SPEAKERS CONTENTS INSERTS
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??–???
1999
[H.A.S.C. No. 106–22]
DEPARTMENT OF DEFENSE ANTHRAX VACCINE IMMUNIZATION PROGRAM
HEARING
BEFORE THE
MILITARY PERSONNEL SUBCOMMITTEE
OF THE
COMMITTEE ON ARMED SERVICES
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
HEARING HELD
SEPTEMBER 30, 1999
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MILITARY PERSONNEL SUBCOMMITTEE
STEVE BUYER, Indiana, Chairman
ROSCOE G. BARTLETT, Maryland
J.C. WATTS, Jr., Oklahoma
MAC THORNBERRY, Texas
LINDSEY GRAHAM, South Carolina
JIM RYUN, Kansas
MARY BONO, California
JOSEPH PITTS, Pennsylvania
ROBIN HAYES, North Carolina
STEVEN KUYKENDALL, California
NEIL ABERCROMBIE, Hawaii
MARTIN T. MEEHAN, Massachusetts
PATRICK J. KENNEDY, Rhode Island
LORETTA SANCHEZ, California
CYNTHIA A. McKINNEY, Georgia
ELLEN O. TAUSCHER, California
MIKE THOMPSON, California
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JOHN B. LARSON, Connecticut
John D. Chapla, Professional Staff Member
Thomas E. Hawley, Professional Staff Member
Michael R. Higgins, Professional Staff Member
Edward P. Wyatt, Professional Staff Member
George O. Withers, Professional Staff Member
Nancy M. Warner, Staff Assistant
(ii)
C O N T E N T S
CHRONOLOGICAL LIST OF HEARINGS
1999
HEARING:
Thursday, September 30, 1999, Department of Defense Anthrax Vaccine Immunization Program
APPENDIX:
Thursday, September 30, 1999
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THURSDAY, SEPTEMBER 30, 1999
DEPARTMENT OF DEFENSE ANTHRAX VACCINE IMMUNIZATION PROGRAM
STATEMENTS PRESENTED BY MEMBERS OF CONGRESS
Abercrombie, Hon. Neil, a Representative from Hawaii, Ranking Member, Military Personnel Subcommittee
Buyer, Hon. Steve, a Representative from Indiana, Chairman, Military Personnel Subcommittee
WITNESSES
Ashcraft, Col. Myron G., USAF, Chief of Staff, Headquarters, Ohio Air National Guard
Blanck, Lt. Gen. Ronald R., USA, Surgeon General of the Army
Colley, Master Sgt. William E., USAF, 137th Airlift Wing, Oklahoma Air National Guard
Hamre, Dr. John, Deputy Secretary of Defense
Handy, Lt. Col. Redmond, USAF (Ret.), Government and Business Consulting, Inc.
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Jeffords, Maj. Jeffrey, USAF, 164th Airlift Wing, Tennessee Air National Guard
Keane, Gen. John, USA, Vice Chief of Staff of the Army
Miyamoto, Gunnery Sgt. Larry, USMC, Chemical Biological Incident Response Force, Camp Lejeune, North Carolina
Oliver, Hon. Dave, Principal Deputy Under Secretary of Defense for Acquisition and Technology
Rohrbach, LTJG Chris, USN, Assistant Officer in Charge, Bravo Platoon, SEAL Team 8, Little Creek, Virginia
Zinni, Gen. Anthony, USMC, Commander in Chief, U.S. Central Command
APPENDIX
PREPARED STATEMENTS:
[The Prepared Statements can be viewed in the hard copy.]
Abercrombie Hon. Neil
Buyer, Hon. Steve
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Colley, Master Sgt. William E.
Gilman, Hon. Benjamin A.
Hamre, Dr. John J.
Handy, Col. (Ret.) Redmond H.
Jeffords, Maj. Jeffrey
Johnson, Hon. Nancy L.
Jones, Hon. Walter B.
Kelly, Hon. Sue W.
Nass, M.D., Meryl
Rohrbach, LTJG Chris
DOCUMENTS SUBMITTED FOR THE RECORD:
[The Documents Submitted for the Record can be viewed in the hard copy.]
Letter to Hon. William Cohen from Hon. Benjamin A. Gilman, Hon. Sue Kelly, Hon. Doug Ose, Hon. Christopher Shays, Hon. Mark Souder, and Hon. James Talent
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QUESTIONS AND ANSWERS SUBMITTED FOR THE RECORD:
[The Questions and Answers are pending.]
DEPARTMENT OF DEFENSE ANTHRAX VACCINE IMMUNIZATION PROGRAM
House of Representatives,
Committee on Armed Services,
Military Personnel Subcommittee,
Washington, DC, Thursday, September 30, 1999.
The subcommittee met, pursuant to call, at 9:06 a.m. in room 2118, Rayburn House Office Building, Hon. Steve Buyer (chairman of the subcommittee) presiding.
OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE FROM INDIANA, CHAIRMAN, MILITARY PERSONNEL SUBCOMMITTEE
Mr. BUYER. The Military Personnel Subcommittee hearing regarding the Department of Defense's Anthrax Vaccine Immunization Program will come to order.
I would ask unanimous consent that Members who are not part of the Armed Services Committee be permitted to not only sit in this hearing, but also to give an opening statement.
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Any objections? Hearing no objections, so ordered.
In March of 1999, the Department of Defense implemented its Anthrax Vaccine Immunization Program, or AVIP, as part of the overall force protection strategy. AVIP was designed to protect deployed forces against their vulnerability to attack by one of the 10 or more nations known or suspected of having weaponized anthrax for use as a weapon of mass destruction.
Last week, the subcommittee heard classified details of that threat. Today the subcommittee will turn its attention to a range of issues and concerns that have been raised about the Anthrax Vaccine Immunization Program. Many service members and others outside the services have expressed their serious reservations about the program, especially about the safety and efficacy of the vaccine, and its effectiveness as a protection against the weaponized anthrax.
Questions have also been raised regarding the corporation which is the sole manufacturer of the vaccine. That company had to undertake a major renovation to prepare to manufacture the large volume of vaccine required by the Department and has already had to renegotiate its contract to avoid financial collapse.
I would also ask of the subcommittee to make sure that they make comments about our allies and what they are doing with regard to the anthrax vaccine. If we, the United States, believe it is a threat, well, hopefully the allies, they concur.
From the outset, the subcommittee has had concerns about the Department's system for tracking the immunization status of individual service members. This immunization tracking system is showing signs it may not be up to the task of recording, storing, and reliably retrieving the huge volume of information that will be created by immunizing 2.4 million troops.
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Immunizing Reserve component personnel is already presenting special challenges. In fact, there is some preliminary evidence that the shot regime among Reserves is falling behind schedule. There have been claims in the media that hundreds of service members are choosing to leave the military rather than take the vaccine. If true, this could be—could have a significant effect on the services' ability to carry out their contingency missions and even their routine deployments.
Given these concerns, it is clear to me that a careful fact-based review of the program is justified. That is why we are here today. We are also here to begin the assessment of whether the benefits and the risks of continuing this vaccination program outweigh the risks of delaying or stopping the program.
We have asked two panels of witnesses to testify here today. Our first panel represents the key leaders of the Department of Defense. The second panel is composed of troops who have had to make the decision of whether to take the vaccine or not.
I see that several Members outside the subcommittee have joined us in this hearing, and I appreciate their interest and will do my best to make sure that their questions have an opportunity to be answered.
I also want to thank Dr. Hamre for being here today and recognizing the seriousness of this situation that we face here today. If we step forward and say we are not going to do this program, then what is the threat, in fact, to our personnel? And I am sure you are going to get into that.
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I also appreciate General Zinni, well-respected general officer and Commander in Chief (CINC), in U.S. Central Command (CINCOM), since that is the most emergent threat. For you to be here today sends a pretty strong signal on how seriously you believe in this program.
[The prepared statement of Mr. Buyer can be found in the Appendix.]
Mr. BUYER. I will now yield to Mr. Abercrombie, the Ranking Member of the Military Personnel Subcommittee, for comments that he may have.
STATEMENT OF HON. NEIL ABERCROMBIE, A REPRESENTATIVE FROM HAWAII, RANKING MEMBER, MILITARY PERSONNEL SUBCOMMITTEE
Mr. ABERCROMBIE. Well, Mr. Chairman, aloha. Thank you so much. I join you in welcoming witnesses today, and I want to commend you for calling and putting together this important hearing.
The threats that our service members face today are many. In the past decade, we have come to understand the fact that added to earlier conventional threats, biological warfare agents are increasingly a real hazard for our troops and for the civilians who serve them. The weaponization of anthrax as a low-tech, inexpensive bioweapon, which is virtually always fatal, represents a most crucial threat of this kind. As such, it is imperative that any and all reasonable efforts be made to protect our military personnel against the use of anthrax as a weapon.
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Mr. Chairman, I might note for the record that this morning news has come that there has been a death sentence given in Japan to the perpetrator of the biological weapon assault in Tokyo in the subways. This is not something that is an abstraction, Mr. Chairman. And I again commend you for having this hearing under these circumstances, a sober and serious reflection on what is proposed and what is, in fact, being undertaken by our armed services.
Having said that, I also recognize that a certain amount of controversy has erupted over the Anthrax Vaccine Immunization Program implemented by the Department of Defense in March of 1998. The Department recognizes, I believe, that it has done a less than effective job of providing information to the service personnel and to the public regarding the details of this program.
On the other hand, I think it is fair to say that there has been a certain level of sensationalizing of the relative risks of this program. Witness the fact that we have got television here today when we have hearings of at least equal profundity taking place.
The value in calling this hearing, I believe, is to use this forum to cut through the rhetoric and to cut through the layers of misinformation or lack of information in an effort to provide a more realistic view of the Anthrax Vaccine Immunization Program. I think realism and information is going to be the—will be the bywords that we will operate with today.
With that, Mr. Chairman, I look forward to hearing from our witnesses, and I yield back the balance of my time and look forward to the rest of the testimony and perspective that will be provided.
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[The prepared statement of Mr. Abercrombie can be found in the Appendix.]
Mr. BUYER. Any other Members care to make an opening statement?
Mr. Gilman.
Mr. GILMAN. Thank you, Mr. Chairman. I want to thank you for permitting us to participate in this very important hearing investigating the implementation of the Defense Department's mandatory Anthrax Vaccine Immunization Program, and I am pleased we have such experts here with us from the Department of Defense.
Since I am not a member of the Armed Services Committee, I appreciate your inviting me to participate and to offer an opening statement.
Mr. Chairman, I first became involved with this matter earlier this year, after being approached by a number of military personnel in my area who were deployed at a nearby Air Force base and were due to begin receiving their vaccine shots this past summer. As I looked into this issue, both through the information that had been released by the Defense Department and testimony presented before our Government Reform subcommittee, which I participated in, and that was investigating this issue, I found that I came up with more questions than answers.
Rather than outline all of my questions regarding the safety, the efficacy, the testing of this program before it was utilized, and the appropriateness of the vaccine, I would ask that a copy of a letter, which I along with five of my colleagues, including Congressman Jones who is seated here with me today—a letter we sent to Secretary Cohen on July 20th, 1999, be included in this morning's record.
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Mr. BUYER. So ordered.
[The information referred to can be found in the Appendix.]
Mr. GILMAN. I note that despite receiving numerous assurances to the contrary from Assistant Secretary de Leon, neither I nor my colleagues have received the courtesy of a reply from Secretary Cohen. Such a failure to answer our sincere and reasonable questions speaks volumes.
I would, however, at this point like to raise two points that should be considered in an evaluation of this progress. The first of these relates to the public relations campaign being waged by the Pentagon. Their official message is that the majority of troops are taking the vaccine with only a small minority of disgruntled individuals refusing. And it should be noted, however, that the Pentagon only lists active duty shot-refusers in their public estimates. Refusals by National Guard and Reserve members are ignored.
Of course, the reality does not support this rhetoric. Recently a military base near my district was due to begin inoculations for half of their base personnel. In the 6 weeks leading up to the deadline, my office received over 100 phone calls, e-mails and letters from personnel and their families who are concerned about taking the vaccine.
This correspondence supported media accounts which reported that had a hurricane-related power outage not occurred and that the inoculations went forward as planned, more than 25 of the 48 pilots at Stewart (Air National Guard Base) were prepared to resign and, as a matter of fact, have submitted resignations to be held in the event this goes forward. Most of them happen to be airline pilots very much concerned about their physical conditions following the vaccination.
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From the initial evidence that I received, each National Guard base that begins to implement the vaccination program will suffer attrition among its pilots. It consistently averages between 20 to 40 percent. All of us are very much concerned about our readiness and about our personnel and about the morale of our personnel or I wouldn't be here.
This is not rumor, it is reality, yet it is a reality that apparently the Defense Department refuses to accept. Irrespective of this, however, is the fact that our military with its current quality-of-life problems, and there are many of them, coupled with an unparalleled rate of deployment under the Administration, cannot afford to continue losing highly qualified personnel, personnel from its Reserve and National Guard units.
Regrettably this fact does not appear to be a consideration of the current Administration, which maintains that any potential benefit of this program far outweighs the possible costs involved in its implementation.
A second point which we should be considering that bears raising at this point relates to consistency. I find it highly ironic that the State Department, whose embassies are far more exposed to a potential anthrax attack, especially by way of terrorism, has chosen to implement a voluntary policy for Foreign Service personnel, just as many of our allies have done in the military sections of their nation.
Moreover, none of our allies has a mandatory vaccination policy for their armed forces. In light of the multinational nature of today's military operations, the Pentagon's argument that maintaining force integrity in the face of an anthrax attack appears a mandatory forcewide vaccination—it appears that a mandatory forcewide vaccination falls apart leaves something to be desired.
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Assuming that the vaccine protects against weaponized anthrax, in off-label use, according to the Food and Drug Administration (FDA), what happens to force effectiveness in a coalition deployment when nonvaccinated troops of an allied nation are hit along with U.S. personnel?
After several months of investigating this issue, I have reached a conclusion that this vaccination program was initiated early on in a very hasty manner before a proper amount of research on the effectiveness of the vaccine and the safety of it was completed. We find that there was no real human testing. There was some animal testing, but truly no human testing. This, I think, creates a serious question about the effectiveness and the efficacy of this vaccine.
The result has been detrimental to both morale and readiness in our second tier units, given the reliance of the active duty of these Reserve and National Guard components for overseas deployments, and it is only a matter of time before our ability to protect power overseas on short notice could be impaired.
So, Mr. Chairman, I thank you once again for your attention to this issue, for permitting me the opportunity to participate today. Our Government Oversight Committee will continue its review of this issue. There are some very serious questions that I intend to call to the attention of our colleagues in the Congress concerning the safety and the efficacy of this vaccine material.
Thank you, Mr. Chairman.
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Mr. BUYER. Mr. Gilman, we have great respect for your work on the International Relations Committee, and we appreciate your concern to be here today.
[The prepared statement of Mr. Gilman can be found in the Appendix.]
Mr. BUYER. I would advise Members that I have been advised Dr. Hamre has a meeting at the White House at 10:30.
Is that correct?
Dr. HAMRE. That is true.
Mr. BUYER. So we can continue with statements, or we can actually get to answers, and if you would like to have an opening statement, your brevity is appreciated.
Mr. Jones.
Mr. JONES. Mr. Chairman, I am going to read as quickly as I can, but I will tell you, I think this hearing today is as important as being at the White House at 10:30, and that is my opinion and my opinion alone.
Mr. Chairman, I thank you for the opportunity to be here today to discuss the Department of Defense's mandatory anthrax vaccination program. This is an issue of critical importance not only to our men and women in uniform, but to the readiness of the United States military and the challenges that we face in recruiting and retaining the best and brightest individuals.
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For this I am thankful to the subcommittee for showing an interest in this issue, as well as to the witnesses for taking the time to be here to share their thoughts on this program. To the witnesses in uniform, thank you for your dedication and service to our Nation.
Mr. Chairman, I have the honor of representing the Third District of North Carolina, which is home of Camp Lejeune, Cherry Point, New River Marine Air Station, Seymour Johnson Air Force Base and the Coast Guard. There was a conversation off-base with officers from the Reserves and active duty at Seymour Johnson last March that I first learned of the grave concerns among our military about the current anthrax vaccination program.
In later conducting my own research, I found myself asking the same questions that officers had brought to my attention. The importance of providing our military with protection against unconventional threats such as biological weapons is absolute; however, DOD implemented its mandatory anthrax vaccination program before conducting the scientific and medical tests needed to reduce any possible unintended health risk. As a result, many of the military now feel that the mandatory program forces them to make a choice: Take a potential unsafe vaccine or leave the service.
It was out of my concern for the safety of men and women in uniform and the concern about the strength and the readiness of the United States military that I introduced H.R. 2543 to make the current mandatory program voluntary. Since introducing this bill, members of my staff and I have spoken with numerous military personnel, their families, friends who have expressed their individual concerns about the safety and efficacy of the Anthrax Vaccine Immunization Program.
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I sincerely believe that our men and women in uniform have a right to be concerned. When I introduced H.R. 2543, I said that if the Pentagon could convince our military that the anthrax vaccination is safe and necessary, there would be no need for my legislation. Since then, representatives from the Department of Defense have been in my office numerous times to convince me that the anthrax vaccine is safe, and I believe they are sincere in their belief. Until the Pentagon can convince our troops that this shot is safe, our highly-skilled, highly-trained Reservists, Guard and active duty forces will continue to leave the service because of the risks they associate with the vaccine.
Currently, more than half of the 301st Airlift Squadron at Travis Air Force Base have already resigned or plan to resign due to the anthrax vaccine. The Air Force estimates that it costs $6 million to train each pilot. If this figure holds true, the United States is losing over $190 million worth of training and 450 years' worth of combined experience in the cockpit at a single base.
Unfortunately, these figures are not limited to one unit or one military base, at least one-third of the F–16 pilots in the Wisconsin National Guard's 115th Fighter Wing are expected to refuse the vaccination. Another Air National Guard unit in Connecticut has already lost one-third of its pilots for the same reason, and the Department of Defense has estimated several hundred active personnel have refused the vaccine and are awaiting disciplinary action.
For a military that struggles to cope with the challenges in recruitment and retention, the anthrax vaccine has proven to be a real problem. Yesterday I had the opportunity to participate in the hearing held by Congressman Chris Shays, the Chairman of the House Government Reform Subcommittee on National Security, Veteran Affairs and International Relations. Like our meeting today, the hearing concerned aspects of the implementation and the impact of the mandatory anthrax vaccine program.
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I realized during these hearings that arguments both in favor and in opposition to the program present valid points, but what we are losing in this battle is the one thing we cannot afford to lose, the trust, and I repeat, Mr. Chairman, the trust, of our men and women in uniform. We have the best, we have the brightest and the most capable military in the world. We trust their dedication to our country and to the principles upon which it was founded. We trust in the abilities of our military to defend our Nation against all the enemies, foreign and domestic. We place enough trust in them that there are few, if any, individuals who lose sleep on any given night for fear of an attack on American soil.
At the same time, our service personnel place a great deal of trust in their leaders, both military and civilian. Unfortunately, there have been times when I feel we have not been worthy of their trust; from breaking promises to new recruits about their future benefits, to the Gulf War illness situation, Agent Orange, or even atomic bomb tests, we have successfully eroded the trust of our military.
A friend of mine, a Marine officer said, and I quote, ''As a leader, I cannot stand to lose one person in uniform for no other reason than the anthrax vaccine.'' That was stated to me recently. I share that feeling and frustration with each and every one of the scores of dedicated military personnel who have resigned. They have not resigned because they are forced to take a series of shots, but because they have lost trust in the leadership that is supposed to look out for their best interests.
Because of that, every single loss is a tragedy to our Nation. As a result, I remain steadfast in my first statement on the anthrax program. Until the men and women in uniform can be assured that the anthrax vaccine is absolutely safe, the mandatory program must be changed.
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Once again, I am calling, Mr. Chairman, on Secretary Cohen to change or put a halt to the current program. I cannot in good conscience pursue any other course of action when the defense of our Nation is at stake.
Mr. Chairman, thank you for giving me that opportunity.
[The prepared statement of Mr. Jones can be found in the Appendix.]
Mr. BUYER. We would now like to turn to the first panel of witnesses. We have testifying today Dr. John Hamre, the Deputy Secretary of Defense. After Dr. Hamre, we will hear from General Anthony Zinni of the United States Marine Corps, Commander, the United States Central Command. Next we will hear from Lieutenant General Blanck, the United States Army Surgeon General. And we will hear from the Honorable Dave Oliver, the Principal Deputy Under Secretary for Defense for Acquisition and Technology. And last we will hear from General John Keane, the United States Army Chief of Staff.
Dr. Hamre.
STATEMENT OF DR. JOHN HAMRE, DEPUTY SECRETARY OF DEFENSE
Dr. HAMRE. Mr. Chairman, thank you for inviting us to participate. Normally you wouldn't get this heavy-duty delegation to come from the Department, but I think it signifies the importance of this issue and how much we appreciate and respect your willingness to bring all of the issues to the table on this important question. And, Mr. Chairman, to you and Mr. Abercrombie, I would like to thank you for taking the lead to do that.
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First, if I may, before I start, Mr. Gilman, I apologize to you, you have not received an answer to your letter. I am deeply embarrassed. This happens to me more times than I can tell you, and it is irritating. You will get an answer before tomorrow sundown, promise.
Mr. BUYER. Can you pull your mike a little closer for me?
Mr. GILMAN. We appreciate the response.
Dr. HAMRE. Mr. Jones, I am supposed to be at the White House. I will not leave until you are satisfied that I have answered any question that you would put to me or that I can take back any message, and I will stay.
Mr. Chairman, and again I said I very much appreciate your holding this hearing, because many people have been focusing on the secondary or the tertiary issues associated with this issue, and your committee is focusing on the primary issue, and I thank you for that.
The primary issue is there are 10 countries in this world that have already taken the steps to put anthrax in a bomb or in a missile and to launch it against our troops for one purpose, to kill them. That is the reason that we have to inoculate our soldiers.
Now, if someone is confronting anthrax on the battle field, there are three courses of action. First one is you die. The second course of action is you put yourself in a protective suit, and you give yourself shots for 45 days hoping that you will survive, and you have stopped being a soldier. And the third option, and the only option that works, is that you get vaccinated so you are protected against it.
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Now, Mr. Gilman asked the question what happens to those volunteers in other countries who have chosen not to take the inoculation, and they are fighting by us, side-by-side? I will tell you what happens: They will die. You will die if you don't get a vaccine. That is the reason why this Department, when we got incontrovertible evidence in 1997 that we were facing weapons on the battlefield that were going to put anthrax on our troops, that we said we are going to have to inoculate.
Now, General Zinni, his job is every morning, he gets up—I don't think he sleeps actually—but he gets up, he is fighting to protect this country in one of the most dangerous regions in the globe, and he is going to talk about that subject.
Now, as I said, if you don't get inoculated, you are going to die. There is another routine. You can do the antibiotics, and there are incredible implications associated with that. I would say—I mean, people are terribly worried about this vaccine. There are 17 vaccines we give to our soldiers, sailors, airmen and Marines, 17. Seven of them are mandatory for everybody. The others are voluntary only if you are not in a specialty, and if you are in a specialty where you are confronted, you are going to have to take it. I mean, this is our policy. And we have it for 17 vaccines, not just one.
Now, Dr. Blanck, who is a world expert here, he is going to talk to you about that. Nobody knows more about protecting soldiers' health on the battlefield than Ron Blanck, and he will address those issues.
Now, you asked us to talk about production, and we are starting something that has never been done before. I mean, most anthrax production has been done in small lots for veterinarians. We are now talking about a very different program where we are having to produce large quantities. And Dave Oliver, who is our Principal Deputy Under Secretary for Acquisition and Technology, has, I think, been four times out to the factory, if not more. He knows more about that factory and its status and what is going on out there than anybody, and he is going to speak very briefly to those issues.
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Mr. Jones, you said very clearly this is a matter of trust. Is there trust? Every one of us sitting at this table has taken the vaccine, the anthrax vaccine shot, every one of us. I am not likely going to go into battle and confront anthrax, but like the Secretary of Defense, I said I am not going to ask a soldier to put something in his arm if I am not prepared to take it first. And every one of these guys has done exactly the same thing. That is trust.
It is to start here to say we are not going to ask them to do it a darn thing that we are not prepared to do ourselves, because we know that there has been a history in this country, there has been a history, and we are not proud of that history, and we are going to overcome that. And the person who is leading that to demonstrate this Department is going to lead and protect its soldiers—we wouldn't send them into combat without bullets, we wouldn't send them into combat without a flak jacket or without a helmet, and we are not going to send them into combat without protection against an agent we know they will use against us to kill our troops—and that is Jack Keane, and Jack is going to talk about that.
So if I could turn to the real experts here, because these are the individuals that you really need to hear from today.
[The prepared statement of Dr. Hamre can be found in the Appendix.]
STATEMENT OF GEN. ANTHONY ZINNI, USMC, COMMANDER IN CHIEF, U.S. CENTRAL COMMAND
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General ZINNI. Thank you, Mr. Chairman. As you have mentioned, my job is to lead our troops in an area of the world that is much troubled. It is an area in the world where we face significant threat from weapons of mass destruction. Earlier last year we were in the midst of a crisis, Desert Storm, and—excuse me, Desert Thunder, and I asked the Secretary of Defense to accelerate the mandatory vaccination program to protect against anthrax.
We were faced off against an enemy, Iraq; we have proof they produced and weaponized anthrax. Anthrax, of course, has already been mentioned, a deadly disease, and one that has significant effect on our ability to conduct combat operations. It would be almost impossible for us to conduct our war plans or to implement them if this were to be used on the battlefield. And I think, as you know, even in small amounts, the level of devastation and the level of casualties we would face would be significant.
We have done many things to try to counter the weapons of mass destruction problems we face. They range from detection, to protective equipment, to vaccination. Some of these other methods are effective in other areas. For example, in the case of chemical weapons, if we can detect early enough and provide warning, we can take protective measures.
In the case of biological agents, like anthrax, detection only tells you it is time to start treating the patients. There isn't anything you can do in that moment that is going to prevent the problem.
We have conducted a series of studies, exercises, and war games, and we find that we could have significant vulnerabilities if we aren't fully prepared to deal with this. Now, I need every soldier, sailor, airmen and Marine and Coast Guardsman capable of functioning in the time of battle, to include selected civilian contractors and civilian employees, DOD employees. I can't afford to have part of the force that can't perform.
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The issue came up about voluntary inoculation. Let me talk about some of the problems as I see them as a commander in the field. First, I would have critical capabilities I couldn't count on, because those that were exposed may not have taken the vaccine. We talked about morale. To any combat commander, this is a significant factor of combat power. What about the morale of that soldier who knows his buddy with him on the same team in the same foxhole has not been inoculated?
The vast majority of people that have received the inoculation know that there are members of the team that maybe they can't count on. I have to worry about that facet of morale as well, and maybe that would be more significant on a battlefield.
On battlefields, we overwhelm our medical capability. If we accept voluntary inoculation, I accept additional casualties. I accept an overwhelming of my medical capability beyond the casualties we will suffer from other sources.
Congressman Gilman mentioned coalition operations. I have commanded coalition forces in the past, many times, and I guarantee I will again if we go into conflict in my region of the world. I would not place U.S. forces in a position in this environment where they would be reliant on coalition forces that weren't inoculated; I assure you of that, and I think I would make that promise to any American mother, father or leader of this country.
I would like to close by saying one thing about trust. I receive my sixth shot next month. My son is applying to Officer Candidate School (OCS), in the Marine Corps, he will receive his shots. I received an e-mail from a staff Non-Commissioned Officer (NCO), who said he had reservations, but when he saw a picture of me receiving the first shot in Central Command, he had the trust to believe it was the right thing to do, and he took his shot.
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My headquarters is 100 percent compliant. I have no refusals. We have provided the information where we can. We are in an age of information warfare. There are those out there that may be well-meaning, well-intentioned. There also may be those out there that try to provide misinformation to work against our forces.
I would be cautious as to what information the troops receive. It is our obligation as leaders to provide the counter to that and to inform them correctly, and where I have seen that done properly, I think the results speak for themselves.
Thank you, Mr. Chairman.
Mr. BUYER. Thank you. Lieutenant General Blanck.
STATEMENT OF LT. GEN. RONALD R. BLANCK, USA, SURGEON GENERAL OF THE ARMY
General BLANCK. Mr. Chairman, distinguished Members, thank you for the opportunity of appearing.
As of today, we have immunized over 340,000 service personnel, including 27,000 Guard and Reserve personnel, with over 1,100,033 doses of vaccine; 72,000 doses of those in Guard and Reserve personnel with a fully Federal FDA-approved vaccine, Food and Drug Administration-approved vaccine. Those service personnel have experienced very few significant and serious side effects, which was anticipated from the extensive studies on safety that have been done over the years in humans. We believe on the basis of our other studies that those personnel are protected against one of the deadliest threats I think that we face as a Nation, as a military, and that is that of the easily produced and weaponized anthrax organism.
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Anthrax vaccine is a biologic, and like all biological agents, there are side effects. Most are mild and self-limiting, and I will be happy to answer questions on those, as I will on our studies on efficacy. But for me as a physician and as the Surgeon General, the bottom line is very, very clear: If we are attacked with this agent, and we have a force that is vaccinated and protected, our soldiers, sailors, airmen and Marines will largely survive. If they are not vaccinated, they will inevitably die.
For me it is an ethical issue. I have to do everything possible to see that they have that protection. I can do no less for those for whom I care. Thank you.
Mr. BUYER. Mr. Oliver.
STATEMENT OF HON. DAVE OLIVER, PRINCIPAL DEPUTY UNDER SECRETARY OF DEFENSE FOR ACQUISITION AND TECHNOLOGY
Mr. OLIVER. Mr. Chairman, with respect to acquisition, BioPort is the only licensed FDA source or facility in the United States. The Army has had a contract for more than a decade with BioPort to buy the anthrax serum. Now, since BioPort is a sole source, it makes for management and contracting difficulties, but these are no different from that we have with the F–15, the F–16, the F–18 airplane or the tank. Once the Secretary of Defense makes a decision that this contributes to our national defense, we in acquisition determine a method to watch this program and to make sure and manage it properly.
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BioPort has completed a $6.7 million renovation to get up to speed so they have the capacity to produce the serum in the quantity that we need. They completed that and started rerunning serum lots in May of this last year. On August 30th, they submitted the first thousand pages for their approval to FDA, and they are submitting the remainder of that package to the Federal Drug Administration today. So I expect that they will be approved and the new production line serum will be approved in April of this next year.
That is all I have, sir.
Mr. BUYER. General Keane.
STATEMENT OF GEN. JOHN KEANE, USA, VICE CHIEF OF STAFF OF THE ARMY
General KEANE. Mr. Chairman, distinguished Members, the Army is the executive agent to the Secretary of Defense for the anthrax program, and as such, the Secretary of the Army has charged me with overseeing the implementation and the execution of the anthrax vaccination program for the Department of Defense.
My responsibilities as a senior uniformed official include monitoring service implementation and execution of the vaccination campaign, and serving as a focal point for information and assistance, and reporting Defense Department efforts to the Executive Branch and also to the Congress as required.
Additionally, as the Army Vice Chief of Staff, I am also responsible for supervising the execution of the Army's vaccination plan.
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Now I want to associate myself with Dr. Hamre and General Zinni's comments that the threat of anthrax exposure to our forces is real. I am also convinced that the anthrax vaccine is both safe and effective. Surgeon General Blanck has addressed some of the medical issues, and when the facts are presented, it is clear that we have a moral obligation to do everything in our power to protect our troops from the anthrax threat.
It is not a question of whether we should vaccinate our servicemen and women against the threat, but rather how can we accomplish vaccination and address the concerns of our troops, their families and the American people?
Our goal in the Department of Defense is to complete timely and safe vaccination of the total force. To achieve this, we must earn the confidence of our service members, Department of Defense civilians, family members, the Congress and the American people. I believe the key to earning the confidence of our troops and their family members is total involvement of our commanders and senior leadership. This is a commander's program backed up by an information campaign to get out the facts on the anthrax vaccine.
We have established two activities at the Department of Defense to help us achieve these goals. The Anthrax Vaccine Immunization Program, or AVIP, and a Flag Officer Synchronization Committee. The AVIP, which has been operational for 18 months, is the agency primarily responsible for the day-to-day operation of the Department's anthrax program. It provides information to commanders and service members through an Internet site, a toll-free information hotline and educational materials for the field. It serves as a stockpile manager for the Department of Defense, insuring demand from the field is met with existing stocks to support vaccination around the world. It coordinates scientific research to support ongoing efforts to improve the program. It compiles data from all services to monitor progress. It also responds to requests for information from the Congress and the Executive Branch concerning the program itself.
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Until recently, AVIP was responsible for coordinating policy for the Department of Defense, but that function is now being transferred to the Flag Officer Synchronization Committee.
This committee which I chair is a multiservice coordinating body made up of flag officers from the four armed services of the United States and the United States Coast Guard. The committee is responsible for monitoring the execution of anthrax vaccination and for recommending policy changes to the Secretary of Defense.
Together those activities coordinate the Defense Department's efforts to ensure that we reach our goal of complete, timely and safe vaccination of the total force. Despite reports to the contrary, as General Blanck mentioned, our results so far have been overwhelmingly positive. We have very few refusals by comparison to the number of troops that we have inoculated.
We have learned many valuable lessons from our efforts to date, and we continue to improve the program. I am confident that we will successfully complete this program and achieve our goal of protecting the force from the anthrax threat.
Thank you, Mr. Chairman.
Mr. BUYER. Thank you very much.
I would like to open with a few questions before I yield to my colleagues.
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Dr. Hamre, as one of the leaders in the Department of Defense, you and the Secretary have to also work with our allies, and we recognize that one of our strongest allies in the world, being Great Britain, the United Kingdom, has a voluntary vaccination program.
I don't know if you have spoken with them. I mean, obviously we don't have to do what our allies do, and we exercise our own judgments in our country, but when I listen to General Zinni and his comments, they seem very rationally based, given his responsibility to protect his force. Obviously he sleeps better at night knowing that, because he would sense what scrutiny would he receive from the Nation had he not.
But have you had conversations with our closest allies with regard to their programs?
Dr. HAMRE. Sir, yes, but it was dated back to last October and November when we were side-by-side again in the Persian Gulf, looking at the prospect of conflict with Iraq, and knowing that we faced an anthrax threat. At that stage we did talk with them, and we provided some supplementary dosages from our stocks. It was their decision, and they have made a decision on how they want to proceed with health protection for their soldiers. We are not going to be able to—and we don't think it is appropriate for us to challenge how they want to proceed and do protection for their people.
What I think General Zinni said was—which is our bottom line—is we are not going to put our troops at risk and depend on them if they have volunteers. We are going to have to make sure we can undertake our mission fully and protect our own people. If other countries choose not to, then that is going to be their decision, and they will have to go through the decision-making process that is appropriate for their culture, for their policies, for their directions. But we will not let that prejudice our ability to operate safely in the field.
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Mr. BUYER. And which our CINC, if he commands those Allied Command forces in a particular operation, has to take into consideration—.
Dr. HAMRE. Yes, sir.
Mr. BUYER. —operationally?
General ZINNI. Yes, sir.
Mr. BUYER. Is that why then for a particular reason that you may go U.S.-heavy in an operation?
General ZINNI. Yes, sir. I may make operational or tactical decisions based on that factor if we are in that environment.
Mr. BUYER. Dr. Hamre, do you think the Pentagon can just line up the soldiers, sailors, airmen and Marines, Reservists and order them and just say, stand there, you are going to take this shot, and they say, wow, wait a minute, what is it? Why? Do you think it is proper they can ask those questions, or do they have to stand there, shut up and take up?
Dr. HAMRE. I think the great hallmark of the American military is that we have got the most thinking soldiers, sailors, airmen and Marines of any military in the world. I have never met a single senior officer that is from another country that has ever come to the United States and gone around and seen our facilities and our equipment and our people, the one thing they comment—they don't talk about the wonderful buildings, they don't talk about the wonderful tanks or fighters, they talk about the remarkable people, and they talk about the remarkable people who think clearly about things themselves and ask hard questions.
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And there isn't a commander out here who doesn't know his true test of leadership is the fact that he has good judgment, and they respect his judgment. They know we are watching out for them. They have to think this through. And I understand their thinking it through, and we worked very hard when we first started unfolding this inoculation program to those who were most at risk—that was the troops that were actually in General Zinni's theater, they had the priority, and we worked very hard to inform them. And that is why we had such an astounding acceptance rate. I think out of the first 100,000 people or 200,000 people, we had only 16 who didn't want to do it. It was because we worked that problem very hard. We focused our energy, frankly, on the people that were at risk immediately and who we were asking to take this on immediately.
We didn't put our efforts—and we should have. I think this was a mistake—in talking to our Reserve community, talking to our people back home, that this is a shared risk we are all going to face if we have to mobilize. Unfortunately, we put our efforts where our first requirements were, and we are now realizing after the fact we didn't do a good enough job educating our folks back home. That is what General Keane is working on.
General KEANE. Sir, there have been some problems with certain units, and when we go back and look at that, we have discovered that in those organizations, the command information program to get the soldiers and the troops the exact facts of the situation has not been what it should be. And so we have learned some things along the way here, and that is why I emphasized that this is clearly a commanders' program. All four services are very sensitive to this, and the chain of command and their leaders are involved in this program. It obviously assisted with the medical community to help them present the facts to their troops.
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Now, Mr. Gilman, in answer to your question, your comment about the problem that the organization had that you referred to, we have very little evidence to support large-scale refusals in the Reserve components. And even the pilot organizations at Wright-Patterson Air Force Base are doing very well, Travis Air Force Base is doing very well. In Florida, where there is a large number of Reservists who are being inoculated, is doing very well, and it has been even reported in the public press as to that testimony.
So one of the things that we have learned from this program, Mr. Chairman, is the proper education of our force. And we have a program that is in place and is doing that, and we believe it is successful.
Mr. BUYER. I just want to make sure, gentlemen, that you recognize this is not a conscript force. I concur with you, Dr. Hamre, they are well-educated. They are very bright young men and women, and the education process of what that is, the efficacy of the drug, the safety factor is pretty important.
And I think you are absolutely right, Dr. Hamre, the Pentagon doesn't have the best track record, dating back to ''stand in the desert and watch the bomb explode, don't worry, the radiation won't hurt you;'' to Agent Orange; to some of the Gulf War illness concerns that we worked very hard with, with General Blanck and his sincerity in that effort, which is appreciated.
So you are right, there is not a great track record there, which leads me to two more questions, and then I will yield. One will go to General Blanck and the other to Secretary Oliver.
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General Blanck, many concerns that individuals have about this anthrax vaccine, perhaps could have been spun off from Gulf War illness concerns. I have also taken the anthrax shot. I didn't view it as much of a choice. When you stand on the front, and the commanders say there is a threat, you really aren't so sure, and you have to just take the trust.
We don't know about your studies and what you have done with the anthrax vaccine in combination with other drugs for which we take and we put it into our body. You testify there are seven which are mandatory. Of that seven, I suppose that now includes the anthrax vaccine.
Can you give all seven in such a protocol that there is no harm to human physiology? And please also incorporate in your answer recognizing that whether it is a hepatitis C vaccine, a smallpox vaccine, you name it, are there not reactions just by having taken a shot—Guillain-Barre—of which manufacturers out there don't even like to say that there are causal connections between certain vaccines? And we as a society even exercise certain judgments on what people, from food handlers to nurses to doctors, have to take certain vaccines.
General BLANCK. Mr. Chairman, the seven immunizations does not include anthrax. That is now an eighth. Those were the routine immunizations that have been mandated that all service personnel take, and anthrax would now be an eighth added to that. The list did not at the time it was compiled include anthrax.
Several groups and organizations have looked at the literature, the studies that have been done of multiple immunizations, seeing if there was a connection, to include, by the way, the anthrax immunization to those who received it in the Gulf War, to see if possible—if it was possible that that combination could have somehow affected the immune system that would have led to certain side effects and certain medical conditions. The conclusion is reported in the Presidential Advisory Committee, the Institute of Medicine Study, a draft Rand report, which have reviewed all of that, and other medical publications. The American College of Physicians in one of their publications has also reviewed this, and there is many, many others. The conclusion has been that immunizations done together, 7, 8, 10, 12 immunizations given to travelers, thousands reviewed, do not singly or in combination cause long-term health problems.
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Now, you ask about individual side effects, and as I mentioned earlier, the anthrax vaccine, as well as all of the other vaccines, are biologics, and that means when they are injected, there are often local side effects that include tenderness, soreness, redness, a lump at the site, fever, muscle aches and pains that are mild and self-limited.
Occasionally with all vaccines there are far more serious side effects. Tetanus causes a generalized reaction we call anaphylaxis that in some cases leads to death. Pertussis vaccine causes an encephalitis, and it has been a tragedy for a few of our children who have received that vaccine and developed a very serious, lifelong health effect from such a vaccine. And we kind of accept that and recognize that that is the cost for the enormous protection that those vaccines provide.
There is no difference with the anthrax vaccine. We have seen significant serious side effects. No deaths in those 340,000 individuals, but 72 have had serious enough reactions that they have either been hospitalized, or have missed duty for greater than a day, 72 of 340,000, and we have a reporting system that when either of those two criteria are met, that is, either a patient is hospitalized following an anthrax immunization or misses duty because of it for greater than 24 hours, we have an active reporting system. That must be reported to us. We in turn report it to the Food and Drug Administration, and they have a group that reviews those reactions. It does include such diseases as Guillain-Barre syndrome. It includes generalized urticaria or rashes that occur in some people who are clearly allergic to the vaccine.
The Food and Drug Administration, along with Health and Human Services, when they reviewed all of these reactions concluded that 55 of the 72 that were serious were, in fact, due to the anthrax vaccine. This compares very favorably with the significant or serious side effects from other vaccines. The mild, less serious side effects are also reasonably comparable.
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Mr. BUYER. We get a lot of criticisms of the government's contract with BioPort. I would like for you to explain what is the investment of the United States with BioPort? Why was the contract renegotiated, and what is the relationship of Admiral Crowe with BioPort?
Mr. OLIVER. The government's investment in BioPort, there is about $6- to $7 million of government equipment, original value, that is worth about $3 million now. Over the years we have put investments into that; since 1991, 0about $11.3 million of investment in new facilities there. As I told you, they are a sole-source producer. They were owned by and operated by the State of Michigan since 1925. In 1971, they started producing the anthrax serum, and they provided it to around the country, and subsequently the Army had a contract with them.
They were sold last year—and I will return to that when I talk about Admiral Crowe—but they were sold last year, and the State of Michigan conducted an auction, brought it down from several people to two companies that bid seriously. They sold to the highest bidder, who bid higher by about $800,000, as I recall, and it turned out that was also the only American bidder. The other was citizens of another country, and the State of Michigan sold it to them because they knew they were losing money because the documentation for what it was costing did not include things like the facilities, things like maintenance, repairs, the people who maintained the facilities, the people who operate the cleaning, et cetera, but they didn't appreciate how much they were losing.
The Army had had a contract since 1991 with them, and they had negotiated new contracts, which were essentially based on the old period in which the anthrax serum for the Army has been subsidized by the State of Michigan since 1988. That is obvious now to us, but we didn't know it at the time. Once they severed the relationship with the State of Michigan, and the true cost of operating the facility came in, then we became alerted. We became concerned that BioPort was not going to make it. So, therefore, we asked the defense contractor audit agency to go out. They looked at them. They did three separate visits to see if they were a viable business and whether or not we had inadvertently negotiated a contract which would put them out of business. They made findings to the Army. The Army Contract Adjustment Board met, took all these factors into consideration, and awarded a new contract.
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Now, the company asked the Army to pay per dose about $19, more than $19. The Army Board ended up awarding the contract for something like $10.60 a dose. We buy 13 different serums, vaccines, from companies, the military does. Most of them run between the range of $20 to $40. The Army Contract Adjustment Board decided the price for this was about $10, which is half of what the company asked for, and in return, the Army insisted on getting a lien on all the land that was there, the buildings and the vaccine license.
So I think that that is what I mean by when you have a sole-source contractor, you have to pay attention to it, and I think the Army is doing so.
Mr. BUYER. I would like to know the role of the former Chairman of the Joint Chiefs of Staff, Admiral Crowe, and his relationship with this corporation as a sole-source provider.
Mr. OLIVER. Admiral Crowe, it is my understanding from talking to him, was friends with the man who decided to buy this. He asked him to be a partner in it. I think Admiral Crowe put up no money, gets no salary, although he does have, as I understand, 11 percent of the company. I do not think he takes any part in the day-to-day running of it. He hasn't been there when I have been, and I think that is the relationship. He is a member of the board of directors.
Mr. BUYER. Mr. Abercrombie.
Mr. ABERCROMBIE. Mr. Chairman, I will yield to Mr. Jones and Mr. Gilman at this point.
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Mr. GILMAN. Thank you, Mr. Abercrombie, for permitting us to ask some questions at this point. I will ask the panelists, whoever feels is most competent in this. I have been meeting with the General Accounting Office (GAO), representatives who did this very important report, and I hope all of our colleagues—and I know it has been distributed to you—would take a look at the medical readiness report dated April 29, 1999, by GAO, prepared for the Subcommittee on National Security, Veterans Affairs and International Relations of the Committee on Government Reform.
It was a report prepared by the Director Kwai-Cheung Chan, who is the Director of the National Security and International Affairs Division of the GAO, and in that report on page 2, the issue was raised about the safety of this vaccine. And the report makes a statement, and I quote, the long-term safety of the vaccine has not yet been studied, and then it goes on to say that, prior to the time of licensing, prior to the time of licensing, no human efficacy testing of the Michigan Department of Public Health (MDPH), vaccine had been performed. And I think that these are very critical questions that we should take a good, hard look at.
And the report goes on to say, the FDA inspections of the facility where the licensed vaccine was manufactured uncovered numerous problems, and a good portion of that vaccine material came out while that was being conducted.
It also goes on to state with regard to the vaccine's safety, there were no questions raised with regard to the question of the safety of the vaccine during prior studies. The long-term safety of the vaccine has not yet been studied. This is as of April of this year. And then it goes on to state that the original vaccine for humans and the study of the efficacy was done mostly through animals. The study of the original vaccine concluded that the vaccine offered protection against anthrax penetrating human skin. The studies on the licensed vaccine focused on the efficacy of the vaccine in protecting animals against inhalation of anthrax, and there was apparently no studies with regard to inhalation by human beings.
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And I ask our panelists, what are we doing to address those questions? Perhaps General Blanck may be able to respond to that.
General BLANCK. Thank you, Mr. Gilman. First—and I am glad you acknowledged the GAO stated that there were no questions concerning the short-term safety; that is, the safety in the original studies.
Mr. GILMAN. If I might interrupt, they also questioned—there has been nothing to verify what the long-term effects were.
General BLANCK. Absolutely, and so short term they were okay. Long term indeed is the question. No vaccine, to my knowledge, has had studies done on long-term safety. The reason is the FDA doesn't require it because there are not long-term, years and years and years after, health consequences known to occur due to vaccines. However, we have been able to follow individuals who have worked at our medical research and material command, our Ft. Detrick command, who have received the vaccine since the 1970s, 500 plus or so of whom still work at the facility, who get yearly physicals, who have that kind of follow-up, and who have evidenced no signs of illness related to this or any of the other vaccines that have been given.
In fact—and I don't want to get into anecdotes—but in the audience is Dr. Anna Johnson Winniger, who is now the Deputy Assistant Secretary for Chemical and Biologic Defense to the Secretary of Defense who has received over 20 anthrax immunizations over that many years and is fine.
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So we have evidence of the lack of long-term problems, and we also now have designed longitudinal studies where we will follow those who have received the vaccine for many, many, many years to come. Obviously we won't have the answers until those later years, but we anticipate no problem.
Mr. GILMAN. General, let me ask you, with regard to the utilization of the present lots of vaccine, I understand this BioPort plant was closed down because of deficiencies in operation, and inspections had found some serious problems with BioPort. And I realize now you are renovating and reopening it, but the lots being used right now came out of that prior manufacturing process; is that correct?
General BLANCK. That is correct.
Mr. GILMAN. And how do you determine whether those lots are safe and not safe compared to what they found to be inappropriate production?
General BLANCK. Yes, sir, and Mr. Oliver can speak perhaps to the facility, but if I may address the vaccine.
First, the renovation was not due to the deficiencies and problems found. It was a planned renovation long before the inspection that found the problems. However, we took the inspection and the deficiencies very seriously.
Second, the vaccine that was produced was revalidated, was approved by the Food and Drug Administration as safe and effective.
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Third, even though that was so, one of the preconditions that Secretary Cohen put into place before we could use that vaccine was that we did supplemental testing, retesting in fact, looking at the purity, the safety, the sterility and the potency of that vaccine. So it went through a more than double testing, much more than the FDA would require to absolutely be certain that the vaccine was safe as well as potent.
Mr. GILMAN. General Blanck, let me ask you another serious question. I understand that there are many, many strains of anthrax. Does this vaccine that you are using apply to all of the strains or just to one or two of the strains of anthrax?
General BLANCK. No, it applies to all of the strains. There are approximately 31. We have tested this in animals against many of them, and the way we make the vaccine is, of course, grow the organism. It is then taken and killed and a precipitate is made through chemical activity, and you end up with serum that doesn't have the even killed bacteria in it anymore. What it has is a portion of that bacteria called protective antigen. The protective antigen is then what causes the body to produce antibodies which protect against subsequent infection with anthrax. This protective antigen is common to all strains of anthrax.
There is some evidence that some of the live vaccines used—the Russians have a live vaccine, for example—may well not protect against all strains because the live organism is that strain, and maybe it will have some cross-reactivity. The protective antigen, however, and I apologize for getting into the scientific detail, but the protective antigen is common. It is something that is the same in all of the naturally occurring strains, and so we believe and have solid evidence that this will protect against all natural strains.
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Mr. GILMAN. General Blanck.
Mr. THORNBERRY. [Presiding.] Mr. Gilman, we have such a limited time with the committee members, I would like to have the committee members have a chance to ask questions before Dr. Hamre leaves.
Mr. GILMAN. I appreciate your patience. Just one last question to Dr. Hamre. What is the contingency that makes this so necessary now? What is the immediate threat, contingency, to protect our military and something we all want to do, that could not permit you to delay this until there is a contingency?
Dr. HAMRE. Sir, in September of 1997, we received unequivocal evidence, absolutely unequivocal evidence, that Iraq weaponized anthrax, and we have never, through the inspection regime, been able to confirm the destruction of those devices. We, therefore, have to conclude that anyone in General Zinni's theater of operations, if we were to get into combat again, could face an immediate anthrax attack. An anthrax attack is fatal if you are not inoculated, and therefore, we have to take these steps. It is unequivocal.
Mr. GILMAN. But, Dr. Hamre, if there was a contingency of Iraq attacking us, wouldn't we still have some time to immunize your forces?
Dr. HAMRE. Sir, you are not protected—first of all, if you are in theater and you have not been inoculated, and the first symptoms—you start to show the symptoms of anthrax, you are going to die. The only thing you can do is before you have ever seen any symptoms, anyone in the theater has to immediately go into a protective antibiotics regime that is three shots a day for 45 days as a minimum, and you are not a good soldier. You are not a soldier when you are taking that shot. So the only solution is to get the vaccine, and the vaccine is not immediately effective when you get the first shot. It isn't effective until—I think there is some level, you have to get the first three I believe, and that takes something like 7 weeks before you can get that.
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Mr. GILMAN. Thank you, Mr. Chairman.
Mr. THORNBERRY. Thank you.
Mr. Ryun.
Mr. RYUN. Thank you very much, Mr. Chairman. I want to thank the panel for coming today.
And I have a bit of a follow-up question. First of all, I think we all recognize that there is a serious threat from the anthrax issue as we continue to look to future warfare, but I want to look at that word ''trust'' a little bit differently. Can we trust the vaccine that it will do what it says it will do? And let me bring this point up, and that is, I have some reading that I have recently come into that indicates that the enemy is able, if you will, to alter the biological agents of anthrax in such a way that the vaccine we are currently giving our soldiers, our military personnel, will not be sufficient to provide them that protection. Can we trust that that will not be a problem in the future, that there won't be an altering of those agents?
General BLANCK. It gets at the whole question of efficacy, and if I may take the liberty of expanding a little bit on my answer to your question, Mr. Gilman raised the point that we have not done human trials with inhalation anthrax, and, of course, we cannot. We cannot. It would be totally unethical, and no one would want us to, because to do a trial means that you immunize some, and you don't immunize others, and you expose them to inhalation anthrax, thus dooming that group that you gave placebo to that you did not immunize.
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So, in fact, anthrax is not a naturally occurring disease in the inhalation form anymore thanks to our animal immunization program. So what we have done with full FDA concurrence is develop several animal models, and that is part of how we know that this protects against the strains, as I have described, the mechanism and all of that kind of thing. We take the closest to humans, nonhuman primates, monkeys, and immunize some, do not immunize others, expose them to the inhalation anthrax, and we find that, in fact, those immunized are protected; those not immunized are not.
Now, we know that for naturally occurring anthrax. What about genetically engineered anthrax?
Mr. RYUN. Yes, the altering of the agent. That is what I am more concerned about.
General BLANCK. Once you genetically engineer an organism, you change it so that it may not be able to be weaponized, it may not be stable. So many things could happen to it, including the fact that our vaccines may change that area that the protective antigen works against. It, in fact, may not be possible to use our current vaccine to protect against that. We don't know, but what we do know is if you take anthrax and genetically engineer it, it isn't anthrax anymore. It is something else that we would have to look at and then develop a vaccine against.
We have no evidence that anyone has genetically engineered anthrax to the point that it is able to be weaponized and is a threat. I read, of course, the information coming out of the former Soviet Union about the possibility of that work being done there. We have actually had dialogue with some of the scientists in Russia. We are doing everything we can to get any samples of anything that might be genetically engineered to see if the vaccine works. We have been unsuccessful in doing that.
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So I guess I would have to say in some cases it may work, but in some cases it may not.
Dr. HAMRE. Mr. Ryun, if I may, we had a long debate 2 years ago when we were making this decision, were we going to go ahead with the mandatory inoculation program? One of the issues was is it possible to genetically engineer anthrax so that this vaccine is not effective? It could happen, and that may require a second shot, but it never excuses you from protecting people against what you know is a threat today. That threat is out there today. Ten countries have that capability, and we have to protect against that.
Mr. RYUN. If I may interrupt just briefly, I don't think we are denying the threat, but at the same time we don't want to present to our troops that, you know, this is the cure-all, that it is going to take care of everything, that this potential does exist. And so that is what I wanted to address, and I thank you for your answers.
Thank you, Mr. Chairman.
Mr. BUYER. Thank you, Mr. Ryun.
Mr. Thompson.
Mr. Thornberry.
Mr. THORNBERRY. Thank you, Mr. Chairman. I will just have a brief comment, and then I want to yield to Mr. Jones.
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Dr. Hamre, it seems to me that this matter has implications far beyond what we are dealing with directly, the increased prevalence of weapons of mass destruction, the need for more realistic discussion about them and how we are going to deal with them, the need for more medical research on those agents, and in addition to that, the prospect that, well, personnel, trust, all of those issues, getting and keeping good people, how does this affect recruiting and retention? And in addition to that, the prospect that General Zinni raises of information warfare and the possibility that some day in the future this could be used, rumors—and this is more than that I think, but just the prospect of the effect that can have. I just think that gives us a little window into the future of some of the things we are going to have to deal with that we all ought to learn lessons from.
But I want to yield to Mr. Jones the remainder of my time.
Mr. JONES. I thank the gentleman from Texas. I only have one question. You somewhat touched on this, Dr. Hamre. When did the leadership at the Department of Defense start the discussion and the debate as to when this shot should be mandated? I mean, you said 1997, but I am sure it started before then. Can you give me the year that you remember being part of that discussion?
Dr. HAMRE. At the time I was the Comptroller, not the Deputy Secretary, and I remember several sessions which were inconclusive, and I believe this was back in 1996 when we first started talking, but I will formally come back to you and give you the date. But we didn't really settle on it at that time because there was too much disagreement, and we really still were questioning the threat. As I said, it was in 1997 when we got absolute, uncontrovertible evidence that we have this threat, and that is when the Secretary said we are going to protect the troops.
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Mr. JONES. But you do believe that the debate started sometime in 1996 as far as the discussion?
Dr. HAMRE. Oh, yes, sir. I will find the date. I don't remember in my mind, but I remember, and we had the discussion, and we didn't go ahead. We saved money—again, I probably was on the wrong side at this time—saying, well, it isn't there, so let us just reserve money to hedge our bets. I probably was the bad guy at that meeting, I don't know, and I will find that out, and if I am, I will come back and tell you.
[The information can be found in the Appendix.]
Mr. JONES. Thank you.
General Blanck, let me ask you, would you implement this same program if FDA did not approve the vaccine?
General BLANCK. Yes, I would, but we would implement it differently because then the vaccine would be in an investigational new drug status, an IND status, and while I would have the same confidence in the vaccine from reasons that I have already described, we would then have to use informed consent and take other measures as part of our implementation program.
Mr. JONES. Let me in addition ask you, how did the figure six shots—I mean, how did the research—what type of research and how did they arrive at the decision that it should be six instead of three or twelve?
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General BLANCK. Excellent question. As we have gone back in this with the FDA, and it is a little bit difficult to put this together since the FDA approval was in 1970, all but 30 years ago, but it was based partially on the safety studies done, measurement of antibodies, partially on that single human efficacy study that was done for cutaneous, for skin anthrax in mill workers. And the feeling was on the part of the FDA that, looking at the response, looking at what it would take to get people immunized, that the current regime that we use was that indicated, and, of course, we follow FDA guidelines. We are mandated to do that. So the shot or the dosage schedule is zero, 2 and 4 weeks, 6 months, 12 months, 18 months and yearly boosters.
If I may even expand on my answer, I would say, because you and I have talked about this, one of the things that we are working very, very diligently with the FDA is a reduced number of dosing schedule so that instead of six shots, perhaps we could provide immunity at three shots or four shots, something less than our current schedule.
Mr. JONES. Just one last question, Mr. Chairman, if I may.
General Blanck, let me ask you, male and female in the military, they all take six shots, right?
General BLANCK. Yes.
Mr. JONES. Okay. Has there been any concern or need for a study by the military to find out if women should be taking fewer shots because of their makeup and their ability to produce antibodies in the body?
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General BLANCK. Yes. As part of what we will do with giving individuals the vaccine and measuring their response is to do something that has not been done very well by the medical community in past years, and that is actually determine gender differences. And there clearly will be some differences, and it is possible, certainly making no commitment, that we would come up with recommendations for different dosage regimens on the basis of those studies. And we are doing them right now. We have actually done some pilot demos. We are now designing the study that will allow the FDA to look at the data and give us their approval for hopefully something reduced, and it may well be that the outcome of that will be a difference.
Mr. JONES. Mr. Chairman, thank you. I will stop with that.
Mr. BUYER. You are welcome, Mr. Jones. Are you satisfied with the answers you have received from Dr. Hamre?
Mr. JONES. Yes.
Mr. BUYER. I will do something which is out of the ordinary from the Chair, and that is, if there is a Member that has a—we have many different experts on this panel, but if there is a Member that has a particular question of Dr. Hamre, I will permit them to be asked right now out of order so that can be answered, and then he can attend his meeting down at the White House.
Mr. Abercrombie.
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We will try to do this as quickly as we possibly can. Is that permissible, Dr. Hamre?
Dr. HAMRE. Of course.
Mr. ABERCROMBIE. Dr. Hamre, I think that your point about Members, high-ranking officers and officials taking the shots is a good one. Is this universal among the Service Chiefs and all the high-ranking people that have taken the shots?
Dr. HAMRE. Yes, sir, every Service Chief, every service Secretary, every CINC has led the way by taking the inoculation first.
Mr. ABERCROMBIE. Just one other thing. This doesn't require an answer now. I consider the question of chemical biological warfare such that we are going to have to take into account whether preemption needs to be involved as a part of the foreign or part of the taking up either in the United Nations or in some other aspect these kinds of agents need to be outlawed, period. Perhaps even more so than dealing with the question of nuclear testing and acquisition of hydrogen weapons and nuclear weapons and so on, chemical biological threats are such that I consider them to be a menace to the planet, and we may need to think about the question of preemption, because if we find ourselves in these kinds of hearings over and over again about having to deal with one biological or chemical weapon after another in terms of mass inoculations or some other extraordinary effort that has to be made by armed services, it is going to be unwieldy logistically, as well as financially.
I realize you can't answer that now, but that question, I think, needs to be dealt with at some point.
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Dr. HAMRE. Well, sir, two things. One is preemption means something a little bit different to us than it does to the diplomats, and we are prepared to follow up on both of those. On the issue of a diplomatic solution, there is a solution that has been in front of the world community. It is the biological weapons treaty, and we still wait to see an effective implementation of that treaty. That is a high priority for everybody, and I think that ought to be a priority for the Congress, to insist that we start seeing the world community working on that.
Mr. ABERCROMBIE. Thank you. I would like to emphasize that point, Mr. Chairman, in terms of an answer, that treaty and the implications of it and dealing with this on a broader basis, I think, is something that our committee time could be—if we could devote committee time to, I think it would serve the interest of the country. Thank you.
Mr. BUYER. Thank you, Mr. Abercrombie.
Mr. Larson, do you have a direct question to Dr. Hamre?
Mr. LARSON. Yes.
Doctor, with respect to informing our allies, and I know discussion has taken place today that our closest allies— through the questioning of the Chairman, in fact—have a voluntary system, and then the question that was posed to the General was that, well, look, he would take every precaution to make sure that Americans were not placed in harm's way or dependent upon them, dependent upon troops that weren't inoculated. Why have our allies, given the incontrovertible evidence that you have been able to come up with, not taken the same position? Is it their medical community that sees this differently from ours? What is the rationale? It befuddles me.
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Dr. HAMRE. Mr. Larson, I think it varies country to country, and I must confess to have only a limited experience in talking with three countries and senior folks about their program. In each instance, every country has a different approach to how they manage not only their military personnel but how public health is treated in their societies, and they have to design a public policy for their military personnel that fits their culture, the way they manage their forces, the way they want to approach combat.
We strongly believe that this is not something that is optional, because you can't afford to let some people die and other people not die in a team effort, and it is a team effort. And as General Zinni said, you can't have two guys on a squad and one guy say, well, I am not going to take the vaccine, and knowing that you depend on him for your life and have him choose not to be protected. That is how we have opted on this case. Other allies have not done that yet.
Mr. LARSON. In a theater such as the Gulf, however, wouldn't that lead to other nations saying, let the Americans do it, let them do all the heavy lifting, let them be in the front lines, let them be the ones who get vaccinated, let the Americans do it?
Dr. HAMRE. These countries have chosen to participate with us as coalition partners. General Zinni counts on them as coalition partners. We make sure that in our tactical environment that we are not going to be at risk if there are problems in that way. You are asking a different question and an important question, but it doesn't change the way we would think about wanting to protect our own soldiers.
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Mr. LARSON. And I commend the general and the troops and your efforts in that area, but it does create a very serious problem for us, especially in view of the lack of long-term definitive proof here.
Are you familiar with the case of the—I believe it is the molecular biologist from Tennessee, molecular biologist Pamela Asa, that was cited in the General Accounting Office report, I believe?
Dr. HAMRE. I personally am not, sir. Maybe somebody else here is.
Mr. LARSON. What about squalene?
General BLANCK. Yes, I am familiar. The allegation has been that some of the lots, all of the lots, of anthrax vaccine were contaminated by a product that is used in some vaccines, known in this country as an adjuvant to enhance immunogenicity. I know how the vaccine was made. I know there was no squalene as part of that process, or added, but just in case, trying to apply the reasonable person test, I had all the lots tested by an outside laboratory. There is no squalene, never has been any squalene, in any anthrax vaccine manufactured at BioPort, which is the only facility that has manufactured anthrax vaccine since the 1970s.
Mr. LARSON. My last question—I don't know, Mr. Chairman.
Mr. BUYER. Do you have any other questions for Dr. Hamre?
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Mr. LARSON. No, I have some other questions.
Mr. BUYER. All right. Would you please hold that.
Does anyone else have any questions of Dr. Hamre?
I do have one before you leave. Have you had any personal meetings either in the Pentagon or outside the Pentagon in your official capacity or as a citizen with Admiral Crowe?
Dr. HAMRE. No, none whatsoever. Admiral Crowe has never once approached me, and I don't believe he has ever approached the Secretary about BioPort at all.
Mr. BUYER. All right. The other thing I would like for you to be helpful is that with this vaccine program, we believe that it would be helpful if there is a tracking of refusals and what you do with regard to those refusals. The word that came to back to us is that you are not tracking that.
Now, maybe General Keane can testify to that. If you can, I want you to do that after Dr. Hamre leaves, but I just want to let you know that we just found that hiccup.
Dr. HAMRE. Yes, sir, and I think it is very important for you to hear from General Keane, because this issue is not stand-alone that you can take away from the normal process of command and control of forces. This has to be a commander's issue, and the way we deal with all of these issues, because there are all sorts of things that come up in the field, that the commander has to be the one that takes the responsibility for seeing—I mean, it is everything from making sure they are getting enough sleep when they are in the field. There is a discipline to it. So that is why it has to be in the hands of the commanders.
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So a central tracking system of who says no, if the implication is that we are not trusting the commanders to be managing this problem in a constructive manner, then I wouldn't want that kind of a tracking system, to be perfectly honest, because I think it would be abused in a political environment. I think what we want is to have this be managed by our commanders, and if people absolutely refuse, then we find solutions for that problem, and every one of the services is making it work.
We have very few refuseniks, but to make a celebrity cause out of people who say they don't want to be, we have people who don't want to be in the military all the time. This is one of the reasons for it. Okay, we understand that. But a central tracking system just for anthrax, and all of a sudden we are going have a central tracking system for meningitis and a central tracking system for other things.
So I would ask you to think about that in the context of what you are asking your commanders to do and their responsibility for the good order and discipline of their units.
Mr. BUYER. On commander's call, this day of the Internet where information and everything is shared immediately, you have individuals of the force, some of whom are being treated differently on refusal. Have you had discussions in the Pentagon about how to take—how or what actions commanders should take with regard to refusals, court-martial versus article 15s versus administrative actions?
Dr. HAMRE. We have had those discussions, and I would much prefer to let General Keane speak to it because the position of the Secretary, and which I firmly agree with, is that the diversity of environment is so complex, a centrally managed approach to something like this would be a failure. And we do that for everything, anything that deals with good order and discipline, and that is why I think if I could defer to General Keane to speak to it, but I would like to listen, to hear his answer to you.
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Mr. BUYER. And, Dr. Hamre, are there any other comments that you would like to make based on any questions of any other Members before you have to leave?
Dr. HAMRE. I would like, first of all, conclude to say my profound thanks not only to you, Mr. Chairman and Mr. Abercrombie, but to you, Mr. Gilman and Mr. Jones. You are ventilating the concerns that soldiers have, and I think that is important.
I do think that we have not done a good enough job explaining to people, and as you say, in this world of the Internet, when it has the immediate authenticity of truth because it looks so pretty on that screen, that people don't look behind it and find there is an awful lot of just absolute nothing but rumor-mongering that is going on the Internetland, and you have to deal with that. That is a reality we have to deal with. The only way we can deal with it is forthrightness, having hearings like this where you come up and ask the hardest questions you can ask, put us on the spot. There isn't anything that we are trying to do here other than to protect the men and women who have decided that they are going to put on the uniform of this country and fight and protect all of us, and that is what we are after, and it is a matter of trust.
I absolutely believe that is a matter of trust. They have to have trust in us that we are not asking them to do something that is going to lead to their death unnecessarily, and that is how we view the issue.
It was a hard decision to make because we know that there are concerns in this country. People are very aware and sensitive to their health. They should be. I think that is a very good thing, and this is one that we had to wrestle with. I would admit we haven't done a good enough job explaining to all of the people at home, because, frankly, we put our emphasis on General Zinni and his theater to make sure people there were protected, and we now have to do the same thing here in the United States.
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But it wouldn't happen if we didn't have an opportunity like this. This is the only way we can speak to the American public and, frankly, to our own troops, and that is why it is just as important to have the criticism here at this hearing as it is to have the support, and I thank you all for it. It is very important to us.
Mr. BUYER. General Keane, Dr. Hamre wanted to hear your answer.
General KEANE. Sure. I am delighted.
Mr. Chairman, in reference to tracking, and there is a difference from that from reporting, we track every trooper who receives an inoculation, the frequency of that inoculation and where that inoculation took place, and each service does that, and it is reported into our DEERS system, which is our Defense Eligibility Enrollment Reporting System, and that is how we are able to determine the numbers that General Blanck provided in terms of how many troopers are, in fact, inoculated, and we have specific detailed information behind those gross numbers.
Now, in terms of reporting refusals by soldiers, that is a sensitive subject for us, and all the services are in agreement. We have our soldiers disobey orders from time to time, not just in this area, and obviously our soldiers have misconduct and misbehavior problems as well. When I say soldiers, I am also referring to sailors, airmen and Marines. For us to ask our commanders to report singularly on this event we believe is undue influence in the chain of command, and it would be burdensome to them for us to do that. We do it for no other offense.
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You may ask, well, how do you know that you have the number of refusals that you refer to? We know that because we can go into the judicial system of the United States military, into the services' judicial systems, and they do aggregate information in terms of nonjudicial punishment that is rendered to our troopers, and what the cause was, and also judicial punishment; in other words, a court-martial and what the cause is.
So that is how we are able to get those numbers, but we do not require the chain of command to report individually on this one occurrence. We don't do it for anything else as well.
Mr. BUYER. You do. I did the review on sexual misconduct. You track rapes, you track sexual battery, you track all types of other offenses.
General KEANE. We do, sir. We do that through the judicial system where we aggregate all of that information. We don't require our commanders to provide a report through the chain of command on that.
Mr. BUYER. If Dr. Hamre wanted to access that information through his Judge Advocate Generals (JAGs), he could get that information?
General KEANE. That is correct. We have all of that available for every indices of misbehavior by our troopers in the United States military.
Mr. BUYER. All right. Thank you.
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General KEANE. Another question about court-martials, let me just bring that to a conclusion. When we have a refusal, the normal process that takes place is first there will be an education and counseling period to make certain that the trooper does understand all the facts and is making an informed decision, and that is usually given over a period of time for them to think about. And if the decision by the trooper is that they are still going to refuse, then the commander has a number of options that he can execute or she can execute, and those options include nonjudicial punishment, separation from the service or court-martial. The court-martials that we have had have been very few, and they have all been as a result of the troopers refusing to accept nonjudicial punishment and forcing the case to be adjudicated in the courtroom.
Mr. GILMAN. Would the Chairman yield?
Mr. BUYER. Yes.
Mr. GILMAN. Do you track resignations as well?
General KEANE. In the service in general?
Mr. GILMAN. Yes.
General KEANE. Beyond?
Mr. GILMAN. With relation to the anthrax vaccination, are you tracking?
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General KEANE. No, sir, we do not. We do not accumulate why our troopers are leaving the service in terms of what the specific reasons are for anything.
Mr. GILMAN. Thank you, Mr. Chairman.
General KEANE. It would be anecdotal evidence.
Mr. BUYER. Thank you, Dr. Hamre.
Dr. HAMRE. Thank you.
Mr. BUYER. Mr. Larson.
Mr. LARSON. Thank you, Mr. Chairman.
I have had the great fortune of being able to talk with Major Russell Dingell, who is an 18-year veteran of the 103rd Fighter Wing that is stationed in Bradley International Airport in my home state of Connecticut. How would you address his concerns when he says there is no equity or consistency in the way the troops are being inoculated? He and two other pilots said their regular jobs as airline pilots would be placed in jeopardy if they took the vaccination. They want very much to stay in the Guard, and they have been committed to their Nation and country and are no less patriotic or no more valorous in their pursuit, but with the medical issues hanging in abeyance and the seemingly different treatment of people across the board, what do you do to answer that policy or correct those decisions?
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General BLANCK. I think there are two parts or two answers to the very real concern you have expressed, and I think pilots are a particular group that we hear from having concerns about this vaccine.
First of all, let me dispel the rumor that if a Guard pilot or some other pilot works for the airline and takes this vaccine, they put their job at jeopardy. They do not. We have been in touch with the airlines. They have no such policy; in fact, will go along with whatever vaccination, mandatory vaccination, the military requires. The Airline Pilots Association insurance program provides the coverage. In fact, it is by contract with the airlines. The Federal Aviation Administration (FAA), surgeon is supportive of this. And so all of the myths or rumors about pilots having difficulties in their civilian employment are just that, myths.
We actually talked to that in our Web site, but perhaps more importantly, there is a Web site by three physicians who are FAA consultants that actually go through each myth and provide the correct information to dispel those rumors, and I would be happy to provide that, both for the record and to you personally.
Mr. LARSON. I would be happy to receive that.
[The information referred to can be found in the Appendix.]
Mr. LARSON. From the standpoint of morale, which was addressed earlier on, again, my concern would be that we are trying to retain people in the services, especially people in highly-skilled positions such as pilots. But inasmuch as I think my understanding is that the long term, quote—and I believe you said that, look, with respect to most vaccines, there aren't an awful lot of long-term indications, but because of the information that has been left, and because of the questions raised by the General Accounting Office in their study, how do we retain and continue to attract people when our allies have a totally different policy than we do?
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And my question is what are we doing in terms of with our allies to say, hey, look, you know, you are asking General Zinni to carry the whole weight on his shoulders, and knowing the Marines, just giving a task, whatever the task, you know, they are like the Spartans at Thermopylae, they will do it. But that is totally unfair to this Nation and totally places us in harm's way. How do we get our allies to respond in such a manner, or at least, you know, do our allies have medical information that we don't? And those are reasonable questions, as was pointed out by our Chairman, in this day and age with the Internet, to at least ask and get the answers to.
General ZINNI. Sir, we face not only the problem of anthrax and biological weapons, but certainly chemical, and in our theater now, the growing concern with nuclear weapons. We have embarked on a program to help our allies understand the threat in the region especially. Obviously, they have no place to go. They can't opt-out of a fight if it comes to them.
We are learning a lot about these threats. We have had the specter of these threats for a while, but lately the scope and the numbers of categories of these threats have increased and become very real. Many of our allies are coming to grips with this threat very recently, far more recently than we are. Some of these decisions are made for possibly political reasons, but our allies are interested in what we know and what we are doing to counter it.
We find in the Gulf extreme interest in the measures we are taking, and we are involved in a process of not only education, but trying to provide them with the information necessary to counter these. They will each, of course, make their own decision, and it may be based on anything from politics to religious or cultural or ethnic rationale. We can't influence that, as Dr. Hamre said, but I would liken it to a unit on any flank that opted out of wearing gas masks, and I as a commander saw a potential chemical threat, I could not put my troops, Americans, at risk in that they would depend on that unit, and I could not put myself in that position.
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You mentioned before whether allies would opt out and let us carry the burden. In our theater, we have a number of allies that are flying with us, working with us. We certainly have allies that live there and have no place or option to opt out, but I think this will be an ongoing process of education that we have to work through, and I am convinced some of them will come around.
Thank you.
Mr. LARSON. I thank you, sir. But, Dr. Blanck, what about the medical personnel from the British standpoint, why did they ultimately reach a decision contrary to ours?
General BLANCK. I can't speak to how they reached that decision. I can speak to the opinion of the British military medical establishment who recommended this as a mandatory program.
If I may also correct a piece of information I gave you, the individuals who have that Web site, the three physicians are FAA-certified flight surgeons. They are consultants, not, however, to the FAA, but to the Airline Pilots Association, which actually perhaps is even better in terms of their credibility.
General KEANE. Sir, if I may follow up General Zinni's comments dealing with our allies. The Israelis just recently announced the development of an anthrax vaccine program for their defense forces and also for the general population. Canada has made some purchase of this vaccine from us, admittedly in a small dosage, for their defense forces, and our office has received requests from eight other countries who would be willing to purchase our entire inventory of this vaccine. And I would be more than happy to provide the committee the list of these countries and what their program is and how their program relates to mandatory versus voluntary.
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Mr. JONES. Would the gentleman yield?
Mr. LARSON. Yes.
Mr. JONES. Would you yield for just one moment?
Mr. LARSON. Yes.
Mr. JONES. Thank you.
Do you know if the Israelis plan to mandate this shot to the troops?
General KEANE. I don't know the answer, sir. I will provide that for you.
Mr. JONES. I wish you would, because the information we have received, Chairman Gilman and myself, is that they are not going to mandate the shot, but again, I don't know that for a fact. So I would appreciate any information.
General KEANE. We will be glad to provide it.
[The information referred to can be found in the Appendix.]
Mr. BUYER. Mr. Kuykendall, you are now recognized.
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Mr. KUYKENDALL. I have got two specific questions, one for Dr. Blanck. You were talking about the protocol as three shots, and then one at 6, 12 and 18 months, and then boosters. A technical question on that. Is there a point where you ever get immunized and then you don't get any more boosters, or once you have got it, in order to stay immunized against anthrax, you must continuously take that booster? Like when I was in the service, we had to continuously take them if we were going in and out of a theater or something. Is that always the case with this vaccine?
General BLANCK. It is always the case, yes.
Mr. KUYKENDALL. Say someone has it, they have been for 3 or 4 years taking it. They leave for 3 or 4 years and come back to another theater, and then they go back. Do they have to start with the six shot series or just back to the booster?
General BLANCK. No, just back to the booster.
Mr. KUYKENDALL. Okay. Thank you very much.
For General Keane, we have just talked a whole lot about one little company producing this vaccine, and we have an extraordinary need for that vaccine in our own military forces alone, it sounds like, let alone people who are willing to buy the whole production of it.
What actions are being taken on the part—on the part of the DOD and the Army under your supervision, I guess, to expand the production of this vaccine or to find other sources where it could be purchased at the qualities and quantities that we are anxious to have?
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General KEANE. Sir, Secretary Oliver will answer that question. He knows more about that program than I do.
Mr. KUYKENDALL. Okay.
Mr. OLIVER. What we are doing, of course, is we put in $6.7 million to upgrade this facility so it can produce at a larger lot size. We expect that by next year this time they will have the capacity to produce in excess of 4 million doses a year as opposed to what they are doing now.
The problem, which you would like to do, what I would like to do, is I would like to have about four or five different places that do this. The problem is the economics of the thing and also how long it takes to qualify for an FDA license. To get this, to get another procedure up or another person up, is about an 8- to 12-year process. That is the problem.
We tried this before after the Gulf War to get somebody up. We tried to get up at Ft. Detrick, which was certainly a very credible place.
Mr. KUYKENDALL. I understand the problem with it now, but I wonder why aren't we figuring that out, because if it is an 8- to 12-year lead time, we have got a single site that if you knock it out, then hit us with anthrax, you just succeeded in winning your biological war.
Mr. OLIVER. Yes, sir, you are correct. So in the budget this year that will come to Congress, there will be funding in there for an alternative method, because what we would like to do is to start this process, no matter how long it is, and make sure we have alternatives, and what we would like to do is then make it, if we could, if this proves out successful, make it more attractive to the main line and larger drug companies.
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Mr. KUYKENDALL. Thank you.
Mr. BUYER. Mrs. Bono, did you want to come back or ask questions?
Mrs. BONO. I will come back.
Mr. BUYER. The committee will stand in recess. We have a 15-minute vote, followed by a 5-minute vote. We will have a 20-minute recess.
[Recess.]
Mr. BUYER. The committee will come back to order. Even though we are waiting for Mr. Abercrombie, I am going to go ahead, and the next questions are from Mrs. Bono of California, but I have some questions that I would like to ask until she arrives.
In particular, General Keane, the Department's literature states that maximally protected members must comply with the FDA-approved protocol of the six shots. Yet your own tracking systems show that in the case of at least one of the services, the active duty compliance rate is in the high 90 percent, while the Reserve rate is only 65 percent.
Why is there such a big difference between the compliance rate between the active and the Reserve forces, and what special challenges do you see for implementing and managing the Reserve part of the total program?
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General KEANE. Yes. We are attempting to get the Reserves to 90 percent, and we believe they are operating in and around the 65 percent range right now, and it is due to a lot of factors. One is the challenge of the Reserve components themselves, isolated locations and the number of those locations itself, the availability of the vaccine to them.
We have increased the available sites that the vaccine can be given now to 12,000 different sites, and to do that, they can access a military medical facility. We have also made arrangements through Public Health Service to use their services and the VA hospitals as well. So some of those initial problems that we have are beginning to be resolved.
The other problem is the reporting for the Reserves themselves has not been what it has been with the active, and we are attempting to correct that. Some of the reports that we have seen, when we noticed that an organization is reporting as low as a 5 percent compliance, which has just happened recently with an organization in Connecticut, when we check with the organization, they actually had 95 percent compliance.
So we do see some errors in that reporting system. I think we are going to get those things cleared up here in the not too distant future.
Mr. BUYER. Special challenges, though, I guess what I was meaning by that with regard to the Reserve components is in a series of six inoculations, the Reserve components are out there struggling—struggling, strike that word struggling—they have many different challenges as they juggle their civilian occupation with their military job, and perhaps they missed that weekend when there was that inoculation, and now they have to go, what, 180 miles maybe or go somewhere.
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There are some special challenges with the Reserve component meeting the six-shot compliance. Would you not agree?
General KEANE. Yes, sir. It is indisputable. We are talking about, you know, 16 hours a month that the Reserve component trooper, you know, will be spending in an organizational setting, and that has contributed to some of our problems, frankly, too, in terms of the command involvement with that trooper. On the active side, obviously there is command and trooper contact on a regular basis, given the full-time nature of that service.
So that has been challenging for us, too, to get the information in the hands of all of the Reservists so they can make competent decisions about this vaccine inoculation. And also the availability of the vaccine has been an issue. We think we are well on our way to solving that as well. And certainly those things do happen.
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