Mark S. Zaid, Esq.
(202) 785-3801


Independent Testing Of The Vaccine For Squalene By Government Contractor Of Little Substantive Value


Facing growing allegations of illegal modification of the anthrax vaccine with the adjuvant squalene, the Offices of the Army Surgeon General and the Assistant Secretary of Defense for Health Affairs have embarked upon a public relations campaign set to disparage researchers who have performed studies linking squalene antibodies to the vaccine.

The latest Pentagon efforts are the work of Army Major Guy Strawder, Director of the Anthrax Vaccine Immunization Program Agency and Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs. In a recent interview, Major Strawder called the allegations "pure fiction" and cited to a telephone conversation between Dr. Carl Alving of the Walter Reed Army Institute of Research and Dr. Robert Garry, Jr., one of the researchers who performed the squalene antibody study and a professor at the Tulane Medical School. A memorandum recounting this conversation criticizes the work of Dr. Garry and his co-author Dr. Pamela Asa, and goes on to assert they hold an "anti-military agenda" and financial motivations. Major Strawder also falsely asserts that the work of Drs. Garry and Asa has not been peer-reviewed.

"The Pentagon's recent escalation of its attack on the squalene allegations is based more on false rhetoric than substance," said Mark S. Zaid, the Executive Director for The James Madison Project and the lead civilian defense counsel for several military service members refusing the anthrax vaccine. "The defamatory and misleading comments being disseminated by the Government are unfortunately typical of the tactics used to support the Anthrax Immunization Program." Zaid added that Dr. Garry disputes the statements attributed to him by Dr. Alving and that their article, although not yet published, has been peer-reviewed by the Journal of the American Medical Association.

In order to demonstrate that squalene has not been added to the anthrax vaccine, the Government retained Stanford Research Institute (SRI) International, a military contractor for the past thirty years, to develop a new method for testing the vaccine for squalene. Based on SRI's work, the Pentagon is now asserting that no squalene has been found. However, the SRI conducted limited tests on no more than three vials of each lot (out of 20,000) of the vaccine utilizing a technique that has yet to be validated as an accurate and reliable test, nor was it able to conclusively prove that squalene was not present.

"At best, the SRI test demonstrates nothing more than that the statistically insignificant small number of vials chosen by the Pentagon for testing may not contain squalene. One must wonder that if the Pentagon is so sure about its position, then why has it refused to provide samples of the vaccine for true independent testing, or turn over its many documents concerning the squalene allegations?" said Zaid.

Both Major Strawder and Dr. Bailey also continue to assert that the adverse reaction rate of the immunization program is as low as .01 percent, a figure derived from the number of reported reactions. Yet, at a Congressional hearing held last April, the General Accounting Office criticized the Department of Defense for passively monitoring the adverse reaction rates of those receiving the vaccine. When individuals are actively monitored, the GAO disclosed that internal, unpublished military studies revealed that the systemic adverse reaction rate is as high as 44%. "Internal Army documentation demonstrates that the systemic adverse reaction rate is consistently 7 to 70 times than what the FDA has approved," said Zaid.

The Defense Department is forcibly inoculating all 2.5 million active duty personnel, regardless of duty station or responsibilities, against anthrax at an estimated cost of $130 million. The immunization series calls for six injections of the vaccine over a period of 18 months, followed by annual booster shots. Vaccinations began in March 1998. The FDA approved the vaccine in 1970. However, concerns have been raised about the vaccine's effectiveness against massive doses of weaponized anthrax anticipated in an intentional biological warfare attack. In addition, the only FDA-approved manufacturer, the Michigan Biologic Products Institute (now BioPort), has been repeatedly cited for quality control problems.

JMP is a Washington, D.C.-based non-profit organization with the primary purpose of educating the public on issues relating to intelligence gathering and operations, secrecy policies, national security and government wrongdoing.