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Stars and Stripes: Lawyers Seek Missing
Anthrax Vaccine Recipe
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Lawyers Seek Missing Anthrax Vaccine Recipe
Sep 4, 2000
David Eberhart
Stars and Stripes Veterans Affairs Editor
Lawyers for BioPort Corp. of Lansing, Mich., have requested
the state government’s help in retrieving missing documents
detailing the recipe for the U.S. military’s anthrax vaccine,
of which BioPort is the sole manufacturer.
The missing documents are at the center of BioPort’s dispute
with three former state scientists who want royalties for their
work on the anthrax vaccine and two other unrelated vaccines.
The employees worked for the vaccine labs before the state of Michigan sold the operation to BioPort in 1998. The missing documents are believed to include “master manuals” for making rabies and anthrax vaccines as well as “an updated version of the anthrax manual written on loose-leaf paper,” according to state records.
This development is the latest wrinkle in the Pentagon’s
frustrated effort to vaccinate 2.4 million U.S. troops against
the deadly bio-warfare agent which North Korea, Iraq and possibly
other countries are thought to have cultivated. The Defense Department
has suspended the 100 million dollar program because of dwindling
supplies of the vaccine.
FDA Approval Needed
BioPort officials maintain that the missing documents would alleviate
production problems that have stalled U.S. Food and Drug Administration
approval of its renovated labs. Without the FDA’s approval,
the company cannot lawfully sell its vaccine to the military or
any other potential customer.
“We look forward to recovering every one of the documents, sooner rather than later,” BioPort spokeswoman Kelly Rossman McKinney said the last week in August.
The documents’ existence came to light during a recent state hearing to determine whether the three former Michigan state employees should get a portion of the profits from the sale of the vaccine profits. Dr. George Burgoyne, Richard Hoort and Judith Boice filed a grievance with the Civil Service Hearings Division in 1998. A new set of hearings began in August.
Brandon Zuk, an attorney representing the three workers, said that the documents don’t belong to the state but rather to the employees, who say the documents can help “prove they invented the formulas for these products.” Zuk said he questioned state officials after allegations of possible “criminality” involving the documents were made during the initial hearings, but the state did not respond.
The three workers have testified that they developed the technology now used to make anthrax and rabies vaccines as well as an experimental product. BioPort, formerly the Michigan Biologic Products Institute, is the only licensed producer of the anthrax vaccine in the United States.
Production Changes
The anthrax vaccine actually was developed before the three employees
joined the state operation, but the workers maintain that they
made key changes in the production process when the U.S. military
needed the vaccine to protect troops against an anthrax threat
posed by Iraq in the 1991 Gulf War.
“It was not until ‘88-‘89 when the...military showed interest in the vaccine that changes had to be made...so that larger quantities could be made quicker. This was just before the Gulf War,” Burgoyne, who headed the production, testified at a Civil Service hearing in March.
Burgoyne also testified that the production changes, including additional filters and a new type of container to in which to grow the vaccine, made the vaccine safer by ensuring its sterility. The changes also made the vaccine cheaper to produce, he said.
BioPort failed a November 1999 investigation of its vaccine labs by the FDA, which cited inadequate monitoring of the manufacturing process among other shortcomings. The agency charged that there was no assurance that BioPort could mix each batch of anthrax vaccine to uniform standards.
BioPort officials insist that the missing documents could fill
some of the gaps as they work toward FDA approval. In the meantime,
Pentagon officials say BioPort remains contractually obligated
to make the vaccine.
Pentagon spokesman James Turner refused to comment on how the
documents went missing or when their absence was discovered.
The military began soliciting a second source for the vaccine
in June. With supplies near zero, the Pentagon has suspended the
vaccination program, saving the few doses it has left for troops
headed to high-risk areas such as the Persian Gulf.
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Last revised: March 2004