JMP Letter to GAO Concerning the Anthrax Vaccination Immunization Program

James Madison Project


David Walker
Comptroller General
General Accounting Office
441 G Street, N.W.
Washington, D.C. 2048

Dear Mr. Walker:

The James Madison Project has taken a leadership role in ensuring an open and truthful debate regarding issues surrounding the Department of Defense's Anthrax Vaccination Immunization Program (AVIP). The undersigned have personally been involved in this debate since the AVIP commenced in March 1998. Mark S. Zaid has represented, through his private law practice, many of the service members who have refused the vaccine. Additionally, he testified at the first of several hearings on the AVIP before the House Government Reform's Subcommittee on National Security, Veterans Affairs and International Relations on March 24, 1999. Patrick Eddington has authored several articles concerning the anthrax vaccine, has appeared on national television on the subject and commenced litigation under the Freedom of Information Act that resulted in the disclosure of thousands of previously unknown records.

As Mr. Zaid attended the most recent legislative hearing on the AVIP which was Thursday, April 13, 2000, before the full Senate Armed Services Committee - the first such hearing in the Senate - and both of us have reviewed the submitted written testimony, we feel compelled to express our concern over the GAO's testimony that was presented by Carol R. Schuster, Associate Director, National Security Preparedness Issues, National Security and International Affairs Division. Quite frankly, we found Ms. Schuster's testimony and presentation to be lacking in completeness and less than helpful in addressing Defense Department statements and claims, many of which were, in our opinion, inaccurate or misleading. The failure of GAO to provide full information to the Armed Services Committee, many of whose members were hearing detailed information concerning the AVIP for the first time, may significantly and negatively impact the lives of millions of service members and their families. Ms. Schuster's testimony also raises concerns regarding the extent to which GAO is objective on politically sensitive issues, especially in light of the fact that one could interpret her testimony as being in contrast to prior GAO reports on the topic.

As you know, GAO representatives have presented key findings to the House of Representatives on four prior occasions in April, June, July and October 1999: Medical Readiness: Safety and Efficacy of the Anthrax Vaccine (GAO/T-NSIAD-99-148, Apr. 29, 1999); Contract Management: Observations on DoD's Financial Relationship With the Anthrax Vaccine Manufacturer (GAO/T-NSIAD-99-214, June 30, 1999); Medical Readiness: Issues Concerning the Anthrax Vaccine (GAO/T-NSIAD-99-226, July 21, 1999); and Anthrax Vaccine: Safety and Efficacy Issues (GAO/T-NSIAD-00-48, Oct. 12, 1999). These reports have specifically highlighted important deficiencies pertaining to the Defense Departments implementation of the AVIP and concerns regarding the anthrax vaccine itself. Few, if any, of the GAO's prior positions were recounted at the Senate hearing. Let us try and summarize three of our primary concerns regarding the GAO's last public appearance on this topic.

First, we are troubled that Ms. Schuster only presented or addressed some very narrow, selected aspects of the AVIP. Ignored altogether was evidence concerning the anthrax vaccine's problems relating to safety, efficacy and quality. For example, as reported in the April 13, 2000 edition of Inside the Pentagon, the Institute of Medicine (IOM), typically viewed as a medically conservative organization, found the AVIP's safety and efficacy claims wanting. In its March 2000 report on the vaccine, which was drafted in response to a request from the Defense Department and was available to Ms. Schuster prior to the Senate hearing, the IOM concluded that " the peer-reviewed literature there is inadequate/insufficient evidence to determine whether an association does or does not exist between anthrax vaccination and long-term health outcomes. To date, published studies have reported no significant adverse effects of the vaccine, but the literature is limited to a few short-term studies." We were quite surprised that Ms. Schuster would not bring this key finding to the attention of the Armed Services Committee either in her testimony or her oral remarks.

Indeed, the two GAO officials most knowledgeable about the AVIP, Kwai-Cheung Chan, Director, Special Studies and Evaluations, National Security and International Affairs Division, and his colleague Dr. Sushil Sharma, appeared not to have played any role in preparing the information to be presented to the Armed Services Committee. Why were these two individuals not in a position to advise Ms. Schuster during the course of the hearing, or offer the Committee information on the troubling problems with the AVIP that have been previously highlighted by the GAO?

Second, Ms. Schuster seemed to attempt to directly avoid any confrontation with Defense Department officials. In our opinion, there were quite a few misleading or inaccurate statements proffered by the Defense Department on which the GAO remained mute. This is particularly alarming given that these Defense Department statements contradicted prior GAO assertions and findings that were on the record. Senator John McCain appeared both frustrated and annoyed at Ms. Schuster's silence, especially in response to his question that sought a GAO recommendation as to the viability of the AVIP. As the investigative arm of Congress, the GAO exists to help the Congress oversee federal programs and operations to assure accountability to the American people. A key purpose is to assess the economy, efficiency, and effectiveness of federal programs such as the AVIP. In doing so the GAO is expected, if not obligated, to arrive at findings and recommendations based on the available evidence. To shirk that responsibility, as did Ms. Schuster, is to completely fail in its mission.

Finally, equally troubling was the fact that in Ms. Schuster's oral and written testimony she appeared to place the burden on the Food & Drug Administration (FDA) by implicitly, if not explicitly, stating that unless the FDA expedites its review process of the vaccine manufacturer and/or the existing lots of vaccine, the AVIP will run out of usable vaccine by July 2000. Frankly, with respect to the ongoing FDA approval process, the FDA is not the problem. The manufacturing facility has been repeatedly cited with numerous deficiencies and violations for years and has yet to satisfactorily cure them. Under no circumstances should the FDA be pressured - even implicitly - to expedite the approval or review process in order to accommodate Defense Department needs or objectives when to do so would have enormous potential health implications for millions of people. Yet that is the perception Ms. Schuster created.

It is our understanding that the Armed Services Committee will hold one or more additional hearings on the AVIP beginning as early as June 2000. We implore the GAO to step up and assume its proper role in providing Congress with objective, credible and detailed information from knowledgeable individuals concerning the AVIP. The American people - and particularly the 2.5 million members of our military service and their families - are looking to the GAO for adequate protection.

We would be pleased to meet with you or a member of your staff to provide elaboration on our comments or additional information. Please feel free to contact Mr. Zaid through his law office at (202) 371-6626. Thank you for your consideration.




Mark S. Zaid
Executive Director

Patrick G. Eddington
Senior Research Analyst


cc: Senator John Warner Senator Strom Thurmond Senator John McCain Senator Bob Smith Senator James M. Inhofe Senator Rick Santorum Senator Olympia J. Snowe Senator Pat Roberts Senator Wayne Allard Senator Tim Hutchinson Senator Jeff Sessions Senator Carl Levin Senator Edward M. Kennedy Senator Jeff Bingaman Senator Robert C. Byrd Senator Charles S. Robb Senator Joseph I. Lieberman Senator Max Cleland Senator Mary L. Landrieu Senator Jack Reed Senator Jesse Helms Congressman Dan Burton Congressman Christopher Shays Congressman Walter Jones Congressman Benjamin Gilman