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




         DEFENSE VACCINES: FORCE PROTECTION OR FALSE SECURITY?

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

                                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?

                              ----------                              


                       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:]
    [GRAPHIC] [TIFF OMITTED] T5604.001
    
    [GRAPHIC] [TIFF OMITTED] T5604.002
    
    [GRAPHIC] [TIFF OMITTED] T5604.003
    
    [GRAPHIC] [TIFF OMITTED] T5604.004
    
    [GRAPHIC] [TIFF OMITTED] T5604.005
    
    [GRAPHIC] [TIFF OMITTED] T5604.006
    
    [GRAPHIC] [TIFF OMITTED] T5604.007
    
    [GRAPHIC] [TIFF OMITTED] T5604.008
    
    [GRAPHIC] [TIFF OMITTED] T5604.009
    
    [GRAPHIC] [TIFF OMITTED] T5604.010
    
    [GRAPHIC] [TIFF OMITTED] T5604.011
    
    [GRAPHIC] [TIFF OMITTED] T5604.012
    
    [GRAPHIC] [TIFF OMITTED] T5604.013
    
    [GRAPHIC] [TIFF OMITTED] T5604.014
    
    [GRAPHIC] [TIFF OMITTED] T5604.015
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.016
    
    [GRAPHIC] [TIFF OMITTED] T5604.017
    
    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:]
[GRAPHIC] [TIFF OMITTED] T5604.018

[GRAPHIC] [TIFF OMITTED] T5604.019

[GRAPHIC] [TIFF OMITTED] T5604.020

[GRAPHIC] [TIFF OMITTED] T5604.021

[GRAPHIC] [TIFF OMITTED] T5604.022

[GRAPHIC] [TIFF OMITTED] T5604.023

[GRAPHIC] [TIFF OMITTED] T5604.024

[GRAPHIC] [TIFF OMITTED] T5604.025

[GRAPHIC] [TIFF OMITTED] T5604.026

[GRAPHIC] [TIFF OMITTED] T5604.027

[GRAPHIC] [TIFF OMITTED] T5604.028

[GRAPHIC] [TIFF OMITTED] T5604.029

[GRAPHIC] [TIFF OMITTED] T5604.030

[GRAPHIC] [TIFF OMITTED] T5604.031

[GRAPHIC] [TIFF OMITTED] T5604.032

[GRAPHIC] [TIFF OMITTED] T5604.033

[GRAPHIC] [TIFF OMITTED] T5604.034

    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.035
    
    [GRAPHIC] [TIFF OMITTED] T5604.036
    
    [GRAPHIC] [TIFF OMITTED] T5604.037
    
    [GRAPHIC] [TIFF OMITTED] T5604.038
    
    [GRAPHIC] [TIFF OMITTED] T5604.039
    
    [GRAPHIC] [TIFF OMITTED] T5604.040
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.041
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.042
    
    [GRAPHIC] [TIFF OMITTED] T5604.043
    
    [GRAPHIC] [TIFF OMITTED] T5604.044
    
    [GRAPHIC] [TIFF OMITTED] T5604.045
    
    [GRAPHIC] [TIFF OMITTED] T5604.046
    
    [GRAPHIC] [TIFF OMITTED] T5604.047
    
    [GRAPHIC] [TIFF OMITTED] T5604.048
    
    [GRAPHIC] [TIFF OMITTED] T5604.049
    
    [GRAPHIC] [TIFF OMITTED] T5604.050
    
    [GRAPHIC] [TIFF OMITTED] T5604.051
    
    [GRAPHIC] [TIFF OMITTED] T5604.052
    
    [GRAPHIC] [TIFF OMITTED] T5604.053
    
    [GRAPHIC] [TIFF OMITTED] T5604.054
    
    [GRAPHIC] [TIFF OMITTED] T5604.055
    
    [GRAPHIC] [TIFF OMITTED] T5604.056
    
    [GRAPHIC] [TIFF OMITTED] T5604.057
    
    [GRAPHIC] [TIFF OMITTED] T5604.058
    
    [GRAPHIC] [TIFF OMITTED] T5604.059
    
    [GRAPHIC] [TIFF OMITTED] T5604.060
    
    [GRAPHIC] [TIFF OMITTED] T5604.061
    
    [GRAPHIC] [TIFF OMITTED] T5604.062
    
    [GRAPHIC] [TIFF OMITTED] T5604.063
    
    [GRAPHIC] [TIFF OMITTED] T5604.064
    
    [GRAPHIC] [TIFF OMITTED] T5604.065
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.066
    
    [GRAPHIC] [TIFF OMITTED] T5604.067
    
    [GRAPHIC] [TIFF OMITTED] T5604.068
    
    [GRAPHIC] [TIFF OMITTED] T5604.069
    
    [GRAPHIC] [TIFF OMITTED] T5604.070
    
    [GRAPHIC] [TIFF OMITTED] T5604.071
    
    [GRAPHIC] [TIFF OMITTED] T5604.072
    
    [GRAPHIC] [TIFF OMITTED] T5604.073
    
    [GRAPHIC] [TIFF OMITTED] T5604.074
    
    [GRAPHIC] [TIFF OMITTED] T5604.075
    
    [GRAPHIC] [TIFF OMITTED] T5604.076
    
    [GRAPHIC] [TIFF OMITTED] T5604.077
    
    [GRAPHIC] [TIFF OMITTED] T5604.078
    
    [GRAPHIC] [TIFF OMITTED] T5604.079
    
    [GRAPHIC] [TIFF OMITTED] T5604.080
    
    [GRAPHIC] [TIFF OMITTED] T5604.081
    
    [GRAPHIC] [TIFF OMITTED] T5604.082
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.083
    
    [GRAPHIC] [TIFF OMITTED] T5604.084
    
    [GRAPHIC] [TIFF OMITTED] T5604.085
    
    [GRAPHIC] [TIFF OMITTED] T5604.086
    
    [GRAPHIC] [TIFF OMITTED] T5604.087
    
    [GRAPHIC] [TIFF OMITTED] T5604.088
    
    [GRAPHIC] [TIFF OMITTED] T5604.089
    
    [GRAPHIC] [TIFF OMITTED] T5604.090
    
    [GRAPHIC] [TIFF OMITTED] T5604.091
    
    [GRAPHIC] [TIFF OMITTED] T5604.092
    
    [GRAPHIC] [TIFF OMITTED] T5604.093
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.094
    
    [GRAPHIC] [TIFF OMITTED] T5604.095
    
    [GRAPHIC] [TIFF OMITTED] T5604.096
    
    [GRAPHIC] [TIFF OMITTED] T5604.097
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.098
    
    [GRAPHIC] [TIFF OMITTED] T5604.099
    
    [GRAPHIC] [TIFF OMITTED] T5604.100
    
    [GRAPHIC] [TIFF OMITTED] T5604.101
    
    [GRAPHIC] [TIFF OMITTED] T5604.102
    
    [GRAPHIC] [TIFF OMITTED] T5604.103
    
    [GRAPHIC] [TIFF OMITTED] T5604.104
    
    [GRAPHIC] [TIFF OMITTED] T5604.105
    
    [GRAPHIC] [TIFF OMITTED] T5604.106
    
    [GRAPHIC] [TIFF OMITTED] T5604.107
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.108
    
    [GRAPHIC] [TIFF OMITTED] T5604.109
    
    [GRAPHIC] [TIFF OMITTED] T5604.110
    
    [GRAPHIC] [TIFF OMITTED] T5604.111
    
    [GRAPHIC] [TIFF OMITTED] T5604.112
    
    [GRAPHIC] [TIFF OMITTED] T5604.113
    
    [GRAPHIC] [TIFF OMITTED] T5604.114
    
    [GRAPHIC] [TIFF OMITTED] T5604.115
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.116
    
    [GRAPHIC] [TIFF OMITTED] T5604.117
    
    [GRAPHIC] [TIFF OMITTED] T5604.118
    
    [GRAPHIC] [TIFF OMITTED] T5604.119
    
    [GRAPHIC] [TIFF OMITTED] T5604.120
    
    [GRAPHIC] [TIFF OMITTED] T5604.121
    
    [GRAPHIC] [TIFF OMITTED] T5604.122
    
    [GRAPHIC] [TIFF OMITTED] T5604.123
    
    [GRAPHIC] [TIFF OMITTED] T5604.124
    
    [GRAPHIC] [TIFF OMITTED] T5604.125
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.126
    
    [GRAPHIC] [TIFF OMITTED] T5604.127
    
    [GRAPHIC] [TIFF OMITTED] T5604.128
    
    [GRAPHIC] [TIFF OMITTED] T5604.129
    
    [GRAPHIC] [TIFF OMITTED] T5604.130
    
    [GRAPHIC] [TIFF OMITTED] T5604.131
    
    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:]
    [GRAPHIC] [TIFF OMITTED] T5604.132
    
    [GRAPHIC] [TIFF OMITTED] T5604.133
    
    [GRAPHIC] [TIFF OMITTED] T5604.134
    
    [GRAPHIC] [TIFF OMITTED] T5604.135
    
    [GRAPHIC] [TIFF OMITTED] T5604.136
    
    [GRAPHIC] [TIFF OMITTED] T5604.137
    
    [GRAPHIC] [TIFF OMITTED] T5604.138
    
    [GRAPHIC] [TIFF OMITTED] T5604.139
    
    [GRAPHIC] [TIFF OMITTED] T5604.140
    
    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.]

                                   -