September 29, 2000

Anthrax Vaccine Had Unlikely Critic - the Pentagon

The Hartford Courant

The anthrax vaccine, under a cloud of questions today over its safety and effectiveness, was sharply criticized by the Pentagon itself in 1989, federal documents show.

During U.S. Senate hearings about the military's readiness to combat biological warfare, then Assistant Secretary of Defense Robert B. Barker stated that "current vaccines, particularly the anthrax vaccine, do not readily lend themselves to use in mass troop immunization."

He cited two key reasons: a higher-than-desirable rate of adverse reactions to the drug, and "in some cases, lack of strong enough [effectiveness] against infection by the aerosol route of exposure.''

Two years later, however, the Pentagon authorized use of the vaccine for the Persian Gulf War, and in 1997, Defense Secretary William S. Cohen ordered a mandatory inoculation program. Coincidentally, Cohen had been a Republican senator from Maine and active participant in the 1989 hearings.

Today, Cohen and Pentagon officials say the department changed its stance because the threat of biological warfare had increased, and because newer tests showed the vaccine was safer and more effective than they once thought.

But two years after the mandatory inoculations began early in 1998, the program is under increasing attack. The military's reassessment of the vaccine since 1989, combined with the continuing questions about the program, is likely to provide new fodder for those who say the government should stop using the vaccine or make the inoculations voluntary.

More than 1,500 service people have complained about side effects of varying severity that they blame on the vaccine. Hundreds of service people have refused to be inoculated and have been disciplined or discharged, while hundreds more in the reserve and National Guard and at least 250 military pilots have resigned rather than take the six shots required. At least 250 military pilots have resigned, raising questions about U.S. battle readiness. Seasoned fighter pilots can cost as much as $3 million to train, according to Air Force pilots familiar with the process.

In September, the manufacturer of the vaccine, BioPort Corp. of Lansing, Mich.was cited for using an expired lot of the drug while failing earlier to gain U.S. Food and Drug Administration approval to make more vaccine. And this week, a newly released FDA study showed the trace amounts of an additive in sample testing of the vaccine, a direct contradiction to Pentagon statements on the issue. The FDA said the additive was in such small amounts that it could not cause health problems.

Still, the National Gulf War Resource Center, the largest veterans organization for U.S. Persian Gulf War service members, called Thursday for a federal criminal inquiry into the matter.

Also, this week, the death of a man employed by the vaccine’s manufacturer, BioPort Corp., was being linked to the fact that he had taken 11 doses of the vaccine while employed there.

Richard Dunn monitored test animals for BioPort Corp. and was required to take the vaccine. He died in July.

BioPort said Dunn's death certificate lists the immediate cause of death as ventricular arrhythmia and makes no reference to an underlying cause, but the county chief medical examiner said Dunn's response to the vaccine contributed to his death. The autopsy findings have not been released.

The various problems are not surprising to one of the vaccination program's most public critics, U.S. Rep. Christopher Shays, R-4th District, who leads a continuing House committee's investigation of the vaccine.

"As early as the 1980s, the Pentagon knew we needed a better vaccine,'' Shays said. "We still do.''

Cohen, however, has staunchly defended the vaccination program he launched. His spokesman, James Turner, insisted the Defense Department had far more information about the vaccine in 1997 when Cohen announced the program, than it did in 1989, when Cohen learned the military opposed it.

In particular, Turner said that in the late 1980s, the threat of biological weapons being used by an enemy was far less than it is today. Thus, he said, the potential of minor adverse reactions to the vaccination is warranted now to protect the troops from that increased threat of deadly anthrax bacteria.

Yet that's not what the U.S. General Accounting Office concluded in an inquiry completed last year for Congress. The GAO said the magnitude of the threat of biological warfare "has not changed since 1990.''

Beyond the relative threat of biological warfare, the biggest debate over the anthrax vaccination program focuses on safety, in particular the lack of studies that could determine whether the vaccine poses any long-term adverse health effects.

It has never been established whether there are more than the 1,500 soldiers the Pentagon says have suffered adverse reactions to the shots, or how many of the adverse reactions were severe or long-term. Some 445,000 of the 2.4 million people in the military have been inoculated to date. Both sides in the ongoing debate about the program have used the lack of detailed information to argue about the accuracy or inaccuracy of the adverse reaction rate.

Turner said anthrax vaccine tests in the 1990s on rhesus monkeys show the drug is safe and effective. But the manufacturing license for the anthrax vaccine specifies that tests should be conducted on guinea pigs.

And a September 1998 report by the U.S. Army Medical Research Institute of Infectious Diseases, which researches and tests military vaccines, showed the vaccine had limited success on guinea pigs.

Col. Arthur Friedlander, the Army's own expert on the vaccination who works for the same institute, made telling statements when he testified last March in a Canadian military court, where that country's use of the same vaccine
was successfully challenged by a serviceman.

Friedlander, chief of the institute's bacteriology division, testified that there is no way of scientifically knowing whether the vaccine tests on monkeys prove the drug is safe and effective for humans. Indeed, the National Institute of Medicine, answering a Pentagon request, concluded in March that medical research is insufficient to demonstrate the safety of the anthrax vaccination.

With the vaccination supply low, and the manufacturer's efforts to make new supplies still failing to receive FDA approval, the program's future is unclear.

The Pentagon is exploring the use of an antibiotic, ciprofloxacin, manufactured by Bayer Corp., whose pharmaceutical division is in West Haven, as an alternative to vaccination.

U.S. Sen. John Glenn, the former astronaut, spearheaded the 1989 congressional investigation. In a recent telephone interview, he said he continues to follow the ongoing controversy of the anthrax vaccine, and is concerned.

"Whatever we are inoculating our people with has to be tested and has to be safe,'' Glenn said.

This spring, a group of 35 congressmen, including Shays, called on Cohen to halt the vaccination program.

"In the early 1990s, the Department of Defense faced a fork in the road to effective force protection and picked the wrong path,'' Shays said.

"Had (the department) followed its own assessments of the inadequacy of the current vaccine, they could have focused on obtaining FDA approval of the modern, improved anthrax inoculation needed to meet the real military threat,'' Shays said. "Instead, precious time and money have been wasted to acquire little more than a false sense of security U.S. troops will be protected against biological warfare.''

September 28, 2000

Medical examiner links death to anthrax vaccine BioPort officials shocked by word of employee's autopsy

By A.J. Evenson and Tim Martin
Lansing State Journal

BioPort Corp.'s controversial anthrax vaccine may have contributed to the death of one of its own employees, a medical examiner said Wednesday.

The July death - if officially tied to the vaccine - could add to safety and financial concerns hounding the Lansing company, which is the sole producer of the U.S. military's vaccine to combat a deadly biological weapon possessed by an estimated 10 nations.

Richard Dunn had worked for BioPort and its predecessor, the state-owned Michigan Biologic Products Institute, since 1992. The 61-year-old Ionia man, who cared for and monitored test animals at BioPort, was required to take the same vaccine given to the nation's military personnel.

Dunn received 11 doses of the vaccine - the last, given in April. An autopsy performed in August suggests the vaccine as a factor, Ionia County Chief Medical Examiner Dr. Robert Joyce said.

The autopsy, Joyce said, showed Dunn had an "inflammatory response" to the vaccine throughout his body. He wouldn't comment further on how the swelling led to Dunn's death, though he did say the worker did not show signs of the deadly bacteria in his body.

"Even though they didn't find any anthrax in the man's system his body's reaction to the vaccine contributed to his death," Joyce said.

BioPort officials, who learned of Joyce's stance Wednesday, said they were shocked. Dunn's death certificate indicated he died of a heart condition, BioPort officials said. The company did not receive notice the autopsy indicated otherwise.

"This is information we absolutely need to look into and don't take lightly," BioPort spokeswoman Kelly Rossman McKinney said. "We're puzzled and stunned. We're going to do everything we can to find out what's going on here."

BioPort said they called the Pentagon, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and vaccine experts after Joyce told them Wednesday of his stance.

Joyce did not perform the autopsy, but as the county's medical examiner is responsible for recording results. He would not release the autopsy results Wednesday.

The Grand Rapids pathologist who performed the autopsy did not return phone calls Wednesday. And BioPort officials say they also were denied a copy of the autopsy Wednesday.

Company officials expect tissue samples taken from Dunn to be turned over to national medical authorities for further review.

Workers at the north Lansing labs have taken the vaccine for 30 years. More than half of BioPort's 210 workers have received the six-dose vaccine, which also requires an annual booster.

The most serious reaction among employees has been a severe headache, said Condalee Decker, the company's nurse. There have been no reports of reactions similar to Dunn's, even to a lesser degree.

A month after Dunn received his 11th dose, he complained of fatigue and swelling, said Mike Tanner, BioPort's director of human resources and corporate services. BioPort sent Dunn to the company's doctors, who examined him three times. They determined there was no connection to the vaccine, Tanner said.

While employees were concerned by Dunn's earlier symptoms, they raised few internal questions about the vaccine's safety.

Dunn's family declined comment Wednesday. A family attorney did not return phone calls.

The military reports 487,098 people had received 1.9 million doses of the vaccine through last week. About 400 military personnel, worried about the impact on their health, have resigned or faced discipline rather than take the vaccine.

Fewer than a half percent of the people who have taken the vaccine - 1,152 people - reported adverse reactions.

A U.S. Health and Human Services review confirmed that 592 of the cases were certainly or probably caused by the anthrax vaccine. They classified 123 of the cases as serious, and 10 required hospitalization - all due to allergic, inflammation reactions.

The military and the Food and Drug Administration say the anthrax vaccine is safe, with no more side effects than many common vaccines and fewer side effects than some immunizations given to children.

The Pentagon also says more than 1,500 vaccinated lab workers at a research and development center at Maryland's Fort Detrick have been tracked for 20 years, with no unexplained symptoms.

Defense Department officials declined to comment Wednesday but were expected to answer questions today.

Critics say a long-term study on the effects of the vaccine is needed to make sure it is safe. A letter signed by 35 members of Congress in May urged Defense Secretary William Cohen to suspend the program until a long-term study was done.

Meryl Nass, a Maine doctor who has studied the anthrax vaccine for a decade, says she believes the Pentagon has access to long-term studies but won't release the findings.

"They should not give anyone else this vaccine until they know it's safe," Nass said. "There are 450,000 people out there who have been made guinea pigs. All we need to do is watch them and report what has happened to them."

Dunn's death is the latest possible controversy for BioPort - a private company that bought the former state-owned Michigan Biologic Products Institute in 1998.

BioPort has been trying to win FDA approval of renovated labs since August 1999. Without that approval, the company has been unable to make new vaccine. BioPort has relied instead on vaccine made when the state owned the lab.

The company has stopped making most of its other products while working toward FDA approval.

Additive Found In Anthrax Vaccine

by Thomas D. Williams
The Hartford Courant

Trace amounts of the additive squalene have been found in the anthrax vaccine used to protect U.S. service members from the biological warfare agent, federal health officials have found.

The finding contradicts repeated assertions by the Pentagon that squalene is not present in the vaccine.

The federal Food and Drug Administration said its results were based on tests of five lots of the vaccine. The agency did not make clear whether those lots containing squalene were used to inoculate troops during the Persian Gulf War, those receiving the vaccine since a mandatory inoculation program began in 1998, or both.

The FDA also did not address potential health problems with the vaccine; agency spokeswoman Lenore Gelb declined to comment.

Squalene is found in the human liver, some vegetable oils and shark oil; as an additive to a vaccine, it 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.

Squalene's safety was called into question when a 1999 Tulane University study of blood samples taken from sick gulf war veterans detected the presence of antibodies linked to the additive. Some of the samples were taken from soldiers who did not take part in the war; but all presumably received the vaccine.

Previously, Congress' watchdog agency, the General Accounting Office, had reported that gulf war veterans were complaining of mysterious, undiagnosed illnesses similar to patients with auto-immune disorders. A Tennessee immunologist, Dr. Pamela B. Asa, concluded those illnesses were caused by exposure to additives in vaccines, the GAO said.

James Turner, a Pentagon spokesman, said Wednesday that officials in his department were not prepared to comment on the FDA's finding.

Last year, the Pentagon challenged the Tulane University study and the implication that gulf war veterans could have become ill from the additive - even if it were in the vaccine. And if antibodies are in the veterans' blood, Pentagon officials said at the time, the tests still did not prove the veterans became sick from the vaccine.

U.S. Rep. Jack Metcalf, R-Washington, who has investigated the additive for three years, told a congressional committee Wednesday that the development raises questions about the vaccine's safety and the truthfulness of Pentagon officials.

Metcalf said his congressional inquiry concludes Pentagon officials "stonewalled" attempts to examine the vaccine's additives, an effort GAO investigators called a "pattern of deception.''

Metcalf distributed his inquiry report Wednesday to the House Subcommittee on National Security, Veterans' Affairs and International Relations headed by U.S. Rep. Christopher Shays, R-Conn.

Shays' committee is continuing a lengthy investigation into the illnesses of gulf war veterans. Shays also is among a group of congressmen who have called for an end to the vaccination program, saying the Pentagon has not proved the vaccine to be safe or effective.

Thousands of gulf war veterans complained of various illnesses in the years after the war. In addition, more than 1,500 service people inoculated since 1998 have complained about side effects of varying severity that some blame
on the vaccine.

Hundreds of service people have refused to be inoculated and been disciplined or discharged, while hundreds more in the reserve and National Guard have resigned rather than take the required series of six inoculations.