.
How does that measure up to the following statements that
have been sent to us by people in the service?
A Sergeant from Oklahoma says,
I have served my country with honor and total dedication
since 1970. To have this unsafe and unproven vaccine put an
abrupt end to my service is a travesty of justice. I have
constantly received excellent appraisals for the past 3 decades
and had nothing in mind but to continue receiving these favored
appraisals.
We in the military have been told too many false statements
about this vaccine. We have been misled about the safety, the
long-term effects associated with this vaccine, the proper
number of adverse reactions, and the attrition and refusals in
our total force. Many will leave the military because of this
vaccine and its problems. Many of these folks will give up a
career dedicated to service to their country.
Or we have a pilot from Maine who said,
I will be forced out of the Air National Guard and lose my
retirement. I have put in 15 good years as a pilot and have
enjoyed every one of them. I will not, however, put my health
and my future ability to take care of my family on the line for
a DOD that refuses to examine their own programs for the safety
and cohesion of our military.
Or the F-16 fighter pilot who stated,
I personally have over 22 years of faithful service in the
Air Guard. My record is exemplary. I was not planning to retire
for at least 2 to 3 years, but the anthrax vaccine program has
expedited my retirement plans. The commander of my unit will
not allow me to stay in until March 7, 2000, when I will have 3
years time in grade to keep my lieutenant colonel rank into
retirement. After almost 23 years of faithful service to my
country, I will not be allowed to stay in for the 67 additional
days needed to carry lieutenant colonel into retirement, 67
days.
Either the Defense Department is being less than
forthcoming about the objections being raised or they have
their heads buried in the sand.
A lot of the concerns have been raised about the actual
number of adverse events from the anthrax vaccine. The numbers
vary greatly--everything from 0.0002 percent reported in the
media in February to two-tenths of 1 percent on the package
insert to 20 percent, 20 percent, in the one active
surveillance currently under way.
We have a slide on this as well. That's the Tripler Med
Center study which shows 20 percent.
If the Department is not doing active followup in tracking
of health care concerns servicewide, then how will we ever
garner an accurate representation of adverse events?
Vice Admiral Richard A. Nelson, Medical Corps Surgeon
General, U.S. Navy, stated,
I am aware of the controversy associated with the anthrax
vaccine immunization program and the concern our troops have
regarding potential side effects. The vaccine is safe. Of over
82,000 marines and sailors inoculated, only eight reactions
have been reported via the vaccine adverse reporting system.
All have returned to full duty.
In cross-examination, one medic from 29 Palms had no
knowledge of the existence of a Vaccine Adverse Event Reporting
System form, as adverse event reports are difficult to file
when the medical personnel are not even aware that they exist.
The Defense Department states that it requires their medical
personnel to report all adverse events that cause the loss of
duty of greater than 24 hours of hospitalization or
hospitalization. Are these the only types of events that are
truly adverse? 24 hours? How is it that the Defense Department
has been allowed to determine what constitutes a reportable
adverse event?
The former FDA commissioner stated that adverse events are
dramatically underreported. Only 1 in 10, 1 out of 10, are
typically reported. We also know from previous statements made
by the Defense Department that military reporting is one-
seventh--one-seventh of the civilian rate, and we have an
attachment up there.
Given these figures, less than 2 of every 100 systemic
adverse events are being reported. And for those who have an
adverse event, is adequate care being provided? Why is it that
many individuals who have been suffering for a very long time
with adverse events are still waiting for appointments with
appropriate specialists? Or the statement from one Sergeant
from Georgia who suffered with memory loss, swelling,
dizziness, a rash, muscle twitching, and a month of diarrhea.
He said, ``The doctors repeatedly ignored my statement that I
became sick after taking the anthrax vaccinations.'' The Master
Sergeant from Michigan was told his symptoms showed that he had
the flu for an entire year. This diagnosis came from a military
doctor who chose only to talk to him and did absolutely no
blood work or examination.
And what about plans for more vaccines? Just how many
vaccines can one human being safely receive in their lifetime?
The Federal Government currently recommends the total of 26
doses of vaccines for children; 26 doses and there you have
them. I would like to go into some of the problems my family
personally has had with those vaccines. One of my grandchildren
is autistic we think maybe as a result of that.
Twenty-six vaccines for children. The typical 20-year
career military member can expect an additional 37 doses of
vaccinations plus the anthrax and other deployment
vaccinations. That would total at least 40 doses over 20 years.
There you see the doses we're talking about. There are
currently another 18 vaccines in development under the Joint
Vaccine Acquisition Program. These are the ones that are
planned. And if all the potential biological warfare threats
are developed into vaccines, these numbers will skyrocket. Are
we going to vaccinate our military to death?
Maybe we need to look at other approaches to dealing with
the biological threat. For instance, with good detection
equipment and protective gear, the use of products like the
orphan drug we just found out about today. We got a call from a
company that makes this or has this under review right now and
research. The use of products like the orphan pharmacy drug
that we have just learned is currently in development that
causes the anthrax spores to explode rather than synthesize and
can also be used to decontaminate equipment and clothing.
Before we start vaccinating everybody, maybe this is an
alternative that ought to be looked at and analyzed.
I hope we can find solutions to these issues, get the full
story on issues raised and, by doing so, take action to begin
to restore trust in the ranks and restore and preserve the
careers that have been destroyed.
I just want to say one thing, General West. One of your
good friends from Florida, the chairman of the Appropriations
Committee, brought to my attention your heroic service to our
country. I want you to know that if we get into a heated debate
today, that does not take away my respect for you or any of
your colleagues
up here at the table. We know of your service to the country
and some of the heroic activities you are engaged in, and I
want you to know that nothing we say diminishes that.
General West. Thank you, sir, but I knew that.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Burton. I now recognize Mr. Waxman, the ranking
minority member.
Mr. Waxman. Thank you, Mr. Chairman.
Today we'll hear testimony about the anthrax vaccine and
its use by the Department of Defense. This is a complicated
issue with compelling concerns on both sides. Some members of
our Armed Services are worried about the safety of the vaccine.
This is an understandable and important concern. We need to be
constantly vigilant in ensuring that vaccines are as safe as
they can be. We must ensure that people are educated about the
potential risks of vaccines. We must also carefully monitor the
production of vaccines, and we must track all adverse events,
treat individuals that suffer side effects, and invest
additional research funding to make vaccines even safer and
more effective than they are now.
Today I look forward to hearing about how we can improve
our performance in some of these areas, but the potential risk
of a vaccine is not the only factor to consider. We must also
consider the risk of not vaccinating. In the case of childhood
vaccines, the risk of not vaccinating is a reemergence of
infectious diseases such as polio, measles, or Rubella,
diseases we now rarely see in this country.
The chairman had a chart of 20 different diseases--it
looked like 20 different diseases--for which immunizations are
given. I looked at that list and I thought to myself, thank God
we have vaccinations that can prevent those diseases. There
were times in our own history and there are places around the
world where suffering from those diseases had been a death
sentence.
In the case of vaccines against biological weapons, the
threat is also severe. The threat of our service members may
come in battle or as a result of a terrorist attack. It may
come without any warning, without the capability to detect it,
and without an opportunity to shield our troops. We are not
talking about merely unpleasant but relatively low-risk
diseases. If you are infected with anthrax, you die. There is
no treatment. All of these risks must be balanced against
potential adverse reactions to the vaccine.
On August 3, the committee heard testimony from Antonio
Spathe who was diagnosed with an autoimmune deficiency, thyroid
disease, anemia, hypoglycemia, depression, hormone imbalance
and anxiety disorder after receiving the anthrax and other
vaccines. Mr. Spathe's condition is a serious one. Not one
person in this room would want someone in their family to be
that one in a million individual who suffers serious adverse
reactions.
Unfortunately, I think we all know, as Dr. Satcher of the
Centers for Disease Control testified at the August 3 hearing,
there is no such thing as a perfect vaccine. The decisions
facing the Department of Defense are not easy. The risks of
anthrax vaccine must be carefully balanced against the risks of
not using the vaccine. I believe we should measure these risks
using the best scientific and medical evidence available, not
inflammatory accusations of unsubstantiated rumors and personal
anecdotes. We should base our decisions on a grave, thorough,
and extremely critical analysis of all the risks involved.
Before concluding, I would like to note for the record the
way in which this hearing was put together and the lack of
cooperation the minority has received from the majority. It is
often difficult to learn in advance who the witnesses are going
to be and prepare for any hearing. In this case, we did not
learn the identity of one witness, Major Rempfer, until this
morning.
I recognize that last-minute issues can come up, but I do
feel there should be a greater effort to ensure that the
minority is informed in advance about these hearings. As a
matter of fact, I think the testimony of witnesses has to be
submitted 48 hours in advance of their testimony. We should be
getting this information in advance so that the minority can
prepare for the hearings adequately. We should be approaching
these issues of health and safety on a bipartisan basis.
I thank all the witnesses for coming today. I look forward
to hearing their testimony, and I yield back the balance of my
time.
Mr. Burton. The gentleman yields back his time.
Do any of the other Members wish to be heard?
Mr. Shays. Thank you.
Mr. Chairman, I don't usually have a statement in a full
committee hearing, but I would like to place this statement in
the record and actually address the chamber here. The recent
outbreak of the West Nile encephalitis virus in the Northeast
should stand as a warning. Nature's abundant and diverse
biological arsenal dwarfs our health surveillance and response
capabilities. We're not ready to deter, detect, or treat
emerging diseases deployed against us by Mother Nature or by
belligerent acts of man.
Responding to a similar warning sounded during the Gulf
war, the Department of Defense [DOD] adopted a policy in 1993
setting a new priority on development and acquisition of
vaccines to defend against validated biological warfare
threats. Today we examine the implications of that policy for
the individual war fighter and for the future of the volunteer
armed forces.
The forcewide mandatory anthrax vaccine immunization
program begun just last year has already raised profound
questions about the wisdom, practicality, and necessity of
elevating vaccines to the forefront of biological warfare
defense. Individual soldiers, sailors, aviators and marines are
asking, will these vaccines alone or in combination with the
many others planned affect my long-term health? How do I know
these vaccines will work against weaponized attack? Will the
development of agent-specific vaccines be funded at the expense
of collective protective systems, remote detectors, and the
physical protective equipment, suits and masks, effective
against all biological threats?
Military strategists and scholars are asking, are we
responsibly confronting the inevitability of biological attack
or surrendering to it out of panic? Does reliance on vaccines
betray a lack of confidence in long-standing tenets of force
protection, international sanction enforced by treaty, and
deterrence backed by the prospect of massive retaliation?
Modern military doctrine dismisses the effectiveness of
fixed fortifications against a mobile enemy. Yet in choosing to
deploy vaccines against specific biological arguments, we are,
in effect, constructing a medical Maginot line. Given the
number of possible biological warfare agents, it does not seem
practical to build biological barricades in every soldier's
body one threat at a time.
Finally, in this important discussion, great care should be
taken to maintain the distinction between the military threat
and the terrorist threat posed by biological weapons. They are
not the same.
Next week the National Security, Veterans Affairs, and
International Relations Subcommittee will hold a hearing on the
scientific dimensions of the terrorist threat and the
thresholds of scale, expense, and technical expertise that
differentiates state-sponsored and military biowarfare programs
from those posing a greater risk to civilian populations. Mr.
Chairman, these hearings can make important contributions to
our understanding of critical national security issues.
I appreciate your convening these distinguished panels of
witnesses today, and I look forward to their testimony.
[The prepared statement of Hon. Christopher Shays follows:]
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Mr. Burton. Thank you, Mr. Shays. I want to commend you for
the work you've been doing on your subcommittee. It's been
extraordinary.
Mr. Horn.
Mr. Horn. I'll save my fire for questions.
Mr. Burton. Save your fire for questions. OK.
Our first panel today, they've already been sworn in
because I didn't want them standing too long. Being in the
military like I was, I got awfully tired when I used to stand
out there for hours and hours, but then I was just an enlisted
man.
Dr. Sue Bailey, thank you very much for being with us
today. General West, who is a very good friend of Chairman
Young, we're very happy to have you here, sir. Colonel
Randolph, very nice having you. Dr. Dumont, Dr. Zoon, and Mr.
Chan. We really appreciate you being here.
And who do you have with you?
Mr. Chan. Dr. Charla.
Mr. Burton. Thank you very much for being here. I would
like to let the record reflect the witnesses responded in the
affirmative to the oath.
We'll start with Dr. Bailey with an opening statement. We'd
like to try to if possible stay within the 5-minute rule
because we have a number of people testifying today.
Dr. Bailey.
STATEMENTS OF SUE BAILEY, M.D., ASSISTANT SECRETARY FOR HEALTH
AFFAIRS, DEPARTMENT OF DEFENSE; MAJOR GENERAL RANDALL L. WEST,
SPECIAL ASSISTANT TO THE SECRETARY OF DEFENSE FOR BIOLOGICAL
WARFARE AND ANTHRAX, DEPARTMENT OF DEFENSE; LT. COL. RANDY
RANDOLPH, DIRECTOR, ANTHRAX VACCINE IMMUNIZATION PROGRAM
AGENCY, DEPARTMENT OF DEFENSE; CEDRIC E. DUMONT, M.D., MEDICAL
DIRECTOR, OFFICE OF MEDICAL SERVICES, DEPARTMENT OF STATE;
KATHRYN C. ZOON, PH.D., DIRECTOR, CENTER FOR BIOLOGICS,
EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION; AND
KWAI-CHEUNG CHAN, DIRECTOR, SPECIAL STUDIES AND EVALUATION,
U.S. GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY DR. CHARLA
Dr. Bailey. Chairman Burton, Congressman Waxman, members of
the committee, my name is Dr. Sue Bailey. I'm the Assistant
Secretary of Defense for Health Affairs for the Department of
Defense. I'm very pleased to be here today with General West
and Colonel Randolph to speak about our vaccination program for
anthrax, and I'd like to submit my written statement and have a
very brief oral statement.
Mr. Burton. Without objection.
Dr. Bailey. Anthrax is a very deadly organism. It causes
cutaneous or inhalation anthrax. It is very stable and can
remain viable for years. The incubation period is 1 to 6 days
after which, if you have not received the vaccine, you do die.
Anthrax is readily weaponized, it is highly lethal, and poses a
clear threat in regions where our service personnel are very
likely to be deployed.
Under our vaccine immunization program, the number of
vaccinations has risen dramatically. We have now given over 1
million of the vaccines. Although local reactions at the
injection area itself are not uncommon, they are usually mild
and very short-lived. There have been very, very few serious
adverse effects, and those are defined as resulting, as you
stated, in hospitalization or loss of duty for greater than 24
hours. These cases have all been medically resolved.
The DOD is utilizing a civilian-based FDA system, which is
the VAERS reporting system, to document these more serious side
effects. Reported reactions are in line with the other commonly
prescribed immunizations, including those that you've seen that
are for school children here in America. The vaccine, which was
licensed by the FDA in 1970, is effective and has an incredibly
safe record.
The evidence of vaccine effectiveness against aerosol
exposure to anthrax is very persuasive. Although obviously it
would be unethical to test human subjects, we are at this point
able to say that our animal models using non-human primates
have shown that the vaccine is very effective in preventing the
disease. Where nearly all of the unvaccinated animals did
succumb to an aerosol challenge, we have a vaccine that can
protect our troops from this deadly weapon. It would be
irresponsible for us to deploy our servicemen and women without
using the safe and efficacious vaccine.
I appreciate the opportunity to speak here today and look
forward to any questions.
Mr. Burton. Thank you, Dr. Bailey.
We'll now go to General West.
General West. Mr. Chairman, Congressman Waxman, members of
the committee, I'm major General West, and I'm honored to
appear before you today and hope we can answer your questions
about the Department of Defense Anthrax Vaccine Immunization
Program.
About 90 gays ago, I was reassigned from the Second
Expeditionary Force where I was the Deputy Commander to work in
the Office of Secretary of Defense as a Special Advisor for
Anthrax and Biological Defense Matters. I was already familiar
with the threat and with the vaccine program, but, after taking
this assignment, I've spent every working moment reading
everything that I could, reviewing all the studies that have
been done, looking at the analysis, looking at the test groups
and going to the field to talk to our servicemen and women who
are taking or expected to take the vaccine.
I also started that effort by going and having a meeting
with what might be referred to as the ``know group'' because I
wanted to know where they were coming from and what their
argument was from the very beginning.
I have to tell you, sir, that I'm more convinced today than
I ever have been that what the Department is doing in terms of
giving the anthrax vaccine to our servicemen and women is the
right and responsible thing to do. I could tell you many
stories that I've run into as I traveled about the field and
talked with different people about servicemen and women that
have taken the vaccine and how well it's worked. I'll limit
that in the interest of time to just two.
One is a Staff Sergeant, one of my fellow marines. He's 43
years old. He's in good health. He has no debilitating disease.
He has five healthy children. He told me that he would give the
anthrax vaccine to his own children if he could. He had his
first shot when he was 9 years old living on his father's farm,
who is a veterinarian. He feels he made the right choice then
and would make the same one again today.
The second account I would share with you is from my own
unit at Camp Lejeune. We have a unit there called the Chemical
Biological Incident Response Force. Their job is to do
consequence management if there should be either a military or
a terrorist attack in the United States or somewhere abroad.
They are literally a 911 force. They're ready to slide down
that pole and go whereever an event might happen. And, God
knows, we hope one never does, but if it does, they're ready to
go with whatever protective equipment and detection equipment
and other things that technology can provide us is available
and do the best job they can to contain the devastation that
can be caused by an anthrax or another biological or chemical
attack.
When they were briefed a three-part brief on the threat,
the safety, and the efficacy of this vaccine, all 400-plus
members of that unit went down and took their shot. Not one
person refused it. Not one person had an adverse reaction that
caused him to miss any duty time. Not one of them asked not to
take it or complained about taking it afterwards. They
understood the threat and they knew that if they went in harm's
way and took one deep breath of air contaminated with anthrax
spores and wasn't vaccinated that they were going to die. That
was motivation for them to take the shot, and that was 1 year
before DOD made the shot program mandatory.
Some have argued that if we protect our forces against
anthrax that the enemy would simply use another bioweapon. The
point I would make here is if the anthrax vaccine serves as a
deterrent it will have already accomplished its mission as
being the prevention of the use of a catastrophic weapon.
One of the CINCs that asked that all servicemen and women
deployed to his theater take the vaccine before they arrive is
a commander in chief in the Korean theater. We have service
members' families there, and there are many South Koreans that
live on that peninsula. If one North Korean airplane with 55
gallon drums of anthrax aerosolized spray flew north of the DMZ
about sunset one evening and sprayed that spray from one side
of the DMZ to the other with a wind that was blowing at about
30 miles per hour to the south, by the time everyone woke up
the next morning, potentially the entire peninsula could risk
breathing in air that had been infected with anthrax spores.
The deterrent, if it worked, would not only protect our
servicemen and women but it would protect the lives of our
family members and our allies that might not have been
vaccinated even when our servicemen and women are.
Let me take just a moment to talk to the threat.
I believe that there are at least 10 potential adversaries
out there who either have weaponized anthrax or are pursuing
it. In December 1990, I was in the Persian Gulf. We later
learned that Saddam Hussein had anthrax weaponized. He had it
deployed on the battlefield. He had it pointed at our troops,
and his commanders had the authority to use it. Deterrents or
something worked there, and they never pulled the trigger, and
I'm tremendously glad of that, but if he had, we would not have
been ready. All of our servicemen and women would not have been
vaccinated. I'm afraid many of them would have died.
At least two of our major theaters where our servicemen and
women go to work every day go to work under the threat of an
anthrax umbrella, meaning that the enemy or a potential
adversary has the capability to deliver it and would only have
to pull the trigger to do so. We have a vaccine that's FDA
approved. It has a proven safety record and we believe a proven
efficacy as well. I feel that I would be derelict in my duties
if I didn't insist that the servicemen and women that I send to
those theaters and other places where it might be used were not
vaccinated against the anthrax threat.
The servicemen and women entrusted to me by the mothers and
fathers of America are the greatest asset that our Nation has.
I would not want to send them there without vaccination.
I wish we had a deterrent that we would know would always
work. I wish we had intelligence that would give us advanced
warning every time. I wish we had biodetectors that had better
sensitivity and we had more of them deployed on the
battlefield. I wish we had clothing and equipment that our
servicemen and women could wear to protect themselves against a
bio or chemical threat and still be able to fight.
But the fact is that we don't. We don't have those things,
and they're not in the foreseeable future. The one thing that
we do have today that works and we know it works is the anthrax
vaccine. The threat is real, and it's now, and I believe we
must take the responsible action in protecting our men and
women before they deploy in harm's way by giving them the
anthrax vaccine.
I can't claim to be an enlisted man now, sir, but I did do
2 years there before I became an officer, so I can understand
what you were saying. Thank you.
Mr. Burton. My respect for you went up just a little bit
more, having been an enlisted man myself.
Let me just add one little caveat here, and I think one of
the reason's Saddam Hussein didn't use other things was because
there was the threat of the possible use of low-yield enhanced
radiation tactical nuclear weapons, and I was glad President
Bush indicated that was not out of the question and General
Schwarzkopf did as well.
Colonel Randolph.
Colonel Randolph. Chairman Burton and distinguished
committee members, I'm honored to appear before your committee
today and address your questions about the Department of
Defense Anthrax Vaccine Immunization Program. We call it AVIP
for short.
I'm Lieutenant Colonel Randy Randolph, and I'm the Director
of the AVIP agency, which is an organization and office under
the Office of the Army Surgeon General.
The AVIP agency is the central source for educational and
informational materials on the Anthrax Vaccine Immunization
Program. As such, I travel around the Nation, in fact,
worldwide, speaking to service members, family members, as well
as spouses and mothers and fathers almost daily.
We manage the AVIP Internet website, which is one of the
initiatives to improve our education and our communication with
our service members and their family members. Our office
manages a toll-free information line, the 1-877-GETVACC line.
We also handle numerous daily informational requests from
service members, family members, Congress, and the media. We're
the focal point for policy coordination for this program and
for vaccine distribution and allocation. We not only monitor
the services execution through reports from the services but in
fact facilitate their execution.
I look forward to answering your questions about this
program.
Mr. Burton. Thank you, Colonel.
I've been out of the service so long I called you major
earlier. I didn't see those silver leaves up there. I apologize
for that.
[The prepared statement of Dr. Bailey, General West, and
Colonel Randolph follows:]
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Mr. Burton. We'll now go to Dr. Dumont.
Dr. Dumont. Mr. Chairman and members of the committee,
thank you very much for the opportunity to testify before your
committee regarding the Department of State's Anthrax
Immunization Program. My name is Cedric Dumont. I'm the Medical
Director for the Department of State, and the Office of Medical
Services is responsible for promoting the health of all the
Foreign Service and all our community members overseas.
Mr. Chairman, in the spring of 1998, when it became clear
that Iraq had developed a biological weapon capability, the
Department of State prepositioned as a precautionary measure
anthrax vaccine and antibiotics at our missions located within
SCUD range of Iraq. These supplies were stockpiled at these
posts with the intent to administer post-exposure vaccination
and antibiotics following an attack.
On August 7, 1998, the bombings of our embassies in Nairobi
and Dar Es Salaam confirmed that we face a global and
multidimensional threat against United States personnel and
United States interests overseas and that we can no longer
assume that missions outside of SCUD range are at low risk.
With the assistance of the emergency security supplemental, we
are improving the security of our facilities, employees, and
our family members. In addition to physical security upgrades
we have implemented a worldwide chemical and biological
countermeasures program which includes the Department's
voluntary Anthrax Immunization Program.
The program we have initiated, Mr. Chairman, is a voluntary
Anthrax Immunization Program that makes the vaccine available
to all eligible individuals at our missions overseas, including
eligible family members. It is administered on a voluntary
basis following strict FDA guidelines.
Mr. Chairman, anthrax as a weapon can be delivered in an
aerosolized form by a variety of devices ranging from SCUD
missiles to portable dispensers. There is presently no adequate
device to detect anthrax in its aerosolized form. It is
colorless and odorless. The detection of an anthrax attack will
most probably occur days after the event with the appearance of
severely, critically ill patients, most of whom we believe
would die in the first 72 hours.
The clinical presentation of inhalational anthrax is
insidious. Patients may have non-specific, flu-like symptoms;
and for the first several days the definitive diagnosis will
most probably elude providers and caregivers. Most of these
initial cases would succumb to the overwhelming infection.
Animal studies demonstrate that the anthrax vaccine
combined with antibiotics can be life-saving if administered
within 48 hours of exposure. In the overseas environment, it is
very unlikely that exposure can be detected within that
timeframe. This is due to the lack of local medical
infrastructure at many of our missions. In most cases, local
medical providers, technologists, microbiologists and public
health officials have neither the training nor the equipment to
rapidly detect and identify the anthrax organism.
Like all vaccines, the anthrax vaccine is most effective
when used prior to exposure. There has been extensive
experience with the administration of this vaccine in
veterinarians, animal handlers and laboratory staff, and it is
approved by the FDA. Lab studies tell us that in animals the
preexposure administration of vaccine is effective against
lethal doses of aerosolized anthrax. The vaccine is
administered in a six-shot series, and studies suggest that it
is protective after the third immunization.
Mr. Chairman, Foreign Service employees and their families
serving abroad receive many immunizations throughout their
careers in the Foreign Service. When serving overseas, our
communities are often exposed to exotic diseases; and when an
FDA-approved vaccine is available to protect them against these
diseases, such as hepatitis and yellow fever, we offer it to
them and to their families.
All our vaccines are administered on a voluntary basis.
From our point of view, we consider anthrax as one additional
health risk for which there is a protective vaccine. This is a
health risk which we believe is worldwide and which is focused
on our workplace. One could argue that families are less at
risk if the anthrax weapon is targeted against the workplace.
We believe that family members are still at risk of exposure,
especially at missions where embassy housing is clustered near
U.S. Government facilities and where services commonly used by
family members are located within the chancery, within the
mission.
One of our most difficult challenges is how to protect
those individuals who are presently ineligible for the vaccine,
those less than 18 or over 65 or pregnant. Recognizing that
these individuals are also at risk, the Department of State is
engaged in a dialog with the Food and Drug Administration and
the manufacturer of the vaccine, BioPort, in exploring the
feasibility of providing the vaccine on a voluntary basis to
presently ineligible individuals through a Food and Drug
Administration approved clinical study. The purpose of the
study is to determine the safety and immunogenicity, the
effectiveness of this vaccine in those individuals otherwise
ineligible.
This concludes my statement, Mr. Chairman. Thank you for
the opportunity to testify before the committee.
Mr. Burton. Thank you, Dr. Dumont.
[The prepared statement of Dr. Dumont follows:]
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Mr. Burton. Dr. Zoon.
Dr. Zoon. Mr. Chairman and members of the committee, I am
Dr. Kathryn Zoon, Director, Center for Biologics Evaluation and
Research at the Food and Drug Administration. I appreciate the
opportunity to discuss the safety and efficacy of the anthrax
vaccine currently manufactured by BioPort Corp.
FDA shares everyone's concern that our military personnel
receive safe and effective medical products. Mr. Chairman, we
are aware that some people question the safety and efficacy of
the anthrax vaccine. Let me be clear. We believe the anthrax
vaccine is a safe and effective vaccine in high-risk
populations for the prevention of anthrax disease, an often
fatal disease, when given as according to the package insert.
Our confidence in this vaccine, like all vaccines, is based
upon four components: first, the clinical trials and the
subsequent clinical experience with the vaccine--in this case,
the Brachman trial and the CDC trial, which I will discuss;
second, ongoing inspections of the manufacturing facility based
on our GMP requirements; third, our lot release requirements,
which is another layer of protection; and, fourth, our ongoing
collection of adverse event reports that serve as an early
warning system.
We will continue our efforts in all four of these areas
with the anthrax vaccine and all vaccines to assure that only
safe products are on the market.
Anthrax is a highly infectious disease caused by spores of
a bacterium known as Bacillus anthracis. The only known
effective prevention against anthrax is the anthrax vaccine.
Use of the anthrax vaccine to immunize people at risk along
with vaccination of animals against anthrax has likely
contributed to a favorable decline in anthrax infections. The
Centers for Disease Control and Prevention data on reported
cases of anthrax in the United States indicate a drop from 130
cases per year to zero cases per year in recent years.
If I could, for the record, I'd like to enter this chart.
Mr. Burton. Without objection.
Dr. Zoon. Thank you.
[The information referred to follows:]
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Dr. Zoon. Let me briefly explain the manner in which a
vaccine is licensed, and then I will discuss the studies that
lead to licensure of the anthrax vaccine. This chart refers to
the process, as you can see.
Before a new vaccine can be studied in people, a sponsor
must submit an IND, or an Investigational New Drug application,
to the FDA. Often we have meetings before the submission of an
IND to discuss with the sponsors trial design issues and
preclinical information which they should submit.
In addition, in the application, once it's submitted, the
sponsor must provide specific information to the FDA. In this
process, the IND process which was described, there are three
phases in general prior to product approval. However, the
distinction between these phases is not absolute.
Phase one trials are focused on basic safety and for
vaccines also usually evaluate the immune response solicited by
the vaccine. These trials are usually small, generally between
20 and 100 subjects, and they frequently are done in healthy,
normal volunteers and may last just several months.
Phase two trials often include several hundred subjects,
are often randomized and last anywhere from several months to
several years. These usually include individuals who are at
high risk for the infectious disease of interest.
Unless severe reactions or a lack of effectiveness surface
during the first two phases, the sponsor may decide to perform
one or more phase three studies that can include up to several
thousand people. These phase three trials are intended to
provide the definitive measure of effectiveness as well as
continue the evaluation of product safety. The size of the
efficacy trial will be affected by the expected incidence of
the disease that the vaccine is intended to prevent.
If at the end of phase three trials the sponsor believes
that there are adequate data to show the vaccine is safe and
effective for its intended use, the sponsor submits a license
application to the agency. After licensure, sponsors generally
submit samples of each licensed vaccine and results of their
own test for purity, potency, safety, and sterility to the
agency before the release of each of the licensed vaccine
products. In addition, licensed establishments are inspected
regularly by the FDA, and there are feedback loops in this
process all along the way.
In the interest of time, I would just like to skip and tell
you a little bit about the VAERS system. FDA uses the Vaccine
Adverse Event Reporting System [VAERS], to track adverse events
possibly associated with licensed vaccines. Any person,
including a patient, can file a report. Reporting is voluntary
for individual health care providers. The vaccine manufacturer,
however, must report to the FDA all reports of adverse events
of which they are aware.
A VAERS report is not documentation that a vaccine caused
an adverse event, but only that an event occurred soon after
the vaccine was administered. From the time VAERS started
participating in 1990 until October 1, 1999, there have been
425 submitted reports of adverse events associated with the
anthrax vaccine. Of those, 29 were considered serious events.
Data gathered from the VAERS system can serve as a useful
tool in detecting potential problems with a vaccine, but VAERS
reports on anthrax vaccine thus far do not signal concerns
about the safety of the vaccine. As more people receive the
vaccine, the number of adverse events reported will increase.
Mr. Chairman, again let me state clearly that we are
confident that the anthrax vaccine is safe and effective for
high-risk adult populations for the prevention of anthrax
infection when administered according to the package insert.
FDA will remain vigilant in its review of anthrax vaccine
adverse events and its oversight of the vaccine manufacturer.
I appreciate the committee's interest in this very
important topic, and I will be happy to answer any questions.
Thank you.
Mr. Burton. Thank you, Dr. Zoon.
[The prepared statement of Dr. Zoon follows:]
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Mr. Burton. Mr. Chan.
Mr. Chan. Mr. Chairman, members of the committee, I'm
pleased to discuss the results of our ongoing examination of
the safety and efficacy of the anthrax vaccine.
My testimony is based on previous studies we have conducted
to determine the need for a six-shot regimen and annual booster
shots; the long- and short-term safety of the vaccine; the
efficacy of the vaccine; and the extent to which problems the
FDA found in the vaccine production facility in Michigan could
compromise the safety, efficacy, and quality of the vaccine.
Finally, I will report on studies conducted to determine the
effects of the anthrax vaccine on children and pregnant women.
Allow me first to discuss the background of the vaccine.
The original vaccine was developed in the 1950's and was first
produced on a large scale by the Merck Pharmaceutical Co. In
1962, a study was published on the safety and efficacy of the
Merck vaccine against cutaneous anthrax.
In 1970, the Michigan Department of Public Health was
granted a license for a similar vaccine that differed from the
Merck vaccine in three ways. First, the manufacturing process
changed when MDPH took over. Second, the strain of anthrax that
Merck used to grow the original vaccine was changed to another
strain. Finally, the ingredients used to make the vaccine were
changed from the original vaccine.
Now let me turn to the results of our study. With regard to
the need for a six-shot regimen and annual booster shot, we did
not find any study to determine the optimum number of doses for
the current vaccine. For the original vaccine, a three-dose
regimen was used initially based on a regimen developed using
animals in the 1950's. However, the number of doses was
arbitrarily increased to six when three people who received
three doses of the vaccine became infected after exposure to
anthrax. And the licensed vaccine adopted this schedule.
Likewise, although annual boosters are required, the need for
annual booster shots has not been evaluated.
With regard to the long-term safety of the vaccine, we
found the long-term safety of the licensed vaccine has not been
studied. DOD is planning a study to examine this issue.
With regard to short-term safety, one study used only the
Merck vaccine and the other used both the Merck and the
licensed vaccine. Safety data from the licensed vaccine is
difficult to interpret since part of the population used both
the Merck and the licensed vaccine. Let me repeat this. The
safety data from the licensed vaccine is difficult to interpret
since part of the population used both the Merck which is the
original vaccine and the licensed vaccine. According to FDA, it
is not possible to determine which individuals received which
vaccine.
Post-licensure data are limited since FDA did not have the
Vaccine Adverse Event Reporting System until 1990, and only a
limited number of doses were distributed each year between 1970
and 1998 with the exception of the Gulf war. Approximately
150,000 of United States troops received the anthrax vaccine
during the Gulf war, but little information is available since
many records were lost. Data collected by Fort Detrick as part
of the Special Immunization Program suggest that women
significantly experienced more serious adverse reactions
attributable to anthrax vaccine.
Since the mandatory program began, DOD has used an adverse
reaction rate based on the number of adverse events it reported
to FDA. The FDA system is a passive surveillance system known
as VAERS. DOD uses two additional criteria for reporting an
event: The individual receiving the vaccine is hospitalized or
is on sick leave for more than 48 hours. This fact, combined
with data from studies conducted on VAERS, has shown that such
systems do not accurately reflect the true incidence of adverse
events due to underreporting.
However, DOD has conducted two other studies which used
active monitoring where DOD personnel contacted the vaccine
recipients directly to find out if they had any adverse
reactions. Data from these studies show that not only were
there a much higher rate of adverse events, but, additionally,
a higher proportion of women reported both local and systemic
reactions to the vaccine than their male counterparts. In
addition, more than twice the proportion of women reported that
they missed one or more duty shifts after their vaccinations
than did males.
With regard to efficacy, a 1962 study on the efficacy of
the original vaccine concluded that it provided protection to
humans against anthrax penetrating the skin and not through
inhalation. However, it is important to note that even this
protection was not 100 percent.
In 1985, the Federal Register stated that,
Immunization with this vaccine is indicated only for
certain occupational groups. It is recommended for individuals
in industrial setting who come in contact with imported animal
hides, furs, wool, hair, bristles, and bone meal, as well as
laboratory workers involved in ongoing studies on the organism.
In general, safety of this product is not a major concern,
especially considering its very limited distribution and the
benefit-to-risk aspects of occupational exposure in those
individuals for whom it is indicated.
In the 1980's, DOD began testing the efficacy of the
licensed vaccine in animals, focusing on its protection against
inhalation anthrax. The studies showed that the vaccine
protected some animals against some strains but not all
strains. Furthermore, the level of protection varied for
different species, and the results cannot be extrapolated to
humans. DOD recognizes that correlating the results of animal
studies to humans is necessary and told us that it is planning
research in this area. DOD also plans to develop a second
generation anthrax vaccine and, as part of this effort, will
need to address whether strains of deliberately engineered or
naturally occurring anthrax can overcome the protective
immunity of such a vaccine.
FDA's inspections of the vaccine production facility in
1996 and 1998 found a number of deficiencies with the Michigan
plant. The deficiencies that the FDA identified in its February
1998 inspection fall broadly into two categories: those that
might affect only one or a limited number of batches that were
produced and those that could compromise the safety and
efficacy of any or all batches. The facility was shut down in
early 1998 for renovation. A new company, BioPort, which
purchased the facility in mid-1998, is addressing these issues.
Finally, you expressed concerns about the effects of the
anthrax vaccine on children and pregnant women. The anthrax
vaccine is not intended to be administered to children and
pregnant women. No studies have been conducted on the vaccine's
effects on these groups.
This ends my statement. Thank you.
Mr. Burton. Thank you, Mr. Chan.
[The prepared statement of Mr. Chan follows:]
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Mr. Burton. Let me start the questioning. How many strains
of anthrax are there, do you know?
Mr. Chan. As I understand it, the natural strains, there
are at least 33 of them at Fort Detrick.
Mr. Burton. Did your research show how many strains of the
anthrax virus or bacteria were going to be dealt with with the
inoculations that they're giving to our military?
Mr. Chan. The vaccine has been tested against guinea pigs,
and the results have been varied. I think we found that guinea
pigs were protected against 18 strains, but not all strains.
We also tested the vaccine in monkeys against the ames
strain, and the results were very promising, but that's the
only strain that I know of that DOD tested in monkeys.
Mr. Burton. It says here, overall results, vaccine fails
against nine of the tested strains. There are 33 anthrax
strains. Is that accurate?
Mr. Chan. Yes, that's correct.
Mr. Burton. Thrirty-three percent of the strains that it
was tested against, it failed against 9 of the tested strains.
Dr. Bailey. I would just like to add, to our knowledge,
that the vaccine we are using protects against all known
natural strains of anthrax. In fact, the testing--I understand
that there were 33 strains tested against guinea pigs and 7
strains with rabbits.
Mr. Burton. How many were tested on human beings?
Dr. Bailey. Well, again----
Mr. Burton. The reason I ask that question--let me just
ask. It's been stated by Mr. Chan that you can't--there
definitely is a question about the correlation between the
animals they tested it upon and human beings. You're talking
about guinea pigs and rabbits. There are 33 strains, and we
just stated here, according to the overall result from the NATO
guinea pig test, it failed against 82 percent of the tested
strains. Now, how do you know that it's going to be effective
for human beings if it has not been tested on human beings?
Dr. Bailey. Mr. Chairman, I would like to share with you
research that was done years ago with people who were working
with wool who had been vaccinated. Among the group that were
vaccinated with anthrax vaccine for cutaneous anthrax they were
exposed to that frequently, and it showed a high ability to
protect. However, there was a natural outbreak of inhalation
anthrax; five people died. No one who was vaccinated died. As
well, it is unethical for us to test human beings. Therefore,
we look to the nonhuman primates who are so similar----
Mr. Burton. OK. Let me just interrupt here. The inhalation
of the anthrax virus has never really been adequately tested,
has it?
Dr. Bailey. That's why I share with you this case in which
we demonstrate----
Mr. Burton. That was----
Dr. Bailey [continuing]. In the naturally occurring----
Mr. Burton. That was in the 1950's, and that was regarding
people who handled animals--animal skins, hair and so forth,
and the vaccine was administered to protect them from having it
conveyed through their skin. And you said that some of them
died but none of them died because of the--none died because of
the aerosol; is that correct?
Dr. Bailey. None of them that inhaled the spores died who
had been vaccinated. The five who had not been----
Mr. Burton. How do you know that?
Dr. Bailey. This is scientific data that we have.
Mr. Burton. How do you know how many inhaled it? Was it in
the air? Did you know that?
Dr. Bailey. I can get you specifics on that and attach it
to the record.
Mr. Burton. Do you know it was in the air?
Dr. Bailey. That is what is reported.
I would also like----
Mr. Burton. No, let me finish. Do you know that it was
inhaled?
Dr. Bailey. That is what is reported. That is in the
scientific literature.
Mr. Burton. Mr. Chan.
Mr. Chan. I do not agree with that statement. Because when
we talked to Dr. Brachman, who wrote the article, he basically
said that there was no attempt to measure the level of anthrax
spore in the air, and it was done--then he told us something
different. Certainly the occurrence of inhalation anthrax did
not, first of all, only occur during the crisis where lots of
people also were infected with cutaneous anthrax.
Let me state something for you. I hate to use this--the way
it's stated appears that there's protection of cutaneous
anthrax fully. The study basically said that even under this
kind of circumstance, they expect that number of people who are
protected it's 92.5 percent with a low confidence of 65
percent. That means that 95 percent of the time, 65 percent to
92.5 percent of the people would be protected against cutaneous
anthrax.
And it also stated in the study that there were
insufficient number of incidents in the inhalation anthrax to
draw the conclusion about the protection, OK? That's what the
report says here.
Mr. Burton. I see my time has expired. I will come back for
a second round.
Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman.
It seems to me that there are--this whole question of the
hearing boils down to two issues: One, is there a need for the
vaccine? And, two, if there is a need, is the vaccine safe and
effective?
Let me address the first one first. Let me see whether
there's a need for the vaccine.
There are witnesses in panel II that are raising questions
about the reality of a threat from anthrax and the need for an
anthrax immunization program. General West, what are your views
on the threat of an anthrax attack on DOD personnel?
General West. Well, Congressman, I certainly hope that
there's never an attack. I hope the fact that our forces have
been vaccinated and the other things that we can apply against
that possibility will be effective. But what we know is that at
least 10 of our potential adversaries, and again I hope we
never have an adversary, but people we've had disputes with,
people that we've been in conflict before, at least 10 of them
either have anthrax weaponized in weapons ready to shoot or
they're actively pursuing it.
We also know of at least two terrorist groups that either
have it and have tried to use it or are pursuing that
capability. As I said in my opening statement, in two of the
major theaters, in Korea and in the Persian Gulf, we have
servicemen and women that go to work every day in areas where
the enemy at any time could deliver an anthrax weapon.
Mr. Waxman. Thank you.
I would like to ask this panel then to address the concerns
that have been raised about the safety of the vaccine. Dr.
Zoon, putting aside concerns about the manufacturer of the
vaccine, put aside problems with the implementation of the
vaccine program by DOD, would you consider the anthrax vaccine
safe if it were properly made and administered?
Dr. Zoon. Yes, sir, I do. Based on the studies originally
done on the anthrax vaccine, including the Brackman studies as
well as the studies done by the CDC, the adverse event profile
in the package insert very much mimics what we are seeing today
in terms of the types of adverse events and depending on the
population, if the population is a high-risk population, then
the risk benefit profile would warrant using the vaccine.
Mr. Waxman. Do any of the other members of the panel have
additional views they would like to share on the safety
question? I understand that Mr.----
Dr. Bailey. I would just share one additional thing. In
looking at the adverse reaction reporting we have, we have 314
that we've reported through VAERS; 17 have had to be
hospitalized, but only 5 of those were shown to directly relate
to, as best you can determine, to the vaccine, and those were
allergic responses.
I would just share with you that the rate that we're seeing
as has been indicated is pretty much what we expected. It
clearly is in line with other vaccines that are given,
diptheria, typhoid, tetanus, the kind of local reactions we
see. So we're seeing safety.
Also, we have not had a death. Often, as you know, there
are more serious reactions at times to vaccines. We have not
had an anaphylactic reaction. We are pleased to report that we
feel this is a very safe and efficacious vaccine.
Mr. Waxman. Thank you very much, Dr. Bailey.
I understand Mr. Shays' subcommittee held five hearings
that focused not on an abstract issue but on the specific
details of the manufacturing of the vaccine and on DOD's
implementation of its program. Dr. Zoon, can you tell us what
the most serious problems are with the manufacturing of the
vaccine and whether the manufacturer is taking steps to remedy
those problems?
Dr. Zoon. Yes, sir. As stated, the manufacturer had
received a Notice of an Intent to Revoke. There were GMP
deficiencies, and the manufacturer is currently engaged in
remedying those deficiencies.
Mr. Waxman. And, Dr. Bailey, could you comment on the most
serious problems with DOD's implementation of this program and
what steps the agency has taken to remedy these problems?
Dr. Bailey. These problems in what aspect of the program?
Mr. Waxman. In the DOD implementation of the program.
Dr. Bailey. I assume that's not an acquisition question in
terms of BioPort but more a question about the program,
actually the clinical aspects of the program.
Mr. Waxman. I will tell you what. Let me withdraw that
question, because we will probably want to bring it up later
for the record.
I couldn't understand this argument, Dr. Chan. You say 82
percent of the strains didn't seem to be affected, and I don't
know if that's an accurate statement or not. But what
difference would it make? It's almost like saying if you find
out a soldier wears a helmet to protect their heads but then
they can get shot in the chest, then you would want to make
them wear a bulletproof vest. You wouldn't tell them not to
wear a helmet any longer, would you?
If it protects against some of the strains of anthrax,
isn't that worthwhile? Then we ought to make sure to continue
working so that it protects against other strains as well.
Mr. Chan. I think it makes a lot of sense, unless you want
to take it to a limit. For example, if we know what strains
Iraqi have and, in fact, DOD had tested the vaccine against
that particular anthrax, that is weaponized, I would agree with
you, Congressman. But first I think you need to ask them
whether they have done that already or not. Let them answer
that.
And the second question----
Mr. Waxman. You wouldn't want to test it on people?
Mr. Chan. No, use whatever animal model you want. I don't
have any problem with that. But my point is that if they are in
existence, 31, 33 different strains that are naturally there,
not engineered, then at the very least, we need to test the
vaccine against those strains. DOD said, well, we will go to
the monkeys model. Try them out and see what happens.
Dr. Bailey. In fact, I would share with you one of the
tests that I think is essential here. We did an aerosol
challenge against the Rhesus monkey, and with the Rhesus
monkey, when they had received more than two doses, they all
survived. Those who had received the vaccine, they survived the
aerosol challenge. Again, it's not a human model study. It
would be unethical for us to do that.
I would also just add in general with vaccines that you're
looking for protective antigen response, and really the strain
itself is not so essential as the mechanism.
Mr. Burton. Before I go to Mrs. Morella, let me just say,
as I understand it, that was not tested against all 33 strains
in the monkey; is that correct?
Dr. Bailey. That's correct.
Mr. Burton. Thank you.
Mrs. Morella.
Mrs. Morella. Thank you, Mr. Chairman.
I thank the panelists for their presentations, too.
It's interesting, as somebody who was very much involved
with having an Office of Research on Women's Health established
at the National Institutes of Health, which has been working
quite well in including women in protocols and clinical trials,
I'm fascinated by our GAO report here which indicates a
tremendous disparity in some of the data with regard to gender
differences, which says something--I mean, there are big
disparities here, and I'm just curious about what this is
saying. Do we need to look at that separately? Would anyone
like to extricate from that data something that adds to our
base of knowledge of this?
Dr. Bailey. Mrs. Morella, first of all, I would like to
share with you that I've had five of my shots already. I was
certainly glad to have done that as I was in the Persian Gulf
last year within SCUD range. But I'm confident, in general.
And, again, if a member of my family were in harm's way or
in a theatre where I knew that to be a risk, I would certainly
want them to have that immunization.
I saw no ill effects. That's beyond the point. The real
point is that you're right. We've looked at the data, and we
know that there seems to be a higher reaction rate, a local
reaction, especially among women, but also in general we're
getting a greater response. One of the theories is that women
have a stronger immune response, and that may be part of what
we're seeing, and I think it would be worth looking at.
But there's a plus to that as well, which means that if, in
fact, you have a stronger response, it may be that you have
stronger protection as well.
Mrs. Morella. I would like to hear from our GAO people,
too.
Mr. Sharma. Let me say a couple of things on this. This is
a very significant finding on this vaccine. This vaccine has
not been used in large numbers. Although Brachman had some
women in his studies--he did not analyze his data on adverse
reactions by gender. So we don't know really how this vaccine
was going to work on women. However, DOD collected data on its
own employees that received the vaccine from 1974 to 1998 found
that women had statistically significant higher reaction rate.
They had, also, higher lost duty time.
It is correct what Dr. Sue Bailey stated, that it means
that women have a better immune system. However, what I would
also like to state is that it also calls into question two
things.
First of all, we have to ask this question: whether women
need the same level of dosing if they have a better, more
sophisticated immune system. And I've indicated that for the
licensing vaccine, no studies were done to determine the number
of doses, the need for the frequency of the booster by gender,
so we have no information. This is very significant and
alarming. And in our military today, we're going to have more
and more women. Right now, there is no protocol to determine
what the antibodies levels are.
I think it is important because a point that I wanted to
mention earlier in the animal data, one of the things that we
found is that antibodies levels which are supposed to be
correlated to protection turned out not to be related to
protection. In other words, animals that had higher levels of
antibodies died than animals that had lower levels. This calls
into question, if antibodies levels are not a good measure,
then how do we determine what do you need for protection?
So we need to do two types of studies: Are women at higher
risk? Is this vaccine or other vaccines in some way impacting
the immune system of women? And, second, what is the optimum
number of doses for men and women?
Mrs. Morella. Would you agree, Dr. Bailey? Did you want to
make any statement from FDA's point of view?
Dr. Zoon. Yes, just one comment based on our data from the
VAERS system regarding adverse events that have been reported.
Although we don't have a denominator for the total number of
minor and nonserious and serious reactions totally, other than
what's reported to VAERS, our data does suggest that, in terms
of the serious reactions, the percentage of the total reports,
the percent of serious over the total number of reports to
VAERS is the same for men and women, about 7 percent.
Dr. Bailey. I would certainly agree we need additional
research. We have $8 million planned over the next--up until
2005, and I think clearly we need to determine if there indeed
is any gender difference.
Mrs. Morella. Thank you. I think that's an important point
to make. Thank you.
Thank you, Mr. Chairman.
Mr. Burton. Thank you, Mrs. Morella.
Ms. Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman.
Whoever can answer this--how many biological weapons are
there that are actually weaponized and that we might be able to
expect could be used aside from anthrax or near weaponized or
could easily be weaponized?
General West. We would get into a classified area pretty
quickly there. I can tell you that several are being pursued.
The one that seems to be the force of choice--or the weapon of
choice is anthrax. There seem to be more countries pursuing and
using that than any other. There are some others that may be
possible, but I cannot tell you of any actually that are in the
weapons and ready to be shot at this time.
Ms. Schakowsky. But, General, if it were widely known, as
I'm assuming it is, since everything we do is out in the open,
that American forces were immunized against anthrax, why would
an enemy directing its offense use anthrax if we have this
program if there were another weapon of choice?
General West. I think there are two parts to that answer,
ma'am.
First of all, I mean, anthrax is the weapon of choice for
good reason. It's easier to obtain. You can buy the ingredients
to grow the culture under the guise of other lawful activities.
Once you make it, it's very stable. It lasts for a long time.
It's resistant to the elements. It's very tenacious. It's
extremely lethal. Some of the other and potential biological
weapons are not as stable. They're easily deteriorated by
sunlight, by wind, by rain, things like that. They are also
easily contaminated. They are also much more dangerous to
build.
So particularly on the terrorist side or the smaller nation
state side, they may not have the advanced laboratories,
they're very dangerous to manufacture and the perpetrator may,
in fact, bring harm upon himself.
Ms. Schakowsky. Does DOD envision at some point in the
future that we will attempt to have a vaccination program for
every biological weapon?
General West. No, ma'am, but what we do is we try to
determine as best we can what's being worked on in the world by
potential adversaries, what capabilities are there, and we try
to do whatever we can to deter that threat. And in some cases
that may be vaccine, and in some cases it may be something
different. And some of those areas we're already pursuing a
vaccine in case they are able to weaponize and in case we think
that it's prudent to give such a vaccine. But that takes a
while, and we can't get ahead of the FDA there, we can only use
one after it was approved for use. But there's work going on in
case that came to pass.
Ms. Schakowsky. Are you concerned, because we are all, of
course, interested in deterrence and our ability to maintain
our readiness, that we're losing a number of pilots because of
their fear of the anthrax vaccine? I mean, if we're talking
cost benefit, where does it kick in that we're losing too many
of our armed servicemen and people?
General West. I'm concerned. I'm concerned about the loss
of one single serviceman or woman of a reason for not taking an
anthrax shot. I would be remiss as a leader if I wasn't. I wish
the problem wasn't out there. I wish that we would have been
ahead in the communication effort so that we would have gotten
to some of these bases where there have been problems before
the people that I assume for their own proper motivations think
that it's bad.
But I know that there's a threat out there. And I know that
on any given day I may have to send our men and women to
operate under the umbrella of that threat. And I couldn't
responsibly send them there without using a vaccine that we're
convinced is both safe and effective.
Ms. Schakowsky. Following up on Congresswoman Morella's
line of questioning, we had testimony from a woman who was--I
know the protocol is that if you are pregnant or suspect that
you may be pregnant that you're not required to--that you
shouldn't take the vaccine.
However, she was not only not asked if she suspected she
was pregnant but there were statements made that implied that
women in the Armed Services would just simply say that they
suspect that they might and, therefore, unless you were proving
that you were pregnant, you were going to take that vaccine. I
know that was later denied, and that there was a ``he said, she
said.'' But I have no reason to doubt that testimony. I mean,
she had no particular motivation, I don't think, to come here
and say that.
So I'm concerned that even the protocols that do exist for
women in the military are not being followed and that we may be
putting some woman at risk, particularly given the little data
that we have on the difference and adverse effects on women.
General West. I wasn't present for that testimony. But I
would agree with you, if that happened, it should not have
happened. It would be contradictory to our policy. Every female
is supposed to be asked before they take the shot. If they are
pregnant, they're excused from taking them. There are no
repercussions. They're not required to take the shot if they're
pregnant. We don't even want them to.
If that happened, I would like to know about it. We would
like to investigate it. If you hear of any other incidents like
that, we would like to know about it, because we have----
Ms. Schakowsky. A lot of incidents of testimony here that
is contrary to what is stated DOD policy is on the record for
you to observe from people who have come to hearing after
hearing after hearing and told us things that we've been then
told are not DOD policy that make many of us very concerned
about the way this is being implemented.
Thank you.
General West. I could add, ma'am, that every one of those
is being looked at by the various services' Inspector Generals.
We will get to the bottom of every one of those, and we will
provide the answers for the record to what we find out.
Mr. Burton. Thank you, Ms. Schakowsky.
Mr. Shays.
Mr. Shays. Thank you.
General West, I know that you sincerely believe that this
is a program that we need to pursue. So I don't question your
sincerity. But we have an all-volunteer service, and you have a
mandatory vaccination program, and you have started a new
course. You have decided that, where in the past we would
protect and provide vaccinations for what nature may throw at
us, the new Army, the new Navy, the new Marines, the new Air
Force is that we're going to vaccinate you on the potential
threats of terrorists and any military force that may use a
biological agent. That's the new voluntary military.
Do you think that will have an impact on our ability to
have enlistees and on retention?
General West. I don't think it will, if we get our message
out that the vaccine is safe and effective. If we convince our
young women and men that there is a threat and what we're going
to do wouldn't hurt them, there won't be a problem with it. We
haven't done that as well as we should. We're trying to get
better, and we're going to catch up.
Mr. Shays. The problem is that is almost like me saying,
trust me, I'm a politician.
General West. I would never say that, sir.
Mr. Shays. There's enough history of politicians in the
military in the past, not you, but the military in the past
that would not make people feel very comfortable with your
sincerity and my sincerity.
Dr. Bailey, do you believe there is a direct correlation
between antibody response to the vaccine and protection from
infection?
Dr. Bailey. The very specific scientific question, and you
already heard it addressed here today, it's one of the
questions as to whether or not a higher----
Mr. Shays. I just want the answer.
Dr. Bailey. Everything in my scientific background tells me
that an antibody response to an antigen does impart immunity
and protection.
Mr. Shays. Then why isn't DOD tracking antibody titers of
vaccinated servicemen and women to see just how much biological
body armor they will actually take into battle?
Dr. Bailey. All of the research at this point indicates
that this is efficacious. There clearly are studies which can--
we can provide for you and show----
Mr. Shays. The military isn't doing this. You are starting
a new policy: We are vaccinating for what a terrorist or a
military might do. And I'm asking why we aren't starting to
gather this information.
Dr. Bailey. Actually, I think maybe, Colonel Randolph, do
you want to respond to that antibody research that has been
done? We certainly do look at the body of knowledge that is out
there. We do not recreate everything.
Mr. Shays. Are you tracking this or are you doing studies?
The answer is no. And so the question is, why not?
Dr. Bailey. Well, you know, one of the concerns is the
amount of medical intervention or therapeutics that are done at
all that would involve a program, I assume you would suggest
that be voluntary to draw blood and to track that.
Again, Colonel Randolph, do you want to add to that in
terms of the research or the body of knowledge?
Colonel Randolph. Congressman----
Mr. Shays. I need to know why you're not doing it, is the
bottom line.
Colonel Randolph. Sir, we don't do titers on military
personnel simply because no one does titers on any personnel
subsequent to a dose of vaccine. We have to follow the FDA
dosing protocol of six doses over 18 months whether we found an
antibody titer after two doses or three doses or four doses.
Mr. Shays. Yes, Mr. Chan.
Mr. Chan. I think the chairman noticed my sense of
frustration here.
I think, as Mr. Shays said, if we are implementing a policy
which is for almost 2.4 million people and potentially even 5
percent have adverse reactions it means 120,000 soldiers are
affected and that's significant, if that's the case. It seems
to me that we need to be proactively looking for ways to
explain the problem to the soldiers so they understand that we
care about them.
Now, I just don't understand why we are sticking with six
dose schedule. If this is the protocol, and if women are
reacting much more adversely than men, and we certainly do not
have the original set of data from the Brackman study,
explaining the safety of that vaccine, which is in fact not the
same vaccine that is being licensed, so there are a lot of
unclear unknowns. And I think it needs to be looked into in
such a way that we don't stand behind this question of is it
safe, is it efficacious because FDA licensed it.
Mr. Sharma. I would like to add too, there is an additional
reason why we should be looking for the antibodies level and
that is--we have protocols from other vaccines whereby when
people have adverse reactions we check for the antibodies level
to determine if they have sufficient levels of antibody that is
required and, if they do them you will waive subsequent shots.
Second, when you find that somebody is adversely reacting
to a vaccine, we can either increase the time between doses or
we can reduce the dose or we also can apply pretreatment. And
this body of knowledge about protocol is not new. DOD applies
similar protocols to other vaccines. Why it's not being applied
to the current vaccine, I do not know.
Mr. Shays. Thank you, Mr. Chairman. Mr. Chairman, will we
have a chance to ask a second round of questions before we go
on to the next panel?
Mr. Burton. Yes, we will go back for a second round of
questions.
Mr. Horn.
Mr. Horn. Thank you, Mr. Chairman.
I wonder if the gentleman on the end, I came in 5 minutes
late, would identify himself. Now would you give me the
spelling on the name, the gentleman to your left?
Mr. Sharma. My name is Sushil S-U-S-H-I-L. Last name is
Sharma, S-H-A-R-M-A.
Mr. Horn. And you're part of Mr. Chan's staff?
Mr. Sharma. Yes, I work with him.
Mr. Chan. He is my colleague.
Mr. Horn. Very good.
Let me just ask this. I was curious when Dr. Dumont said,
well, we don't give them to those under 18 or over 65. Now
we've had some discussion on the children. Will that policy be
changed so that children and seniors over 65 who are abroad--
because a lot of these missions aren't State Department
missions, they're other agencies. There are military. There's a
whole series of people that is in every country we have, and if
we should be protecting those individuals, we need to look at
people who are over 65. Since I'm over 65, I would have a few
concerns if I was in your embassy and you weren't doing it.
Now, if a person asks to do it over 65 or says I want my
children done who are in high school, elementary school, under
18, do they get the anthrax vaccine or don't they?
Dr. Dumont. Congressman, at this point in time, we are just
in the beginning of looking at a feasibility----
Mr. Horn. Move that microphone, please, a little closer to
yourself.
Dr. Dumont. Excuse me, again. Congressman, at this point in
time, we're concerned with trying to protect in the overseas
environment all of those who are not eligible for the vaccine
at this point. And so what we're trying to do is we're in the
preliminary stage of exploring the feasibility of doing a study
for those that are not eligible and that means over 65 but also
less than 18.
And so what we could do is do a study that would be FDA
approved, but it would involve doing dosing and it also would
involve doing blood drawing and assessing titers in that
community.
Mr. Horn. What's the evidence in science that says don't
give that vaccine to someone over 65?
Dr. Dumont. To my understanding, and I really would defer
to the scientific experts on the FDA side that there is no
data, but it's just never been tested and offered to those
communities, and that's why there's no information.
Mr. Horn. Well, then we've got an arbitrary standard here.
In other words, we've got age discrimination, and there are
laws against that, and I don't understand why we have that.
Suppose you're 64\1/2\, suppose you're 64 and 11 months, are
you not going to give that person the vaccine?
Dr. Dumont. Again, what we would like to do--and I think
we're--we want to protect as many people as we can. We are
forced to follow FDA strict guidelines in the administration of
this vaccine. If we can make this vaccine available through a
study this would be----
Mr. Horn. You're telling me ageism at a point in time is an
FDA policy? I think that's silly. Now, unless there's some
evidence that people drop over when they get the anthrax shot
because they hit 65, I find this unusual and weird. So let's
hear it FDA.
Dr. Zoon. Yes, sir. The age in the package insert is based
on the studies that were done to support licensure of the
vaccine. So the population that was used to show the safety and
effectiveness of the vaccine was in that age group, between 18
and 65. To promote vaccines in areas outside that range would
be an off-label use of the vaccine.
Now, under some new rules, such as the pediatric rule and
some new guidances, looking at special populations now is an
important part of them extending medicines to the young and the
elderly. The development of the application of existing
licensed medicines, can be studied, but they need to be studied
under an IND where you have special monitoring of the
individuals. To a large degree, many times the very young and
the elderly will elicit a different immune response.
So one needs to study the particular agent, in this case
the vaccine, to get information and data to assure that the
safety and efficacy of that vaccine will be appropriate in
those populations.
Mr. Horn. Well, they've picked an arbitrary cohort there,
and it seems to me--where's the evidence one way or the other?
Let's deal with women below 18 or women over who might
become pregnant some day. It might be 1 month, it might be 1
year, it might be 10 years. I mean, is there any evidence at
this point that when you give the anthrax vaccine that 2 years
later a woman became pregnant and something deformed the child?
Where is the evidence?
Dr. Zoon. At this point in time, no studies have been done
to assess that. This particular product is labeled pregnancy
category C, which means animal reproductive studies have not
been done nor has it been tested in pregnant women, and
according to the labeling, this should only be used in pregnant
women in extremely high-risk situations where that exposure
would be really an imminent hazard.
So the answer to your question is, one can study this in
animal models, but it has to be under a properly controlled
study with appropriate safeguards, informed consent, et cetera,
in order to examine the particular safety and efficacy of any
product, including vaccines.
Mr. Horn. OK. And that's because you're following an FDA
cohort-type of analysis, is that it?
Dr. Zoon. This would be an IND study, and that population
would be studied for the safety and efficacy very closely under
an IND with informed consent.
Mr. Horn. Mr. Chairman, I just think sometime maybe the
committee would like to get into the FDA regulations on this
that they're following, because it sounds to me like it's
simple ageism, and I thought we got rid of that 15 years ago in
this city. I don't know what happened.
Mr. Burton. I think the FDA is aware that we will be having
a number of hearings involving them.
Before we go to Mr. Terry, let me just say that the immune
response that I heard Mr. Chan talking about a while ago varied
greatly between individuals of the same age, same gender,
everything else. I mean, the amount of immune response varied
greatly with the same number of inoculations. And the second
thing is you mentioned this stuff was tested--it's not the same
shot you're giving today that was tested by Merck, is it? It's
a different one, isn't it? I mean, the tests you're talking
about were the Merck Laboratories. Has this new shot been
tested like the Merck tests were?
Dr. Zoon. Sir, are you addressing me?
Mr. Burton. Any one of you. You keep referring to this
stuff being tested. This is not the same vaccine that Merck
tested back in the 1950's. It's a different one. Has this been
tested thoroughly?
Dr. Zoon. Let me describe what the situation is. The
particular type of anthrax that is used to make the vaccine
comes from the vollum strain. That is the parent strain. The
Merck vaccine and the current vaccine are both derived from the
vollum strain. The original Brachman study used a strain which
was slightly different but still derived from the parental
strain of vollum.
Now, when the additional studies were done by the CDC, they
used some of the Merck vaccine and they also used some of the
Michigan vaccine, and over 3,000 individuals got almost
completely the Michigan vaccine, and those patients were
studied for their safety and comparable immunogenicity levels
were observed, and it came from the vollum strain.
Mr. Burton. Let me interrupt you. You have not tested this
vaccine thoroughly? This is not the same vaccine that was
tested initially? You've already said there are variations,
right?
Dr. Zoon. Yes, I said that the Merck vaccine has some
differences, but they're both a variant and avirulent.
Mr. Burton. I understand. You don't need to--the fact is,
it's not the same vaccine and there could be different
reactions because of the changes, could there not be?
Dr. Zoon. Well, under the studies that were done, under the
IND that supported licensure of the vaccine, that strain was
studied for its safety and its immunogenicity.
Mr. Burton. But it was manufactured differently, was it
not?
Dr. Zoon. That other strain was also used in the clinical
studies done by the CDC, and it was compared to the original
Merck vaccine. Under the FDA Modernization Act that was
recently passed, this would not be unusual for it today----
Mr. Burton. I don't want to belabor this. I want to go to
my colleague today. But do either one of you have a response to
that?
Mr. Sharma. I think one of the difficulties in interpreting
that data is that we do not know which individual received
which vaccine, and the adverse reaction data has not been
analyzed by gender and by type of vaccine. We do not know what
proportion of the adverse reaction are specifically
attributable to the Merck versus the licensed vaccine from the
IND data.
Mr. Burton. Mr. Terry.
Mr. Terry. Thank you, Mr. Chairman. Your question and the
answers exemplify what I was going to bring up, and that is I'm
sitting here and, you know, I only have 7 years of college and
about 9 months here, and I haven't learned the languages that
I'm hearing here today.
Some of the testimony is confusing with the bureaucratic
and scientific-ese that is being exposed. So let me--my
questions are not that probing. I just need some clarifications
on some of the testimony.
Dr. Bailey, maybe you can help me out here. I'm not
accusing you of being the leader of bureaucratic-ese here. You
seem to be taking a lead on answering a lot of these types of
questions. And again following up on what the chairman brought
up in his first questions, there are 33 strains of anthrax, and
through this one study that has been discussed almost
throughout the hearing today it shows that the current vaccine
is only good against, what, 18 percent of the nonstrains? First
of all, do you agree with that? It seemed to me in some of your
comments that you disagree with that conclusion. Am I correct
that you don't agree with that?
Dr. Bailey. With--I don't know.
Mr. Terry. The fact that the current vaccine does not
inoculate against, what, 82 percent of the known strains?
Dr. Bailey. It's my understanding that the vaccine we have
protects against all known strains. Some of that is because of
the data--you were out of the room when I presented some of the
data of the studies that were done, animal studies, on the
majority or many of those strains. But, more importantly, the
antigen antibody response is vaccine theory and scientific
theory that we are depending on here and is good science.
Mr. Terry. So the answer is that the vaccine covers all
known strains?
Dr. Bailey. It does.
Mr. Terry. General West, do you agree with that?
General West. I do, sir. And I certainly don't have the
scientific background that Dr. Chan has, but from the limited
look that I've taken at it, if you only look at the guinea pig
studies, you can go look at guinea pig studies for any of those
vaccines that you had on those charts over there, and the data
is not nearly as impressive as it is in mice or rabbits or
Rhesus monkeys. The tests that we did with all of the strains
that have been tested against in the Rhesus monkey model, if
they had at least 2 shots, they lived; if they didn't, they
died.
Mr. Terry. Mr. Chan, help me through this now. Have you not
incorporated the Rhesus monkey research into your conclusions?
Mr. Chan. We tried to present them separately. We didn't
combine them. What we did look at is the evidence for guinea
pigs first, and as we stated 18 out of 33 strains that were
tested were found to be efficacious.
Mr. Terry. What does that mean?
Mr. Chan. That means it worked.
Mr. Terry. Thank you.
Mr. Chan. But with the monkey model, as I stated before, as
far as we know, it's only tested against one strain. So my
answer is I don't know the efficacy of this vaccine in monkeys
against other strains.
Mr. Terry. Is the one strain, parent strain that is
representative of all 33 strains?
Dr. Zoon. The strain that is used to make the vaccine is
not virulent, meaning it doesn't cause disease and that's why
it's used for the vaccine. It is a particular strain of the
organism that has certain characteristics, so it doesn't give
the disease you're trying to protect against.
Mr. Terry. Mr. Chan, are these characteristics inherent to
all 33 strains?
Mr. Chan. I think----
Mr. Terry. If you can reasonably inoculate focusing on
those similarities.
Mr. Chan. Let me state it differently. If, in fact, that
theory is correct, then it should be OK--either it works for
all guinea pigs or it doesn't work for all guinea pigs. You
know, if it doesn't, then you say, well, whatever the
catergorization you're talking about of the Protective Antigen
and so on, how come it didn't?
So, as Dr. Sharma just said, when we looked at the animal
models, we found that the level of the antibody in those
animals does not correlate well with protection. That means it
does not imply the higher antibody levels are associated with
greater amount of protection. OK.
So it suggests that maybe something else is going on,
that's all. I don't know the answer to that.
Mr. Terry. I only have one more minute, Dr. Bailey, so I
want to ask General West one question here. Do we know what
strain of anthrax North Korea and Iraq use?
General West. We believe that we do. We believe that we've
tested for it, and we believe our vaccine will be effective
against it. I can't guarantee you that we know everything about
them that we would like to know. But based on what we've been
able to gather, our vaccine is effective against what they
have. And I can't give you all the data on what's been tested,
and we tested animals.
Mr. Terry. Are we testing the vaccine in the general sense
that it is your statement that the vaccine works against all 33
strains, or have we done testing with the specific strains that
through our intelligence we have found North Korea possesses
and Iraq possesses?
General West. We could give you for the record how many
strains have been tested in each of the animal models. I
recollect from the readings that I've done that we tested in
the Rhesus monkey model at least four strains. And it was those
against all four.
Mr. Terry. Including what your intelligence has found is
used by North Korea and Iraq?
General West. Yes, and in our interrogation.
Mr. Terry. Would you please supply that for the record?
That would be helpful.
General West. I will, sir.
Dr. Bailey. Let me just add that the strain--again, I
believe you were out of the room--is immaterial in that we're
looking at the antigen antibody response. But I would like to
say that USAMRI, the Army Medical Research Institute, in the
guinea pig, 33 strains have been tested; in the rabbits 7
strains have been tested; in nonhuman primates, 4 strains have
been tested. We believe this vaccine works.
Mr. Terry. Thank you, Mr. Chairman.
Mr. Burton. We now have our guest, Mr. Jones, who has
sponsored legislation of which many of us have cosponsored
dealing with allowing members of the military to have a voice
in the decision on whether or not to take the vaccine.
Mr. Jones.
Mr. Jones. Mr. Chairman, thank you, and thank you for
allowing me to join your committee today on what I think is a
most, most important hearing regarding military and, quite
frankly, the readiness of our military.
I would like to, if I may, Dr. Chan, just ask you a yes or
no question. Would you agree with General West--I have great
respect for--his comment that we know that--10 adversaries that
we should be concerned about as it relates to anthrax? Would
you say yes or no?
Mr. Chan. Yes.
Mr. Jones. OK. Let me ask you, Dr. Dumont, would you think
a Member of Congress that writes the Secretary of State to ask
how she arrived at a policy of whether this should be voluntary
or not should get answered back?
Dr. Dumont. I think you would get an answer back, yes.
Mr. Jones. So you think if the letter was written on August
23rd, sometime before the end of this year, that the Member
should receive an answer?
Dr. Dumont. I can't tell you more than I would think that
if the letter was written, that you had sent her the letter,
that she would respond.
Mr. Jones. You would be glad if the Member asked you to
look into it if--when maybe he should look for an answer.
Dr. Dumont. Most certainly.
Mr. Jones. I'm asking if you would, please. My name is J-O-
N-E-S, and if you would find out when I might get a response to
that letter to her.
Let me also--and I'm basing this question on the fact of
your response to this committee, and I believe I wrote this
down correctly. You argued that the anthrax threat is such that
they are compelled--meaning the State Department--to offer the
vaccine. Is that somewhat correct to what you might have said?
Dr. Dumont. That is correct.
Mr. Jones. OK. Let me tell you what I found on the website
today, and I'm going to read this for the committee: The
Department of State has no information to indicate that there's
a likelihood of use of chemical or biological agent released in
the immediate future. The Department believes that the risks of
the use of chemical, biological warfare is remote, although it
cannot be excluded.
Did you know that's on the website?
Dr. Dumont. Yes, I do, sir.
Mr. Jones. OK. So, therefore, if you don't feel like the
likelihood of an attack is imminent so therefore there's some
justification for the fact that the State Department says this
should be voluntary?
Dr. Dumont. Congressman, I guess the key piece is that we
cannot eliminate the risks completely. And again, as I
mentioned in our testimony, is that we believe that, and again
I'm coming from the medical background, the information with
regard to threat and our missions being at high risk, really
comes in from other expertise versus diplomatic security or
from the intelligence field.
But the information that I'm given is that our missions
overseas are at some risk. And again our point is that if there
is a vaccine out there that works and that we can protect our
communities, why not offer it to them? Why not make it
available to them?
Mr. Jones. Right. And so your decision, because you want to
offer this to the employees of the State Department, is that it
should be voluntary, not mandated?
Dr. Dumont. All of our vaccines, sir, under our program are
voluntary. We do not have any mandatory vaccines.
Mr. Jones. OK. That's what I needed to know. Even though I
have great respect for the men and women in uniform, and
particularly from all levels up, that it just amazes me, Mr.
Chairman, that this handout--that we have NATO allies that
mandate anthrax vaccine and there's only one, and that's
America.
Dr. Bailey. Mr. Jones, may I respond?
Mr. Jones. Yes, ma'am.
Dr. Bailey. I met with the Minister of Defense from the UK
last week, Mr. Spellers, and he told me that, in fact, they
would like to have access, but it is a production problem in
the UK that prevents them from implementing as aggressive an
anthrax vaccine program as we have.
Mr. Jones. Dr. Bailey, as of yet, as far as the government,
they have not made a decision to mandate it. It might be what
they would like to do or they might be debating whether they
should or should not, is that correct, at this time?
Dr. Bailey. Yes, sir, it's a moot point at this time.
Mr. Jones. OK. Thank you.
Dr. Chan, would you pick up mainly for me, because I'm not
on this committee, I am somewhat amazed by Dr. Zoon's answer
and that is how the FDA--is this a normal practice that you
take the research done by a separate company, even though it
relates to the issue, and this issue being anthrax, and they
take the data from another company to make a decision to
implement a vaccine that was produced by someone other than
that company? Is that normal?
Mr. Chan. I don't think we have found another case like
that.
Mr. Jones. Dr. Zoon, would you pick up on that, if that
doesn't seem to be a normal course of decisions?
Dr. Zoon. Yes, sir. This is not a unique case. And, in
fact, there were data in the license file that used the
particular vaccine produced by Michigan at that time in the
studies conducted by the CDC. So there were data in the file
regarding the material that was manufactured at the Michigan
facility in the license application.
Now, in terms of are there other situations where a certain
vaccine has modifications during its clinical development and
changes are made, the answer is, yes, that does happen.
Mr. Jones. Mr. Chairman, thank you.
Mr. Burton. Thank you. We really do need to get to the next
panel, but I'm going to yield to Mr. Shays. He has a few more
questions, and I have a couple more. Then we will go to the
next panel.
Mr. Shays.
Mr. Shays. Thank you.
Dr. Zoon, what supports the DOD's statement that the
anthrax vaccine is effective after three shots?
Dr. Zoon. I think DOD needs to answer that question.
Mr. Shays. No, I'm asking you.
Dr. Zoon. I'm not aware of any data that supports its use.
Mr. Shays. But you were in this room and you heard the DODs
make that statement, correct? I heard it today. And I heard it
at other hearings, and it's in their documents. What protocol
allows them to make that statement?
Dr. Zoon. The only thing I could say, sir, that the
information in the package insert requires the full
administration of the vaccine, and that's what it's approved
for.
Mr. Shays. It's approved for six shots. Is there any data
that you have allowed--any protocol that allows this shot to be
three shots?
Dr. Zoon. Not to my knowledge.
Mr. Shays. OK. Do you have any concern that DOD has said
consistently that this is effective after three shots? If we're
supposed to trust the DOD and trust me as a politician, what
right do they have to make that claim?
No, I'm asking you.
Dr. Zoon. Sir, my----
Mr. Shays. You're supposed to oversee what DOD does, and
FDA did not do that when we had TB. We didn't keep any records.
And we're not going back a few decades. We're in this decade.
They didn't do what you required them to do, which is to keep
records. You all said you would do a better job at watching
what the DOD does now. So I'm asking you that question.
Dr. Zoon. I wrote a letter to the DOD reminding them of
what the package insert said regarding the administration of
anthrax vaccine. I reminded them, as well as Dr. Henney sent a
letter saying that this vaccine should be used according to the
schedule on the package insert, which is the six injections
plus annual boosters.
Mr. Shay. They are not allowed to change the protocol?
Dr. Zoon. They can do studies to study whether the three
dose regimen has comparable properties using an IND if that is
what they choose to do.
Mr. Shays. They can do studies?
Dr. Zoon. Yes, they can.
Mr. Shays. They have to come back to you, don't they? They
have to come back to the FDA in order to gain validity for
their claim?
Dr. Zoon. The FDA is responsible for oversight of the
manufacture--the DOD, if they were to file an IND to explore
that option, FDA would be actively engaged in studies
surrounding those studies that would be submitted to the FDA
for review.
Dr. Bailey. Mr. Shays, may I offer some information that I
think could be helpful? We have a preliminary report to the FDA
for a comparative study to determine the best dose schedule. In
fact, by the way, it does look at the antibody response that we
discussed earlier.
Mr. Shays. That's a request to the FDA?
Dr. Bailey. Right.
Mr. Shays. Have they approved it?
Dr. Bailey. That has not been approved yet. We asked for
further studies.
Mr. Shays. Why would you tell your military personnel that
they're going to be protected after three doses?
Dr. Bailey. Sir, the policy is that we follow the regimen
dictated by the FDA, and that is the one that we are adhering
to.
Mr. Shays. You're just playing a game with me. The fact
that you made a request to the FDA is meaningless. You have
already gone out in the field and told people that they are
safe after three, that this is proved to be effective.
Dr. Bailey. Sir, the human antibody response data shows
that the peak antibody level following the first three shots
occur at 6 weeks after starting the anthrax vaccine series.
That does not mean we move off the protocol, however. There are
people, however, they're in harm's way in the Persian Gulf
today, and we are doing everything we can to protect them.
Mr. Shays. I know you're doing everything you can to
protect them, but you have a protocol. You're supposed to keep
records, and you're supposed to give six shots, and you have
gone out into the field and said because you have determined,
not yet approved by FDA, that they are safe after three, that
they have----
Dr. Bailey. No, sir, that's not the case.
Mr. Shays. That is the case. Is it not true that in your
literature you say that it's been proven to be safe after
three? It's been proven?
Dr. Bailey. No, I'm sorry, we have not proven that. In
fact----
Mr. Shays. Do you have any documentation that says it's
safe after three?
Did you not say it today?
Dr. Bailey. Yes, sir, I did say it, but that was a study,
and we are doing ongoing--we follow the protocol at this point.
Mr. Shays. But the problem is, you're following the
protocol, but you are telling your military that they are safe
after three.
Dr. Bailey. We're providing them all the protection we
possibly can.
Mr. Shays. That's a different issue. That's a different
issue. That's your judgment. It hasn't been approved by the
FDA.
Dr. Bailey. Yes, sir, because I have sons and daughters out
in those areas where we know the risk to be high. I cannot move
up the schedule and provide any better protection.
Mr. Shays. It's irrelevant whether you have daughters, sons
or whatever. You have a legal obligation to follow what the FDA
has said, and you have decided to introduce information not yet
approved, not yet proven.
Dr. Bailey. Information I presented today is research
information about the rhesus monkey and the challenge that was
given after two, three, four doses and that they survived after
that challenge.
I would like for those who are in harm's way to survive as
well. I am doing all I can.
Mr. Shays. Isn't it true that you have not kept up with the
protocol, you have not kept with the schedule? Isn't it true
that you have a responsibility to follow a certain period of
program for the first shot, the second shot, the third shot,
and so on? Isn't it true that you have not kept on schedule
with the fourth, fifth, and sixth?
Dr. Bailey. Sir, it is the policy to follow that schedule
and we are tracking that, yes, sir.
Mr. Shays. I didn't ask the policy. I asked whether, in
fact--the policy means nothing if it's not followed. Isn't it
true that you have a deadline, and you have not kept up with
the deadline?
Dr. Bailey. We are at compliance, over 90 percent
compliance with that. If someone is 2 days late for a shot, if
you feel that that means we're out of compliance, yes, we're
out of compliance.
Mr. Shays. Dr. Bailey, I don't know ultimately how I am
going to come down on this program or how our committee is, but
I just want a straight answer. In order to have faith that we
can trust you, I just want honest answers. And the honest
answer is that you haven't kept up to the schedule, and a
simple and honest answer would have been, yes, we have not kept
up with the schedule.
You have not abided by what the FDA has said you should
abide by; is that not true?
Dr. Bailey. If being late for an immunization, whether it's
your second DPT shot or your third anthrax shot, means you feel
we have not kept up with the schedule, of course, with over a
million vaccinations, we have not always kept with the
schedule, but that is our intent. It is the policy and that is
what we are attempting to do.
Mr. Shays. Dr. Bailey, intent doesn't cut it. You have to
abide by the protocol, and if you don't abide by the protocol,
the FDA has a moral obligation, a legal obligation to withdraw
your right to use that vaccine.
Your job is to keep up to the schedule or not to do it;
isn't that true?
Dr. Bailey. Well, again, I would go to other vaccines in
this country that are also on a schedule. You do not withdraw
polio vaccine or DPT because a child is late getting a shot.
Mr. Shays. So you've decided on your own that you don't
have to abide by the FDA requirements?
Dr. Bailey. No, sir. I am making every attempt to abide,
but with over 340,000----
Mr. Shays. Why do you say, no, sir? You just told me that
you aren't keeping up with it, and then you used as an excuse
that you're not doing it with other vaccines, and you have
decided that you were going to do it anyway.
Dr. Bailey. It is all we have to protect against this
deadly threat.
Mr. Shays. So the bottom line is that because you believe
that this is so important, you are not going to abide by the
FDA requirement.
Now, I'd like to ask you, Dr. Zoon, given that fact, what
is your requirement?
Dr. Zoon. DOD is not the licensee; DOD is a user. FDA has
regulatory control over the licensee, which in this case is
BioPort.
Mr. Shays. Are you going to withdraw their ability to do
this vaccine now that you find that the people who are using it
aren't abiding by the protocol?
Dr. Zoon. We have control over the manufacturer, which is
BioPort. We don't have control over the users.
Mr. Shays. Have you not given DOD the right to use this
vaccine?
Dr. Zoon. This is a licensed vaccine. If a physician uses
it, or DOD uses it, that does not really fall under our
jurisdiction.
Mr. Shays. So it's your statement before us now that if DOD
doesn't abide by the protocol, you have no responsibility, that
you have set out a requirement--who is responsible then? Who is
going to make sure that DOD abides by the protocol, if you
don't do it?
Dr. Zoon. We don't have the authority.
General West. Sir?
Mr. Shays. I just want to say, Dr. Zoon, I cannot believe
that you have just said under oath that you do not have
responsibility to deal with this issue or the authority. You
said you don't have the authority.
Dr. Zoon. Yes, that's correct.
Mr. Shays. That is your testimony?
Dr. Zoon. We don't have the authority.
Mr. Shays. Well, who is going to protect our men and women
if you aren't going to do it? Who? Who has the authority?
Mr. Burton. I don't think you're going to get an answer,
Mr. Shays.
General West. Could I add to that answer, Mr. Chairman?
Mr. Burton. General West.
General West. Sir, we want to abide by the six-shot
protocol. We want to give every one of them on time. There will
be cases when a person is due for their second or their third
or fourth or fifth or sixth shot, that they will be ill, that
they will be pregnant, that they won't show up for drill day,
that for some reason they will get an exemption; and we will
have to, to follow the FDA protocol, deviate from the exact day
on which the shot is due, but we don't want to.
We don't want to stop after three shots. We want to give
six shots, and we're going to try to stick to that as best we
can. Nobody in DOD has decided that three shots is enough and
we're going to stop there. We're not going to do that, sir.
Mr. Shays. I honestly don't believe that. I believe that
because we have a problem in productivity and production of
this, and because there has been such a resistance to take it,
that you all have decided to turn away when you get to four and
five and just make sure you get up to one, two, and three.
You have decided as a military to do it because you
sincerely, sincerely believe that will protect them, you've
already told us that, but you don't have the legal right to do
that.
General West. No, sir, and we know that, and I certainly
hope you're wrong. I don't believe that. I believe that we're
trying to stick to it as religiously as we can. In some cases,
we fail. Some cases are really good reasons for it.
Mr. Shays. I have had six hearings on this and I haven't
lost my cool or temper. I've been able to kind of, you know,
just look away and just ignore these statements, but it's
finally getting to me because, Dr. Bailey, you told us that
there has been less of a response than what the label said
would be accounted and yet we have Mr. Claypoole saying he
expected it would be more, and it's like you say whatever you
need to say in order to satisfy the event of the day.
And, Dr. Zoon, for you to say that you have no authority is
the most amazing thing I have ever heard at a hearing because
the FDA has the obligation, whenever it licenses a drug, to
make sure it's used the way the protocol requires, and you
don't allow the military or anyone else to deviate from that.
That is your requirement.
Mr. Burton. Let me move on here just a little bit.
We've had hearings on other drugs and we know of doctors
and pharmaceutical companies who have had the wrath of the FDA
come down upon them because things weren't being used in
conjunction with what the FDA specifies as the way it should be
done; and that's why I concur with Mr. Shays, because I have
heard it before that you do come down on them, you close down
companies. You pound them on the head with a meat cleaver, for
crying out loud, and yet you say you have no authority over the
military.
Let me go on to a couple of questions, because I don't want
to debate this endlessly. A lot of the concerns--and this was
in my opening statement; a lot of the concerns have been raised
about the actual number of adverse events from the anthrax
vaccine. The numbers vary greatly. Everything from two ten-
thousandths of a percent reported in the media in February, to
two-tenths of 1 percent on the package insert, to 20 percent--
20 percent in the one active surveillance that's currently
under way, the Tripler Medical Center study.
Now, what I don't understand, if the Department is not
doing active followup and tracking of health concerns, service
wide, then how we will ever garner an accurate representation
of the adverse events? I mean, this Tripler Med Center study
shows 20 percent side effects, adverse events. Why the
disparity in what's in the package and what was in the
newspaper?
Dr. Bailey. May I explain the Tripler study?
Mr. Burton. Sure.
Dr. Bailey. That is a study that is under way at this time
looking for any kind of adverse reaction. It's with health care
workers. They are, in fact, instructed to bring forth any
symptom whether they feel it's related to the vaccine or not.
Findings were generally encouraging. We're being more proactive
and encouraging reporting what may or may not relate to the
vaccine.
At the same time, I would also say that the original
reports were from the vaccine program when we had at that point
not provided the vaccine to that many of our personnel. As we
continue the program now and have over a million vaccinations,
we are seeing a report which puts it about in line with other
vaccines.
Mr. Burton. Well, Vice Admiral, let us see here, Vice
Admiral Richard A. Nelson, Medical Corps Surgeon General, said,
``I am aware of the controversy associated with the anthrax
vaccine immunization program and the concern our troops have
regarding the potential side effects. The vaccine is safe.'' He
said, ``Of over 82,000 Marines and sailors inoculated, only
eight reactions have been recorded via the vaccine adverse
reporting system. All have returned to full duty.'' But in
cross-examination, one medic from 29 Palms had no knowledge of
the existence of a vaccine adverse events reporting system
form.
Now, how can you know what the percentage of adverse
reactions is if the people that are supposed to be on the front
lines reporting the adverse reactions don't even know you have
a system to do it? I mean, this guy was a medic; he said he had
no forms, nothing. He said he had no knowledge of the existence
of a vaccine adverse events reporting form, and yet this
admiral was saying there were only 7 cases out of 82,000.
Now, if you don't have a reporting system or the forms to
report it, how in the heck do you know? Explain that to me. I
mean, this guy was a medic up front that was supposed to be
giving the inoculations. He was supposed to have a form there
that said, here's an adverse reaction, here isn't and so forth.
He didn't even have a form, didn't even know about it, and yet
you guys can make a categorical statement, there are very
minimal, adverse reactions. How could you do that?
Colonel Randolph. Sir, I'd like to make a comment, and I'd
like to make a comment based on the fact that I am not a
physician, I'm just a soldier, and I think the disparity here
can be explained in the way that the FDA and physicians define
an adverse reaction versus an adverse event.
A serious adverse reaction is defined by the FDA as death,
life-threatening illness, hospitalization or chronic long-term
illness. As soldiers and sailors and airmen and Marines, people
who are not physicians, what we look at perhaps as a reaction,
whether it's serious under this definition or not, is a broader
spectrum.
And so the lumps, the bumps that we commonly see and the
common side effect profile of this, and other vaccines for that
matter, means that what the common soldier like me sees are 30
percent of the minor reactions at the injectionsite--the
redness, the swelling, the occasional nodule, and in women,
actually about twice that.
Mr. Burton. Well, Colonel, I appreciate your answer, but
that does not address what I am talking about. You have people
who are medics who are the front line people giving the shots
in many cases. There have been categorical statements made by
the military, by this Admiral Nelson and others, saying there
are very minimal reactions, and yet the people giving the shots
don't know of any adverse reporting system, don't have any
adverse reporting forms, don't have anything.
So if there are severe adverse reactions, how do you find
out about them if they don't have any way of reporting them?
Colonel Randolph. Sir, we have advertised in our health
care providers briefing that every health care provider is
supposed to get and then obviously in this one case someone
didn't. We have advertised in all our commanders briefings
about the VAERS report. It is on our DOD website exactly how
you report an adverse event. In all of our forums, we explain
to our people how you file a VAERS 1, and in fact we encourage
patients to file, other than a health care provider.
Mr. Burton. Well, there are an awful lot of military
people, I had a young man come into my office this past week.
He's a pilot. He's got a family. He said he'd like to be an
airline pilot when he leaves. If he doesn't take the shots, he
says he won't be able to get a job as an airline pilot because
of the kind of discharge he's likely to get, No. 1, and if he
does take it and it adversely affects his health, he says he
won't be able to get an airline pilot job because it might
cause dizziness, not focusing properly with his eyes and all.
And he says he's a mess, he doesn't know what to do; and his
wife wants him to get out of the military, and he doesn't know
what to do.
And that is not an isolated case. Every Member of Congress
has had somebody contact them with these same kinds of
problems--not just one or two, but many--and these things need
to be answered, and the answers have not come forth.
Today, I don't think Mr. Shays feels it and I don't feel
it. I don't think Mr. Jones feels it. We simply don't have the
answers yet, and so we're probably going to have to look into
this further. But the military who defends this Nation needs to
know that they're not being unduly jeopardized when they take
these shots, and they need to know that the protocol's being
followed and everything's being explained thoroughly, and they
know what's going to happen. And I don't think anybody in
Congress knows, and I don't think anybody in the military
really knows, other than maybe those of you who are so-called
experts.
Let me just say this, I'd like to, since we're running out
of time and want to get to the next panel, we'd like to submit
to all of you for the record a number of questions, and we'd
like for you to respond to those since we haven't had a chance
to get to it.
Dr. Zoon, really quickly.
Dr. Zoon. Yes, I want to have one clarifying point made,
Mr. Chairman.
When you said that FDA gives oversight to the
pharmaceutical industry, that is absolutely true because they
are the individual corporations or sponsors that are regulated
by the FDA; and that is true--similar to BioPort for the
anthrax vaccine. Certainly, we are concerned about the use of
the vaccine, which is why we sent DOD a letter when we found
out, actually from members of this committee, about some
information.
So we are very much interested in this, but in terms of our
authority, our authority is over the people we license or over
people manufacturing the vaccine.
Mr. Burton. So what you're telling Mr. Shays and me and
others is that there's a gap there. Once the pharmaceutical
company makes the product, and it is given to a doctor or the
military or whatever, it's up to them to administer them; and
if they don't, there's no way to enforce it.
Dr. Zoon. We can write letters, but that's correct, we
don't have the authority.
Mr. Burton. OK.
Mr. Shays, do you have any final questions?
Mr. Shays. Yes, thank you. Who owns BioPort? Does the
military have any financial interest in BioPort?
General West. No, sir.
Mr. Shays. No financial interest at all? They've received
no loans, you've built no plant?
General West. No, sir.
Mr. Shays. The military has not paid for any expenditure at
the plant?
General West. I am sure that there are things that we have
invested in at the plant to make it possible to produce the
drug and produce it correctly.
Mr. Shays. Well, the answer is, yes, you have invested
money in the plant. You are not stockholders in the plant. You
are the plant's basic--only customer, practically.
Mr. Burton. Would the gentleman yield real briefly?
There was an $18.7 million advance that was given to
BioPort by the military for what you're talking about.
Mr. Shays. Have you put liens on the facility? Is there any
obligation there?
Dr. Bailey. Let me just say that as BioPort is the only
manufacturer of the FDA-licensed vaccine, DOD has funded a
total of 11 million since 1991 to ensure that continuous
supply. We also are providing significant administrative,
scientific, technical, and consultative assistance to assure
that production is safe.
Mr. Shays. Basically, this is a military operation.
Mr. Jones. Would the gentleman yield for just a moment?
Mr. Shays. Yes.
Mr. Jones. May I ask Dr. Bailey if it's true, in addition
to the $18.7 million that has been advanced, that they have
increased the cost of the vaccine from $4-and-something to $10
a shot; is that correct?
You've approved that type of increase; is that correct?
Dr. Bailey. Well, again, we are out of my area, but let me
just say that we have a contractual relationship with this
organization, and I think that General West should answer that,
particularly about pricing.
General West. Sir, I think your numbers are correct or very
near correct. When we first started buying the vaccine, we were
buying it from a facility owned by a State and a university.
Part of the overhead for that plant was covered by the State
and by the university.
During the process of buying the vaccine from the only
supplier that there is in the country, the State of Michigan
decided to sell that facility to a private owner. That
corporation, once they had to take care of paying the light
bill and mowing the grass and a lot of other things, had to
increase their cost. We're disappointed that it went up from $4
to $10, but I can tell you that if we compare that to the cost
of a lot of other vaccines, it is less than half as much--more
than we'd like to pay, but it could be worse.
Mr. Burton. I ask the gentleman to yield real quickly.
$18.7 million advance, according to what we have here in
front of us. So I want to make sure I understand this. They
received an $18.7 million advance and then you also increased,
or they increased, the cost per share from $4-and-something to
$10. So you not only gave them an advance, but they also
received over double, two and a half times the amount of money
they were getting per shot to help them cover their expenses?
General West. They will, yes, sir, whenever they sell the
vaccine. That's been reviewed by the contracts and the legal
people, and they did not pay the price that the company asked
for. We are paying significantly less than they asked for, but
we're paying what the contractual and legal people believe to
be a fair and justifiable price.
Mr. Burton. Two and a half times what they were getting
when it was the State of Michigan producing it?
General West. That's correct, sir.
Mr. Burton. Did you have one more question? Because I want
to get to the next panel.
Mr. Shays. I know that, Mr. Chairman.
Dr. Zoon, you have allowed BioPort to sell this vaccine to
the military for a use it wasn't directly tested for. This is
being used to combat a weaponized aerosol challenge, and so
whereas you have acknowledged that the standard procedure is 65
and older, you weren't technically tested for, but this wasn't
technically tested for aerosol. So you have given a lot of
leeway to the military BioPort to use this. BioPort is
basically funded by the military, and in the quarterly
readiness report, at the bottom of this quarterly readiness
report, it says, ``Note, soldiers with three or more
vaccinations are protected.'' Could you approve that statement
by the manufacturer if the manufacturer made that claim?
Dr. Zoon. If the manufacturer wanted to claim three doses
were protective and safe, we would have to evaluate the data
before adding that to their package insert.
Mr. Shays. So you would not allow the manufacturer to make
this claim, soldiers with three or more vaccinations are
protected, but we're allowing the military--and I'll just
conclude, General West, to you.
Bottom line, Dr. Zoon has said she doesn't have the
authority. Basically, you're allowed to run this program as you
see fit. Then, basically, you don't have to follow the protocol
evidently, which is news to me. Today it's news. Why should I
feel comfortable that I can trust the military?
You are making a statement that the FDA would not allow a
private manufacturer to make. So why should I feel comfortable
with the military?
General West. It may very well be that we put a statement
on the brochure that we shouldn't have put, because it's being
interpreted as meaning something different than we implied. The
only thing that we mean when we say that is that the research
analysis indicates that if you've had at least three shots you
have protection against the anthrax virus. We never, ever, sir,
planned to stop there. We intend to follow the protocol unless
it's changed.
Mr. Shays. I know that's your intention, but you're doing
something we wouldn't allow the manufacturer to do.
General West. We'll take that statement up, sir.
Mr. Burton. I want to thank the panel. You've been under
some pretty heavy grilling today, and we appreciate your
patience, and we may be talking to some of you later. And we
will be submitting a number of questions to you for the record.
Thank you very much.
Our next panel is former chairman of the Joint Chiefs of
Staff, Admiral Crowe; Major Bates; Major Rempfer; Dr. Melling;
Dr. Leitenberg; Dr. Classen; and Dr. Halsey. Would you all come
forward, please. Thank you, gentlemen. Once you all come
forward, we want to put everybody under oath as we always do.
I want to thank you for your patience as well. We went much
longer on that first panel than we anticipated.
Would you raise your right hands, please.
[Witnesses sworn.]
Mr. Burton. Have a seat. OK. I think we'll start with the
former Chairman of the Joint Chiefs of Staff, Admiral Crowe. We
are looking forward to hearing from you, Admiral, and we
appreciate you all being here today.
STATEMENTS OF ADMIRAL WILLIAM J. CROWE, JR. (USN RET.); JACK
MELLING, BIOLOGICS DEVELOPMENT CENTER, THE SALK INSTITUTE;
MILTON LEITENBERG, SENIOR SCHOLAR, CENTER FOR INTERNATIONAL AND
SECURITY STUDIES AT MARYLAND; JOHN B. CLASSEN, M.D., MBA; MAJOR
SONNIE BATES, PILOT, USAF; MAJOR THOMAS L. REMPFER, PILOT, USAF
RESERVES; AND NEAL A. HALSEY, M.D., DIRECTOR, INSTITUTE FOR
VACCINE SAFETY, JOHNS HOPKINS UNIVERSITY
Admiral Crowe. Thank you, Mr. Chairman. I answer to both
Crowe or Crowe, but I do pronounce it Crowe, and I found one
very disturbing thing in the previous testimony. They made an
age line of 65. I've taken it at 74. Maybe I should retreat.
I'm not sure.
Mr. Burton. You look much younger.
Admiral Crowe. Mr. Chairman, I've submitted a statement,
and with your permission, I will summarize it. This will be
highly compressed.
Mr. Burton. Thank you.
Admiral Crowe. As your invitation requested, my statement
reviews in more detail the development of policy during my term
as Chairman of the JCS, 1985 to 1989. In the way of background,
the President announced in 1969 that we would dismantle our
inventory of biological weapons. In 1975, the United States
ratified the Biological Weapons Convention.
Clearly, by 1985, we no longer had the option of deterring
biological weapons with their own agents. It was the view of
the JCS that our conventional and nuclear capabilities offered
a high degree of deterrence against hostile governments. Still,
we were painfully aware that the Biological Weapons Convention
offered no guarantees.
We had evidence that several governments continued to
experiment with and to produce biological agents. While our
appraisal did not anticipate frequent employment of such
weapons, it concluded that, if used, they could reap appalling
casualties. We initiated a multifaceted effort to improve our
passive defenses. I can describe this effort in more detail, if
you think it necessary, but it is covered in that statement.
During that period, the subject of biological agents had
not reached the urgency it enjoys today. We did launch an
exploration of the potential role vaccines might play in an
antiterrorist effort, but we were primarily seized with the
problem of deterring or countering biological attacks on U.S.
forces by the military units of hostile governments. It was a
deliberate process that received normal funding and did not
carry an especially high priority. By the time I retired, we
had not fully grappled with the possibility of covert
terrorists mounting serious biological challenges.
When I served as Ambassador to Great Britain, the State
Department had also not begun to address the problem seriously.
In 1998 and early 1999, I headed two accountability review
boards to examine the August 1998 embassy bombings in Nairobi
and Dar es Salaam. We concluded that although these weapons
were not used in these two cases, we concluded that the United
States would sooner, rather than later, see terrorist groups
turn to biological or chemical agents trying to harm Americans
overseas.
Desert Storm, of course, demonstrated that American
strength is vastly superior to any conventional forces the
Third World might employ. The lesson that came out of that
conflict, I believe, was for nongovernment organizations and
governments hostile to the United States; it was clear that if
they wished to harm our interests, they were going to have to
resort to some covert method, more than likely terrorism.
Such groups are extremely difficult to isolate or retaliate
against. Ease of concealment and delivery, when coupled with
difficulties in detection of agents, severely complicates the
retaliation problem. Unquestionably, the threat level is
increased because of these developments. My statement examines
this subject in some detail.
The anthrax spore, which you've heard a great deal about in
the first tranche, is an ideal terrorist biological weapon. I
won't go into it because it was examined at some length
previously. In fact, the Department of Defense rates anthrax as
the No. 1 biological threat today.
As you know, I am a director of BioPort Corp. I'm well
aware that the issue of safety has provoked some dispute.
BioPort has a deep interest in providing a safe and pure
product, and that's exactly what its current owners are bending
every effort to produce. The popular press often confuses the
issue by mixing up questions of safety and effectiveness, but
actually anthrax vaccine has a rather impressive safety record,
putting aside the question of effectiveness, starting in the
1960's.
Again, there a number of studies, and I talk about the
things that were persuasive to me in my statement. I don't
think I should spend time on that since you have explored it at
some length already. I will say, though, that I am convinced
that the opposition, or rather, that there were some statements
about service people that are being rather exaggerated.
In the current program--and I have checked this week with
Defense. In the current program, over 340,000 military men and
women have taken shots, including myself, and of that,
approximately 200 have refused. I also checked with all the
personnel organizations of every service as to whether they
were actually seeing vast numbers leave the service or that
they were concerned about this problem, and they have no
evidence, hard evidence, to support that.
Frankly, there is no question in my mind that we should
bend every effort to protect our forces against anthrax
attacks. I should note, which came out in the previous hearing,
that not one dose of the vaccine has been released without FDA
approval and will not be released without FDA approval.
Before closing, I would like to comment on one peripheral
issue. It has, on occasion, been rumored that the decision to
inoculate all personnel was made to benefit BioPort and,
indirectly, to benefit me. If the charge were not so
ridiculous, it would be offensive. It outrageously exaggerates
my influence. I didn't have that much influence when I was the
chairman, much less now.
Let me be completely clear: I never, never solicited any
official of the administration to install or promote a
mandatory inoculation program. Even the timetable of events
firmly refutes the charge. I would of course be happy to
elaborate on this. The attempt to link me with the Secretary's
decision is pure fantasy.
And that concludes my summary, Mr. Chairman.
Mr. Burton. Thank you, Admiral Crowe.
[The prepared statement of Admiral Crowe follows:]
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Mr. Burton. Dr. Melling.
Mr. Melling. Thank you, Mr. Chairman and members of the
committee, for your invitation to present testimony to this
committee. My name is Jack Melling, and I am the former
director of the Salk Institute Biologicals Facility in
Pennsylvania and also the former director and chief executive
of the UK's Center for Applied Microbiology Research, which was
also involved in defense vaccine work.
Vaccines for defense against biological agents differ from
normal public health vaccines in several important ways. First,
the effectiveness of defense vaccines cannot be determined by
normal human epidemiological trials, due to the rarity of the
diseases involved. Animal models are therefore critical to
assess efficacy. Such models are limited in their ability to
predict what will happen in humans, and in most cases, can at
best indicate some possibility of efficacy, but do not allow us
to determine if a vaccine will protect 40 percent, 60 percent,
80 percent or whatever in the case of humans.
Nor, in fact, can we predict the human vaccine
effectiveness against different levels of biological
challenges. I have heard this afternoon also comments about
being able to measure antibodies in humans and use that as a
predictor. In some cases that is indeed true, but in many cases
of infection, the immune response is much more complicated than
that which can be measured by a simple antibody response. I
believe that a number of the agents that are of concern to us
fall in the category of having that complicated an antibody
response.
Now, the uncertainty about the level of effectiveness has a
number of implications, I believe. First, if vaccines are used,
then they should only be one of several protective measures
incorporated in a prudent strategy. It also means that if we
don't note the level of the effectiveness, then an unknown
proportion of vaccine recipients can remain vulnerable. For
example, if the vaccine is 60 percent effective, then 4 out of
10 persons remain at risk. Even with 80 percent efficacy, it's
one in five. I think this counts as one key argument against a
voluntary policy, that is, that it's unacceptable to have a
mixture protected and unprotected troops, since even a
mandatory policy will leave some people who are vulnerable.
It's just that we won't know ahead of time who they are.
And the final implication of the efficacy issue is,
certainly for me, that antibiotic administration still remains
an ethical essential in the event you know or believe people to
have been exposed.
The second way in which these agents differ from normal
public health vaccines is in terms of--and I won't dwell on
this, as it was discussed earlier--the number, the range and
the potential variability of the threats; and taken together,
that means that developing, producing, and gaining regulatory
approval for a large number of vaccines becomes extremely
difficult. I think it also becomes questionable whether in fact
the pace of vaccine development, which has to move in accord
with regulatory approval, can in fact match the weaponization
ability of an aggressor.
The third point is that, unlike diseases which are
prevalent in the community where assessing the risk----
Mr. Burton. Excuse me for interrupting. I just want you to
cover that last sentence again, because it seems so relevant.
You indicated that keeping pace with the ability of an enemy to
produce other biological agents would be difficult. I want to
make sure I got that straight.
Mr. Melling. That is what I said, sir.
You know, our record in developing, producing and
monitoring defense vaccines is that in the course of some 30
years we have licensed, I think it is correct to say, in the
United States, two vaccines in the defense field. We have
licensed two in the UK out of that range of agents; and
therefore, if that time scale is indeed appropriate, I think it
does mean that vaccines alone as a counter to aggression raise
major problems simply because, unfortunately, the balance will
tend to be with the aggressor because they can weaponize
potentially faster than we can develop approved vaccines.
If I may continue, unlike diseases which are prevalent in
the community where assessing the risk of a person acquiring a
disease is based on epidemiological data, determining the risks
from BW agents depends basically on intelligence assessments,
and the basis of these reports is not open to the same kind of
debate and scrutiny that we see in the public health field.
In respect of safety, I see no inherent technical reason
why defense vaccines should be any less safe than vaccines in
general. I would, however, say that because of their specialist
nature, because we don't have several firms producing the same
vaccine and competing, I think there is a risk that defense
vaccines could be stuck in a time warp, and if we are not
careful, we could end up with a vaccine equivalent to a bunch
of Model T Fords, which were great in their day, but not many
people would actually use them today.
And last, I think acceptability is a key issue. Government
agencies are heavily involved in research, development,
regulatory approval, assessment of disease risks, vaccine
procurement, and decisions on use; and therefore, to maintain
confidence, it's going to be essential to avoid conflicts of
interest, even perceived conflicts of interest, and to clearly
demonstrate that especially the regulatory agents treat these
vaccines in the same evenhanded way that they do other
medicines.
Last, Mr. Chairman, it's my belief that these issues raise
serious questions about the feasibility of relying on defense
vaccines to protect large numbers of people against numerous
disease agents. It is vital that these problems are addressed
based on objective and sustainable factual information if we
are to properly protect those people on whom we rely for our
security.
Mr. Chairman, members of the committee, thank you for your
attention, and I'll be happy to answer questions.
Mr. Burton. Thank you, Dr. Melling.
[The prepared statement of Mr. Melling follows:]
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Mr. Burton. Dr. Leitenberg. Did I pronounce your name
correctly?
Mr. Leitenberg. As in ``light.''
Mr. Burton. Leitenberg. Dr. Leitenberg, I'm sorry. Thank
you.
Mr. Leitenberg. Mister, actually mister.
Mr. Burton. Mr. Leitenberg.
Mr. Leitenberg. My role is a bit different. Thank you for
permission to present testimony. I am an arms control
specialist, not a vaccine specialist, though I was a trained in
biochemistry. I began working on chemical and biological
warfare problems some 33 years ago, and over that period have
gone back to the subject many times, and since 1992 nearly full
time. I will discuss three things: first, a review of
biological weapon proliferation since the Biological and Toxin
Weapons Convention treaty was signed in 1972 and ratified in
1975; then a discussion of the potential for terrorist use in
the United States; and last, as a subset on that, because I
have done some research on the Aum Shinrikyo, the Japanese
group, to tell you what that group was able to do and not to do
because, in fact, it's significance is exactly the opposite as
it's been portrayed for the last 4 years. It's been both
misunderstood and purposefully misrepresented.
First, about the proliferation of biological weapons. The
kind of things you would want to know are: Which Nations have
sought to have biological weapons? How advanced were their
programs? Do we know why they were started? And is there any
likelihood of getting any of them to stop?
There are official U.S. Government statements, many of
them, stating that in 1972 there were four nations that had
these weapons, and in 1989 we said 10, and beginning in 1989
repeated congressional testimony from senior administration
officials identified these nations, and you have that
summarized in table 1 in my prepared statement. You see that I
have grouped them: in the Middle East, Iraq, Libya, Syria,
Iran, Egypt. In Southeast Asia, China, North Korea, Taiwan,
India with a question mark, and South Korea.
The first two columns are the official U.S. Government
sources. There is no official UK government source naming
individual countries, but they have said 10. I put in the only
official Russian Government source, their foreign intelligence
report in 1993, because in fact it said something about North
Korea beyond what our own official statements contained.
There were some countries which didn't appear in these
statements, though in 1995 both the United Kingdom and the
United States said that South Africa had had a biological
weapons program. We also believe that Israel has a program,
though we don't talk about that because Israel is not
``noncompliant.'' It is not a signatory of the Biological
Weapons convention and, therefore, the United States Government
does not include Israel in the noncompliance statements. There
are also obvious political reasons; we don't discuss it, but
that's the formal reason.
All of these countries have offensive biological programs.
That does not mean they have deployed usable biological
weapons. Anything beyond offensive research is a violation of
the treaty and, therefore, not compliance; but you can have
offensive research, you can have experimental production.
That's what we call development. You can then have testing of
the agent you develop. Then you can weaponize. Then you can
produce your stockpiles.
I tried to distinguish those aspects--the U.S. Government
has never chosen to do this--which you find in table 2. I tried
to extract this information from both the official United
States and the official Russian statements, to attempt to
distinguish these separate categories. And that's terribly
important. We have a habit in official statements, not only of
confusing things by lumping those nations that have biological
and chemical weapons programs together in one statement--there
are administration statements that even include nuclear weapons
programs and supply a single number for all together--but we
also use the same phrase for all of those different stages in
proliferant biological weapons programs.
There's only one statement in the public record, dating
1989 and not dealing with biological weapons, but dealing with
chemical weapons, in which official United States statements
said that there were 20 countries that had offensive chemical
programs, and in that single statement, it said, aside from the
United States and Soviet Union, only five or six others had
chemical weapons. So that indicated a difference, between 8 and
20, and that's significant.
We don't have anything on the public record which indicates
the same thing for biological weapons. So one cannot provide in
the public domain, out of the 10 countries that the United
States previously identified, and two others which we added in
November 1997, raising that number from 10 to 12, but United
States officials didn't identify them. I cannot therefore tell
you from the public record which or how many of them have
biological weapons. There's an attempt to do that in table 2,
but beyond that, I can't go further because no one can. If
General West can in classified testimony, that's another
matter. In the public domain you cannot.
Table 3 was an attempt--and time does not remain to go into
that--it was simply to show you that those nations who have
made biological weapons don't just make biological weapons.
They have either made all three weapons of mass destruction,
nuclear, chemical and biological, or at least two, and for
biological, and I think in every case after already having made
chemical weapons.
Four specific little remarks, and I then have to leave the
subject of biological weapons proliferation.
BW isn't new. BW has been around for a while, and all those
programs that I named and the U.S. Government has named have
been there for about 15 years. These are not new developments.
Second, one country, South Africa, supposedly ended and
dismantled its BW program, in the same way as it ended its
nuclear weapons program, and that's accepted in the
international community.
Now, two things which are important and overlap with the BW
terrorist in question. There's no available evidence that the
former Soviet laboratories since 1992 have leaked material or
personnel to countries of proliferation concern, in other
words, those countries listed in table 1. As for the total
number of people that left the former Soviet BW laboratories,
at least to my knowledge, the U.S. Government thought it knew
that number at the end of 1997. It was a small number, and 90
percent of them went to the United States, Western Europe, and
Israel. That left a very small portion for all other places,
and some of the other places were not countries of
proliferation concern, which left a still smaller fraction.
I want to say something about the Japanese Aum Shinrikyo
group, because that's really the event that started everything
that's going on now. In March 1995, that group used Sarin, a
chemical agent which they had produced, in the Tokyo subway. It
killed a dozen people--those are not mass casualties--and it
injured a few hundred, not the 5,500 that went to hospitals. It
injured a few hundred. The year before, in another Japanese
city, the same group killed 7 people and also injured 200 using
the same chemical agent.
It was then discovered that the same group had been trying
to produce and use biological weapons agents, and that they had
tried to disperse such agents nine times in Tokyo and in
surrounding areas. That event produced the hearings in the U.S.
Senate, by the Committee on Government Operations, at which I
also testified in October 1995, and that hearing and its
consequences produced all the government decisions since. So
that's been the seminal event.
Now the Aum supposedly had been working on two agents, and
they're usually said to be the simplest--botulinum toxin which
you extract from clostridium botulism, which is food poisoning,
which we know of in poor caning, or when people get that in
jars, and anthrax. It turns out they were not able to produce
either agent, so, of course, their dispersion attempts failed.
They were in effect dispersing nothing--water and culture
medium. They may, in fact, have grown anthrax, but they had a
vaccine strain of anthrax. Therefore, it couldn't make anyone
ill. It's probable that the person who was in charge of the
program understood that, because that's what he had been able
to purchase from a Japanese academic.
They did not have Q fever, so they were not working on Q
fever, which has been claimed in the literature and in the
Senate report. They did not have Ebola virus. They did not do
any genetic engineering. That's a brief summary of what they
did and didn't do.
What's important about that? The Aum group had 4 years in
which to work. They had the appropriate facilities, two rooms
about the size of this hearing chamber. They bought all the
right equipment. They had virtually unlimited funds; the
estimates go into the hundreds of millions of dollars. They
didn't spend that much for BW, but they did spend tens of
millions of dollars for it.
They had about a dozen academically trained people, not all
in the right discipline, but when you have postgraduate
degrees, you in theory know how to learn what you need to know.
Nevertheless, they failed in all their BW efforts. That's
significant.
The other significant thing is that after I did this
research, it was circulated in the U.S. Government and I was
told that the U.S. Government knew all this and that everything
I had found was the same as the best information that the
government had. Nevertheless, no one in the U.S. Government has
bothered in 4 years to make public a proper assessment of what
the Aum did and was not able to do.
Mr. Burton. Mr. Leitenberg, we have a number of panelists.
Could we go on with the rest of them? I'll come back to you.
Mr. Leitenberg. Well, the last section was on BW terrorism.
Let me just say one more thing.
Mr. Burton. OK, sure. Go ahead.
Mr. Leitenberg. The third portion of my presentation was
simply to discuss the way the BW terrorist potential is
currently understood in the United States. I will leave that
aside if you don't have time.
I want to say one thing, however, since my presentation is
as an arms controll specialist. My testimony should not be
understood as being either pro or con the basic question you're
addressing, the military anthrax vaccine initiative, but no
arms controller would oppose passive defenses. If our troops
are faced with chemical weapons, any arms controller wants to
have that antidote inoculation available after U.S. troops
would be exposed to chemical weapons. If the forces are
exposed, it saves lives; if the forces are not exposed, it's a
deterrent. So as a general issue, any arms controller is very
much in favor of passive defenses, of which vaccines are one.
So my testimony, whatever it is, should not be understood
to bear against that question.
Mr. Burton. Thank you very much, Mr. Leitenberg.
[The prepared statement of Mr. Leitenberg follows:]
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Mr. Burton. Dr. Classen.
Dr. Classen. My name is Bart Classen. I am a physician and
an immunologist. Thank you very much, Mr. Chairman and
committee members, for inviting me to speak.
I oppose mandatory anthrax vaccination. This vaccine has
not undergone proper testing and will increase the recipient's
risk of autoimmune diseases, including diabetes. My research
involves studying the long-term effects of vaccines on
autoimmune disease, including diabetes.
I started working with this anthrax vaccine 8 years ago.
The vaccine was approved for marketing in 1970 without a single
controlled clinical trial. I know of no controlled clinical
trial performed since approval. This is documented in the FDA
letters enclosed in my written testimony. My animal studies
indicate that even low doses of the anthrax vaccine caused
significant immune stimulation, and the effect is additive with
other vaccines such as diptheria, tetanus and pertussis. The
results indicate immunization starting in the first month of
life can prevent autoimmune diseases. However, immunization
starting after 2 months increases the risk in both humans and
animals.
My work with the anthrax vaccine involves starting
immunization in the first month of life. However, based on
similarity with other vaccines I have worked with, I would
expect that it would increase the risk of autoimmunity,
including diabetes in recipients, including humans.
Published data supports an association between military
vaccines and an increased risk of diabetes. A very high rate of
insulin-dependent diabetes exists in the Navy. Those entering
the Navy have a similar rate to the general population.
However, after being in the military for several years, their
rate of diabetes exceeds the rate reported for the general
population. In Sweden, where all men are drafted, but women
traditionally aren't drafted into the military, the rate of
diabetes prior to the draft is about the same in men and women.
After the draft, however, when the men receive the vaccines,
their rate is about twice that of women between the ages of 20
and 34. By contrast, in the U.S. Navy where men and women
receive the same vaccines, their rate of diabetes is about the
same.
This suggests that military vaccines may be doubling the
risk of diabetes in the recipients. Based on my work with
vaccines and diabetes, I estimate the anthrax vaccine may cause
diabetes in 1 out of every 1,000 recipients and some form of
chronic adverse event in 1 in every 200 recipients. These
effects may not occur until 4 years or more after immunization.
I can give numerous examples where employees of the U.S.
Public Health Service lacked commitment to medical science and
instead appeared to be furthering their careers by acting as
propaganda officers to support political agendas pertaining to
vaccines. In one case, I can demonstrate that employees of a
foreign government who are funded and working closely with the
U.S. Public Health Service submitted false data to a major
medical journal.
The true data indicated that the vaccine was dangerous.
However, the false data indicated that there was no risk. An
employee of the NIH, who manages large vaccine grants, jointly
published a misleading letter about the subject with one of
these foreign civil servants.
In May, the U.S. Public Health Service assured Congressman
Mica's subcommittee that the hepatitis B vaccine was safe.
Weeks later, the U.S. Public Health Service, however, changed
its hepatitis B vaccination policy because there was too much
mercury in the vaccine. It's hard to imagine that they didn't
know a problem existed when they tried to convince Congressman
Mica that the vaccine was safe.
I have several recommendations that are discussed in my
testimony. However, I think the most important is that there's
a need to hire a special prosecutor to determine if public
health officials are following the laws enacted to ensure
safety of vaccines, and if public health officials, along with
manufacturers, are misleading the public about the safety of
these vaccines.
France investigated the actions of its own public health
officials and found that they had not followed the law in
ensuring the safety of biological products. After imprisonment
of several public health officials in France, France now has a
leadership position in ensuring vaccine safety as demonstrated
by their discontinuation of the routine hepatitis B
immunization program for school-age children in France.
Simple improvements with vaccine technology may lead to
over a 50 percent reduction in insulin-dependent diabetes and
other autoimmune diseases.
I want to thank you very much for the opportunity to speak.
This ends my testimony.
Mr. Burton. Some of the things you brought up there are
very interesting. I'd maybe like to talk to you a little bit
more about this later, Dr. Classen.
[The prepared statement of Dr. Classen follows:]
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Mr. Burton. Major Bates.
Major Bates. Mr. Chairman, members of the committee, I
thank you for the opportunity today to speak here on this
critical issue. I'm a C-5 pilot, newly assigned to Dover Air
Force Base. Two months ago I arrived at Dover in high spirits,
excited about the new challenges that lie ahead. However,
within the first few weeks I became aware of some very
disturbing facts. I learned that people were suffering, and I
have an attachment here to run down this list of suffering.
A captain on active duty, pilot, has been grounded for
several months. She was healthy before receiving the vaccine--
suffers from autoimmune disorder, has sustained thyroid damage
and has testified before Congress.
Another captain, active duty C-5 pilot, has been grounded
for several months after taking the fourth shot. He was healthy
before receiving the vaccine, and he developed cysts on
numerous places on the inside and outside of his body, to
include his heart. He has undergone surgery to remove the cysts
and was hooked up to an IV for 6 weeks. He says the medical
group is working on a waiver to get him back on flying status,
even though he still has a cyst around his heart. He is afraid
for his future. He is afraid he will never fly again in the
military or civilian community. He said the flight doctor did
eventually hand him a VAERS report and told him she was going
against her instructions to do so, but she thought he should
fill one out anyway.
Another major, pilot, C-5 pilot, is being treated for an
autoimmune disorder.
Another major, active duty C-5 pilot, has been grounded for
several months. He was healthy before receiving the vaccine. He
has been suffering crippling bone joint pain and ringing of the
ears. The pain is so bad he can't climb into the airplane. He
has been battling the various infections continuously during
the past several months and has developed new allergies in the
past month. He's been in physical therapy for the last 3 months
with no progress.
Staff sergeant, active duty C-5 flight engineer, after the
fourth vaccine began to experience diverse symptoms which
included chronic bone joint pain, chronic fatigue and a loss of
ability to concentrate. He's been cross-trained into another,
less demanding career field.
Tech sergeant, active duty flight engineer, has been
grounded for 8 months after receiving the vaccine. He's
experienced eight seizures. Other symptoms include crippling
bone joint pain, memory lapses, ringing of the ears, dizziness,
and inability to concentrate.
Tech sergeant, active duty flight engineer, grounded for 4
months after the vaccine, being treated at Walter Reed.
Master sergeant, retired, C-5 flight engineer. During his
retirement ceremony just a couple of weeks ago, the squadron
commander described him as becoming very ill in the last
several months of his service and not being able to fly, and I
found out that he had diabetes.
Staff sergeant, active duty C-5 loadmaster. He was healthy,
33 years old, until receiving the vaccine September 1998. Since
then he's suffered from pneumonia, chronic pneumonia, more than
once, memory loss, severe bone joint pain, dizziness, and
hearing problems. The recent bone scan revealed lesions on his
ribs, spine, and pelvis. They're treating him for skeletal
tuberculosis, although the doctors are still puzzled. He's been
grounded since February.
Staff sergeant, active duty loadmaster on C-5. He
experienced chronic bone joint pain after receiving the
vaccine. Said his arms frequently go numb. He filed a VAERS
report. He's been grounded for so long the medical group asked
him about a medical discharge, but he's not interested. He's
been on active duty for 17 years and he wants to try to keep
his pension.
Tech sergeant, active duty loadmaster, healthy prior to
receiving the vaccine, first shot September 1998, 33 years old.
Started having severe sinus problems, bone joint pain in
October, started having memory lapses in December, and he
described these memory lapses as, why am I standing in this
room. He didn't know how he got there. And there's more than
one testimony like that.
He was on convalescent leave during February following a
surgery and told by the squadron supervision to get up to the
base now and get your third anthrax vaccine. He had a friend
drive him up there because he couldn't drive. He was
uncomfortable to get the shot since he was on antibiotics and
he had just come off a steroid IV 2 days prior. He described
the condition to the med tech. The med tech gave him the shot
anyway, to receive the fourth shot on March 10th, and then 2
days after that has thyroid damage. He says he will be on
thyroid medicine the rest of his life. He's been grounded since
February. The VAERS report the base completed for him had
incorrect data on it he found out. His home phone was
incorrect, and they said he was not on medication when he
received the vaccines so he filled out one on his own.
Airman, first class, active duty mission control
specialist. She was healthy prior to the vaccine. After the
second shot she started experiencing episodes of vertigo,
ringing in the ears, and memory lapses. She has had five
vertigo episodes. She describes them as being so severe she
can't walk. The vertigo has ceased since the vaccine stopped
and she is on a waiver not to receive anymore anthrax vaccine
until her health improves. She said the anthrax issue is one
reason why she plans on not reenlisting.
And by the way, we have more than one of those anthrax
waivers after people have had a couple of shots until their
health improves or for a period of a year depending on how the
letter is written.
And I'd like to talk about one other person I wasn't
planning on talking about because they're not in my squadron.
It was the anaphylactic shock incident we had earlier this
year. We have had one. The first panel said there hasn't been
one. The chief of the immunization clinic at Dover had an
anaphylactic shock experience. They are now putting her on
antiallergy medicines, so she can maybe get the shot in the
future I was told by the chief flight surgeon.
All these people have three things in common. They've all
received the anthrax vaccine; they're all healthy prior to the
vaccine; and they're all, except for the antephialtic shock, in
my squadron. I've never seen anything like this before. I've
been to five bases, to include Dover. If the Ninth Squadron
health figures were the norm, then 101,000 troops would be
suffering from this.
Excuse me. I'm getting a little shaken up here.
Our leadership seems to be desensitized, and that is not an
attack on my chain of command. I believe there are people so
close to this issue, they are so deep in the woods, they can't
see the forest.
I'm a new guy. I've got a fresh set of eyes, and I can see
the forest. It is as if it were snowing in the summer, and
nobody wants to acknowledge it.
I'll close by saying I don't have any physical evidence. I
don't have the resources for that. I don't have any physical
evidence to link the anthrax vaccine to the illness, but I
would like to close with a quote by who was then Senator
William S. Cohen about drawing conclusions during the 1974
debate relating to the impeachment of President Nixon. ``If you
went to sleep on the ground outside here and woke up with fresh
snow on the ground, certainly you would reasonably conclude
that snow had fallen during the night even if you did not see
it.'' I couldn't agree more. I would like to close by thanking
you and the committee for allowing me to testify today.
Mr. Burton. Thank you, Major Bates. I know that you and
Major Rempfer had to take some risk to come here today. We
appreciate that, and we'll do our dead-level best to make sure
you're treated fairly. We appreciate your bravery in coming
forth.
[The prepared statement of Major Bates follows:]
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Mr. Burton. Major Rempfer.
Major Rempfer. Thank you, Chairman Burton, members of the
committee.
I open my testimony with the core values of the United
States Air Force: ``Integrity first, service before self, and
excellence in all we do.''
I've served our Nation faithfully and honorably for 12
years as an officer, 4 prior to that as an Air Force Academy
cadet. I've flown F-16's and F-117's and most recently A-10's
for our Nation's Air Force, and I intend on serving for many
years to come.
I'm not here to speak about the safety of the vaccine or
the efficacy. Instead, I'm here to discuss another reason for
the growing retention problem generated by the Anthrax
vaccination policy. Its integrity and its relationship to this
policy and how it extends to doctrine. After exhausting all
avenues within my chain of command and communicating with
hundreds of service members for the past year, I've concluded
that the root cause of the negative reaction to the anthrax
vaccination policy is a sense that the professional standards
demanded of military personnel have been consistently violated
by those implementing this program. It is not, as DOD officials
assert, simply a failure to educate the troops. Instead, it is
a failure to communicate the truth, the whole truth, and
nothing but the truth, and I'll offer up a few examples.
First, when the Anthrax vaccination policy was announced on
December 15, 1997, a senior officer who refused to be named
told reporters, ``It's been licensed since 1970 and has a
proven safety record. It's been documented.''
The whole truth is that in April 1998, Dr. Catherine Zoon
of the FDA stated in a letter that, ``clinical studies
conducted on the long-term health effects of taking the anthrax
vaccine have not been submitted to the FDA.'' The Government
Accounting Office reiterated this fact on April 30, 1999, and
just recently the Army has announced that they will now conduct
a study.
Next, the Assistant Secretary of Defense for Health
Affairs, who is a physician, also told Congress on March 24
that, ``The safety of our AVIP was also confirmed by an
independent review of the program.'' She was referring to a
report by a Yale University medical professor who was selected
by DOD to review the health and medical aspects of the anthrax
vaccination policy before its implementation. This is one of
the four mandates by the Secretary of Defense.
The whole truth is that the doctor our DOD repeatedly cited
for over a year as their independent expert is really an
obstetrician and gynecologist. He wrote Congress, upon being
requested to testify last April, that he had informed the DOD
at the time of the review that he had no expertise in anthrax.
DOD has never acknowledged this admission by their ``expert''
or explained why they asked an OB/GYN to review a biological
warfare immunization program. As a result, by service members
the DOD's independent review is considered to be a sham.
Finally, the Assistant Secretary of Defense for Public
Affairs has also asserted for months that the number of
refusals is only about 200 service members, inferring no
significant impact to readiness. Yet on September 30th a DOD
spokesman finally acknowledged that the DOD has made no effort
to track refusals.
The whole truth is that the DOD has carefully crafted a
``no bad news'' tracking system that only tracks the
administration of the shots but does not track adverse
reactions or refusals. The Deputy Secretary of Defense admitted
to Congress on September 30 he was reluctant to count refusals
through a central tracking system because it would undermine
command authority. He did not elaborate why telling the truth
would undermine the chain of command.
I have seven additional examples of contradictory
statements by DOD and senior officials that elaborate on this
concern of service members. One is from the Assistant Secretary
of Defense for Public Affairs, two from the Assistant Secretary
of Defense for Reserve Affairs, one from the Deputy Secretary
of Defense, one from the Secretary of the Army, one from the
Director of the Air National Guard, and one from the Secretary
of Defense. I can hold those off until later, and they are
included in my written testimony unless you would like me to
elaborate at this time.
Mr. Burton. Major Rempfer, I think we'll get to those after
a bit. I really appreciate the research that you've done on
this, and we will have those for the record. We will look at
those.
Major Rempfer. And so, to conclude, I would just like to
say that these three lapses and the others that I've included
are merely the beginning of the unraveling of the truth. They
have placed the military commanders at all levels in an
untenable position, either implement a questionable policy or
sacrifice their careers. Consequently, the anthrax vaccination
policy has turned into a biological loyalty test.
The anthrax vaccine is no longer perceived by the troops as
a health policy. Instead it's become an issue of good order and
discipline. Loyal service officers must now show their loyalty
to the chain of command by submitting to the vaccine. For those
who don't, there is arbitrary discipline, incarceration and
court marshal for some, dismissal and disgrace for others. And
some are merely asked to leave and keep quiet.
Each of these examples demonstrates a breakdown of
intellectual honesty, which is the linchpin of integrity and
doctrine between commanders and their troops. Without honesty,
doctrine is merely dogma, as Congressman Shays referred to with
the ``medical Maginot Line'' concept today. Doctrine would
require the tacit cooperation of our adversaries to use the
only biological agent against which we have invasively defended
ourselves. It requires our adversaries to not use chemical
agents at all. It requires our adversaries to attack only the 1
percent of Americans who are vaccinated.
Recognizing the long-term logical implications of this
facade of force protection, Dr. Ken Alibek, the former deputy
director of the Soviet biological weapons program, told the
Joint Economic Committee of Congress that, ``In the case of
most military and all terrorist attacks with biological
weapons, that seems to be of little use.''
Further, he recently stated, ``We need to stop deceiving
people that vaccines are the most effective protection and
start developing new therapeutic and preventive approaches and
means based on broad-spectrum protection.''
I think that's what your service members are asking for as
well. Service members have discovered an acute dichotomy
between what defense officials are telling Congress and the
information readily available in government documents,
congressional testimony, medical research, and news reports.
This contrast creates an ethical dilemma for service members
whose core values require the questioning of immoral orders.
Consequently, out of respect for the constitutional
imperative of civilian control of the military, we have
reluctantly and repeatedly asked for Congress to intercede and
stop the corrosive impact the anthrax vaccination policy is
having on our Nation's military. If Congress is not proactive
in response to the DOD's absence in this case, the unfortunate
reality is that those members of the voluntary military who are
tying to embody these core values simply leave.
I'll close with an excerpt from the Soldier and the State
by noted Harvard military scholar Samuel Huntington. He
rhetorically asked, ``What does the military officer do when he
is ordered by a statesman to take a measure which is militarily
absurd when judged by professional standards?'' Huntington
answered, ``The existence of professional standards justifies
military disobedience.''
Our professional standards have been made very clear to us:
Integrity first, service before self, and excellence in all we
do. I believe I would be derelict in my duty if I did not take
this opportunity to express this professional dissent. As well,
it would be unconscionable for me not to seek redress for all
the service members that have been affected by it, that are
dedicated to the profession of arms and who have inextricably
been drawn into this professional military dilemma.
Mr. Chairman, thank you for listening to us today and
looking out for the interest of service members.
Mr. Burton. Thank you, Major.
[The prepared statement of Major Rempfer follows:]
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Mr. Burton. Dr. Halsey.
Dr. Halsey. My name is Dr. Neal Halsey. I'm a pediatrician
specializing in the study of infectious diseases and vaccines
at the Johns Hopkins University School of Public Health. I
thank you, Mr. Chairman, for the opportunity to provide this
committee with my perspective on the important issue of vaccine
safety.
I've had the opportunity to care for children who have
suffered from each of the infections that can be prevented
through vaccination. I've also cared for children who have
developed serious adverse reactions to vaccines. My objective,
and I believe the objective of most people in this room, is to
ensure that both children and adults receive the safest
vaccines possible to protect them from serious infectious
diseases.
I've had the opportunity to review the written testimonies
of Drs. Harold Margolis, Samuel Katz, and David Satcher in
their appearances before this committee and Congressman Mica's
subcommittee. These witnesses have detailed the enormous
benefits from immunizations, and I agree with their statements.
Therefore, I will not reiterate the benefits of vaccines in my
testimony today, but I will be happy to answer any questions
regarding this issue.
I was asked to comment on three issues: one, the number of
vaccines that children receive; second, combination vaccines;
and, third, diabetes. I am not concerned about the number of
vaccines that children receive, and I look forward to the
availability of several other vaccines that will help us
prevent serious infections and cancer.
The human immune system is remarkable in its capacity to
respond to millions of different antigens. Children are exposed
to many thousands of bacteria, fungi, and viruses beginning at
the moment of birth. Exposure to a single bacteria stimulates
an immune response to 17 to 50 different proteins.
Some new vaccines, such as the Haemophilus influenzae, or
Hib vaccine as it's called, contain only one or two bacterial
antigens. Therefore, children immunized with this vaccine are
exposed to fewer antigens than naturally infected children, and
immunized children are protected against meningitis and sepsis.
Recently, concerns have been raised about the amount of
thimerosal, a mercury containing preservative, and other
products in some vaccines. Manufacturers, the Food and Drug
Administration, the CDC, and the American Academy of Pediatrics
have responded rapidly to these concerns to make new products
available and reduce infants' exposures to these components. I
anticipate that further steps will be taken in the near future
to eliminate these concerns. The use of combination products
reduces the total exposure to these components and theoretical
concerns about these issues.
Children benefit from combined vaccines because they're
protected against several different diseases with a single
injection, thereby reducing pain and discomfort. If vaccines
that are currently given in combination were administered at
separate visits, children would be left unprotected against
some diseases for varying periods of time. As we learned a
decade ago with the resurgence of measles in this country,
leaving children unprotected even for a few weeks or months can
lead to epidemics and unnecessary suffering and deaths. We do
not need to learn those same lessons over again.
I know that you, Mr. Chairman, are concerned about
combining measles, mumps, and Rubella vaccines in the same
syringe. The studies and theories that were raised by Dr.
Andrew Wakefield have not held up to careful review by
investigators in this country, in Japan, and at his own
institution in the United Kingdom.
We know that encephalitis predisposes children to autism.
All three of the diseases prevented by the MMR vaccine,
measles, mumps, and Rubella, can cause encephalitis. We would
not want to leave children unprotected against these diseases
for even a short period of time. I support the continued use of
the combined measles, mumps, and Rubella vaccines as the safest
and most effective means to protect children against these
diseases.
With regard to diabetes, there have been two workshops that
have been conducted to investigate the possible link between
childhood diabetes and vaccines. One was held at the Institute
for Vaccine Safety at Johns Hopkins and the other at the
National Institutes of Health. The conclusions from both
inquiries have revealed no scientific evidence to support the
hypothesis that any vaccine causes diabetes. I will append to
my testimony the conclusions of one of those workshops and
provide a summary of the other one.
The history of medicine is filled with stories of
physicians and others who have been quick to claim that they
have answers to complex medical problems based on inadequate
studies. Just as people should not be misled by promises of
cures from fake medications, we should not mislead people with
false villains to blame when unexpected illnesses occur.
The parents of children with diabetes, autism, and other
disorders that we do not fully understand deserve answers as to
why their child developed these diseases. These answers should
be based on sound scientific inquiries. Congress should support
increased funding for research to identify the basic causes of
these disorders.
Identifying the safest vaccines is a process, and there are
no absolutes. Promoting unproven hypotheses and hearsay about
vaccine safety could have a negative effect on the willingness
of vaccine manufacturers to invest the large amount of
resources necessary to develop new vaccines that will protect
our children against cancer and other serious diseases.
Congress should be concerned about vaccine safety and
provide sufficient resources to assure that the best possible
science is conducted to assist with the development of vaccine
policy. We need highly qualified scientists who are on the
cutting edge of their fields to be conducting reviews of new
and existing vaccines. Therefore, it is disconcerting to learn
that the research budget for the agency responsible for
approving vaccines, the Center for Biologics and Evaluation
Research of the FDA, has been cut to one-third the level that
it was just 5 years ago. If this committee is truly concerned
with assuring that the safest possible vaccines are used for
children and adults, I urge you to investigate the issue and
restore funding for vaccine safety research. You should also
query the other agencies to determine the funding needed to
address other aspects of vaccine safety.
Thank you for the opportunity to share my views on these
subjects. I've provided a much more detailed statement,
including references, for the record. I would be happy to
answer any questions.
Mr. Burton. Thank you very much, Doctor.
[The prepared statement of Dr. Halsey follows:]
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Mr. Burton. I share your concern about the cut in funding
for that research regarding the safety of vaccines. I think
that's extremely important.
I hope nobody that's followed our hearings believes that I
and members of this committee don't believe that vaccines are
absolutely necessary. I think they're the reason that we have
the highest quality of life and health of any nation in the
history of mankind.
However, in my family, my granddaughter received a
hepatitis B shot, and 6 hours later she was not breathing. Now,
that does cause a little bit of concern.
My grandson received the shots that you referred to, a
perfectly healthy young man who is going to be 6 foot 10,
according to his doctor, his pediatrician, when he grows up. I
want him to be in the NBA so he can support me. He's autistic,
and there was no manifestation of anything like that prior to
him getting these shots. So I think more research needs to be
done.
I would like to ask you one question, however. Do you
receive any funding or any kind of research grants or anything
of that type from any pharmaceutical companies?
Dr. Halsey. Yes, I have received in the past year funding
for research on Lyme disease vaccine, the safety of Lyme
disease vaccine in children.
Mr. Burton. From what company?
Dr. Halsey. That is from SmithKline Beecham, the only
manufacturer of Lyme disease vaccine.
Mr. Burton. I just wanted to know if you had any funds
being received from the pharmaceutical companies.
Dr. Halsey. Could I address the point you made, just
briefly?
I think it's the No. 1 issue that people have trouble
understanding, from the testimony that I heard from this panel,
from what I heard on the earlier panels, and from what I just
heard from you. The science of causality assessment is not
understood by most people, and I think we need to do a better
job of educating as to how we do determine that something that
occurs following a vaccine, a drug, or a food is or is not
caused by that problem. We must have good science to say that
either there's a very specific test that can be done, which is
the case with some situations with adverse events to vaccines,
such as live virus vaccines, or you must demonstrate a
difference in risk.
Mr. Burton. I have to ask other questions, but that's one
of the reasons why we're having all of these hearings.
We had the DPT shot. There's been substantial information
coming to us from doctors and others that there were side
effects that could have resulted in autism; and the DPAT shot,
which is a substitute, has been on the market for some time.
It's much safer. Everybody knows that, and yet they're still
using the DPT shot. We're trying to find out why that's the
case, among other things, but we're looking into the things
you're talking about.
Let me go to Major Bates here, real quickly. How many
people are in your squadron?
Major Bates. 270, sir.
Mr. Burton. Of the 270, how many did you say have had these
kinds of problems?
Major Bates. Twelve, sir.
Mr. Burton. Twelve out of 270.
Major Bates. About 4.4 percent.
Mr. Burton. Did you have any others that refused the shot?
Major Bates. Yes, sir. There was an airman a few months ago
that was discharged with less than honorable conditions. He's
the only active duty member at our base that I'm aware of.
However, the new group of pilots--and not just pilots, the
new group of people that come in the summer, usually we do a
lot of moves in the summer, none of us have received the
vaccine yet. When we walk around the halls and talk to each
other, everybody looks both ways. They say, man, I don't want
this vaccine. I hope the Congress stops it. That's what the new
people say. But, of course, we have to wait to see when it
comes time to roll up the sleeve where they stand on that.
Mr. Burton. I've had a couple of flight engineers and
pilots come in and talk to me about this. They've indicated the
same consternation that you have.
Major Rempfer, how many people do you have in your
squadron?
Major Rempfer. The squadron I was in prior to transferring
over to the U.S. Air Force Reserves, my situation was I didn't
want to disobey the order, and we were--it was made very clear
to us that--leave the unit if you're not planning on taking the
shot. So I've done that. There's a pattern all across the
country of that occurring in many bases.
In my squadron, we had approximately 32 A-10 fighter
pilots, and 8 of us ended up choosing to leave the unit in lieu
of accepting the vaccine. And there was an additional couple of
individuals that chose to take non-mobility positions within
the unit.
Mr. Burton. They were no longer in flight status.
Major Rempfer. That's very true. They were in mobility
slots, but they chose to go ahead and allow themselves to be
grounded and not fly anymore. That was the ultimatum. We're
going to ground you and process you out of the unit.
Mr. Burton. Of those who had the shots, were there any
adverse side effects that you know of?
Major Rempfer. I don't think there have been any VAERS
forms filed in the unit. I'm not aware of any at least. But our
informal communications with all our friends who still remain
in the unit are that many of them felt like they had adverse
reactions. Nobody reported, and they back us up 100 percent.
Mr. Burton. Why did they not report it? Did they say
whether they were afraid of losing their flight status?
Major Rempfer. I think most folks are reluctant to do it
because most of them also hold FAA certifications as well.
Mr. Burton. They'd like to be pilots in commercial aircraft
after they----
Major Rempfer. In my case, in this unit most of them are
commercial airline pilots.
Mr. Burton. I see. You're in the reserves?
Major Rempfer. Yes, sir.
Mr. Burton. Admiral Crowe, during your career was there
ever discussion for the need to use the anthrax vaccine to
protect our troops against a biological attack?
Admiral Crowe. Mr. Chairman, I retired in 1989; and in my
statement I went through some of the measures that we took in
the JCS. But the question of toxin or anti-toxin and terrorism,
et cetera, really had not--the urgency had not developed to
that point. We were just beginning to explore the potential of
this problem but not individual vaccines, et cetera.
Mr. Burton. Let me just ask one more question, and I'll go
to Mr. Shays. You state that you had no contact with the
Defense Department in negotiations with regard to the BioPort
contract. Have you had any communications with anyone in the
Department or the Pentagon since your retirement?
Admiral Crowe. First of all, I didn't say in regard to the
contract. I said in regard to the decision to make
inoculations--mandatory inoculations.
Mr. Burton. Did you have contact with them or talk to
anybody at the Department of Defense about the BioPort company
or what----
Admiral Crowe. I did after it became a BioPort company but
not at the policy level. This was at the working level. And I
wrote a letter to Secretary Cohen after we became a company to
point out some of the problems we would be experiencing with
foreign sales, et cetera.
Mr. Burton. Did you ever talk to them about anything like
the financial problems the company was having and the need for
additional funding?
Admiral Crowe. I had one contact where I said that, if that
is true, we want the U.S. Government to be in on it, and all
the records would be accessible to them at BioPort. That was
all that was said. I really had very few conversations on this
subject with anybody in the Defense Department.
Mr. Burton. There was $18.4 million that was advanced
because the company was in difficulty. I just wondered if you
ever talked about that.
Admiral Crowe. I'm aware of that. That, incidentally, is a
contract that's been signed, but it's not been forwarded yet.
Mr. Burton. But did you discuss that with anybody, sir?
Admiral Crowe. Not within the Department. No, I did not,
sir.
Mr. Burton. Thank you.
Mr. Shays.
Mr. Shays. Thank you.
Admiral, I wasn't going to get into this because there are
so many issues that concern me more, but I'm surprised that you
actually had retired a good number of years before you started
working for BioPort.
Admiral Crowe. Yes. I was retired about 5 years, and then I
was Ambassador for 3 years, and I retired again.
Mr. Shays. I didn't know that, because I hadn't paid much
attention to the issue. I thought you had left sooner. It's
clear, though, you joined this facility, this operation,
because you had value to add to it.
Admiral Crowe. I think that's correct, yes.
Mr. Shays. It's also clear to me that you sincerely must
believe that this potentially is an important business to be in
because you believe it is a serious problem?
Admiral Crowe. Well, I thought terrorism--I had a great
deal of experience with that in England, and also these two
boards I was on--I felt that, No. 1, terrorism was a coming
threat. They need more attention to it. And, No. 2, that it was
a business that didn't engage in offensive weapons. It was not
engaged in killing people. It was engaged in a passive defense,
and I thought it was necessary for the military to have that
kind of thing.
Mr. Shays. Thank you.
Dr. Halsey, I may have sounded that my mind is made up more
than I think it is on this issue. I am leaning toward a
voluntary program until DOD and BioPort get their act together
before it becomes mandatory. But I would really appreciate--and
I'm not practicing the lawyer's creed of knowing the answer to
the question before I ask it, so I would be very interested in
knowing what your answer is. And that is what should be the
role of the FDA as it relates to the oversight? This is a very
interesting----
Dr. Halsey. I can speak from my experience as a
practitioner and with my experience serving with the Academy of
Pediatrics in an advisory committee capacity, and I believe
that what Dr. Zoon stated is correct and applies not just to
the military but it applies to the practice of medicine
everywhere.
The military is a little different in that it is part of
the Federal Government, and that may change things certainly
from your perspective, but there are many instances when people
are obligated to, because of the science that's out there, to
do some things with--drugs is much more common, vaccines I
don't favor at all--to do things that are slightly different
than what the package labeling says.
From the pediatrician's perspective, our biggest
frustration is that many drugs and vaccines are not tested in
children adequately. This has been addressed recently by
Congress in a law which I've forgotten the name of that
requires more testing in pediatric patients so that we do know
how we can use these effective products in them. But the FDA
cannot govern the day-to-day practice of medicine of
physicians.
I am not prepared at all to speak about the military. My
service has been with the Public Health Service, a branch of
the military, but----
Mr. Shays. Would BioPort, though, be allowed to claim that
the vaccine is proved to be effective after three----
Dr. Halsey. Again, that's a regulatory issue, but my
understanding is that any advertising----
Mr. Shays. I don't understand your answer, that's a
regulatory issue. This is something you get involved in all the
time.
Dr. Halsey. Yes, I am involved in it. But I'm not the FDA,
and I can't speak for the FDA, but I'll tell you what my
understanding is.
Mr. Shays. Let me ask you, do you have any--can you answer
honestly? There's not--nobody has anything over you, do they?
Dr. Halsey. No, nobody has anything over me at all at this
time.
Mr. Shays. I just want to know your expertise. And we have
certain rules that apply to one group. Should it apply to the
DOD?
Dr. Halsey. The question, as I understand it, should--does
FDA have regulatory authority over BioPort's advertising----
Mr. Shays. Let me ask you this.
Dr. Halsey. Let me try to answer.
Mr. Shays. No, I can tell you exactly the question. Should
a company that has been given a license be able to advertise
that the drug will do something that the license doesn't give
approval for?
Dr. Halsey. No. And the FDA does have authority over
advertising by companies.
Mr. Shays. And promotional material and so on.
Dr. Halsey. Correct.
Mr. Shays. So if BioPort was doing this, you have a
problem. You would have a problem with them claiming that it is
efficacious after three when their license says and they only
have the documentation to be licensed for six.
Dr. Halsey. I believe that the answer is yes to your
question.
I would have to say that my understanding of the response
from--and I've forgotten the General's name who is responding--
is that it is their effort to try to get all six doses in, but
they have looked at the immune response after three doses, and
there is evidence of an immune response which they believe will
provide some protection, may not be all the protection. But I
don't believe there was a state--the response that I heard was
that there wasn't any conscious effort to say that's all you
need, that they're trying to do that. But they recognize that,
gee, maybe we get some protection after three rather than six.
That's my understanding.
Mr. Shays. Why did you want to make that point? That wasn't
my question, but why did you want to make that point?
Dr. Halsey. Well, I believe there's a difference between--
--
Mr. Shays. You sound like you're an apologist for the
military.
Dr. Halsey. I'm no apologist for anybody--the military, the
FDA or vaccines in general.
Mr. Shays. That's exactly what they said. But I want to
know who watches the military, who protects our soldiers, our
sailors, our pilots? Whose role----
Dr. Halsey. I can't answer that question. I think you have
to--you have better access to the people who can answer who
watches over the military. I think you do.
Mr. Shays. That's true. And, because of that, I have a
gigantic problem with what I'm hearing. Because the FDA
basically has given the military the ability through the
license of BioPort to use a vaccine in a way that is new, an
aerosol type of exposure, not tested for. We're letting them do
that, and we're saying, though, you've got to follow the
practice. They've said to the military that you need to follow
the protocol. But now I learn today they don't have the
authority to back up that requirement.
So I'm asking you, as someone who is very close and is
concerned about vaccines, I want to know who should do it and
then tell me what I should do. You said it's up to me, so what
should I do about it?
Dr. Halsey. If you believe there was false advertising
taking place by someone in the Federal Government, then I think
you have a right or an obligation to try to determine if that
is true or not. Now, I can't speak to whether it's true,
because I haven't seen any of this material.
Mr. Shays. But this is what I'm trying to understand. What
I'm trying to understand is, you said, this is my
responsibility, so I'm going to exercise it. I need to know
whether or not we should ignore the licensing procedures, the
six shots, and go with new studies that haven't yet been
accepted by the FDA as valid for the licensing of the product.
Dr. Halsey. Based on everything that I've heard here today
and my previous reading, I think everybody in the military
would be happy if there were additional studies that----
Mr. Shays. Could a private company get away with saying to
FDA we would like to follow it? We would be happy if we could,
but we can't follow the protocol? That's a good enough answer?
Dr. Halsey. A company that manufactures the vaccine cannot
advertise such things without approval by the FDA, but a
private physician or a health maintenance organization or such
can actually do some things with drugs or vaccines that are not
exactly in accord with what is in the package label.
Mr. Shays. And they've been given this right by the FDA.
The military has been given this right by the FDA, correct?
Dr. Halsey. I don't believe that that's who grants that. I
believe--I don't know the law in this situation. I do know the
practice of medicine.
Admiral Crowe. I think he was talking about private
doctors.
Mr. Shays. Pardon me, sir? I didn't hear what you said.
Admiral Crowe. I said I think he was talking about private
doctors.
Mr. Shays. Yes. It's a wonderful circumstance that we have
right now. Basically, we're supposed to trust the military--and
I wonder why, based on past experience, whether it was Agent
Orange, whether it was people my office has had to help that
have been exposed to radiation--we're supposed to trust the
military to do the right thing, and now we have a program where
we had 300 people, give or take, a year who got the vaccine,
and they were tested under one type, and now we have a
circumstance where it's to be used as a prophylactic from
exposure by a terrorist or a military organization through
aerosol spraying, and we now have 2 million plus who are going
to get this vaccine, and we're supposed to trust the military
to govern itself.
And I made the assumption when I walked into this hearing
that the FDA was in fact going to make sure its protocol was
maintained, and in fact the FDA wrote the military and said,
you haven't kept up with your schedule. And if they didn't have
that authority, I wonder why they even bothered to write the
letter. I mean, I just thought they had that authority.
Mr. Burton. Can I come back to you in just a moment?
Mr. Shays. Just to make one point.
I'm not comfortable with generals practicing medicine, and
I'm not comfortable with doctors planning wars, and, frankly,
I'm not comfortable with doctors planning war doing medicine.
I'm not comfortable with doctors planning wars, I'm not
comfortable with politicians planning wars or doing medicine.
This was an area--I was eager to get into it, but I basically
see we have no one watching the military, and they have no
basis in which to say, trust us, based on past experience.
Mr. Burton. I'll come back to you in just a moment if you
have further questions, Congressman Shays. Let me just ask a
couple of questions, and that will do it for me.
Dr. Melling, I want to go back to something you said in
your opening statement. I think it's extremely important that
everybody who may be paying attention to this hearing
understand it. You said in your opinion that if we start--and I
may be paraphrasing what you said--but if we start inoculating
people against things like anthrax, that the potential enemies
who would use anthrax as a weapon would see that, and there are
a number of things that they could use to counter that, other
biological weapons which they undoubtedly would do. I mean, why
would they attack us with anthrax if they knew that nobody was
going to get it? They would go to somebody else. Is that what
you were saying?
Mr. Melling. It wasn't precisely that, but I do agree with
the comment that you made. I think what I was really saying was
that the time it takes to develop vaccines and take them
through the approval process is long. This is true not just for
defense vaccines, it's true for commercial products. Because an
aggressor is not constrained by the need for regulatory
approvals, ethical considerations and all the rest of it, I
think the pace at which they could move is likely to be faster
than the pace at which we can defend through vaccine
development.
Mr. Burton. While we're going through the process of
developing and passing through FDA and the other agencies the
anthrax vaccine, they knowing what we're doing, would say, why
should we concentrate on perfecting this weapon when we can
perfect another one very quickly?
Mr. Melling. Yes.
Admiral Crowe. May I make a comment?
First of all, if we succeed in doing it, that would be
progress. In other words, we convince terrorist organizations
not to use anthrax against us. That's the purpose of this whole
thing. What it would do, you're absolutely right, it would go
to other weapons. We feel that when you get into more
sophisticated forms of biological warfare, that's not as easy
for the terrorist to wage, and it causes him big problems.
Mr. Burton. How many biological agents are there that could
be used?
Admiral Crowe. Probably three or four. In the next 10
years, there will be even more maybe. But whether they're
practical for terrorist use severely limits the number, and
anthrax is one of the easiest for them to make. We would like
very much if they reached the conclusion they couldn't attack
us with anthrax.
Mr. Burton. The only concern that I have is that with the
Internet and all the new technologies we're seeing develop
very, very rapidly, it seems to me in the not-too-distant
future they'll be able to move more quickly with these agents
than they have in the past, and to try to vaccinate against all
of them is going to be very difficult. I think the point that
Dr. Melling is making is that they can move faster because they
have no restrictions than we can in producing a vaccine.
Admiral Crowe. But their resources are limited to certain
things.
Could I make a comment in this regard, Mr. Chairman? You
asked me to talk about development of policy. One of the things
you have got to be aware of is when the Secretary of Defense
makes the decision to do these sorts of things, there are lots
of pressures that act on him. They have the same kind of
testimony you're having. They try and look at the pros and
cons. They try to look at the entire spectrum. But I don't get
any feeling in these hearings that his problems are being
considered.
One of his major problems is that he is in command of
several million men. He is given a lot of information that says
anthrax vaccine will work in many, many cases. It's not
flawless. There will be some reaction, et cetera. I would just
like to imagine a hearing where, if we didn't use the anthrax
vaccine and all of a sudden our forces are hit with it and
several thousand people in this country are killed by anthrax,
then we'd have a real hearing on why we had a vaccine that
wasn't used and didn't save those people. That would be a real
situation.
Mr. Burton. There's no question that we believe that the
troops ought to be protected, and I think everybody here agrees
with that. What we're asking is has there been proper testing?
Have we been very straight with the military personnel about
the side effects of all this? And should there be informed
consent?
I was in the military, too, and if I thought there was a
real chance that I might be incapacitated for life by taking a
vaccine, even though I might be more at risk if I went into
combat and had to face that, I think I might make a different
kind of choice. I think that's what a lot of these people are
talking about.
I want to ask you, Major Bates, quickly one thing. Were you
threatened at all if you refused to take the shot, that you'd
be court-martialed and incarcerated?
Major Bates. Yes, sir.
Mr. Burton. Tell me exactly what they said to you.
Major Bates. I spoke with my squadron commander, told him I
was very uncomfortable with this. He reiterated the policy. If
I didn't take the vaccine, I would be court-martialed. There
were no other options. I asked him about a religious waiver. He
said, no chance.
Mr. Burton. They told you flat out you'd be court-martialed
and probably incarcerated for up to 2 years?
Major Bates. He sent me to the area defense counsel after
he told me I would be court-martialed. I went to the area
defense counsel; and they said, because of your rank, you have
the chance of spending up to 2 years in prison.
Mr. Burton. That's the same case for your colleagues in the
military who might refuse to take this.
Major Bates. Yes, sir.
Mr. Burton. There's no way that we could really tell how
many people who don't want to take it or feel they might be in
jeopardy because of the threat of prosecution or dishonorable
discharge.
Major Bates. Yes, sir. And one female naval officer has
been released from the military with an honorable discharge. I
would like to see this kind of lack of consistency across the
country with the military corrected.
Mr. Burton. What you would like to see, if military
personnel says, OK, we don't want to take this shot because we
think it's a risk to me and my future, rather than to having
face a court-martial that they just be able to be discharged if
they want to do that?
Major Bates. Yes, sir. And if you don't mind, I don't want
a dishonorable discharge from the military.
Mr. Burton. Under honorable----
Major Bates. I don't want an honorable discharge from the
military. I want an honorable military.
Mr. Burton. You want an honorable military.
Major Bates. Yes, sir.
Mr. Burton. OK. Very good.
What about in the reserves?
Major Rempfer. In the reserves and the guard, as a matter
of fact, the Assistant Secretary of Defense of Reserve Affairs
testified on September 29th, after he was reminded that he was
under oath by Congressman Shays, that, ``If someone is going to
resign over anthrax, they are certainly not going to be subject
to any penalties. This is one of the points of the guard and
reserve.'' And, unfortunately----
Mr. Burton. That was before Congressman Shays'
subcommittee?
Major Rempfer. Yes, sir. Unfortunately, the whole truth is
that, 5 days after that, the commander of the 184th Bomb Wing
in Kansas for the Air National Guard issued a written warning
and a letter of reprimand to a B-1 bomber pilot threatening a
$500 fine and 6 months in jail because the pilot had asked to
transfer out of the unit in lieu of submitting to the vaccine.
And we have similar contradictory occurrences compared to Mr.
Cragin's testimony.
In the U.S. Air Force reserves they've recently, again just
after that hearing, come down with a policy that says anybody
who's essentially refused the anthrax vaccine is not going to
be allowed to transfer.
Mr. Burton. Let me ask just one more question, and I'll
yield back to you, Mr. Shays.
Dr. Classen, you're the only one who has really come out
and said categorically that this vaccine being administered
would cause and could cause side effects, including diabetes.
On what do you base that?
Dr. Classen. Based on extensive animal studies and human
studies with vaccines. We find that when you stimulate the
immune system you're going to get an increased risk of
autoimmune diseases, including diabetes. There is a lot of
substantial evidence, including related literature and
interferons as well.
Mr. Burton. Was that just because of this one vaccine or
any vaccine?
Dr. Classen. It's any vaccine, practically. If you
stimulate the immune system, you stimulate macrophages cells.
You release interferons. You are going to increase the risk
of----
Mr. Burton. Is it greater with the anthrax vaccine or
vaccines of that type?
Dr. Classen. I can't say that for sure. Aluminum maginate
probably is not a good thing to have. It stimulates certain
cells. Six doses is probably not as good as having two or one
dose. So there are some problems with the anthrax vaccine.
Also, anthrax vaccine is made from a filtrate which is an
unpurified sort of material, as opposed to certain vaccines
that may just have a specific amino acid or specific protein.
The anthrax is less pure, and so that would tend to stimulate
the immune system as well.
Mr. Burton. Thank you.
Mr. Shays.
Mr. Shays. Thank you.
Dr. Melling, you made--in point one of your statement you
said the effectiveness of defense vaccines cannot be determined
by normal human epidemiological trials due to the rarity of
diseases involved. Animal models, therefore, are critical to
assess efficacies. Such models are limited in their ability to
predict what will happen in humans and in most cases can best
indicate some possibility of efficacy but do not allow us to
determine if a vaccine will protect 40, 60, or 80 percent or
whatever of humans, nor can we predict the human vaccine
effectiveness against different levels of challenge. Is that,
your view, generally accepted or if I ask Dr. Halsey would he
disagree with that?
Mr. Melling. I believe that my view is one that is
generally accepted; and, in fact, this has been traditionally,
I think, one of the reasons agencies both here and other
countries have required human epidemiological trials before
they actually license vaccines in order to demonstrate
efficacy.
Unfortunately, our detailed knowledge of the human immune
system is still limited, and this has meant the number of
vaccines where we can make an accurate prediction of human
efficacy solely based on animal studies is also equally
limited. This really is the problem we're wrestling with.
I think we've heard and certainly I've personally done work
on animal models relating to anthrax, the guinea pig model that
was referred to earlier, and what we see is different animals
respond in different ways. It doesn't mean that the vaccine
will not protect humans.
In fact, I'll answer the question you haven't asked me, but
I do believe it has some protective effect in humans. What I
can't estimate is the level of that protective effect, and
that's why I personally would not wish to rely solely on the
vaccine, that I would look at one of several measures.
It's interesting, the Institute of the U.K. that I used to
direct, we have people working on anthrax. They were all
vaccinated, but we took great care that, if they were working
with the organism, they were also protected by other
containment measures, and there was no way we'd be able to rely
solely on the vaccine.
Mr. Shays. Thank you.
Dr. Halsey, what is your sense of that?
Dr. Halsey. Well, I think all of us would prefer to have
epidemiologic studies proving efficacy for any vaccine prior to
it being licensed, but I do understand the difficulty in this
situation where the disease is so rare that it virtually is
impossible to do that study. I mean--and the other way in which
we sometimes can learn an enormous amount is through human
volunteer challenge studies, but I don't think anybody wants to
do that with this organism, just as we are not doing that with
HIV vaccines. It's too dangerous to do that.
Now, I can't say that it might not be done under some
circumstances, but then you must depend upon the animal data
and you look for a correlation with protection. And that
correlation with most vaccines is antibody, but that is not the
only measure of an immune response, and for many other vaccines
there are other factors which we are not very good at measuring
which are associated with protection.
Mr. Shays. Dr. Leitenberg.
Mr. Leitenberg. I just want to clarify one thing.
During World War II, the natural mode of infection by BW
agents in the natural world was not through aerosol inhalation.
The ``breakthrough,''--unfortunate breakthrough--in the World
War II United States-U.K.-Canadian BW program was to discover
aerosol dissemination of BW agents. You cannot expect to have
aerosol BW agents being tested against a human population.
That's impossible. That's really at the crux of your conundrum,
and what you've been asking for. You can't do that in the
United States.
Mr. Shays. Let me ask you, Admiral Crowe, did we ever
provide anthrax to any of our Middle East allies or
adversaries?
Admiral Crowe. I think we did. I know that some other
countries in Desert Storm received it, but I think most of that
was furnished by U.K.
Mr. Shays. I mean before that. For instance, did we ever
give Saddam Hussein anthrax?
Admiral Crowe. I'm not aware of that. I don't think so.
Mr. Shays. Mr. Leitenberg.
Mr. Leitenberg. I think what you're asking about for that
is Iraq was able to obtain from the type culture collection in
the United States some of their anthrax cultures.
Admiral Crowe. But that was not a government----
Mr. Leitenberg. That was certainly inadvertent, and that
was a universal practice. Such international supply has now
been tightened up enormously, subsequent to the discovery that
that's where some of Iraq's cultures came from. Iraqi strains
of anthrax were also obtained from other sources, but some were
obtained from the United States type culture collection, yes.
Mr. Shays. Mr. Classen, any of the questions I asked, did
you want to respond to?
Dr. Classen. The only issue I guess that really I want to
address is the previous panel where you kept saying you're not
getting a straight answer. You know, that is what really gets
my blood boiling, too, is that we just don't--when you confront
these people, which are public health officials, they just
aren't upfront, I believe, and they're not doing their job. I
think they're looking after their career. They are career
government people who are going to say what they say to improve
their career.
And I think that the real problem here is that there's no
downside. You don't have to obey the laws. You just do what you
have to do to promote your career, and then there's no
repercussions.
I think that is why we need a special prosecutor to come in
and to look in fact and see are these people in the public
health service, are they obeying the laws and the legislation
that Congress has enacted to ensure safety of biological
products.
And I think if you look at France, France did that. I think
they sent four public health officials to jail. They clearly
were looking after their own careers and not abiding by the
laws. In doing so, they jeopardize the health of the public.
And I think that clearly that's what's going on here, and I
think we really need some changes in that regard.
Mr. Shays. Mr. Chairman, I just have a few more questions,
not long.
I would like to put in the record a letter received--excuse
me, a copy of a letter that Sue Bailey, the Assistant Secretary
of Defense, received; and it's stamped September 29, 1999. It's
from Kathryn Zoon, and it's three paragraphs. I'll read the
last paragraph.
We reiterate our previous statement made to DOD on December
16, 1997, that FDA approval of the anthrax vaccine is based on
the six-dose regimen found in the approved labeling. Because we
are unaware of any data demonstrating that any deviation from
the approved intervals of doses found in the approved labeling
will provide protection from anthrax infection, we strongly
recommend the anthrax vaccine immunization program follow the
FDA-approved schedule. We would like to hear from you as soon
as possible regarding this matter.
[The information referred to follows:]
[GRAPHIC] [TIFF OMITTED] T5604.141
Mr. Shays. I read this letter and made an assumption, and I
started to smile as I read it. I didn't realize when she said
recommend, it wasn't a joke. She was recommending it. And one
of the things that--instead of requiring it.
And one of the things that I just think is of interest to
me is that the bottom line from this hearing, I've learned
something that I clearly should have known before, but bottom
line is the--this program run by the military does not have to
follow the protocol and that the FDA does not have to make them
follow the protocol. And so that the military says they're
trying to follow the program. They don't have to. And we have
no one I guess who can make them do it, I guess, unless
Congress.
Clearly, one of the recommendations that I'm going to
recommend to our subcommittee is that we not allow a government
agency to administer drugs without there being some outside
source or organization or institution that is there to protect
from the misuse of a potential drug.
I'll yield back.
Mr. Burton. The gentleman yields back his time.
Mr. Leitenberg.
Mr. Leitenberg. Since I previously answered ``yes'' to your
question, Congressman Shays--you had asked did the United
States ever provide anthrax to Iraq--and I really shouldn't
have answered an unqualified ``yes.'' The U.S. Government
didn't give the Iraqi Government anything. An institution in
Iraq was able to obtain the culture from the type culture
collection. That's really a better answer.
Mr. Shays. It is a better answer. There's always
speculation that in this battle between Iran and Iraq that we
were helping Iraq, and I appreciate your answer.
Mr. Burton. Mr. Waxman.
Mr. Waxman. Thank you very much, Mr. Chairman.
I think that the FDA position is that they don't regulate
the practice of medicine. They approve a product that is
presented to them by the manufacturer to be safe and effective
in order to get their approval, and then I don't think FDA has
ever been the appropriate agency to go and police how medicine
is practiced by government or nongovernmental agencies. So I
think that point you raise is an interesting one, but I'm
trying to think it through.
Off the top of my head, I find it very difficult to expect
the FDA should have to deal with that burden. And then if you
take the position that no government program can be run unless
it follows the protocols you're making an assumption that the
Department of Defense has not followed the protocols, and I'm
not convinced of that, although I am convinced that they didn't
do what they should have done in monitoring. And it's upsetting
that they didn't because they have a captive audience, so to
speak, where they should have been monitoring any adverse
reactions. But I don't think they would admit to the conclusion
you've reached, that they weren't going to give all the shots
required.
Mr. Shays. Would the gentleman yield?
Mr. Waxman. Sure.
Mr. Shays. The challenge I have is I'm wondering if this is
the practice of medicine when in fact we have our soldiers who
are basically ordered by the superior officers to take a
particular drug.
Mr. Waxman. I think you raise a good point--if I could take
back my time, I think you raise a very good point.
I was responding to FDA's responsibility, but we as a
government have a responsibility, if our young men and women
are going to be required to take a vaccine, to make sure that
it's administered to them in a way that's proper and will
protect them and if there are adverse effects that we know
about them.
I think we need to know more about adverse effects. There
are all sorts of pharmaceutical products that we don't know
about because we rely on the self-reporting of a lot of the
companies, sometimes voluntarily, particularly in the area of
medical devices, and we need to know more.
Let me just ask a few questions unless I get more time.
Dr. Halsey, Dr. Classen has described his theory that
vaccines cause various diseases such as childhood diabetes. I
understand NIH conducted a workshop in May 1998 to address Dr.
Classen's claim; is that correct?
Dr. Halsey. Yes, that is correct. And I had mentioned in my
testimony that there were two workshops. We also conducted one
at the Institute for Vaccine Safety at Johns Hopkins. Both
workshops concluded that no vaccines have been shown to cause
diabetes in humans.
I would add part of where some of the confusion has
occurred is that there is work in at least four different
laboratories with animals predisposed to get diabetes, and you
can prevent diabetes in those animals with some vaccines given
very early in life. Dr. Classen has done some of those studies,
but it is inappropriate to move from that to then say that you
can cause diabetes with vaccines. There is no evidence to
support that statement.
Mr. Waxman. I have a statement from the National Institutes
of Allergy and Infectious Diseases which reported on the
meeting, and this summary expressed the following findings:
``the consensus was that existing studies in humans do not
indicate an increase in Type 1 diabetes attributable either to
any vaccine or to the timing of vaccine administration.''
So the summary says this was a consensus. Do you agree with
these findings and, if so, why?
Dr. Halsey. I agree completely with those findings. We
could go through all of the data and the problems that occurred
with the methods and the logic that were presented by Dr.
Classen, but I think you would have to give me 15 minutes to
say that. But basically, you cannot use what we call ecologic
data, temporal trends that are occurring, to draw a conclusion
about causality assessment.
The most telling evidence is in a clinical trial that was
done in Finland, and those data were published. I will provide
the committee with the final publication of that study, which
clearly demonstrated in a randomized trial of Hemophilus
influenza vaccine, that there was no difference between the two
groups, it was a random chance that there would be a slight
difference in numbers, but they're basically identically the
same in children that got multiple doses early in life versus a
single dose later in life. And it's very convincing data.
Mr. Waxman. Thank you very much. I see the time is running
out, but Admiral Crowe, I wanted to thank you for being here on
such short notice and making yourself available to the
committee. I know you had to shuffle around your schedule. I
want to thank you for raising that issue of your relationship
to BioPort, the anthrax vaccine manufacturer. There have been a
lot of rumors floating around; you addressed it head on in your
statement.
Some of these rumors are on the Internet. Several members
of the Armed Services Committee suggested last week that you
may have benefited improperly from inside information when you
joined BioPort. And you just said that's absolutely not true;
is that correct?
Admiral Crowe. Yes, sir. I sometimes think the Internet is
more dangerous than taking the vaccine.
Mr. Waxman. You stated that anyone could have bid on the
purchase of the Michigan facility with the full knowledge of
DOD's planned vaccination program; isn't that correct?
Admiral Crowe. I'm sorry, would you say that again?
Mr. Waxman. Anybody could have bid on the purchase of the
Michigan facility and had the knowledge about DOD's planned
vaccination program?
Admiral Crowe. Oh, yes. That was public knowledge as early
as 1996.
Mr. Waxman. And did other companies compete for that
contract?
Admiral Crowe. They all knew about that. They all competed
in that environment. They were all aware of it. Secretary
Cohen's announcement, of course, in May, which was an official
one, formal one, intensified the competition, but it didn't
bring anything new to the debate.
Mr. Waxman. I'm pleased that you set the record straight
and people should have known that.
Admiral Crowe. Thank you.
Dr. Classen. Can I set the record straight on my own
research, if that's possible?
Mr. Waxman. It's OK with me, let me find out what the
chairman wants to do, because my time is up.
Mr. Burton. Let me followup on that very quickly.
Mr. Shays. Can I ask a question, Mr. Chairman? We don't
have any time restraints do we? We just have three members
here.
Mr. Burton. No, we don't. I would like to ask a question or
two. Henry is welcome to ask questions. I would never stop
Henry.
Admiral Crowe, it's my understanding that in September of--
what year was that, 1998--the BioPort company was formed, and
the papers were filed with the secretary of state, I guess, in
Michigan who formed BioPort; and within 30 days of the filing
of those papers, BioPort had the government contract. And
during that interim period, you became a member of the board;
is that correct?
Admiral Crowe. I became a member of the board because
BioPort completed the transaction.
Mr. Burton. But it was a 30-day period within about a month
or so?
Admiral Crowe. The contracts were already set, and that was
part of the agreement with the State of Michigan they would go
on with the new owner.
Mr. Burton. Before you became a part of BioPort, did you
have any contact over----
Admiral Crowe. We had nothing to do with the contracts.
Mr. Burton. Did you have any contact at all with the
Department of Defense about the company at all?
Admiral Crowe. I visited the GPO office with my CEO 1 day.
The State of Michigan, during the process of the negotiations,
wanted to ensure--and this applied to all of the bidders, not
just to BioPort--to ensure that if they won the bid, that the
Defense Department would express some sense that it could
accept their ownership of the firm. And all the bidders had to
do that with the Defense Department, and that's what we did.
The negotiations----
Mr. Burton. But you were the one that talked to them about
that?
Admiral Crowe. Well, I went with the meeting where we asked
them to answer this question. They didn't answer it in the
meeting, they wrote a letter later, but----
Mr. Burton. Did any of the other bidders, to your
knowledge, have people who had been formerly high officials in
the Pentagon?
Admiral Crowe. Certainly members of the government and the
military.
Mr. Burton. But high up in the Pentagon?
Admiral Crowe. Not that I know of, no, sir.
Mr. Burton. OK.
Dr. Classen, you didn't have a chance to respond to the
comments that Dr. Halsey was making regarding Mr. Waxman's
questioning.
Dr. Classen. Right, I would like to make the record
straight.
There were two meetings to discuss vaccines and diabetes.
The first was Dr. Halsey's meeting. That was a meeting that was
funded by several vaccine manufacturers. My understanding is
that that they fund Dr. Halsey's institute on safety, hundreds
of thousands of dollars. I called the public health school and
asked them particularly what vaccine manufacturers were funding
this meeting.
It was not an objective meeting. Before the data was even
presented, Dr. Halsey attacked me for being on TV regarding
this issue, and that was clearly inappropriate since the data
should have been discussed before his conclusions were made,
but his conclusions were made beforehand.
He asked the panel, from what I was told, to sign a
consensus statement essentially denouncing my findings. The
panel absolutely refused to sign a consensus statement that
denounced my findings. Therefore, I don't think there's any way
you can say there's consensus if people would refuse to sign a
consensus statement.
However, in his publication that he did on this meeting,
there were numerous false information in this publication
including the statement that there was consensus.
Mr. Waxman. Excuse me, Dr. Classen, you're talking about
Dr. Halsey, but the National Institute of Allergy and
Infectious Diseases had a meeting.
Dr. Classen. Right, I'm going to discuss that.
Mr. Waxman. They had a consensus at their meeting from what
I understand from their summaries.
Dr. Classen. They did not have a vote. I mean, how can you
say there's a consensus without some type of formal vote? It
would be like saying, OK, this is----
Mr. Waxman. This isn't a report from Dr. Halsey, this is a
report from the NIAID, and they say the consensus was that
existing studies in humans do not indicate an increase in Type
1 diabetes attributable either to any vaccine or to the timing
of vaccine administration.
Dr. Classen. That's exactly why I'm so upset, and I talked
to Mr. Shays about this. I mean, they're not being honest. They
didn't have a vote. The only vote they had, from my
understanding, was at Dr. Halsey's meeting where they in fact
refused to sign a consensus statement. Then they had somebody
go up in front of them, in front of this meeting saying, we
have come to consensus, good day.
There was no vote. You can't have a consensus unless you
take a poll and find out what's going on.
And the same day that Dr. Halsey is talking about was, in
fact, his data from Finland where in fact the investigators
submitted false data. This data was in fact funded in part by
the United States Government; they submitted false data to the
British Medical Journal. They did not include their sources of
funding, that partially funded this study. In fact, the British
Medical Journal then--as a neutral party, the British Medical
Journal reported--whereas in the process of reporting these
investigators to an ethics committee on ethics in publication
in the UK--so it's a complicated issue and the people weren't
always telling the truth.
And in fact----
Mr. Waxman. Excuse me. If people disagree on a scientific
issue, is that not telling the truth if they disagree with the
conclusions?
Dr. Classen. It's not a consensus.
Mr. Waxman. You're saying one thing, somebody else says
another thing. If they disagree with you, are they liars?
Dr. Classen. No, but it's not a consensus. If they say
there is a consensus, then there had better be a consensus.
Mr. Waxman. The National Institute of Allergy and
Infectious Diseases says there was a consensus. You say there
wasn't a consensus?
Dr. Classen. Absolutely.
Mr. Waxman. Then we have a disagreement on that point.
Dr. Classen. OK.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Burton. I'm not sure this is going to be resolved
today. I'm sure that you and Dr. Halsey have strong differences
which we can't resolve. But I would like to have information
from both of you that we can put into the record on your
positions which we can't go into because of time constraints
today.
Do you have some more?
Mr. Shays. Mr. Chairman, I apologize for extending this.
There are different people here I would love to get their
answers; and some of the answers I don't think I will like, but
I want them on the record.
My fear is, and maybe I don't need to be afraid of this,
but my fear is that we are entering a whole new area of--and I
address this to you, Admiral Crowe, and, Dr. Halsey.
Admiral, my understanding is that you obviously believe
there is the threat of biological, chemical, and potentially
nuclear threat. I believe--I happen to believe that; I think we
share that.
My sense is that you have gotten involved in this area
because you believe this is an area that you are doing good; as
you said earlier.
Admiral Crowe. I originally thought that, yes.
Mr. Shays. The question I have is, though, do you see that
this is just the first of many vaccines that we will take as a
prophylactic against the terrorists or attack by a military
force?
Admiral Crowe. I don't know that I'm competent to answer
that question. I don't foresee it specifically.
Mr. Shays. You are competent because I'm asking from your
military background. Your military background said this was an
area you should get involved in.
Admiral Crowe. Yes.
Mr. Shays. But I did make the assumption that you weren't
just getting in for anthrax.
Admiral Crowe. Military history would suggest that in this
challenge and many others that there will be movement in the
weapons themselves and counterweapons.
Mr. Shays. And that the way to protect our military is
through a vaccine?
Admiral Crowe. We will look at that.
Incidentally----
Mr. Shays. Don't run away too quickly here.
We're opening the door; this is a whole new approach for
the military?
Admiral Crowe. Absolutely.
Mr. Shays. And I gathered from you that you believed this
is a very positive development.
Admiral Crowe. That you could get protection from a
vaccine?
Mr. Shays. And that we would go down that road.
I don't view it as positive.
Admiral Crowe. When you say ``go down that road,'' I would
agree with the comment made that it should be one of many
steps.
Mr. Shays. OK. So this would be, the same logic that
applies to anthrax could apply to some of the other threats?
Admiral Crowe. Possibly.
Mr. Shays. Because when you say to us, because I think
about this, I mean if I have a role that makes this a voluntary
process, and then there isn't some circumstance where anthrax
is used, you know, that would be a pretty horrible thing to
live with.
But you could say that about almost any threat?
Admiral Crowe. Yes.
Mr. Shays. And so I can't think that way. I have to kind of
take myself out of that, you know, that consequence.
Dr. Halsey, do you see this as a positive development? I
mean, are you concerned that we could have a military--drawing
the military and get not only so many vaccines for natural
potential, you know, Mother Nature, but also what your enemy
may do, we're going--you're going to get 10 or 15 vaccines in
the course of your service?
Dr. Halsey. Well, I don't think that I or probably anybody
else here wants to pretend that they can predict what will
happen in the field of bioterrorism over the next decade or two
with regard to what organisms might occur. Just from an
infectious disease standpoint and a history of infectious
disease, the military have had to be out front with routine
immunization of troops against so many other organisms which we
don't normally use for the general public.
I personally am more comfortable knowing that should there
be a bioterrorism event that we at least have some troops who
are not going to be susceptible to the organism and who will be
available to help defend the country in any way they can.
So I see it as a positive development, because it does look
to me as though anthrax is a very real risk.
Mr. Shays. So this just may be the beginning. And I don't
say that other than just to say this may be just the beginning,
correct?
Dr. Halsey. Certainly. But I don't want to predict the
future.
Mr. Shays. OK. Then do you not think it makes sense that if
we are going to go down that route that there be some ability
to monitor and regulate how the military does this?
Dr. Halsey. Certainly everybody needs oversight. And I
would agree with what I think you're saying, in that there
should be some oversight of this process. Who that is, I don't
know, but you're in a much better position to determine who
that might be.
There is the Armed Forces Epidemiologic Board which has in
the past provided a lot of this coordination, but I don't know
the oversight mechanisms.
Mr. Shays. The DOD acknowledges they're not in technical
compliance. They are trying to comply. But even their
definition of ``compliance'' is, if they miss within 30 days,
they're still in compliance.
So we have got this double challenge; one is, first, to
acknowledge that they're not even within their 30 days past
date, but even their writing a rule that basically says they're
in compliance if they're 30 days late.
Doesn't that tell you something about how the DOD is
approaching their effort to live up to the protocol, and
forgetting--I'm not talking about the whole issue of getting
involved in medicine. I'm just talking about abiding by the
protocol.
Dr. Halsey. I probably am not qualified to speak, because I
don't know the precise protocol that they're following and what
windows of time that they provide opportunities for people to
meet the requirements of the protocol. And I think you should
address that to the military.
Mr. Shays. If a protocol says you're supposed to have a
shot and--six shots, and it gives the exact dates of time
within a certain period, I'm asking--this is your area of
expertise.
Dr. Halsey. I will be glad to respond.
And I think it's very evident to me as a pediatrician that
has been concerned about vaccination of children that we do
have guidelines that call for precise ages at which those
vaccines are given. But, unfortunately, there are many children
in this country, in spite of having very conscientious parents,
who don't get those vaccines at exactly the time that we
recommend them--2, 4, and 6 months. We don't call them
delinquent unless they go at least a month beyond the time that
is recommended and then we consider them behind.
So the principle of setting up some guidelines like that is
widespread in immunization.
Mr. Shays. OK, thank you.
Thank you, Mr. Chairman.
Mr. Burton. These people look like they're getting hungry.
Mr. Shays. Don't give up here. Let's pursue this.
Mr. Burton. I can handle it, if you can, Henry. Go ahead.
Mr. Waxman. Thank you, Mr. Chairman.
Admiral Crowe, as a military proposition, if you've got a
possible enemy with a new weapon, you want to figure a way to
counter that new weapon.
Admiral Crowe. Yes.
Mr. Waxman. And what we're talking about is a vaccine that
can, we would hope, be able to counter a terrorist activity.
Admiral Crowe. Hopefully.
Mr. Waxman. I'm sort of surprised that we wouldn't be
pleased that we have such an opportunity.
Admiral Crowe. That was my original approach. I thought the
country would be--would welcome this.
Mr. Waxman. I have my doubts about the strategic defense
initiative, because it's very expensive and I don't know
whether it will be effective. And I tend to think that one of
the dangers would be not a nuclear weapon sent by a missile but
a nuclear weapon being brought in by a terrorist. I suppose the
answer to that would be, well, you don't leave your troops
vulnerable to that attack.
Is that the way you would look at that, or how would you
respond to that?
Admiral Crowe. There are many ways to deliver the weapon,
it's a multifaceted problem, and it's a very serious threat.
Mr. Waxman. So bioterrorism can be multifaceted as well?
Admiral Crowe. Yes, as well.
Mr. Waxman. You try to figure out, as best you can, how to
do that?
Admiral Crowe. Actually, we do a variety of things. We do a
great many things besides this to try to protect our men, our
equipment from--to live in a biological environment. One of the
things that we should consider about this vaccine is, we
discuss the military aspects today, but it also should be--if
it's successful, and we can refine it so that it is, it should
probably be administered to civilians at some point. If we ever
have an anthrax scare on this country, there is going to be a
great demand for it on the civilian market.
Mr. Shays. Would you like to advertise in the hearings?
Admiral Crowe. I find that sort of upsetting, not
comfortable.
Mr. Waxman. I'm not sure if I agree with that, because I
know that the larger the population that we immunize, the
greater the chance of risks.
Admiral Crowe. OK.
Mr. Waxman. And I think that, as Mr. Shays indicated, we
have a responsibility wherever our people are taking risks.
Especially if the government is telling them to take those
risks, we have to be very responsible and cautious to be sure
that it's a risk that is a prudent one for us.
Admiral Crowe. I will say one thing. If I was exposed to
anthrax, I sure would like to have this kind of protection and
I do have it.
Mr. Waxman. And I would agree with you there. Thank you
very much. I know you've been on for hours, and I had another
committee hearing, so I'm coming in fresh. But I thank you, Mr.
Chairman, for being so indulgent of me and the members of the
panel.
Mr. Burton. No problem, Mr. Waxman.
Did you have anything else, Mr. Shays?
Mr. Shays. No, thank you.
Mr. Burton. I want to thank you very much. You've been
patient. And you gentlemen in the military, if you have any
undue pressure, I hope you will contact my office and maybe we
can help. We will do our best to help you out.
Thank you very much. We stand adjourned.
[Whereupon, at 5:40 p.m., the committee was adjourned.]
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