August 25, 2000

Documents hold anthrax secrets - BioPort asks state to help it retrieve recipe from scientists

LSJ NewsXtra LansingBeat
By A.J. Evenson

Legal transcripts show the recipe for making the U.S. military's anthrax vaccine is among the documents missing from BioPort Corp. The Lansing-based company on Tuesday requested the state's help in retrieving those documents, whose existence surfaced during a dispute with three former state scientists who want royalties for their work on the anthrax vaccine and two other vaccines.

The employees worked for the vaccine labs before the state of Michigan sold the operation to BioPort in 1998.

Transcripts from a state hearing involving the royalty issue indicate the missing documents include master manuals for making the rabies and anthrax vaccines and an updated version of the anthrax manual written on loose-leaf paper.

The saga is the latest roadblock in the Pentagon's beleaguered efforts to vaccinate 2.4 million U.S. troops against the deadly bio-warfare agent developed by North Korea, Iraq and others. The Defense Department has virtually suspended the $100 million program as supplies of the vaccine dwindle.

BioPort officials say the missing documents could help solve production problems that have kept the company from getting U.S. Food and Drug Administration approval of its renovated labs. Without that, the company can't sell its vaccine to the military or anyone else.

"We are deeply troubled by the entire situation and look forward to recovering every one of the documents - sooner rather than later," BioPort spokeswoman Kelly Rossman McKinney said Thursday.

The documents surfaced during a state hearing to determine whether the former state workers should get a portion of the vaccines' profits. Dr. George Burgoyne, Richard Hoort and Judith Boice filed a grievance with the state's Civil Service Hearings Division in 1998. A hearing on the matter is scheduled to resume Tuesday.

A lawyer representing the three workers called the missing documents a "non-issue."

Attorney Brandon Zuk said Thursday that the documents don't belong to the state but rather to the employees, who are using them to 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 first hearing. But the state didn't respond, he said.

The three workers say they developed the technology now used to make the anthrax and rabies vaccines and an experimental product. The former Michigan Biologic Products Institute, which became BioPort, is the only licensed producer of the anthrax vaccine in the United States.

The anthrax vaccine was developed before the three employees joined the state operation. But the workers say they made extensive changes to 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 quicker could be made. This was just before the Gulf War," Burgoyne, who headed the production, testified in a March 3 Civil Service hearing.

Burgoyne also testified that the changes - including the use of additional filters and a new type of container to grow the vaccine - improved the vaccine's safety by ensuring sterility. The changes also made it cheaper to produce.

Some of the changes, Burgoyne said, may have been prompted by FDA concerns. "We needed to find a new method and continue producing it that way."

Assistant Attorney General Ron Styka, who received BioPort's request for help in retrieving the missing documents, would only say Thursday that his office continues to "look at the issue."

BioPort failed a November 1999 FDA investigation of its vaccine labs in 30 areas, including inadequate control or documentation for its manufacturing process. The federal agency was concerned that there was no guarantee BioPort could make each batch of anthrax vaccine to the same standards.

BioPort officials say the missing documents could help fill in some of the gaps as they work toward FDA approval. They would not comment on whether lab workers had identified documents were missing or their absence had gone unnoticed.

Pentagon officials said BioPort remains contractually obligated to making the vaccine and the military continues to work with them to reach that goal.

Pentagon spokesman James Turner wouldn't comment on the missing documents, saying: "That is a legal matter between BioPort and its former employees."

The military began soliciting a second source for the vaccine in June. Meanwhile, 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.