Criticism, skepticism surround anthrax vaccine -- BioPort defends product despite lawsuits, studies
By STEVE EDER
The State News
Editor's note: This is the second part of an ongoing series on Lansing's BioPort, the nation's sole producer of the anthrax vaccine.
Lansing - BioPort Corp. executives are the first to admit that a cloud of doubt seems to linger above their anthrax vaccine. Critics relentlessly question if the Lansing-based company's product would be effective against a bioterrorist attack. Others contend the immunization is harmful to those who receive it.
Company executives, however, maintain that scientific fact and a series of medical studies vouch for the safety and effectiveness of the nation's only federally licensed anthrax vaccine.
Last week, Dennis Michael Duggan, The American Legion's deputy director of national security, testified before the U.S. House Armed Services subcommittee in Washington to raise concern about the vaccine.
Testimony centered on the health and protection of U.S. troops engaged in combat. More than 1 million troops have received BioPort's vaccine.
After acknowledging support for protecting soldiers against biological weapons, Duggan testified that "serious concerns with past problems associated with BioPort, the sole manufacturer of the vaccine, and the way adverse reactions are tracked and followed up by (the defense department) continue to worry The American Legion."
Two years ago, BioPort gained federal approval for its renovated laboratories, enabling the 5-year-old company to continue supplying the nation's stockpile of the vaccine. During the anthrax scare of 2001, BioPort was caught in a transition period as it focused on preparing its plant for approval.
In 1998, a group of investors purchased the aging facility from the state-owned Michigan Biologics Products Institute. Since 1970, the state laboratory has been the nation's only producer of anthrax vaccine.
"We have been challenged with the Internet conspiracy theories and whether or not this vaccine is safe since we've been here," said BioPort spokeswoman Kim Brennen Root, who has taken four shots of the vaccine.
"What we have to come back to is the science. The science is this vaccine."
More than 18 studies have attested to the safety of the vaccine, BioPort officials said. In 2002, the Institute of Medicine released a report certifying BioPort's vaccine was safe and effective in protecting troops from the deadly disease.
Michael Zamiara, BioPort's chief financial officer, said that study took some of the mounting pressure off BioPort to continuously defend its vaccine.
"When the Institute of Medicine report came out, that really put a lot of that to rest," said Zamiara, who has taken six shots of the vaccine. "It made our lives a heck of a lot easier."
In 2002, defense officials reinstituted their program for mandatory immunization of select troops against anthrax. Mandatory vaccine programs have been a constant source of tension in the military.
A year ago, six service members filed suit in U.S. District Court, charging that the vaccine was being used experimentally and illegally. The plaintiffs requested a preliminary injunction to stop mandatory vaccinations.
U.S. District Court Judge Emmet Sullivan granted their request on Dec. 22, ruling that the packaging of the vaccine does not specify that the product protects against inhalational anthrax.
A day after Sullivan halted the program, William Winkenwerder Jr., the assistant secretary of defense health affairs, told reporters that the safety and protection of troops is the defense department's chief concern.
"This court ruling is not supported by medical science or by medical facts," he said during a briefing in Washington. "It challenges the conclusions of America's best medical experts."
In early January, the injunction was lifted after Food and Drug Administration officials ruled that the vaccine is "safe and effective for the prevention of anthrax disease - regardless of the route of exposure."
Zamiara said the FDA decided "to use the sledgehammer on the mosquito" to quickly end the suspension of the mandatory immunization program.
Still, the final ruling does not have an impact on the ongoing litigation, and it hasn't altered opinions of some long-standing doubters of the anthrax vaccine.
"Every single study about this vaccine, except for those done by the U.S. Army, shows major problems," said Dr. Meryl Nass of Maine, an expert on bioterrorism and anthrax.
"Nobody will admit in the military that it won't do what it is intended to do."
Nass, who has studied the disease for about 15 years, said most experts agree there is a need for a new and improved vaccine to counter anthrax. BioPort currently is working to improve its product, while other companies are developing new vaccines.
Nass added, "We have solid evidence that this is a terrible vaccine."
The State News
Editor's note: This is the second part of an ongoing series on Lansing's BioPort, the nation's sole producer of the anthrax vaccine.
Lansing - BioPort Corp. executives are the first to admit that a cloud of doubt seems to linger above their anthrax vaccine. Critics relentlessly question if the Lansing-based company's product would be effective against a bioterrorist attack. Others contend the immunization is harmful to those who receive it.
Company executives, however, maintain that scientific fact and a series of medical studies vouch for the safety and effectiveness of the nation's only federally licensed anthrax vaccine.
Last week, Dennis Michael Duggan, The American Legion's deputy director of national security, testified before the U.S. House Armed Services subcommittee in Washington to raise concern about the vaccine.
Testimony centered on the health and protection of U.S. troops engaged in combat. More than 1 million troops have received BioPort's vaccine.
After acknowledging support for protecting soldiers against biological weapons, Duggan testified that "serious concerns with past problems associated with BioPort, the sole manufacturer of the vaccine, and the way adverse reactions are tracked and followed up by (the defense department) continue to worry The American Legion."
Two years ago, BioPort gained federal approval for its renovated laboratories, enabling the 5-year-old company to continue supplying the nation's stockpile of the vaccine. During the anthrax scare of 2001, BioPort was caught in a transition period as it focused on preparing its plant for approval.
In 1998, a group of investors purchased the aging facility from the state-owned Michigan Biologics Products Institute. Since 1970, the state laboratory has been the nation's only producer of anthrax vaccine.
"We have been challenged with the Internet conspiracy theories and whether or not this vaccine is safe since we've been here," said BioPort spokeswoman Kim Brennen Root, who has taken four shots of the vaccine.
"What we have to come back to is the science. The science is this vaccine."
More than 18 studies have attested to the safety of the vaccine, BioPort officials said. In 2002, the Institute of Medicine released a report certifying BioPort's vaccine was safe and effective in protecting troops from the deadly disease.
Michael Zamiara, BioPort's chief financial officer, said that study took some of the mounting pressure off BioPort to continuously defend its vaccine.
"When the Institute of Medicine report came out, that really put a lot of that to rest," said Zamiara, who has taken six shots of the vaccine. "It made our lives a heck of a lot easier."
In 2002, defense officials reinstituted their program for mandatory immunization of select troops against anthrax. Mandatory vaccine programs have been a constant source of tension in the military.
A year ago, six service members filed suit in U.S. District Court, charging that the vaccine was being used experimentally and illegally. The plaintiffs requested a preliminary injunction to stop mandatory vaccinations.
U.S. District Court Judge Emmet Sullivan granted their request on Dec. 22, ruling that the packaging of the vaccine does not specify that the product protects against inhalational anthrax.
A day after Sullivan halted the program, William Winkenwerder Jr., the assistant secretary of defense health affairs, told reporters that the safety and protection of troops is the defense department's chief concern.
"This court ruling is not supported by medical science or by medical facts," he said during a briefing in Washington. "It challenges the conclusions of America's best medical experts."
In early January, the injunction was lifted after Food and Drug Administration officials ruled that the vaccine is "safe and effective for the prevention of anthrax disease - regardless of the route of exposure."
Zamiara said the FDA decided "to use the sledgehammer on the mosquito" to quickly end the suspension of the mandatory immunization program.
Still, the final ruling does not have an impact on the ongoing litigation, and it hasn't altered opinions of some long-standing doubters of the anthrax vaccine.
"Every single study about this vaccine, except for those done by the U.S. Army, shows major problems," said Dr. Meryl Nass of Maine, an expert on bioterrorism and anthrax.
"Nobody will admit in the military that it won't do what it is intended to do."
Nass, who has studied the disease for about 15 years, said most experts agree there is a need for a new and improved vaccine to counter anthrax. BioPort currently is working to improve its product, while other companies are developing new vaccines.
Nass added, "We have solid evidence that this is a terrible vaccine."
