Washington, DC

Good afternoon. We are here this afternoon to discuss the development of the United States’ Defense vaccine policy. The National Security Subcommittee chaired by Mr. Shays has conducted a series of hearings looking at the Defense Department’s current Anthrax vaccine program.

The Full Committee today will examine the overall picture of vaccines for defense. As part of our ongoing investigation into vaccines, we are examining their safety, efficacy, the importance of informed consent, the concerns about vaccine ingredients, purity, and the long-term safety concerns. We are looking into the role of vaccines as a defense mechanism for biological warfare. Is it viable and appropriate to use vaccines as a defense mechanism? Will it be possible and practical to develop vaccines to protect against all known and potential biological threats.

Much has been said by numerous Government officials about the biological warfare threat. We have been told in previous hearings and in testimony prepared for today that "at least 10 nation-states and two terrorist groups are known to possess, or have in development, a biological warfare capability." Are all these nation-states our enemies? How many are confirmed to actually have weapon-dispensable anthrax poised and ready to launch?

Intelligence and military officials have testified that it is relatively easy to develop and produce chemical and biological weapons. However, they have also testified that it is much more difficult to successfully deploy chemical weapons. For instance, the Deputy Commander of the Army's Medical Research and Materiel Command testified in 1998 that, "an effective mass-casualty producing attack on our citizens would require either a fairly large, very technically competent, well-funded terrorist or state sponsorship." And in March 1999 another expert stated, "the preparation and effective use of biological weapons by potentially hostile states and by non-state actors, including terrorists, is harder than some popular literature seems to suggest.

We’ve also been told that anthrax is the most likely candidate for a biological warfare threat. What is the basis for that determination? With the aggressive information offensive the Department has launched to its military members and the American public, it’s made to sound like the equivalent of the Cuban Missile Crisis. If that is so, then those who are in harms way, and the American public, deserve to know the whole story. A State Department fact sheet on chemical and biological warfare states, "The Department of State has no information to indicate that there is a likelihood of use of chemical or biological agent release in the immediate future. The Department believes the risk of the use of chemical/biological warfare is remote, although it cannot be excluded."

There are several issues that need clarification regarding the current anthrax vaccine program. Including answering why the United States is the only member of NATO that mandates this vaccine? (Attachment)

The Defense Department would have us believe that the concerns raised about the anthrax vaccine are minor and by a "small and vocal group." In fact, on their website, Major Guy Strawder, states, "Much of the hand-wringing and bizarre allegations about the vaccine is coming from a vocal minority of people who think the "field" is where a farmer works and "Gortex" is one of the Power Rangers. Most of these folks have never spent a single moment in harm’s way and have no appreciation of what that sacrifice means"

How does that measure up to the following statements that have been sent to us:

"I have served my country with honor and total dedication since 1970. To have this unsafe and unproven vaccine put an abrupt end to my service is a travesty of justice. I have constantly received excellent appraisals for the past three decades and had nothing in mind but to continue receiving these favored appraisals. We in the military have been told too many false statements about this vaccine. We have been misled about the safety, the long-term effects associated with this vaccine, the proper number of adverse reactions, and the attrition and refusals in our total force. Many will leave the military because of this vaccine and it's problems. Many of these folks will give up a career dedicated to service to their country."

Or the Pilot from Maine who said, "I will be forced out of the Air National Guard and lose my retirement. I have put in 15 good years as a pilot and have enjoyed every one of them. I will not however, put my health and my future ability to take care of my family on the line for a DOD that refuses to examine their own programs for the safety and cohesion of our military."

Or the F-16 fighter pilot who stated, "I personally have over 22 years of faithful service in the Air Guard. My record is exemplary. I was not planning to retire for at least two to three more years but the anthrax vaccine program has expedited my retirement plans. The commander of my unit will not allow me to stay in until March 7, 2000, when I will have three years time and grade to keep my LTC rank into retirement. After almost 23 years of faithful service to my country I will not be allowed to stay in for the 67 additional days needed to carry Lieutenant Colonel into retirement."

Either the Defense Department is being less than forthcoming about objections being raised, or they have their heads buried in the sand.

At lot of the concerns have been raised about the actual number of adverse events from the anthrax vaccine. The numbers vary greatly. Every thing from .0002 % reported in the media in February, to .2% on the package insert, to 20% in the one active surveillance currently underway. (Attachment) If the Department is not doing active follow-up and tracking of health concerns service-wide, then how will we ever garner an accurate representation of adverse events?

Vice Admiral Richard A. Nelson, Medical Corps Surgeon General, US Navy, stated, "I am aware of the controversy associated with AVIP and the concern our troops have regarding potential side effects. The vaccine is safe. …Of the over 82,000 Marines and Sailors inoculated, only eight reactions have been reported via the Vaccine Adverse Reporting System. All have returned to full duty." In cross-examination, one medic from 29 Palms had no knowledge of the existence of a Vaccine Adverse Events Reporting System form. Adverse event reports are difficult to file when the medical personnel are not even aware that such a thing exists.

The Defense Department states that it requires their medical personnel to report all adverse events that cause a loss of duty of greater than 24 hours or hospitalization. Are these the only types of events that are truly adverse? How is it that the Defense Department has been allowed to determine what constitutes a reportable adverse event? The former FDA Commissioner, stated that that adverse events are dramatically underreported, only one in ten typically. We also know from previous statements made by the Defense Department that military reporting is one-seventh of the civilian rate. (Attachment) Given these figures, less than 2 of every 100 systemic adverse event are being reported.

And for those who have an adverse event, is adequate care being provided? Why is it that many individuals who have been suffering for a very long time with adverse events, are still waiting for appointments with appropriate specialists? Or the statement from one Sergeant from Georgia who suffered with memory loss, swelling, dizziness, a rash, muscle twitching, and a month of diarrhea, "the doctors repeatedly ignored my statement that I became sick after taking the anthrax vaccinations." And the Master Sergeant from Michigan who was told that his symptoms showed that he had the flu for an entire year. This diagnosis from a military doctor who chose only to talk to him and did absolutely no blood work or examination.

And what about plans for more vaccines? Just how many vaccines can one human being safely receive in their lifetime? The Federal Government currently recommends a total of 26 doses of vaccines for children. (Attachment) The typical twenty-year career military member can expect an additional 37 doses of vaccinations, plus the anthrax and other deployment vaccinations that would total at least 40 doses over twenty years. (Attachment) There are currently another 18 vaccines in development under the Joint Vaccine Acquisition Program. (Attachment) And if all the potential biological warfare threats are developed into vaccines, these numbers will skyrocket. Are we going to vaccinate our military to death?

Maybe we need to look at other approaches to dealing with the biological threat. For instance, with good detection equipment and protective gear, the use of products like the orphan drug that we have just learned is currently in development that causes the anthrax spores to explode rather than synthesize and can also be used to decontaminate equipment and clothing.

I hope that we can find solutions to these issues, get the full story on issues raised, and by doing so, take action to begin to restore trust in the ranks and restore and preserve the careers that have been destroyed.

Sue Bailey, M.D., Assistant Secretary for Health Affairs, Department of Defense.

Cedric E. Dumont, M.D., Medical Director, Office of Medical Services Department of State

Kathryn C. Zoon, Ph.D., Director, Center for Biologics, Evaluation and Research, Food and Drug Administration.

Kwai-Cheung Chan, Director, Special Studies and Evaluation, U.S. General Accounting Office

William J. Crowe Jr. (Adm, USN Ret.), Former Chairman, Joint Chiefs of Staff

Major Thomas L. Rempfer, Pilot, USAF Reserves

Dr. Jack Melling, Former Director; The Salk Institute, Biologics Development Center and the UK Centre for Applied Microbiology & Research

Mr. Milton Leitenberg, Senior Scholar, Center for International and Security Studies, University of Maryland

John B. Classen, MD, MBA, of Baltimore, Maryland

Neal A. Halsey, MD, Director, Institute for Vaccine Safety, Johns Hopkins University School of Hygiene and Public Health