Page 1       TOP OF DOC
[H.A.S.C. No. 106–22]








SEPTEMBER 30, 1999

 Page 2       PREV PAGE       TOP OF DOC



STEVE BUYER, Indiana, Chairman

J.C. WATTS, Jr., Oklahoma
LINDSEY GRAHAM, South Carolina
JIM RYUN, Kansas
MARY BONO, California
JOSEPH PITTS, Pennsylvania
ROBIN HAYES, North Carolina

MARTIN T. MEEHAN, Massachusetts
 Page 3       PREV PAGE       TOP OF DOC
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






    Thursday, September 30, 1999, Department of Defense Anthrax Vaccine Immunization Program


    Thursday, September 30, 1999
 Page 4       PREV PAGE       TOP OF DOC


    Abercrombie, Hon. Neil, a Representative from Hawaii, Ranking Member, Military Personnel Subcommittee

    Buyer, Hon. Steve, a Representative from Indiana, Chairman, Military Personnel Subcommittee


    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.
 Page 5       PREV PAGE       TOP OF DOC

    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


[The Prepared Statements can be viewed in the hard copy.]

Abercrombie Hon. Neil

Buyer, Hon. Steve
 Page 6       PREV PAGE       TOP OF DOC

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


[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
 Page 7       PREV PAGE       TOP OF DOC


[The Questions and Answers are pending.]


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.


    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.
 Page 8       PREV PAGE       TOP OF DOC

    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.
 Page 9       PREV PAGE       TOP OF DOC

    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.
 Page 10       PREV PAGE       TOP OF DOC

    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.


    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.
 Page 11       PREV PAGE       TOP OF DOC

    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.
 Page 12       PREV PAGE       TOP OF DOC

    [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.
 Page 13       PREV PAGE       TOP OF DOC

    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.
 Page 14       PREV PAGE       TOP OF DOC

    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.
 Page 15       PREV PAGE       TOP OF DOC

    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.
 Page 16       PREV PAGE       TOP OF DOC

    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.
 Page 17       PREV PAGE       TOP OF DOC

    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.
 Page 18       PREV PAGE       TOP OF DOC

    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.
 Page 19       PREV PAGE       TOP OF DOC

    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.
 Page 20       PREV PAGE       TOP OF DOC

    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.


    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.
 Page 21       PREV PAGE       TOP OF DOC

    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.
 Page 22       PREV PAGE       TOP OF DOC

    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.
 Page 23       PREV PAGE       TOP OF DOC

    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.]


 Page 24       PREV PAGE       TOP OF DOC
    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.
 Page 25       PREV PAGE       TOP OF DOC

    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.
 Page 26       PREV PAGE       TOP OF DOC

    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.


    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.
 Page 27       PREV PAGE       TOP OF DOC

    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.


    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.

 Page 28       PREV PAGE       TOP OF DOC
    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.


    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.
 Page 29       PREV PAGE       TOP OF DOC

    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.
 Page 30       PREV PAGE       TOP OF DOC

    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.

 Page 31       PREV PAGE       TOP OF DOC
    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.
 Page 32       PREV PAGE       TOP OF DOC

    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.
 Page 33       PREV PAGE       TOP OF DOC

    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.
 Page 34       PREV PAGE       TOP OF DOC

    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.
 Page 35       PREV PAGE       TOP OF DOC

    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.
 Page 36       PREV PAGE       TOP OF DOC

    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.
 Page 37       PREV PAGE       TOP OF DOC

    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.
 Page 38       PREV PAGE       TOP OF DOC

    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.
 Page 39       PREV PAGE       TOP OF DOC

    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.
 Page 40       PREV PAGE       TOP OF DOC

    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.

 Page 41       PREV PAGE       TOP OF DOC
    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.
 Page 42       PREV PAGE       TOP OF DOC

    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.
 Page 43       PREV PAGE       TOP OF DOC

    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.
 Page 44       PREV PAGE       TOP OF DOC

    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.
 Page 45       PREV PAGE       TOP OF DOC

    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.
 Page 46       PREV PAGE       TOP OF DOC

    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.
 Page 47       PREV PAGE       TOP OF DOC

    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.
 Page 48       PREV PAGE       TOP OF DOC

    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?
 Page 49       PREV PAGE       TOP OF DOC

    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?
 Page 50       PREV PAGE       TOP OF DOC

    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.

 Page 51       PREV PAGE       TOP OF DOC
    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.
 Page 52       PREV PAGE       TOP OF DOC

    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.
 Page 53       PREV PAGE       TOP OF DOC

    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.

 Page 54       PREV PAGE       TOP OF DOC
    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?

 Page 55       PREV PAGE       TOP OF DOC
    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.
 Page 56       PREV PAGE       TOP OF DOC

    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.
 Page 57       PREV PAGE       TOP OF DOC

    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.
 Page 58       PREV PAGE       TOP OF DOC

    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.
 Page 59       PREV PAGE       TOP OF DOC

    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.
 Page 60       PREV PAGE       TOP OF DOC

    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?
 Page 61       PREV PAGE       TOP OF DOC

    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?
 Page 62       PREV PAGE       TOP OF DOC

    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?
 Page 63       PREV PAGE       TOP OF DOC

    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.
 Page 64       PREV PAGE       TOP OF DOC

    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.
 Page 65       PREV PAGE       TOP OF DOC

    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.
 Page 66       PREV PAGE       TOP OF DOC

    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?
 Page 67       PREV PAGE       TOP OF DOC

    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.
 Page 68       PREV PAGE       TOP OF DOC

    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.


    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?
 Page 69       PREV PAGE       TOP OF DOC

    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.
 Page 70       PREV PAGE       TOP OF DOC

    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.

    You know, a trooper that is scheduled to get that vaccine in that particular month, if he is sick that particular day and he cannot make his drill, is adversely affected in a way that an active component trooper is not affected. And certainly we recognize that.

    Mr. BUYER. So you are working with Surgeon General Blanck on these medical teams that will go around to the Reserve centers, or what is the response? General Blanck?

    General BLANCK. Well, there is a severalfold response. The first is, of course, the medical teams. It is to make sure that the Guard and Reserve medical forces are both trained and ready to do that job and have the tracking system available so that when an immunization is provided, that it gets entered into the—into our automated tracking program.
 Page 71       PREV PAGE       TOP OF DOC

    But, General Keane, if I can expand on his answer, alluded to other ways that service personnel can get the vaccine. So if that Air Guardsman did not on that one weekend get the vaccination for any one of a number of reasons, was ill or what have you, they can in their community go to somebody with whom we have contracted or can go to a much closer VA hospital at their convenience and get that immunization.

    Now, having the education in place to make sure everybody knows where these locations are and that we have our automated tracking system in place and so forth is really the challenge. Actually as the Reserve components, the Guard and Reserve, have looked at where they are with the compliance. The feeling is that they are much better than what the tracking system shows, though that is kind of anecdotal and speculative, because we rely on the tracking system.

    And the issue is both making sure the vaccine is available in the community, and they can get it any time through the VA, through occupational health clinics, through civilian contracts, nearby Medical Treatment Facilities (MTFs), but also when the vaccination is given, that it is entered into the tracking program rather than kept in a paper record.

    We have gone through that before; when they go to drill next month, it is entered into the system. Some of it is working through those problems.

    Mr. BUYER. Mr. Oliver, I want to go back to the questions with Admiral Crowe. Have you ever had a meeting with Admiral Crowe in the Pentagon?
 Page 72       PREV PAGE       TOP OF DOC

    Mr. OLIVER. Not in the Pentagon, although I have met with him, I went—took him to lunch, also took my executive assistant so I had a witness, because I didn't want to meet with someone that we had—that we might possibly have a problem with.

    Mr. BUYER. When was this?

    Mr. OLIVER. July, I think; sometime in the summer, June, July.

    Mr. BUYER. Of this year?

    Mr. OLIVER. Yes, sir. Because why I wanted to meet with him, I wanted to meet with him on how important that facility was with him, how important he maintain the quality control and get this refurbishment done and back up on-line and how important I thought that was. And I wanted to emphasize that to him. That was the discussion.

    Mr. BUYER. Have you or anyone in your Department, to your knowledge, had meetings, either in the Pentagon or outside the Pentagon, with Admiral Crowe?

    Mr. OLIVER. No one, to my knowledge, except me that one time.

    Mr. BUYER. Some of the criticisms about this relationship, and I am going to articulate them, not that they are my views, but I want you to comment on them. The years that I served on the Judiciary Committee, we made sure that we had very particular rules with regard to insider trading. If I am in a room and have privileged access to an FDA-approved drug, I know that they are about to approve that drug, yet I somehow gain an inside position to my pecuniary benefit.
 Page 73       PREV PAGE       TOP OF DOC

    We have got laws against that type of thing. So there is an uncomfortableness by some who have a genuine concern to say that here we have the former Chairman of the Joint Chiefs of Staff who has great ties and relationships in the building and among contractors, an individual who broke ranks at a time when then-candidate Bill Clinton was being beaten up for having dodged the draft, stepped forward and said, I extend my credibility to him as Commander in Chief, and has said that this President operates in the quid pro quo and has a track record of that. So they said, now we have—is this the payback, is this now—and this is a great attack upon the character of Admiral Crowe. There is some incredible things being written out there on the Internet about Admiral Crowe. I wish he were here to be able to defend himself.

    What I want you to be able to testify to is an individual of whom gains 11 percent without having putting up any money whatsoever, then is part of a company that is the sole source contractor to the government— you see, your testimony to us was about a word called trust. Things like this have a coercive effect upon trust; does it not?

    Mr. OLIVER. If you—no, sir. If you believed that web that you spun, then it would—.

    Mr. BUYER. Wait a minute, I am going to correct you. Not the web that I spun, the web that is being spun out there and I am going to give you an opportunity to comment on.

    Mr. OLIVER. Yes, sir. I was convinced when I talked to Admiral Crowe that he had no insider information and that he understood how important this was to us as a Department. I also took the trouble to read, and I had my staff go out to Michigan, get all of the hearings that the state of Michigan held, and read the minutes of each of the meetings, because I wanted to see how the contract came to be awarded to BioPort.
 Page 74       PREV PAGE       TOP OF DOC

    And when I got through, I was comfortable, I felt that the government of Michigan had done a really nice job in making sure that they got the best value, and who they were going to select had swung back and forth depending on what people had put up, and people had fallen out of the business, and other people had fallen in, and, finally, they had chosen BioPort over the other company, and it was really close. In other words, they were both about offering the same. As I said, I think it was about $800,000 difference. That competition was going on in 1988, late 1988.

    Mr. BUYER. Was this before or after the decision—.

    Mr. OLIVER. That is what I am coming to.

    Mr. BUYER. —to do this program?

    Mr. OLIVER. It was well after the decision to do this program; in other words, the decision to sell—.

    Mr. BUYER. The decision to sell the program came first.

    Mr. OLIVER. Yes, well before they sold—well before Admiral Crowe became involved with BioPort and buying this product.

    Now, that is the history line. As to the specific question, I didn't ask Admiral Crowe those questions, but when I just look at the history line from the earlier questions that Dr. Hamre talked about, about when the discussions were and when the decision to make that, that was well in advance of when Admiral Crowe became associated with the company, and at that time there were other people associated with the company.
 Page 75       PREV PAGE       TOP OF DOC

    And it became an issue for the state of Michigan to decide who to sell that company to. In their records, there is no indication of any influence at all, other than they were trying to get the best deal for the state of Michigan. I think the state of Michigan, the Governor and his team did a good job, because I went back and read it, because I was concerned about when I got into this job and I got into this problem, I wanted to make sure that I knew what had gone on before and I understood these things. I am confident that the state of Michigan made the decisions based on their own judgment.

    Mr. BUYER. The reason I am asking these questions is because the appearances of impropriety, individuals of whom have such allegations against them should have opportunities to clear the air, and that is the reason I have asked the questions for you to come forward on the record.

    Mr. OLIVER. Yes, sir.

    Mr. BUYER. Mr. Jones.

    Mr. JONES. Mr. Chairman, thank you. I would just like to ask a follow-up question, and I am certainly not one of those that says Admiral Crowe or anybody else has—you know, done anything behind closed doors, so to speak. But I would like to know the name of the CEO and president of BioPort.

    Mr. OLIVER. It is Haub, H-A-U-B—F-A-U-D, E-L-H-A-B-R-I.

 Page 76       PREV PAGE       TOP OF DOC
    Mr. JONES. I hope I don't have to spell it.

    Mr. Oliver, tell me, in addition to this gentleman—he is an American citizen, right?

    Mr. OLIVER. Yes, he is a naturalized American citizen.

    Mr. JONES. When did he get his citizenship; do you know?

    Mr. OLIVER. He got it—now, I only know this from hearsay or talking to him, he told me he got it during the process of bidding for BioPort.

    Mr. JONES. Okay.

    Mr. OLIVER. In fact, he told me—relative to our previous question, he told me that was Admiral Crowe's biggest contribution to the team was he told him that he ought to be an American citizen, and he would be—and he ought to convert.

    Mr. JONES. Okay. Let me ask you, in dollars what would 11 percent ownership of this company equate to?

    Mr. OLIVER. I don't know. I haven't looked up—the company paid about $25 million in cash considerations, et cetera, for BioPort.

    Mr. JONES. Okay. Thank you, Mr. Chairman.
 Page 77       PREV PAGE       TOP OF DOC

    Mr. BUYER. What was the nationality of the president of BioPort?

    Mr. OLIVER. He is a naturalized American citizen now. He was Lebanese.

    Mr. BUYER. I have a question for General Zinni before we excuse this panel. If you could put within your own vocabulary for public dissemination regarding the threat, how easy—when you say that it can be weaponized, and, therefore, deployed, how easy or how difficult would it be to deploy the anthrax virus in what manner, and if it was airborne, what quantity would be required to have a plume of a particular size that would influence a particular population? And put it in the parameters of your theater.

    General ZINNI. Well, Mr. Chairman, anthrax is a very easy weapon for the enemy to use. It is very stable. It is highly effective. As I mentioned, the lethality rate is very high. The cost is low. It is relatively easy to weaponize. It could be done in many forms; aerosol sprays from aircraft, we even know of experimentation with unmanned aerial vehicles for potential biological use, rockets and missiles that potentially could have the warheads artillery to deliver the anthrax.

    It takes very little anthrax to affect a large area. Of course, this is dependent on prevailing winds and some other factors. We have done studies for our region. I can provide you—I would rather provide the details because of the classification for the record.

 Page 78       PREV PAGE       TOP OF DOC
    Mr. BUYER. We received that in our threat briefing, but I wanted you to be able to explain it publicly.

    General ZINNI. I would say it would take very little to jeopardize our forces in a place like Kuwait. Kuwait is not a very large place. It is very close in proximity to Iraq. The ranges for aircraft, missiles, even unmanned aerial vehicles, which happened to be one of our largest concerns during the Desert Thunder time period when we asked for acceleration of the vaccine, very little, even in one of those systems, could have affected virtually all of our troop installations in that area and troops arriving to reinforce and execute any of our potential war plans.

    Mr. BUYER. I hate to live with a hypothetical, but let us say we withdraw from southern Iraq. How easy would it be and how much quantity would it take for them to fly an aerial spray along the southern part of Iraq, along the border of Kuwait; what would it take for the winds that circulate there to cover the country of Kuwait, for example? What are we talking about?

    General ZINNI. If we did not enforce the southern no-fly zone, obviously they could move aircraft and unmanned aerial vehicles and short-range rocket systems, which they are allowed to maintain, short-range missile systems, much closer to the border. They would have the capability within minutes or less to affect Kuwait and northern Saudi Arabia; not much more time than that to get further down to the Gulf, to places like Bahrain, Qatar, and even range as far as Oman.

    In general terms, perhaps one airplane with aerosol tanks could effectively endanger the entire population of Kuwait, obviously concentrated in Kuwait City along the coast, and the forces that might be located there.
 Page 79       PREV PAGE       TOP OF DOC

    Mr. BUYER. Now that the inspection teams have not been allowed back in Iraq, and you have had difficulty with the recalcitrance of Saddam Hussein, even though we are in our containment policies, we don't know what he is doing with regard to his biological program now. Is this a relatively easy biological compound to manufacture? If you can speak on it, or, General Blanck?

    General ZINNI. Well, I am glad you asked that question, Mr. Chairman, and it goes back to the point that Mr. Abercrombie made regarding preemption. The difficulty is that this is easily made, and there are many dual-use facilities like pharmaceutical plants, agricultural chemical plants that could be quickly converted or easily produce this. It is difficult to find the sources of this production. It is difficult to target.

    In Desert Fox, we went after weapons of mass destruction capability. This was one type of capability that was extremely difficult for us to find, as it was for the United Nations Special Commission (UNSCOM), when they were in place. I would defer to Dr. Blanck or others that are the experts on the actual production capability, but we do know from our own problems in finding and discovering this that is not difficult at all. It can be embedded in other plants that have other dual-use, civil-use capabilities.

    Mr. BUYER. And, General Zinni, are you not the CINC that pushed the hardest for the acceleration of the immunization for anthrax?

    General ZINNI. Yes, I am. I requested very strongly the Secretary accelerate the program, so that early 1998 we could begin the program for our forces in theater and then obviously to the forces that would flow into theater as a contingency built up.
 Page 80       PREV PAGE       TOP OF DOC

    If you remember, Mr. Chairman, during Desert Thunder, we had a buildup of over 30,000 troops into the area of responsibility, ground troops, air, naval and others, and we wanted to rush this program in to get the vaccine. And it was at a time we were concerned about some delivery systems and some experimentation that we saw on the other side; and, of course, our knowledge, proven by UNSCOM and discovered when the Kamel brothers, the sons-in-laws of Saddam Hussein, defected, the proven stockpiling and the proven capability and weaponization that we knew Iraq had possessed from the Gulf War on.

    Mr. BUYER. General Blanck, would you please incorporate in your answer how long these spores also live?

    General BLANCK. It is possible in almost any university or similar kind of bacteriologic laboratory to produce anthrax. You can do it in such a small area. It could be mobile labs, back of a tractor-trailer truck, that sort of thing. In fact, if you are only looking at small amounts, it could legitimately be produced in a hospital microbiology laboratory.

    Generally to produce the kinds of organisms we are talking about and the volumes you would need, you would need a small fermenter, quite a small piece of equipment, in which you put a little seed amount of the anthrax, and it grows from there. This is easily produced.

    The anthrax spores can survive for a long, long time. We have examples, for instance, in Scotland, an island off of Scotland, where the British did experimental work with anthrax during World War II that there were spores still found, making the island uninhabitable 40 years later, and it took a great deal of effort to go through and purify that soil with seawater. There was some incineration done and some other ways to inactivate it.
 Page 81       PREV PAGE       TOP OF DOC

    A New York Times article in the last few months referred to a biological dump that the former Soviet Union had used in one of the Soviet republics, where even after the inactivation was completed, on the residue from some closed laboratories, they still found a few viable spores. So this is a very hardy organism and can last for a long, long time.

    Mr. BUYER. Before I ask the last question, let me yield to Mr. Bartlett.

    Mr. BARTLETT. Thank you very much.

    I have here testimony from our next panel. It says why Congress should stop DOD's use of this forced vaccine before readiness, recruiting, and retention morale fall further.

    I have had a number of family members and servicemen who have come to my office soliciting my help so that they would not have to take this; what they considered a very dangerous vaccine.

    My good friend and colleague, Congressman Walter Jones, who has joined us here, remains unconvinced. General Blanck, what I need is for you to convince Walter Jones so that I can convince my service people that this is okay.

    General BLANCK. I will begin by saying that if the vaccine was available to me, I would give it to my wife and children. I have two daughters, 22 and 24 right now. That is how confident I am in the safety and the efficacy of it, and it speaks to what I believe as far as the threat not only to our military forces, but potentially at some point in domestic—possible domestic terrorism as well.
 Page 82       PREV PAGE       TOP OF DOC

    Having said that, let me begin by saying this is an FDA-approved vaccine. We have the FDA look at other biologics, other medications, other substances that we use, and we trust them to do the safety and efficacy trials or to review the data necessary for them to give that kind of certification.

    And in testimony before, I believe it was Mr. Shays' committee some months ago, the FDA again reiterated their conviction, not just belief, but conviction, that this was a safe and effective vaccine. I add that the vaccine is produced through technology that we have used for a long time. We know how this works. We know how to do it. We know how to produce the right product. It is not a live agent. I have had people express concern to me that if we take this, we might actually get anthrax. Impossible. Not only is it killed, but as described earlier, it undergoes a chemical process that produces a protein precipitant, that is the product of a chemical reaction, so that you are only dealing with a small residue from the killed bacteria. It can't give you the disease, it can only provide immunity.

    Last, I talked about side effects, and I will go into that in a little bit more. We have actually compared the usual range of side effects with this vaccine with some others. If I may have the chart, if somebody could put that up, please.

    These are from our own studies of the anthrax vaccine in the kind of lime green compared to a very similar vaccine that—against Lyme disease, placebo; that is, it was not the actual vaccine itself; then the Lyme vaccine in purple going over further. You see the diptheria-tetanus-pertussis-typhoid vaccine and hepatitis A vaccine, also a new one. And without going into great detail, these kind of nonspecific side effects are very, very comparable in all of the vaccines. The one side effect that is more prevalent, more common in the anthrax vaccine is having a tender, sore area or a lump at the site of immunization, and that speaks to both the way that we give it, subcutaneous, like the lyme vaccine, but it also speaks to its immune effect. It creates a local reaction. That is what it is supposed to do. So that is fairly common; self-limiting, goes away in 48 to 72 hours. Actually my lump lasted a little longer than that, but it goes away and creates no difficulty.
 Page 83       PREV PAGE       TOP OF DOC

    We have also—and I testified earlier—have seen serious side effects, and with any vaccine there is going to be side effects, let us not kid ourselves. Nothing is so totally safe that you are not going to have any risk. And, of course, I also refer to the childhood vaccines that we mandate be given to our children which are far more serious and have more frequent side effects than the anthrax vaccine.

    Because of the benefits that it provides, it protects against a lot of diseases, it has almost eradicated many diseases; smallpox, polio come to mind. At any rate, the serious side effects we have had, and we have an active reporting system, mandated reporting system, 72 who have had significant diseases requiring hospitalization who have missed duty, of those 55 were judged by a Health and Human Services review group that looks at adverse events to have been caused or causally related to the anthrax vaccine.

    Every single soldier, sailor, airman and Marine who has a serious side effect, who has had a problem with this vaccine, has recovered, has returned to full duty, and in the case of the most serious side effects, Mr. Chairman, you mentioned Guillain-Barre, a full recovery has occurred, and there is no sequelae.

    Should there be a significant side effect to the extent that an individual could not return to active duty, and is that a possibility? Of course, this is a vaccine. It is with any vaccine, whether it is diptheria or tetanus or mumps, rubella and measles, then we would deal with them just like we do with any other illness; that is, provide medical retirement pay, medical care and take care of them for the rest of their lives. And this is what we are bound to do and would do in this, as we would with any other significant illness, long-lasting or chronic illness. But we have not seen any that are chronic.
 Page 84       PREV PAGE       TOP OF DOC

    Mr. BARTLETT. Congressman Jones, are you convinced?

    Mr. JONES. My friend from Maryland, I have had numerous meetings with representatives of the Department of Defense, which I very much appreciate. I told them I am not their problem. The problem is convincing the men and women in uniform that this shot is safe and is necessary. And when they are convinced, then I am satisfied. Thank you.

    Mr. BARTLETT. Thank you, Mr. Chairman.

    Mr. BUYER. General Blanck, there is a group of physicians, Physicians for Social Responsibility, who have a different opinion of what you had stated here today. Would you care to comment upon this group's findings?

    General BLANCK. Well, I have great regard both for the group and for the individuals, because I think they are, as we all are, trying to do the right thing and trying to do the best that we can in terms of providing protection for everyone.

    I go back to how I opened my testimony. I believe we have the moral obligation to provide that force protection. I believe they are not convinced of the threat. I am. I believe they are concerned with the lack of human testing as far as the efficacy, and I am, too, but I have also described why we cannot ethically do that human testing. We are certainly not going to expose those who have received a placebo vaccine to something that is close to 100 percent fatal. And I am very comfortable having reviewed this and lived several years of this with the animal models that we have.
 Page 85       PREV PAGE       TOP OF DOC

    I actually am in dialogue with some of the members of that organization and continue to provide them data. The most recent paper in vaccine done by a group reviewed all of the studies on safety and efficacy, and that was published in 1998, and their conclusion was, we see no reason for further studies on safety. This is a safe vaccine. We believe it to be effective based on the studies that we have.

    So with the data that we have, and we can always look for more data, and we have the studies that I have described to follow folks out for a number of years, I think the choice is very clear. I think what you have heard here is what I hope has been a convincing demonstration of a very real threat.

    I know as a physician what will happen. I have read the accounts of inhalation anthrax. It is close to 100 percent fatal left untreated, rapidly. We even have more recent experience of the biologic facility in the Soviet Union that released a very, very tiny amount of organism and killed at least somewhere in the seventies, probably many more that—68 actually was the number that we know of, but it is probably much more than that. So this is clearly a deadly disease.

    If you accept that, then why wouldn't we take the next step of using an FDA product; I have described the studies, to protect our forces? That is my obligation, that is all of our obligations, and I think we can do no less.

    Mr. BUYER. We have done plume analysis, have we not, for the airborne? We have?
 Page 86       PREV PAGE       TOP OF DOC

    General BLANCK. Yes.

    Mr. BUYER. So I can understand this better, give me an idea, if I were to take—not me particular, some terrorists were to take an airborne spray just outside of Chicago, how large—and in what—I don't know, he drives for 10 miles, flies for 10 miles, I don't know, give me an idea of how large this plume will be before the spores would dissipate. I mean, just give me an example or an idea here so the American people can understand is the threat real or not real, or how large, in fact, would something cover?

    Put it—people understand the map of the United States. They don't necessarily understand the area of the world, General Zinni, that you deal with.

    General ZINNI. Mr. Chairman, the release of something along the lines that you mentioned would probably threaten an area that would range from around Minneapolis all the way down to the Gulf coast, and probably in terms of east to west dimensions, from West Virginia out to Texas, just to give you an idea of the scope of the problem.

    Of course there are factors like winds and climatic conditions that might affect this. But in a general sense, that is what we are talking about, something with a very little bit of anthrax and how effective it can be. And, of course, you have heard from Dr. Blanck the ability for this to remain active and deadly for such long periods of time. So it is not only the immediate effect, but it is the prevailing effect that it can have as these spores continue to live.

 Page 87       PREV PAGE       TOP OF DOC
    Mr. BUYER. That is pretty serious. Thank you, General Zinni.

    Any other questions?

    I want to thank the panel for their testimony. I will now excuse the first panel.

    We have one 15-minute vote. This committee will stand in recess, and we will come back for panel number two.


    Mr. BUYER. The personnel subcommittee will come to order. We have before us today our second panel of witnesses. We will ask that each of you testify under the 5-minute rule.

    First to testify will be Lieutenant Colonel Handy, the United States Air Force, Retired? You are retired?

    Colonel HANDY. United States Air Force Reserve, Retired.

    Mr. BUYER. Reserve, retired. All right.

    Major Jeffords, United States Air Force, a member of the 164th Air Wing, Tennessee Air National Guard; is that correct?
 Page 88       PREV PAGE       TOP OF DOC

    Major JEFFORDS. Yes.

    Mr. BUYER. Master Sergeant William Colley, United States Air Force from the 137th Air Wing, Oklahoma Air National Guard; is that correct?

    Sergeant COLLEY. Yes.

    Mr. BUYER. Colonel Myron Ashcraft, United States Air Force, the Chief of Staff of the Headquarters of the Ohio National Guard.

    Colonel ASHCRAFT. Yes, sir.

    Mr. BUYER. Lieutenant Chris Rohrbach.

    Lieutenant ROHRBACH. Rohrbach, sir.

    Mr. BUYER. United States Navy Assistant Officer in Charge, Bravo Platoon, Team 8, Little Creek, Virginia.

    Lieutenant ROHRBACH. Yes, sir.

    Mr. BUYER. It makes you a SEAL.

    Lieutenant ROHRBACH. Yes, sir.
 Page 89       PREV PAGE       TOP OF DOC

    Mr. BUYER. Gunnery Sergeant Larry Miyamoto— .

    Sergeant MIYAMOTO. Correct, sir.

    Mr. BUYER. —United States Marine Corps, is with the Chemical Biological Incident Response Force, Camp Lejeune, North Carolina. You are going to have to explain what that is.

    I will open now with Colonel Handy.


    Colonel HANDY. Thank you, Mr. Chairman, and honorable members of the subcommittee, for this opportunity to testify. I would like to tell you how I believe the anthrax vaccine is being perceive—.

    Mr. BUYER. First of all, if I may interrupt you, each of you, I know, have written statements. Your written statements will be entered into the record. All right. And I also know how difficult it is to express your personal views here today, and so I want you to know that it is appreciated.

    So your candor is extremely important to us. Thank you. I apologize, Colonel.
 Page 90       PREV PAGE       TOP OF DOC

    Colonel HANDY. I would like to tell you how I believe the anthrax vaccine is being perceived by the vast and increasingly vocal majority of the service members, about 80 percent of whom we believe, according to three surveys, are against this program, and explain my involvement with the issue.

    Last year about this time, I had been newly appointed to the rank of full colonel in the Air Force Reserve and had done some research on the program, knowing it would affect me and many Reservists I worked with during the last 10 years. Initially I found disturbing information and soon discovered I would be unable to agree with or help enforce this policy as a senior officer, nor could I envision taking the shot myself. I became concerned for fellow service members I have known over the years that they would invite needless health risks while taking a questionably efficacious vaccine against a somewhat theoretical threat.

    Subsequently I cosponsored a Reserve Officers Association resolution which recommended against using the current mostly quarantined anthrax vaccine stockpile. Additionally, I testified against this program in March.

    Realizing an irreconcilable difference had occurred between my principles in this DOD policy, I retired in May of this year in protest of the program. Now, instead of meeting my first Brigadier General Officer screening board this year, I elected to forego even the status of full colonel and now am a retired lieutenant colonel and civilian using what time and resources I can to raise awareness of this policy's ramifications and dangers, which I believe are putting the military on a course of self-destruction.

 Page 91       PREV PAGE       TOP OF DOC
    And I would like to touch briefly on just three or four of the those areas. First of all, on the area of recruiting, morale, retention and readiness, it seems that in this current and very difficult recruiting environment, the anthrax vaccine can by itself destroy a potential recruit's interest in the military. The growing awareness from media sources of the problems with this policy is contributing to an increasingly negative image of military life and service. What other career field requires as a condition of employment 24 vaccinations over the career of just one type as an adult?

    This would seem to pose a virtually insurmountable risk to any legitimate recruiting efforts in the future. And we have seen just recently in the Wall Street Journal, Mr. Chairman, where there was an article in the last several days where the anthrax issue did come up, and the recruit happened to turn it down just based on that consideration alone.

    In terms of other issues that cause problems with the policy, we might want to back up just for a minute and examine the prospect of an anthrax attack a little more closely. Perhaps the public's first suspicions about the legitimacy of the program should have occurred when the Secretary of Defense announced the program by holding up a 5-pound bag of flour and saying if it was anthrax dispersed across D.C. And across the D.C. area, half the population—half the area's population, about 3 million people, would die. He left out important details as to how this scenario could actually occur.

    And this pronouncement has been characterized by reputable biological warfare experts such as Dr. Ken Alibeck of the former USSR, who ran the Office of Biological Warfare programs for them, and he, himself, characterized it as an extremist solution, as an extremist tactic.
 Page 92       PREV PAGE       TOP OF DOC

    Other DOD officials have followed suit in that scare tactic more directly by constantly saying, ''Fear the disease, not the vaccine.'' Some of the military are saying in response, ''Sorry; other service members have been there, done that and got the effects from the Gulf War.''

    Quite disturbing also to many in uniform and the public, if they know, would be the level of the commitment the President appears to have to this program and his apparent fictional influence for biological concerns from reading a novel entitled The Cobra Event, according to a New York Times article last year.

    Taking the President's lead, the FDA recently said in an article, and they revealed the following plans: ''in regards to bioterrorism, the goal of the FDA is to foster the development of vaccines, drugs and diagnostic products.'' So the Administration, the DOD and the FDA are committed to going down the vaccine defense road, but, again, the former USSR's Dr. Alibek and others have cast grave new world doubts on whether vaccines will provide the desired protection.

    In his book, Biohazard, Dr. Alibeck offers the following observations, and these are worth quoting. First of all, he does not place anthrax at the top of our threat list, as our doctrine does, but instead says that plague and smallpox are probably the more perfect biological warfare threats. I quote, ''America has done more than any other nation to protect civilians from biological weapons, but it is not clear for all of its efforts that its citizens are any safer. The vaccines can trigger significant changes in the blood and endocrine system. Some have been known to affect the functioning of the heart, lungs, kidneys and other organs. It is not medically advisable to combine too many different courses of vaccination. A vaccine works against a single pathogen or occasionally several similar ones, but an all-purpose antidote does not exist. Continued advances in weapons-making knowledge will always put us a step behind.''
 Page 93       PREV PAGE       TOP OF DOC

    So one might conclude that not only is the threat arbitrarily magnified, but the effectiveness of the anthrax vaccine is highly questionable. This being the case, it is possible that every tax dollar spent on this program is a wasted expenditure, and, because of the measurable health disadvantages, constitutes a cruel and unusual program. One of the greatest and most inexcusable travesties of this program is that service members are being denied adequate medical care because medical professionals are obsessed with the policy enforcement rather than open-minded investigations into possible vaccine reactions.

    The issue of the Nuremberg Code is also relevant here. And I just want to mention in that regard that it is relevant because although the drug—or the vaccine—is FDA-approved, it has also been in Investigational New Drug (IND), status since 1996, according to testimony back in July, because of the desire of the DOD to provide better evidence of inhalation efficacy and a reduced dosage regimen. So on the one hand, DOD says it is effective; on the other, it is not yet proven effective. This is DOD and Administration doublespeak. Which is it? It can't be both. If it is in IND status, informed consent should be required.

    There are precedents for a time-out and for evaluation of the program administration, as we can see from the swine flu vaccine debacle in the 1970s which indicated in the research that I have done in a couple of books that a mechanism should be built into such programs from the start which requires periodic evaluation of the premises upon which decisions are made and reconsideration of those decisions made based on the latest available information. And it included recommendations for outsiders in the areas of law, logistics, production and other fields to give the program a good scrub.

 Page 94       PREV PAGE       TOP OF DOC
    Additionally, recent Congressional development that is instructive regarding this program is in the legislation regarding the use of Pyridostigmine Bromide (PB), tablets. Now the military can no longer administer those tablets unless the President approves their use.

    Under the law sponsored by Senator Byrd, the nerve agent pill and the botulism toxoid vaccine are considered investigational drugs. The amendment by Senator Byrd was passed in 1999, and in the prepared statement, Byrd said it was intended to improve the oversight and approval process for granting waivers to use investigational drugs without the informed consent of the troops. Included in that law was a provision to study the safety of the anthrax vaccine, again, making us all wonder whether it is experimental or not.

    As I see it, in conclusion, the FDA and the DOD Memorandum of Understanding allowed the involuntary—in the Gulf War—allowed the involuntary use of unapproved or questionable substances under the name of chemical and biological force protection. Because no one has been held accountable for the related health consequences of that action, the Nation is now reaping a harvest of crushed military morale, resignations, rebellion and legitimate fear from the renewed use of a poorly proven vaccine that is still considered by many a potential cause of Gulf War-type illnesses. The situation could become a national defense nightmare as readiness ratings plummet with the growing exodus from military service over this issue, combined with the recruiting challenges not faced by the services in the past two decades.

    The DOD is pursuing the mandatory vaccine regardless of its criminal effect as characterized by the Congressional press conference on HR 2548 and HR 2543, which both place restrictions on the policy. I believe the policy should be abandoned, and the Nation must adopt a more appropriate, logical and responsible biological warfare defense policy.
 Page 95       PREV PAGE       TOP OF DOC

    An unknown author said the willingness with which our young people are likely to serve in any war, no matter how justified, shall be directly proportional as to how they perceive the veterans of earlier wars were treated and appreciated by their Nation.

    This concludes my opening remarks, Mr. Chairman. Thank you very much.

    [The prepared statement of Colonel Handy can be found in the Appendix.]

    Mr. BUYER. I would remind the panel that even though I just granted extraordinary leeway, that you are restricted to 5 minutes.

    Mr. Jeffords.


    Major JEFFORDS. Mr. Chairman, distinguished members of the committee, I am undertaking the task of addressing the Congress as a messenger for my fellow Guardsmen, as well as for dedicated active duty and Reserve component members of the military. My message is that there must be a time-out to address the legitimate concerns of the members of the military, a growing number of Congressmen and the families of military members. The mandatory Anthrax Vaccination Immunization Program, AVIP, must be reexamined on behalf of all 2.4 million members of the military before the controversial program causes further damage to the morale, retention and recruiting of our armed forces.
 Page 96       PREV PAGE       TOP OF DOC

    Mr. Chairman, I have been associated with military culture my entire life. My first active duty assignment after pilot training was a 3-year assignment to the Memphis Air National Guard unit under a program called Project Season, followed by another 5 years of active duty overseas. I exceeded my active duty service commitment by 2 years and joined the Tennessee Air National Guard in Memphis immediately following my voluntary separation from active duty.

    Since 1991, I have flown both C–130 Hercules and C–141 Starlifter aircraft with the Tennessee Air National Guard. In 1993, I was honored with the title of Tennessee State Airman of the Year. I am currently a command pilot with approximately 4,500 hours of military flight time.

    I am here to tell you all that all I want is to protect the priorities that enable me to serve my country faithfully. Those priorities are family first, my civilian job second, and the Guard third. My fellow traditional Guardsmen are likely to share my views, especially pilots. Our traditional Guardsmen pilots are leaving the citizen-soldier ranks in large numbers, and the AVIP is largely to blame. I say largely because the anthrax shots are not exclusively the reason many are leaving anymore. The deceptive tactics and insensitive, heavy-handed methods for program enforcement employed by the DOD and even our own National Guard leadership have also taken their toll.

    Our leaders are correct when they say our Guard and Reserve forces are built on the premise of acquiring highly motivated volunteers to serve, but we must never forget those people are there by choice, and anytime they lose faith in their leadership or they feel they are being abused, they will leave. This is what is happening as I speak at units all over the country and, in particular, at various units on my base at Memphis over the past few days leading up to our deadline for submission to the AVIP on October 3rd.
 Page 97       PREV PAGE       TOP OF DOC

    The National Guard is composed of highly-motivated citizen-soldier volunteers. Many of us are veterans of active duty service who faithfully served our country before leaving to pursue our diverse goals and in ranks of the National Guard. We brought with us experience, skills and a keen familiarity with the inner workings of the military. I have heard the Guard described only half jokingly as the Wal-Mart of national defense since the taxpayer is getting a brand-name product for a fraction of what it costs to support our active duty counterparts. The reason we are willing to stay is simple: We are self-motivated. When that motivation is removed, for whatever reason, the entire country will suffer as these citizen-soldiers part ways with their part-time military jobs.

    I am here to tell you, the time is now to address this emerging crisis. As of now only about 10 percent of Air National Guardsmen and a much smaller percentage of Army National Guardsmen have been told to submit to the mandatory AVIP.

    My unit in Memphis is converting its C–141 aircraft to different cockpit layouts and must conduct some retraining of its air crews. We are in a compromised state of mission readiness as a result. Despite these facts, Memphis inoculated over one-third of its members in July and is slated to resume inoculation of the entire base this weekend. Why is the priority to vaccinate low-ranking airmen in clerical, nonmobility positions more important than vaccinating combat infantrymen in other units that won't be scheduled for the shots until late 2002? Why are we vaccinating these people before soldiers in the designated high-threat areas, who fall under Phase I of the DOD directive concerning vaccination priorities?

    Yesterday, Charles Cragin, the Principal Deputy Assistant Secretary of Defense for Reserve Affairs offered the following in written testimony: All military personnel are not being immunized immediately, due largely to limited production capabilities and stockpiles. Initial immunization is a priority for personnel deploying to the Korean Peninsula or Southwest Asia. Second priority goes to those who are on mobility status and who have the potential to deploy early to high-threat areas.
 Page 98       PREV PAGE       TOP OF DOC

    And my comment is that Memphis is one such unit in Phase II. The lowest priority and consequently the last to begin the immunization program will be the remainder of our personnel.

    Why is a Phase II unit being forced to submit to AVIP before some Phase I units already in theater? If the vaccine supply is so limited, causing a drawn-out schedule for vaccination, why aren't combat troops always vaccinated before clerks? Is DOD aware of this apparent violation of its own phase implementation directive?

    It is not my intent to make a case for disobeying a direct order, but I will say it is inevitable that I will not be included in the group of persons with an adverse reaction. My moral sense of duty calls on me to take up the fight for those with fewer options than I have. If I can save even one person, it will be worth the effort. Not only will I save the person from potentially debilitating illness, I will be serving the best interest of good order and discipline and military readiness, especially for our unit. A policy reversal is the only option for saving the mental well-being of all those who know the truth about the AVIP, but as we saw from the Vietnam conflict, bad policy decisions can simultaneously be costly to implement and difficult to reverse.

    The best way to resolve this issue is, in the short term, is either halt the program or make submission voluntary. Following this, the issues that have caused so much concern among our personnel must be resolved in an intellectually honest manner. Additionally, military members must be acknowledged by the DOD to have the same medical rights as other U.S. citizens. The problem is not just voluntary consent, but informed consent. The DOD has a long history of neglecting to inform its members of the risks associated with medical treatments. As long as doses of this specific vaccine formulation are used, there will continue to be problems with adverse reactions.
 Page 99       PREV PAGE       TOP OF DOC

    Finally, and most ominous, there are many other vaccines against biologics under development. The Joint Vaccine Acquisition Program, JVAP, is a fully-funded $322 million program whose purpose is the development, stockpiling and administration of up to as many as 75 new biological warfare vaccines. I foresee the annual booster for the anthrax vaccine evolving into a soup of investigational biowarfare vaccines, which were previously tested only on animals. The DOD will almost certainly try to rush these vaccines into the veins of their best-controlled, healthy population, the 2.4 million members of the military.

    This concludes my testimony today, and I wish to thank the members of the committee for inviting me to testify. I will be happy to answer any questions.

    [The prepared statement of Major Jeffords can be found in the Appendix.]

    Mr. BUYER. Mr. Colley.


    Sergeant COLLEY. Thank you, Mr. Chairman. I want to thank the committee for inviting me here to discuss the concerns about this policy, and I want to thank you for your willingness to review this very important issue.

    My name is William Colley. I am a dual-status member of the 137th Airlift Wing in Oklahoma City. I am a civilian technician and a master sergeant in the Oklahoma Air National Guard. My job in the Oklahoma Air National Guard is a C–130 loadmaster instructor. I have approximately 7,200 flying hours as an enlisted crew member. This job requires flying into many hot spots around the world, delivering cargo and troops. It also requires constant training at low-level altitudes and formation flying with other aircraft. I have served proudly in this position for 20 years. I also have 2 years civil service at Tinker Air Force Base and 7 years on active duty with the United States Navy. My service in the Navy was spent aboard two different aircraft carriers working long and tiring days and nights on the flight decks. I have also been held under gunpoint while on duty in a foreign country during a coup attempt while I was standing my duty. I am familiar with the dangers of serving my country.
 Page 100       PREV PAGE       TOP OF DOC

    Today, our military is being torn apart by a force protection policy that is causing illness within our ranks, forcing experienced personnel to leave in the middle of their careers, and putting our national defense in possible jeopardy. Damage is being done to the morale of our own forces at a rate never seen before. Morale is at an all-time low. Anger, hurt and confusion has all but replaced our once spirited efforts in serving our country in the United States Armed Forces. Never in my 29 years of serving this great country did I ever expect to see the division and animosity that I am seeing today. Lies are replacing the truth. Suspicion is replacing trust.

    One of the common thoughts being expressed in today's military is the lack of trust that we have in our leaders not only from false statements being made about the safety and efficacy of this vaccine, but also the attitude being displayed towards many of the personnel that are asking serious and concerned questions about this program. Honesty is the hallmark of the military profession because in the military our word is a bond. Well, today that bond is being broken.

    My testimony about the problems of the anthrax vaccine program have been many, but this is only the tip of the iceberg what you are seeing today. In brief, the threats against our members have been many. Health care providers who are civil service technicians are being coerced into stating that they will cover any ailments caused by the anthrax vaccine, when in the past they said they will not cover any illness.

    The only company that makes this vaccine has been closed for renovations since March of 1998 due to 84 major violations found in the manufacturing process of the anthrax vaccine, and that vaccine is still being used today. Statements that veterinarians are routinely vaccinated with the anthrax vaccine have been found to be false. Almost daily I learn of another service member falling ill after taking this vaccine and then being told not to worry about it.
 Page 101       PREV PAGE       TOP OF DOC

    I brought a letter from a gentleman that I met Saturday night that he wants me to deliver his remarks to his Congressman here today if I get a chance. He is on the committee. He asked to be anonymous. He is afraid of retribution if his commanders or his medical people find out about his problem or what he thinks may be the problem. He has had four vaccinations and is suffering some of the basic problems that folks are showing with this vaccine. So, I will continue.

    Implementation of this program has continually been misused and improperly put into place in many units around the country. The answers to why our service members are getting so sick from this vaccine are out there. So are the answers as to why we are not being told the truth about the efficacy of this vaccine.

    To the honorable members of this committee, I plead to you to deeply investigate this program and its lack of merits. Thank you for giving me the time to testify here today.

    [The prepared statement of Master Sergeant Colley can be found in the Appendix.]

    Mr. BUYER. Colonel Ashcraft.


 Page 102       PREV PAGE       TOP OF DOC
    Colonel ASHCRAFT. Thank you. Mr. Chairman, members of the subcommittee, my name is Myron Ashcraft. I am a traditional Guardsman from the State of Ohio and currently serve as the Chief of Staff for the Headquarters, Ohio Air National Guard. The chief of staff position in Ohio is the senior traditional position for our nearly 5,000 Air National Guard members in the state. In Ohio we have a wide range of military units with KC–135 refueling aircraft, C–130 transport aircraft, F–16 fighter aircraft and numerous ground units operating at a total of eight locations throughout Ohio.

    The wide variety of capabilities in the Ohio Air National Guard allows our units to support numerous worldwide missions for the United States Air Force. Currently, the 180th Fighter Wing from Toledo, Ohio, has F–16s patrolling the northern no-fly zone over Iraq. The 179th Airlift Wing from Mansfield is currently supporting Air Force expeditionary tasking in Oman. One of our ground units is preparing for a 90-day Presidential Selected Reserve Call-Up (PSRC), rotation to Southwest Asia, and the 121st Air Refueling Wing from Columbus, Ohio, just returned from a rotation to Turkey.

    Members of the Ohio Air National Guard are consistently deploying to what are considered high-threat areas for terrorist activity. I am concerned about the safety of the men and women of the Ohio Air National Guard as they deploy to these dangerous parts of the world. I can ensure that their training is the best we can offer. With the help of Congress and the Air Force, I can ensure that the aircraft they fly and the equipment they operate are the very best we can afford. I can make sure that all predeployment training is completed to include self-protection training, and I can offer them protection from at least one biological warfare threat, that, of course, being protection from anthrax.

 Page 103       PREV PAGE       TOP OF DOC
    The key is that we can offer them the protection. In a truly volunteer force like the Air National Guard, where many of our men and women have no remaining obligation, members always have the option of simply leaving the force. The challenge then is to make sure that on a local level sufficient and accurate information is presented to allow our men and women to make a truly informed choice. I believe, given the real information, most Air Guard members will choose to protect themselves from this very real threat.

    Some Air National Guard members are reluctant to take the anthrax vaccine because they fear it might affect their civilian employment. Seemingly the most vocal of all groups are the airline pilots. I myself have been a commercial airline pilot since 1978 and can assure you that anything that might jeopardize my career has my full attention. Much of our earning capacity as airline pilots occurs in the final years that we serve with the airline. Our retirement is also affected greatly by our final years of service with the airline. For that reason, it is imperative that we reach the age 60 mandatory retirement age still able to pass the physical examination every 6 months.

    The issue is clear. Is there an appreciable risk associated with the taking the anthrax vaccine? I believe the answer is no. All of the scientific evidence points to a safe and effective vaccine. Based on the scientific evidence, I have taken the first three shots in the series and have every intention of taking the remaining shots.

    I welcome the opportunity to be with you this afternoon and to talk to you about this very important issue, stand ready to answer any questions that you may have, sir. Thank you.

 Page 104       PREV PAGE       TOP OF DOC
    Mr. BUYER. Thank you.

    Lieutenant Chris Rohrbach.


    Lieutenant ROHRBACH. Thank you. Mr. Chairman, distinguished members of the committee, I am Lieutenant Junior Grade Chris Rohrbach, United States Navy. I am stationed with Sea/Air/Land (SEAL), Team 8, in Little Creek, Virginia, where I am currently assigned as the assistant officer in charge of Bravo Platoon.

    I have just recently been on one major deployment on the USS Enterprise, and that was from November 1998 to 1999. Prior to that, I was in underwater demolition/SEAL training and advanced SEAL training.

    My experience with the anthrax vaccine includes taking four of the six-shot regiment. I took my first shot prior to my deployment on the USS Enterprise; my second and third shots while on the Enterprise. Soon after returning from deployments, I received my fourth. I am scheduled to take my fifth shot in November. While I had a sore arm after each shot, the soreness was comparable to other shots I have received.

    I view the anthrax vaccine similar to any other force protection measure that I receive or use. I may not need the protection every day, but I never know when I will need it. Consequently, for my safety and the safety of my teammates, I want all the protection I can get.
 Page 105       PREV PAGE       TOP OF DOC

    I train in a high-risk environment on a day-to-day basis. Routinely we take steps to conduct this training safely. For instance, although it could be said all SEALS are good swimmers, we always wear some type of life-saving flotation device while we are working in and around the water. When training with air assets for different evolutions, including parachuting, rappelling, fast roping or cast and recovery out of helicopters, we wear helmets. Helmets and life jackets are not necessary for all operations we conduct, but we still wear them to create a safe environment.

    The same can be said about the numerous vaccinations I receive, including the anthrax vaccine. Will I come in contact with hepatitis? Maybe, but if the vaccine protects me from contracting the disease, I am glad to take it. Will I be exposed to anthrax? I hope not, but if I am, I know that without the vaccine I probably will die.

    From my personal standpoint, and what I have observed in my team, taking the anthrax vaccine has not been an issue. I am aware that there is information out there that attempts to discredit this vaccine. However, I am also aware that this is an FDA-approved vaccine and has been used successfully for years.

    In closing, I am not a corpsman or a doctor. With my limited knowledge of medicine, I really can't endorse any medical procedure. However, I am all for any procedure or device which will make my life and my teammates' lives safer without hindering operational performance. The anthrax vaccination is one of these safety measures.

    [The prepared statement of Lieutenant Rohrbach can be found in the Appendix.]
 Page 106       PREV PAGE       TOP OF DOC

    Mr. BUYER. Gunny Sergeant.


    Sergeant MIYAMOTO. Good afternoon, Mr. Chairman. The rest of you, hello, good afternoon. I am Sergeant Miyamoto. I have been a Marine for 15 years, and I am 34 years old. My occupational specialty is an Explosive Ordinance Disposal (EOD), technician, which for our purposes would equate to a local or a large metropolitan bomb squad, and right now I am stationed in Camp Lejeune, North Carolina, in a unit called CBIRF, the acronym stands for Chemical Biological Incident Response Force. And Mr. Chairman, I would like to take a minute and explain that to you just a little bit.

    We are a consequence management force designed to respond to a terrorist incident involving weapons of mass destruction, and we do that with our force of approximately 350 Marines and sailors by turning them from victims into patients, through going downrange into the incident area, extracting them out, decontaminating them, and taking them to whatever triage or medical facility is available in the area, and we do this best by being predeployed into a venue site where a threat may occur. Just a few examples of missions that we have supported were the Summit of the Eight, the Olympics, and, just recently, the NATO summit. We are a self-supporting unit which kind of equates to first responders, sir.

    Following after the quick, brief—sir, does that kind of clear that up? Okay, I am sorry.
 Page 107       PREV PAGE       TOP OF DOC

    At CBIRF I am the EOD team leader. Shortly after reporting to the unit, I received an educational brief on the anthrax vaccine shot, and I received my first shot on 6 of August, 1997. I had no reservations of taking the shot or any of the five following it for no reason, and I continued to feel the same way even after my 18-month shot on 6 August, 1999. I didn't have to decide whether or not to take the vaccination series due to the fact that the requirement existed by a competent authority and the fact that my chain of command was well under way with their vaccine series also. And the largest part of why I didn't have to decide whether or not to take the vaccine is because as a gunnery sergeant of Marines, I would set the example. This is the right thing to do.

    The shots were given by a Navy corpsman at a standard sick call, and all shots were fully documented in my medical record. All the sequences were basically the same. My reactions varied from shot to shot. They ranged from no pain to localized swelling and burning, which lasted up to an hour to 3 hours. The other Marines in my unit and sailors have experienced the same thing, and all in all, they range exactly from what the corpsman told us to anticipate. On your third shot, you might experience a little burning sensation, it lasts about 30 minutes.

    There weren't very many deviations from what we were told. The most severe reaction that I saw was a fellow Marine, he had infection and a severe redness from his elbow to his shoulder, which he was treated with antibiotics, and he was back on full duty within 2 weeks.

    Once the news circulated about several DOD personnel refusing the vaccine, my question that always came to my mind was why, and I would say this as I answer, is as a matter of force protection, you can't go back for something that you should already have. Thank you, sir.
 Page 108       PREV PAGE       TOP OF DOC

    Mr. BUYER. I thank this panel for your testimony. I want to share something with all of you here, and boy, if I could have a moment, I don't have the ability to speak to the country, but I do want to say this. I find myself in a very unique role with a tremendous amount of responsibility. I am also a lieutenant colonel in the Army Reserve, and there is probably not a Member of Congress that is harder and tougher on our leaders in the Pentagon, both NCOs and General Officer Corps, than me. I do it for a reason. At times I think they like it because they want the oversight.

    Dr. Hamre, the first word out of his mouth was trust. We know the Pentagon doesn't have the best record, track record. I remember the pains of having returned from the Gulf War. It took over 2 years for me personally to admit that I had health problems from the Gulf, and I remember how difficult it was getting the answers with the Gulf War illness issues, at a time when the Pentagon said there was no problem, and how difficult it was, every time we would open up the door, plow new ground, somebody would fill in the furrow right behind us or they would circle the wagons and get tighter, and it was very difficult.

    Finally, we were able to, over a series of years, as we are trying to take care of many of whom were sick and could no longer take care of themselves, began to find the answers, but there are still many questions that perhaps may never be answered.

    When the issue came to me, since I find myself in this unique position, I serve on the Veterans' Affairs Committee and I serve on Armed Services, I have taken the anthrax shot myself, and they came to me and said, we want to implement this program. I forced them to explain to me the threat. So when, Colonel Handy, when you use these words, a threat arbitrarily magnified, or words, somewhat theoretical threat, you have read words that were written prior to the testimony of General Zinni. Is there any reason at all that you would somehow question the credibility of the testimony of General Zinni?
 Page 109       PREV PAGE       TOP OF DOC

    Colonel HANDY. Mr. Chairman, there seems to be a divergence of opinion as to how bad the threat is. For instance, material obtained through a Freedom of Information Act lawsuit last year on this issue showed that in 1995 there was a meeting that decided that there was a need to make the case that anthrax was the top threat. Those are the words from the meeting minutes. I found that wording disturbing, considering that we have had this anthrax threat as a threat ever since World War II. In fact, Congress has received testimony that this was a threat in the same number of nations, 10 nations, in 1988. We have quotes to that effect.

    The big question is what has changed to make our response different, and there are others besides General Zinni, and I respect the man profusely, but when you have other biological warfare experts such as Dr. Alibek who say that anthrax is not the top threat, our own offensive expert, Bill Patrick, who says that vaccines are not the response to that particular threat that would work, these are credible experts as well, and because of that, I think we have a much greater controversy than we would otherwise.

    Mr. BUYER. Let me respond to you by saying this. I asked for the defense intelligence agencies to come to my office, to brief me regarding the threat before any of this was ever implemented. The first meeting was a very painful meeting, painful because they didn't—I don't know what it is about the intelligence community. They have the information, and they will give it to you if you ask nicely. They like to hold on, and you have got to milk them to death to get the answers. I didn't care for that meeting at all, so I demanded a second meeting.

 Page 110       PREV PAGE       TOP OF DOC
    Rudy de Leon (Under Secretary of Defense for Personnel and Readiness), came to the second meeting. After that meeting, it was a Top Secret classified brief, and I wish I could talk about it, but I was left with a great deal of comfort. I just want you to know that.

    Colonel HANDY. I understand.

    Mr. BUYER. Based on the responsible position that I stood in, and especially someone who is so hard on the Pentagon and have lived personally through the pains of my own illnesses and taking care of those who bore many, many risks of the unknown Gulf War illnesses, so when I moved into a comfort zone with regard to the threat, I just want you to know that.

    Now, everyone is entitled to their own opinions. We share some tremendous—I am not lecturing here. I just want you to know where I am coming from. We share some tremendous responsibilities here about force protection. There are some things that I am curious about and that are bothersome to me, and you probably picked that up in some of the questioning, but I want you to know that with regard to the threat, there isn't a general officer out there that I respect more than General Zinni. We have got the right man at the right place at the right time in history, and probably what concerns me the most is how easily this thing is to manufacture and how easy it is to deploy.

    Can you imagine what would happen if you were the CINC and you had the ability and capacity to inoculate your troops, but you chose not to because there were a very small minority that couched their fears? How would you be judged if, in fact, you permitted the deaths of tens of thousands when, in fact, it could have been prevented? I just throw that out. I mean, there are certain things we have to weigh in the balance. I didn't throw that out as a question, but just as a thought of pondering, and I want you to know that this is an area not only of personal responsibility, but also of my professional responsibility.
 Page 111       PREV PAGE       TOP OF DOC

    I now yield to Mr. Bartlett for any questions he may have.

    Mr. BARTLETT. Thank you very much. This is clearly a requirement to balance risks. There is a risk of side effects to any inoculation. Apparently there are no more risks of side effects from this inoculation than from usual inoculations. As a matter of fact, the placebo for Lyme disease had many or more side effects than the anthrax vaccine, but there can be side effects.

    The other judgment one has to make is to the risk. Colonel Handy took the position that the efficacy of the vaccine was questionable and that the risks were exaggerated. Clearly the decision to proceed with vaccination or not to proceed has to rest on an evaluation, a weighing of these two risks. There will be some side effects. We believe that they will be minimal, but if there are any side effects, and the risk is essentially zero, why should you be subjected to those side effects? So I think the responsibility, the requirement we have is to convey to the American people as a whole and to the military specifically the risk.

    If you are exposed to this agent, about 90 odd percent will be dead. Now, what are the chances that you will—I will tell you my personal response to this dialogue was when I first heard that this vaccine was going to be available to the military, my reasoning was that this is more likely to be used by terrorists than it is in a war. But the terrorists are more likely to use it against civilians, because if they use it against the military, they are likely to get hurt, and therefore, as a civilian, I was more likely to need this vaccination than the military, and maybe as a Member of Congress I could get it, but as a civilian right now I couldn't get it. So my first thought was, gee, how lucky the military is that they can get this vaccine, because my perception was that since the risks of taking it were, I felt, minimal, and the risks of not taking it could be absolutely catastrophic if we were exposed, therefore, I would be personally willing to assume the what I think are minimal risks of taking it.
 Page 112       PREV PAGE       TOP OF DOC

    Clearly, the task now is to convince those of you who see it differently that the risk is large enough and the consequences of taking the vaccine are small enough that you ought to take it. What do you have to hear to come down on that side of the argument?

    Major JEFFORDS. May I address that?

    Mr. BARTLETT. Yes, sir.

    Major JEFFORDS. Well, I would say you need to dig deeper because I believe the DOD has its own internal data that contradicts your assumptions that the vaccine reaction rates are lower than for the Lyme disease placebo. The Tripler Army Medical Center studies—.

    Mr. BARTLETT. Sir, even if they were meaningfully higher, even if there was a meaningful instance of side effects, the alternative, if you are exposed to the agent, is that you are dead. Now, what do you have to hear to come down on the side of supporting taking the vaccine?

    Major JEFFORDS. Okay. Well, I think you are assuming 100 percent protection on behalf of the vaccine if you are inoculated with it, and there is certainly no data to back that up. The monkey studies are their best data by their own remarks yesterday at the Shays (Subcommittee on National Security, Veterans Affairs and International Relations of the Government Reform Committee) hearing. The monkey studies were only with one strain, that was the Ames strain, of the bacterium, and there are at least six more virulent strains out there naturally occurring, and we are not even talking about genetically engineered strains. And Ken Alibek, the author of that book Biohazard, addresses that, too, the genetically altered strains.
 Page 113       PREV PAGE       TOP OF DOC

    Mr. BUYER. Can I interrupt a second? I have heard this several times about an argument about why I shouldn't take the anthrax shot, because it doesn't inoculate all strains. Even if I got a vaccine, inoculated against all strains, I do believe there are those that still wouldn't take it. If it were inoculating all strains, Colonel, would you take that anthrax shot?

    Colonel HANDY. No, I wouldn't, simply because it won't protect against other biological agents. There is an infinite variety of stronger doses, more permutations, other biological agents that could be used. There is a principle here, and I heard this described to me, and I think this was accurate, that unlike naturally occurring infections, where you get a vaccine, there is still a random chance out in Mother Nature that you are going to get whatever is out there, but in this case we are broadcasting to our enemy what we are doing. So every time we use this vaccine, we are immediately ensuring that the enemy will switch to something else, which makes the vaccine useless.

    The guinea pig study is very instructive. Now, it is only half the data, but I think in statistical courses you learn about the value of additional information. The guinea pig study that was done on this, 82 percent of the strains used defeated the vaccine to the level of 50 percent survivability, which is our criteria in the Gulf for unit effectiveness. Additionally, of the last six strains that protected the 50 percent or better, three of those strains only protected to 55 percent.

    And the fact that it was injected anthrax and not inhaled anthrax is relevant as well. If it was inhaled anthrax, you could almost expect there would be no value of this vaccine whatsoever, at least in guinea pigs. Additionally, in this study they used 16 guinea pigs with each particular strain, and the monkey studies, it was very, very, very few monkeys. So you have got hundreds of guinea pigs. It is a credible study, and when half your data says it doesn't work, and the mouse studies are even worse than that, they are about 90 percent abysmal failure, then how do you conclude it is an effective vaccine?
 Page 114       PREV PAGE       TOP OF DOC

    Mr. BUYER. I suppose I am not following your logic because you like to jump to the conclusion it doesn't work. No, it isn't 100 percent.

    Colonel HANDY. Well, it is 90 percent failure according to that particular study and according to the mouse studies. So half the studies say it works great; half the studies say it doesn't. That doesn't give me a real good sense of comfort that it is going to protect, especially when you consider all of the other arguments that are thrown in here that indicate that there are going to be problems with effectiveness.

    Mr. BUYER. Mr. Bartlett.

    Mr. BARTLETT. Your answer makes a point I was trying to make, that if we are going to have our military people take this vaccine without having them leave the service, without having it impact on recruitment, it is doing both now. Both retention and recruitment is being hurt, and we can't proceed this way. We have to got do something. My personal conviction is that the risks of not taking it are far, far greater than the risks of taking it, and I will be happy to take it. I will be happy to ask my family to take it, and I recognize there are some risks of taking it, but I think the risks of not taking it are very much higher.

    The answer to your other question is that if this is just one of many agents the enemy might use, then I would like to be vaccinated against all of them that I think he might use because I think that we are enormously vulnerable in this country. We are a great, open, free country. We have been very lucky. Time is running out on that luck, in my view, and I think that we, as a country, not just our military, but our civilians as well, need to be focused on being protected against these agents because I think we are going to be exposed.
 Page 115       PREV PAGE       TOP OF DOC

    Asymmetric warfare is the next kind of warfare we are going to have. Nobody can contend with us with conventional warfare, so it is going to be asymmetric. This is the poor man's atomic bomb, you know, and so I think that the risks of taking it are far, far less than the risks of not taking it, and I would. But, you know, we need to convince you so that all of our military people can be convinced so it is not going to hurt retentions, not going to hurt recruitment.

    Again, I ask what do you need to hear so that you are going to be convinced that the risks of not taking it are greater than the risks of taking it?

    Colonel HANDY. Just real quickly if I may, for me to be convinced—and if I was on active duty right now, I would have to see my buddies not getting sick. I don't see that. If you look at the first five pages in the supplemental area of the testimony that I have provided, you can see at one installation there—actually, I have reflected 50, but there are more like 70 people at that installation that several of them have direct, contradictory experience to what
General Blanck said, where he said everybody has recovered. We have people who have not recovered for up to a year. He said fully recovered, able to do their normal duties. These people are grounded, they are not able to do their normal duties, for up to a year. There is probably a dozen of them in my testimony, and this is being tracked by the GAO.

    So the information age has details available on these sicknesses almost instantaneously. In transfers and reassignments, people know who, you know, their buddies are on their last assignment, and they will call them up or they will come to the new assignment and know people, and there are too many people getting sick in reality that it isn't just information on the Internet somewhere. They know people that are sick, and when that stops, then I think you will have a lot less concern.
 Page 116       PREV PAGE       TOP OF DOC

    Mr. BUYER. I am going to do this. What you have just done by your statement is then question the credibility of Lieutenant General Ron Blanck. I am going to meet with General Blanck. General Blanck and I have 7 years of history with the Gulf War illnesses. There is not a general, a doctor in the military, that has done more for Gulf War veterans in opening up more doors and windows and tunnels for me than that man. So if he has testified here today that there are 72 cases, and you say, wrong, I have got 70 cases on one base by itself, I am going to ask him, because either he is relying upon information that someone gave him, or if, in fact, there are other cases, he will go find them. That is the kind of man he is. So I will have that meeting. I will have that meeting.

    I will now yield to Mr. Jones.

    Mr. JONES. Mr. Chairman, thank you very much, and if I could make a request for unanimous consent to submit to the committee the statement by Dr. Meryl Nass, please.

    Mr. BUYER. Who is that?

    Mr. JONES. She is an expert on this issue of anthrax, and certainly she takes the other side of the issue versus what the Department of Defense takes. She has testified numerous times before other committees.

    Mr. BUYER. No objection, Mr. Jones.

 Page 117       PREV PAGE       TOP OF DOC
    Mr. JONES. Thank you, sir.

    [The information referred to can be found in the Appendix.]

    Mr. JONES. Mr. Chairman, before I ask a couple of questions, I do want to say because of my respect and regard for you, I have the utmost respect for you and want to thank you for giving us this opportunity today on this very important issue, and something you were saying about the briefing from the Department of Defense which is classified. Last night, Chairman Gilman and I had a classified briefing by the GAO, by Director Chan, National Security and International Affairs Division, and where your position of the need for this shot was enhanced, I can honestly tell you from hearing that briefing last night for 2 hours, if anything, it strengthened my resolve that this shot is not necessary, and like you, there is no more that I can say than that.

    But I hope that Members will get a chance to hear both positions of the Department of Defense as well as the GAO, and that will help all of us make better decisions, and I am not talking about you, sir. I am talking about myself included.

    Mr. BUYER. Mr. Jones, I would like to meet with Dr. Chan, and I expressed that to Chairman Gilman.

    Mr. JONES. Thank you, sir. Thank you. I guess you know I want to thank each and every one on active military and the gentleman from Camp Lejeune and the gunnery sergeant from Jacksonville, which is in my District, and I want to thank each and every one of you for being here. Those who have served our Nation, you are now retired, thank you, and those that are in the Air National Guard Reserves, thank you as well as the active military.
 Page 118       PREV PAGE       TOP OF DOC

    I guess what my concern is, Mr. Chairman, has been from day one, is that I realize—and I don't have the background that you do, but I realize being a member of the Armed Services Committee for 5 years that we are relying more and more on the Reserves and the National Guard. And some people say this is good; some people say maybe it is not good, maybe we need to strengthen the active military, but that is not the issue here today.

    My concern is the morale, retention and how this plays into the readiness of our Air National Guard because, again, as you might have heard me say today, I was familiar with anthrax, but I was not into the issue, but five officers, five officers, some who had been in the desert war, some who had been even before that in wartime situations, were saying to me that if we don't get this issue straight, you are going to lose some very good, qualified men and women that you as a government have spent a lot of money in training so that when called upon they could help defend America.

    So my question is, and it is more to the men in the National Guard than the active military, is to reiterate, if you will, and I know, Colonel Handy, that you are now retired, but before you retired, be very candid with this committee as to what kind of impact and concern this played with your unit. I want to go to Major Jeffords and also to Master Sergeant Colley and also to Colonel Ashcraft, if you would, please.

    Colonel ASHCRAFT. He would like me to start, sir, if that is all right.

    Mr. JONES. Yes, sir.
 Page 119       PREV PAGE       TOP OF DOC

    Colonel ASHCRAFT. There is an awful lot of anecdotal information out there. There are an awful lot of statistics that say it hasn't affected the actual retention rates yet, and which you heard yesterday. I can give you statistics from the state of Ohio. I won't try to speak to things I don't know about, but we have a wide variety of units and a wide variety of experiences.

    There are really two programs that we offer in the Air National Guard because it is such a difficult regime. We offer some of our units the opportunity to inoculate everybody or to vaccinate everybody at one time, then 2 weeks later and 2 weeks later. What that does is it allows them to schedule their weekend drills such that everybody can be there at the same time. One of our units elected to do that. It is a heavy civil engineering unit, 200th Red Horse in Sandusky, Ohio. We had one person who is retiring in December who said, I am retiring in December, I would really rather not start the series because I am not going to be able to complete it, and they weren't on the bubble. He was the only person, sir, that elected not to take that shot.

    We have a C–130 unit, as I mentioned in my opening statement, that has just rotated a couple of their planes and some crew members to Oman. It is a volunteer status, so we didn't take the whole unit, but we certainly had enough people that we could support the mission. Are there people in that unit that may have some questions about the vaccination? Sure. There are in most of our flying units.

    The Toledo unit has been rotating in and out of Northern Watch in Turkey, and we have had no problems with that unit, although Northern Watch has not had the requirement to have the shot. So, if you lined all those people up and said tomorrow, take the shot, we may have some refusals there.
 Page 120       PREV PAGE       TOP OF DOC

    Springfield, a flying unit down there is not on the bubble. We don't give the shot there. What I am trying to give you is a flavor for the state.

    We have the unit that is getting ready to deploy to Southwest Asia, it is a required shot. It will be a PSRC when the time comes, and when I talked to my executive staff back in Ohio last evening, there is no problem with anybody refusing to take the shot. These are actual, not anecdotal, information. This is stuff that is happening in my state and people that I know.

    We do have the KC–135 unit at Rickenbacker Air National Guard Base, and there are some pilots there who are airline pilots as well who I think need more information, and when I get back in the state—I have been here in Washington for 30 days—when I get back in the state, I will hopefully provide them with some information that may be valuable.

    The fact is none of the pilots who work for my airline are senior to me. I am the senior ranking pilot from that airline in the whole state of Ohio. I took the shot, and I am still walking around, and I am not going to give them my seniority number. I am going to stay. I didn't have any problems with the vaccination, and I think maybe that will help influence some of them.

    There are also some Web sites that we have in the Air National Guard. We have what is called an anthrax commanders tool box. It has been up since March of this year. I do believe that that tool box should be available to people while they are at home. Currently on the Internet we have dotmil sites only accessible from a military computer, so you have to be at the Guard base or at a military computer to get to that site. But it has a vast amount of information there, some of it neutral, some of it positive, some of it negative. If more people, I believe, had access to that, they may be able to make a more informed decision.
 Page 121       PREV PAGE       TOP OF DOC

    Mr. JONES. Thank you very much.

    One last question, Colonel, for you. Percentages; how many people would you say in the Ohio Air National Guard have been vaccinated, even one shot, two shots, three, but how many, 50 percent, 40 percent?

    Colonel ASHCRAFT. In terms of the actual numbers, I would have to get back to you on that, sir, and I will be happy to furnish you with that information. I can tell you that 100 percent of the Red Horse Unit, with the exception of the one guy who is going in December, 100 percent of that unit has been vaccinated. One hundred percent of the people deploying to Southwest Asia with our C–130 unit have been vaccinated.

    [The information referred to can be found in the appendix.]

    Mr. JONES. So basically you are saying with the Air National Guard, both recruiting or retention, it really doesn't seem to be a problem; is that correct?

    Colonel ASHCRAFT. I would say that it is an information problem. It is a problem where we have to go to the specific units where there are questions being raised, and it is a matter of trust on a local level. I think telling the people from Washington that this shot is good for you is probably not going to work this time. I think you have to have a flight surgeon in your unit that says, I have looked at all the data. I am the professional doc here, and I have treated you in a number of different ways, and you are still flying. I think this is a safe shot. You can take it and continue to fly. I think that is what we need, sir, and it has to be on a local level. Mandating it from Washington won't work.
 Page 122       PREV PAGE       TOP OF DOC

    Mr. JONES. Mr. Chairman, if the other three gentlemen would answer the same question, then I would be through. If you would permit them, I would appreciate it.

    Sergeant COLLEY. Thank you, sir. I can only speak for Oklahoma City and most of the people that I have visited with around the base that I have had an opportunity to. I haven't visited with everyone.

    On our pilots' side, we are looking at eight pilots have now turned their resignation or retirement papers in. We are looking at six more that will be doing this once the vaccine becomes mandatory. We were told that we were going to begin our vaccines on August 6—or excuse me, October the 16th, coming up soon, and that is when we had those eight individuals go ahead and decide and move on, rather than take a chance with this. Two or three of them may come back. They may pull their resignation papers until this thing becomes mandatory again. Others are just tired of having the threats given to them out there, either get the shot or get out, and they feel like it has been a slam to them just basically to say get it or get out. A lot of these people have spent many years in this unit and other units, too, and they have flown for many years for the airlines.

    On the enlisted side, I can actually say I visited with 50 people at our unit that have said that they will get out, either flat get out or retire or go ahead and submit their paperwork to get out.

    So we are looking at a morale problem here, just mainly because, like I said earlier, we are not getting the truth about a lot of things that are coming down. The veterinarian issue really got a lot of people's attention; the Dr. Burrow situation where he did some work for the DOD and then come to find out he refused to come up and testify before Congress on that issue, and just the general overall attitude that a lot of our leaders are showing us out here right now. And like I say, if you are not going to take a shot, get the car keys out of your pocket and drive out the gate, and that is not what we live for here.
 Page 123       PREV PAGE       TOP OF DOC

    Mr. JONES. Excuse me for interrupting. Would you go back? You said someone—I am sorry, I didn't hear it clearly—refused to come to Washington to testify that I missed. Speak up just a little bit. I can't hear.

    Sergeant COLLEY. Dr. Burrows was chartered by the DOD to do an overall view of the AVIP back in 1997. Is that when it was?

    Major JEFFORDS. He was an OB/GYN for Yale University, and one of the four points of the program or to ensure the safety of the vaccine, as directed by the Secretary of Defense, was for the program to be reviewed by an outside expert and certified as safe. Well, Dr. Burrows was chosen, but when he was called to testify before the House committee, he instead declined and said he had too many patients. This is the best information I have. I think he had patients that day that he needed to see, and he submitted a letter instead and claimed that he had no particular expertise in anthrax or biological warfare, and that his role, he viewed, was to give an overall view of the program, not to specifically certify it as effective as a biological, antibiological prophylactic. So I think that is what this was about.

    Then we touched on the supplemental testing question. Due to irregularities in the program, testing was suspended, and instead, to the best of my knowledge, a review of the production testing data was incorporated instead by a nonpharmaceutical company called Modern Tech. And so their data was, although they did not handle any lots of vaccine and actually did not test them themselves, they reviewed the data, and that was called supplemental testing, but of course it is not.

 Page 124       PREV PAGE       TOP OF DOC
    So that was two points of the four-point program that were failures, and there were a lot of other problems, but we should get back to the personnel issues, I think, as you said.

    At our base, we have had a lot of concern from our pilots, and as of this week, we have had from our commanders 15 pilots fill out their paperwork.

    Mr. JONES. Pending?

    Major JEFFORDS. Yes, because our deadline is this weekend. So this is the time. They are scrambling for the door basically because they are being threatened with discharge if they either don't show up for drill this weekend or they show up for drill and refuse.

    Mr. JONES. Is it correct that—we having been on Armed Services, you hear this quite often—is the figure 2,000 pilots short, meaning the United States Air Force, whether that be Reserves or active duty, is 2,000—this came up yesterday in Congressman Shays' hearing, and I didn't know. Do you feel like that number is correct?

    Major JEFFORDS. Well, there is a GAO report that came out earlier this year addressing retention in the armed services, specifically addressing the pilot issue, and the number that—I remember percentages, not numbers. I remember 5 percent short for the Air Force, and 15 percent short for the Navy now, and both are projected to get worse, and this is before the introduction of the anthrax issue, I believe, because we had nine at Connecticut leave last year over this issue. And I still think, as I said in my opening statement, we are still on the leading edge of this, and talking about the Guard and Reserve forces, we are still on the leading edge, and for us to say that all it is going to take is just more reeducation, I mean, how long are we going to continue to pursue that mode? That is not going to work.
 Page 125       PREV PAGE       TOP OF DOC

    I mean, there is too much information out there. There are two bills before Congress. All we want is a time-out. We don't want to be here debating the medical issues like we are now. That is not our role. I think that is the role of the Shays subcommittee. I think that is the role of maybe another subcommittee. But for me to be called here and argue the medical aspects of this issue, that is out of my arena. I can relay you information I have from medical experts and from the DOD's internal data that was unpublished, and the reason it was unpublished is because it was unfavorable to their position, but I can tell you that.

    But I am here to discuss personnel issues, and I am telling you that we only have 46 pilots in our unit. We have got 15 pilots with paperwork sitting there right now, and there is probably going to be more out of our unit. The AVIP costs $130 million. It is $6 million a copy for a pilot. We have got an average of 10 years experience in the Guard. We are experience-heavy in the Guard. We came from a weapons system, most of us, from the active duty. We already have the training. It is a much more effective way to utilize manpower in the National Guard than it is in active duty, I believe, and most National Guard generals will tell you that, and they are proud of that fact.

    But what we have here is a program that costs are spiralling out of control. If we lose 15 pilots out of our unit, multiply that times $6 million, that is $90 million. The AVIP is only $130 million? So, now, where one unit is going to cost, you are going to almost double the cost of the AVIP.

    And we have only had 10 percent of the forces in the Air National Guard inoculated so far, so what is going to happen with the other 90 percent? We are sitting here talking about we are going to have more education; that is the answer. I don't think so.
 Page 126       PREV PAGE       TOP OF DOC

    And I agree when we say that units have had this program sprung on them on short notice, that is exactly what happened to our unit. And from listening to testimony yesterday, it appears to have happened at other units, where at one month, this was in March—I go to staff meetings every Saturday morning at 7:30, and we were talking about the anthrax issue while we were talking about the end of 2002, which is the end of Phase II, and that is a sensible—that seemed sensible at the time, because we are in Phase II.

    But the very next month, there is an announcement, we had 3,000 doses of the vaccine on base, and we are going to start in July. It is just out of the blue came from nowhere. And it still makes no sense to me, because they are supposed to be—there is an Air Force directive that says the National Guard—I have it, I have it right here, annex E to the AVIP implementation plan. It says that the Air National Guard will follow the phase implementation plan. And here we are, Phase I is for the people that are in the Area of Operations (AOR), they are not for anybody that might deploy to the AOR as a unit. No, it means people in the AOR or imminently deploying on an individual basis.

    That Phase I, I called the AVIP hotline yesterday and the day before, and I talked to them about this, and I wanted to get the straight skinny on this before I came to this committee. But Phase I has to be completed before Phase II begins, and Phase II does not begin until the second quarter of fiscal year 2000; that is, 1 January. So why is our unit getting the shots now? I mean, our commanders know that there are 15 people with their paperwork sitting there. And according to my friends that were there yesterday, they say it is really 18, but that is inconsequential right now. I think the numbers are going to go up by this weekend. But what is it going to take? I mean, the commanders, they are going to have to face reality at some point.
 Page 127       PREV PAGE       TOP OF DOC

    I mean, we have a chance like Oklahoma City did, they got an out for 3 more months. There were three units that were about to get these inoculations in the near term. One of them was Oklahoma, one of them was Memphis, another one was New York. New York had the hurricane go through. A storm cut the power in the base. The temperature of the vaccine went up. BioPort and DOD say it is okay because when they manufacture the vaccine, it goes to room temperature before they bulk it out. But the commander said, no, we think we are going to wait on the next lot. We are going to destroy this. We are going to put it on the waiting list for the next one.

    Why do you think they did that? Because they were facing the possibility of mass resignations. Our own Congressman said that in a letter that he sent to the Secretary of Defense, the possibility of mass resignations. So why is it that we are continuing full steam ahead, and we are still talking about the possibility of educating the people some more, and suddenly they are all going to change their mind after 4 months of knowing this is coming? That is not going to happen.

    We have got a train wreck that is scheduled to happen in our base, and I think it is going to happen at more bases around the country, but I can't guarantee that. I have no idea. All I know is that from our unit—and I am here to testify about these personnel issues—that I think we have a train wreck, and that was described that way by one of our own base legal officers to me months ago.

    Mr. JONES. Thank you.

 Page 128       PREV PAGE       TOP OF DOC
    Mr. BUYER. Thank you, Mr. Jones.

    I want to share with all of you this. I have deep respect for Mr. Jones, and when he takes a great deal of personal concern about an issue, he gains some of our attention, a lot of our attention. What I find unique here at the moment is perhaps not a specialty in the force, the pilots, that I end up spending so much of my personnel time on their issues. Gunnery, you would love the amount of attention that we pay to pilots. They are the most pampered in the world. If you don't get your air conditioning and your pizza on time, you complain. I would love to have had the conditions that you had in the Gulf. I didn't have a shower for 5 months. I thought it was a tan.

    I showered last night, though, Mr. Abercrombie.

    You know, if you don't want to do something, you can do two things; you can argue procedure, and you can argue substance, and you have done both today. I want to convey to you that I have great respect for your service to this country, and I do.

    I have to personally tell you, though, that I do not see a reason at this moment to move to mark up Mr. Jones' bill. Now, I am going to continue the oversight, and I am going to continue to look, but I have to be able to sleep at night, too, and the sleeping at night is the responsibility of—if the threat that is out there, the emergent nature of that threat, it is on my conscience, if, in fact, thousands die if we stop. I just want you to know that that is very real.

    I don't trust them across the river as far as I can throw them, so I am going to keep my eyes wide open in this. But I just want to be very candid with you, okay?
 Page 129       PREV PAGE       TOP OF DOC

    I do have a question for the SEAL. You live and work and operate in the dark world.

    Lieutenant ROHRBACH. Yes, sir.

    Mr. BUYER. So if you can, within your restraints, tell me about what that emergent threat that you have to face from rogue nations or individuals or groups who don't play by the rules. Is it real or not?

    Lieutenant ROHRBACH. I believe it is very real. In fact, I would feel very uncomfortable going into—going in harm's way with a teammate of mine that hasn't been vaccinated against the anthrax; that is one more casualty I will have to worry about. If he gets vaccinated for anthrax, as far as I am concerned, that is one less thing that I need to worry about. We can take our chances with that.

    Mr. BUYER. So you concur with the gunny's comments that you need to have this done before you ever walk into that theater?

    Lieutenant ROHRBACH. Yes, sir.

    Mr. BUYER. I yield to Mr. Abercrombie for comments he may have.

    Mr. ABERCROMBIE. Anybody can answer this. Is this a question of the Guard having a different viewpoint as to what their obligation is with respect to carrying out orders? Because I have gone through this testimony and the observations made, and I do not have clearly in mind what the differentiation—what I have in mind is that there seems to be a differentiation between the active duty military and the Guard view.
 Page 130       PREV PAGE       TOP OF DOC

    Colonel HANDY. If I might attempt to put into words some concerns from, I think, both the Guard and the active duty. First the health concerns are cross-cutting. The information is available to both Guard and Reserve and active. The active side certainly has less maneuvering room in terms of what they can, cannot do, refuse the shot without facing the Uniformed Code of Military Justice (UCMJ); they can't resign, they can't retire just maybe on the spur of the moment, they can't transfer so easily. So it appears as more of a captive research market as was characterized by another hearing.

    There is one—there is great value in the way the total force, the all-volunteer force, was set up, and I think the differences that you might see in perspective are beneficial, and the advantages of the total force come out here.

    And in partly answering this, I want to get back to Congressman Jones' question. This is my own experience. I was in an organization from the Pentagon that is very different from what these gentlemen are in, and those are flying units. My organization was composed of individual mobilization augmentees. They consisted of 12,000 Air Force officers and enlisted members across the Air Force Reserve.

    We were assigned staff positions in mostly major command headquarters organizations. Depending on the philosophy at the time, we would fill in as active members and other civilians deploy, or sometimes we would come in, and we would take over staff positions while they were still there in the event of a surge. But what we brought to the table in terms of experience was somewhat different.

 Page 131       PREV PAGE       TOP OF DOC
    I can give you an example from my background that relates directly to an issue that you brought up, Mr. Chairman, regarding the BioPort sale. I have background of 3 years as a business broker in Middle, Tennessee. When you started asking the questions you did, my ears perked up quite a bit, because my own interest in that area when I first started examining this deal bothered me greatly. When you asked whether—when you asked—started addressing whether the cash value of the sale as opposed to the credit value of the sale was similar, my immediate question was why in the world did the state of Michigan—from my experience, why in the world did the state of Michigan accept a credit offer for the same amount of money as they did a cash offer?

    We would always as business brokers tell the seller, take the money and run. And in this case, it only raises further questions as to why the credit deal didn't involve 20 to 30 percent more value in that—.

    Mr. ABERCROMBIE. Excuse me, my time is limited, and I am trying to get at the difference in the order here.

    Colonel HANDY. The difference is—.

    Mr. ABERCROMBIE. And I will tell you why I ask, and maybe that will enable somebody to answer a little bit better, because one of the arguments that we made, or one of the points of contention here is especially where the Guard and Reserve are concerned, because I have been a strong supporter of it, saying, look, under the all-volunteer force in the 21st century, the role of the Guard and Reserve is going to be more pronounced than it was before. It is going to be first-line. It is not going to be something that you call on as a last resort or anything of that nature or somebody shoved into the background and their qualifications and their expertise and their professionalism, et cetera, is all suspect at best; quite the contrary, that anybody in the Guard and Reserve is going to be expected and can expect of themselves the capacity to operate front line first and foremost and not have a second thought as to what was going to be the outcome.
 Page 132       PREV PAGE       TOP OF DOC

    Now, if that is not going to be the case, we need to know. We have got to figure out what we are going to do in that regard.

    Colonel HANDY. Mr. Congressman, without any questions concerning the lawfulness, legality, morality or ethics of a particular situation or order, we are going to be there. And we are there first, especially in the Air Force. We are there first to the fight in many cases.

    Mr. ABERCROMBIE. Okay. Then let us have that as our working premise. What bothers me at this stage then is I indicated at the beginning of the hearing, perhaps you were not here, today, in Japan, in Tokyo, the thought-to-be chief perpetrator of the Sarin gas attack was sentenced to death. Very unusual in Japan, that is for sure. And I think it probably speaks of the judgment that has been made in Japan as to the assault on civil life in Japan that this constituted.

    My thought was—is that if there is to be an attack, particularly on civilian areas, or perhaps in planes, something of that nature, airport, something like that, that chances are it will be the National Guard, the chances are it will be the Guard and Reserves, that may be first called on along with the police and fire fighters to take on the question of domestic terrorism; therefore, doesn't it make sense that anthrax and/or other vaccinations might need to be seen, if anything, in order of priority, in the Guard and Reserves first?

    Colonel HANDY. It would probably depend on the mission of the particular unit. But just in quick response, since you brought up the Sarin attack group, interestingly enough being an article in the Washington Post said they tried anthrax eight times, had unlimited funds in 4 years to develop a capability, and they failed. In regards to the capability of the Guard and the Reserve, one of the best things that we provide is, because of our civilian experience and perspective and our analytical capability, we sometimes have a tendency to look more critically at these kinds of policy issues and bring things like my own background in to bear and provide, in a sense, protection for the entire force, so that the policies that are made and the issues that we bring to you are then more thoroughly analyzed.
 Page 133       PREV PAGE       TOP OF DOC

    Mr. ABERCROMBIE. I can say, because my time is running out, I agree with that. And I think, if nothing else, this anthrax episode has led certainly the Pentagon and members of this committee and the broader committee to realize that we have to come at this a different way, a much more—a lot more thorough consultation ahead of time and so on and so forth.

    I think that will be the result of this regardless. So your testimony today is valuable, and the exercise itself is more than valuable, because I don't think—regardless of how we resolve the anthrax vaccination situation, this will not be the end of issues of this nature that we are going to have to come to grips with and resolve.

    Thank you, Mr. Chairman.

    Mr. BUYER. Thank you, gentlemen. We appreciate your contribution to your country. It is hard for me as we work so hard to have the seamless military—(former Representative) Paul McHale and I created the Guard and Reserve caucus for a reason. We talk about a seamless military, we want to be a seamless military, and we want to be there when called upon.

    I suppose you made me think a moment, Major Jeffords, because I never in my mind ever placed together the priority that you did. You went family, civilian job, Guard. I—never, ever had I done anything like that before, because I guess, in my own mind, I had always gone by family, my service to country before thyself. Now that is just me, and that is why I am a Reservist. That is why we are kind of unique people in our society. We are individuals of—who want—we want to do more. We are a unique breed, we really are.
 Page 134       PREV PAGE       TOP OF DOC

    You got me thinking. I am going to the mindful of your objections. I recognize that your objections do not speak for the force. In my oversight, there are certain pockets of objection. It is a curious factor that the pockets come out of the Guard. I will have a follow-up meeting with the GAO. I will have a follow-up with General Blanck to address the concerns about the numbers, and our oversight will continue.

    But I will reiterate that based on my analysis, and I lay my credibility on the table here, that I believe the threat is real, and I also at this moment have trusted the advice about the efficacy of the drug, because if I had any inclination that it was not there, I wouldn't do it.

    Thank you. The hearing is now concluded.

    [Whereupon, at 2:05 p.m., the subcommittee was adjourned.]