SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS,
AND INTERNATIONAL RELATIONS
Christopher Shays, Connecticut
Room B-372 Rayburn Building
Washington, D.C. 20515
Tel: 202 225-2548
Fax: 202 225-2382
Statement of Rep. Christopher Shays
February 17, 2000Today we release an oversight report entitled, "The Department of Defense Anthrax Vaccine Immunization Program: Unproven Force Protection." Based on testimony from more than 50 witnesses at six subcommittee hearings and many thousands of pages of DOD and FDA documents, we conclude the program is not sustainable in its present form. It is an unrealistically broad undertaking built on a dangerously narrow scientific, medical and industrial base.
Plagued by unstable supplies, uncertain safety and unproven efficacy against the anthrax threat, the mandatory, force-wide immunization program should be suspended until DOD gets approval to use an improved vaccine. Meanwhile, except in very limited circumstances, the current vaccine would be used only when service members give their informed consent.
The recommendation to suspend the program should come as no surprise. Due to the inability of the vaccine manufacturer to pass Food and Drug Administration (FDA) inspection, DOD has already been forced to defer the next two phases of the program. In this report, we are simply asking DOD to end the mandatory inoculations while focusing on the research and testing that should have been done before the program began.
Designed in the 1950s and 60s, the vaccine was licensed in 1970 for protection against cutaneous (under the skin) anthrax infection. Before the Gulf War, it had not been widely used. After the war, DOD scientists acknowledged the vaccine caused adverse reactions and contained inconsistent amounts of the desired antigenic protein.
They also knew it was unsuitable for broad military use due to the elaborate, arbitrarily established inoculation schedule of six shots over 18 months, plus annual boosters. DOD began, but did not aggressively pursue, research and testing on a purer, safer vaccine and an optimal shot course.
We would not ask our armed forces to fight a battle using rifles and tanks designed in the 1950s. We should not ask them to risk their lives by relying on 1950s vintage medical technology, when modern science has the capacity to produce a safer, more effective vaccine.
When Defense Secretary William Cohen announced the Anthrax Vaccine Immunization Program (AVIP), he set four explicit conditions on implementation of what he apparently knew then would be a complex and controversial program. They were the right conditions. Had they been more than cosmetically addressed, there might be no need for a report like this.
First, to address concerns about vaccine safety raised by deficiencies at the manufacturing plant uncovered by Food and Drug Administration (FDA) inspections, Secretary Cohen ordered supplemental testing of stockpiled vaccine lots. But when more than half the lots failed the supplemental review, DOD exempted 9 lots from the tests even though they had been produced under the same deficient conditions as all the others.
Second, to address concerns about lax medical record keeping, such as occurred in the Persian Gulf War, Secretary Cohen required an accurate inoculation tracking system to assure compliance with the vaccines lengthy dosing schedule. But we found the unified tracking system unreliable. Even the Secretary of Defense got his fourth shot three weeks early. Many others missed scheduled shots, sometimes by weeks or months, particularly members of Reserve and National Guard units.
Third, the Secretary required each military service branch to finalize AVIP operations and communication plans. But witnesses testified AVIP operational protocols, particularly with regard to vaccine waivers and adverse event reporting, were not being followed. A DOD witnesses acknowledged communication to reserve component members had not been effective.
Finally, Secretary Cohen assured service members the program would be subjected to an independent medical and scientific review. But we discovered only a cursory review of DOD materials by a friend of the Department who, while well meaning, acknowledged he had no expertise in anthrax.
Because the anthrax vaccine is still being studied as a possible causative or contributing factor in Gulf War veterans illnesses, its use in a vastly expanded and demographically diverse population should be monitored carefully. Women report adverse events after receiving the vaccine at twice the rate among men. But we found DODs reliance on a passive reporting system very likely, if not predisposed, to understate the true health effects of the vaccine.
To address that problem we recommend DOD enroll all vaccine recipients in a comprehensive clinical evaluation and treatment program for long term study. Because DOD has concluded the vaccine is essential "body armor" that cannot be removed, we concluded it ought to come with a health insurance policy just as permanently attached.
The strength of this report flows from the personal courage and sacrifice of the men and women of the military who testified before our Subcommittee.
Some had taken the vaccine and become ill. Captain Michelle Piel, a C-5 Galaxy pilot from Dover Air Force Base lost her flying status when she developed chronic fatigue, dizziness joint pain and other debilitating symptoms after taking the vaccine. She doesnt care what made her sick. She just wants to get better and start flying again. But the resistance she encountered to the mere suggestion her illness was related to the vaccine frustrated her, hurt her, and discouraged others from reporting post-inoculation symptoms.
Capt. Jon Richter, another C-5 pilot at Dover AFB, suffered chronic joint pain after receiving two anthrax inoculations. Because doctors could not definitively attribute his condition to the vaccine, no waiver was offered and he was ordered to take another shot. For the sake of his health, it was an order felt he could not follow.
Others had refused the vaccine and given up a career of service they loved. Major Thomas Rempfer, an Air Force Academy graduate and active duty veteran, was an A-10 pilot with the Connecticut Air National Guard. When his questions about the vaccine program could not be answered, and his chain of command stopped trying, he felt betrayed. He and several of his colleagues left the Guard or transferred to non-mobility positions not requiring the vaccine yet. To this day, DOD leadership refuses to acknowledge any impact of the AVIP on National Guard retention or morale.
Still others shared their struggle to decide which path to take. Major Cheryl Hansen, an Air Force Reserve nurse, found DOD communications about the risks and benefits of the vaccine one sided. She wanted to finish her career in the Air Force reserves. But she expressed a legitimate fear of being ignored or abandoned in the event she suffered a serious, albeit rare, reaction to the vaccine.
These people were not troublemakers or conspiracy theorists. They were not malingerers looking to duck tough duty. They are among the most level-headed, dedicated and patriotic Americans it has ever been my privilege to meet. They deserve a better vaccine, and a better vaccination program.