Thursday, September 28, 2000
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.
A look at key events for BioPort this year:
Feb. 17: House subcommittee recommends Department of Defense suspend its anthrax vaccination program. The Pentagon says the vaccinations will continue.
March 22: Audit requested by Rep. Walter Jones, R-N.C., says BioPort may need an $18 million bailout from the federal government to stay in business while awaiting Food and Drug Administration approval of its new labs.
May 16: Thirty-five members of Congress call for an end to anthrax vaccination program. Pentagon again says the program will continue.
July 10: Military curtails anthrax vaccination program because of vaccine shortages. Only troops headed to high-risk areas such as Persian Gulf will receive vaccine.
Aug. 29: Former BioPort employees return missing documents to company as part of a state civil service grievance. BioPort says the documents are copies of material it already had.
Aug. 30-Sept. 1: BioPort recalls three products, including anthrax vaccine. Anthrax recalled because wrong expiration date was put on labels.
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