Hearing Focuses On Anthrax Vaccine

by Thomas D. Williams

The Hartford Courant

October 4, 2000

During a congressional hearing Tuesday in which military personnel and others attributed sicknesses and even one death to the anthrax vaccine, two congressmen initiated an investigation of how traces of an additive got into the vaccine.

"How did squalene get into the anthrax vaccine?" U.S. Rep. Jack Metcalf, a Washington state Republican, asked the House Government Reform Committee in Washington. "Scientists agree ... that this question must be answered."

Metcalf said U.S. armed forces members being ordered to take the vaccine need to know the significance of the U.S. Food and Drug Administration's tests that found the squalene and what research has been done on its effects.

As an additive to a vaccine, squalene is used to foster a faster, stronger or longer protective reaction, according to a 1999 U.S. Government Accounting Office report. It is not approved by the FDA for use in the anthrax vaccine.

The U.S. General Accounting Office has already found what it called "a pattern of deception" in Pentagon officials' repetitive assertions that the additive was not in the vaccine, Metcalf said. Now the GAO needs to uncover whether it was used by the manufacturer or the Defense Department to bolster the vaccine's strength, he said. U.S. Rep. Dan Burton, R-Ind., chairman of the reform committee, joined Metcalf Tuesday in authorizing the inquiry.

But Kenneth Bacon, the assistant secretary of defense for public affairs, said Tuesday that no squalene was added to the vaccine.

Barbara Dunn, the widow of Richard Dunn, a vaccine manufacturer employee who died recently after receiving 11 doses of the vaccine, told the committee: "Nothing can be done to bring my husband back, but I ask this committee to rethink this program and make it a safe one.''

And U.S. Navy Petty Officer 3rd Class David M. Ponder, married with a 1-year-old son, told of the suffering his family has encountered because he faces a possible court-martial for refusing the vaccine.

U.S. Rep. Christopher Shays, R-4th District, told the panel, "it boggles the mind'' how Pentagon officials have falsely denied the seriousness of the vaccine's adverse effects and have in the past denied the drug is forcing military personnel to resign in droves. He said he agrees with one hearing witness, a Harvard University doctor, that it is bad medical practice and a violation of their fundamental rights to force patients to take a vaccine, as the military is doing.

The FDA found squalene in five lots of the vaccine, but did not make clear whether those lots were used during the Persian Gulf War, or since a mandatory inoculation program began in 1998, or both. Tuesday, Bacon said the Pentagon still doesn't know whether the lots were given to the troops.

Lenore Gelb, an FDA spokeswoman, said last week that the amounts of squalene were so minor they are not significant. She added the additive has been found in trace amounts in other vaccines. Gelb suggested it is not really surprising, since squalene is a common element found in vegetable and fish oil and the human liver.

However, a 1999 Tulane University Medical School study cited by Metcalf showed that gulf war era veterans, who presumably took the anthrax vaccine, had anti-bodies used to fight squalene and were sick with long-term undiagnosed illnesses. More than 150,000 gulf-war era veterans were given the vaccine, despite earlier opinions from the Pentagon itself that the vaccine was not that safe or effective.